Environmental Fate and Ecological Risk Assessment for the 

Registration of the New Chemical Fluensulfone 

Fluensulfone

CAS: 318290-98-1 PC Code: 050410

Prepared by:

 Donna Reed Judkins, Ph.D., Biologist 

 James Lin, Ph.D., Environmental Engineer 

U.S. Environmental Protection Agency

Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch II

1200 Pennsylvania Ave., NW

Mail Code 7507P

Washington, DC 20460

Reviewed by:

Christine Seeible Hartless, Ph.D., Wildlife Biologist

Greg Orrick, Environmental Scientist

Jean Holmes, DVM, Risk Assessment Process Leader

Brian Anderson, Branch Chief
-Page 2 of 117- 

Table of Contents 

1. Executive Summary ............................................................................................................................................. 4

1.1. Nature of Chemical Stressor ....................................................................................................................... 4

1.2. Exposure Characterization .......................................................................................................................... 4

1.3. Effects Characterization ............................................................................................................................. 5

1.4. Potential Risks to Non-target Organisms .................................................................................................... 6

1.5. Data Gaps and Uncertainties ...................................................................................................................... 7

2. Problem Formulation ................................................................................................................................................ 8

2.1. Nature of Regulatory Action ...................................................................................................................... 8

2.2. Stressor Source and Distribution ................................................................................................................ 8

2.2.1. Nature of the Chemical Stressor .......................................................................................................... 8

2.3. Receptors ................................................................................................................................................... 9

2.3.1. Aquatic and Terrestrial Effects ............................................................................................................ 9

2.3.2. Ecosystems Potentially at Risk ..........................................................................................................10

2.4. Assessment Endpoints ..............................................................................................................................10

2.5. Conceptual Model ......................................................................................................................................10

2.5.1. Risk Hypotheses ................................................................................................................................10

2.5.2. Conceptual Diagram ..........................................................................................................................11

2.6. Analysis Plan ..............................................................................................................................................12

2.6.1. Residues of Concern ..........................................................................................................................12

2.6.2. Measures of Exposure .......................................................................................................................12

2.6.3. Measures of Effect .............................................................................................................................12

2.6.4. Integration of Exposure and Effects ..................................................................................................14

3. Analysis ..................................................................................................................................................................15

3.1. Use Characterization................................................................................................................................. 15

3.2. Exposure Characterization ........................................................................................................................15

3.2.1. Environmental Fate and Transport Characterization .........................................................................15

3.2.1.1. Transport and Mobility ....................................................................................................................16

3.2.1.2. Degradation .....................................................................................................................................17

3.2.1.3. Field Studies ....................................................................................................................................17

3.2.1.4. Environmental Degradates ..............................................................................................................18

3.2.2. Measures of Aquatic Exposure ..........................................................................................................20

3.2.2.1. Surface Water Exposure ..................................................................................................................20

3.2.2.2. Spray Drift Only Exposure ..............................................................................................................24

3.2.2.3. Aquatic Bioaccumulation ................................................................................................................25

3.2.3. Measures of Terrestrial Exposure ......................................................................................................25

3.2.3.1. Terrestrial Wildlife ..........................................................................................................................25

3.2.3.2. Sub-terrestrial Animals ....................................................................................................................26

3.2.3.3. Terrestrial Plants ..............................................................................................................................26

3.3. Ecological Effects Characterization .........................................................................................................27

3.3.1. Aquatic Toxicity Characterization .....................................................................................................27

3.3.1.1. Toxicity to Freshwater Fish .....................................................................................................29

3.3.1.2. Toxicity to Freshwater Invertebrates .......................................................................................31

3.3.1.3. Toxicity to Estuarine/Marine Fish ...........................................................................................34

3.3.1.4. Toxicity to Estuarine/Marine Invertebrates .............................................................................35

3.3.1.5. Toxicity to Aquatic Plants .......................................................................................................36

3.3.2 Terrestrial Effects Characterization ...................................................................................................39

3.3.2.1. Toxicity to Birds ......................................................................................................................40

3.3.2.2. Toxicity to Mammals ...............................................................................................................44

3.3.2.3. Toxicity to Terrestrial Invertebrates and Beneficial Insects ....................................................47

3.3.2.4. Toxicity to Terrestrial Plants ...................................................................................................50
-Page 3 of 117- 

4. Risk Characterization .........................................................................................................................................54

4.1 Risk Estimation ........................................................................................................................................54

4.1.1. Aquatic Organisms ............................................................................................................................54

4.1.1.1. Aquatic Animals ......................................................................................................................54

4.1.1.2. Aquatic Plants ..........................................................................................................................56

4.1.2. Terrestrial Organisms ........................................................................................................................57

4.1.2.1. Birds .........................................................................................................................................58

4.1.2.2. Mammals ................................................................................................................................. 59

4.1.2.3. Terrestrial Invertebrates ...........................................................................................................59

4.1.2.4. Terrestrial Plants ......................................................................................................................60

4.2. Risk Description .......................................................................................................................................60

4.2.1. Risks to Aquatic Organisms ..............................................................................................................61

4.2.1.1. Risks to Aquatic Animals ........................................................................................................61

4.2.1.2. Risks to Aquatic Plants ............................................................................................................61

4.2.2. Risks to Terrestrial Organisms ..........................................................................................................61

4.2.2.1. Birds, Terrestrial-Phase Amphibians and Reptiles ...........................................................................61

4.2.2.2. Mammals ..........................................................................................................................................62

4.2.2.3. Terrestrial Invertebrates....................................................................................................................63

4.2.2.4. Terrestrial Plants ...............................................................................................................................64

5. Federally Threatened and Endangered (Listed) Species Concerns ....................................................................64

5.1. Action Area ..............................................................................................................................................65

5.2. Taxonomic Groups Potentially at Risk .....................................................................................................65

5.2.1. Probit Dose-Response Analysis ........................................................................................................67

5.2.2. Conclusions, Uncertainties and Potential Reduction Measures .........................................................68

5.2.3. Listed Species Occurrence Associated with Fluensulfone Use .........................................................70

6. References ..........................................................................................................................................................71

6.1. Submitted Product Chemistry and Environmental Fate Studies ...............................................................72

6.2. Submitted Ecotoxicity Studies ..................................................................................................................74

Appendix A. Aquatic Model Input/Output Data. ........................................................................................................83

Appendix B. AGDRIFT v.2.01 Output. ......................................................................................................................87

Appendix C. T-REX and Terrplant Output for Fluensulfone. ....................................................................................97

Appendix D. Earthworm Fugacity Model ................................................................................................................ 100

Appendix E. TerrPlant Output .................................................................................................................................. 105

Appendix F. Fluensulfone Degradate Toxicity Summary. ....................................................................................... 106

Appendix G. Submitted Ecological Effects Studies for Fluensulfone and Remaining Data Gaps. .......................... 111
-Page 4 of 117- 

1. Executive Summary 

 1.1. Nature of Chemical Stressor 

Fluensulfone (i.e., 5-chloro-1,3-thiazol-2-yl 3,4,4-trifluorobut-3-en-1-yl sulfone or 5-

chloro-2-[(3,4,4-trifluoro-3-buten-1-yl)sulfonyl]thiazole; CAS: 318290-98-1), is a pyrazole 

nematicide used mainly to control root-knot (Meloidogyne spp.) and lesion nematodes 

(Pratylenchus spp.) on transplanted crops. The compound is moderately mobile in soil, and is 

not expected to bioaccumulate in fish. Fluensulfone is proposed for use on transplanted crops 

for cucurbit vegetables - crop group 9 includes cucumbers, melons, (cantaloupes, watermelon, 

honeydew) squash; and fruiting vegetables - crop group 8 includes bell pepper, eggplant, 

groundcherry, hot pepper, pepino, pepper (except black), pimento, sweet pepper, tomatilo, and 

tomatoes for processing. 

One end-use formulation of fluensulfone is proposed for registration in the United States, 

Fluensulfone 480EC, an emulsifiable concentrate containing 40% fluensulfone active ingredient, 

(a.i.). The label-recommended single application rates for proposed U.S. registration are 1.75 to 

3.5 lb a.i./A, with a minimum delay of seven days before transplanting. Only one application is 

allowed annually, with a maximum annual application rate of 3.5 lb a.i./A per year for all 

proposed crops. The proposed crops are cucurbit vegetables, which include cucumbers, melons, 

(cantaloupes, watermelon, honeydew) squash; and fruiting vegetables, which include bell 

pepper, eggplant, groundcherry, hot pepper, pepino, pepper (except black), pimento, sweet 

pepper, tomatilo, and tomatoes for processing. No aerial applications are allowed. Applications 

can be broadcast incorporated, banded and incorporated, or applied by drip irrigation. 

 1.2. Exposure Characterization 

Fluensulfone is not expected to volatilize from water or moist soil but may volatilize in 

dry field conditions. It is moderately mobile in soil Fluensulfone does not undergo hydrolysis. 

Aqueous photolysis is the fastest route of fluensulfone degradation (half-lives of 0.58 and 0.68 

days). The compound persists in anaerobic soil with a long half-life of 397 days, compared with 

the half-life range of 8 to 15 days for aerobic soil. For aquatic systems, the aerobic metabolism 

half-life ranged from 39 to 42 days, and the anaerobic metabolism half-life ranged from 23 to 26 

days. Terrestrial field dissipation study results are relatively consistent with those of the 

laboratory studies, showing that fluensulfone’s dissipation half-lives range from 7.4 to 10.8 days 

(laboratory aerobic soil metabolism study half-lives ranged from 8 to 15 days). Fluensulfone has 

an octanol-water partition coefficient (KOW) of 91.2, for this reason, the fish bioaccumulation 

study is not required. 

Major identified environmental degradates of fluensulfone are thiazole sulfonic acid 

(TSA), methyl sulfone (MS), and butene sulfonic acid (BSA) in soils. In aquatic systems, the 

major degradates included MS, deschloro-fluensulfone, BSA, and butene sulfinic acid. 

Deschloro-fluensulfone, butene sulfinic acid, and deschloro thiazole sulfonic acid (a minor 

degradate) were only detected in an aquatic study. The chemical structures of these degradates 

are provided in Table 3.3). 
-Page 5 of 117- 

To model aquatic exposure, the total toxic residues (TTR) approach was used to combine 

the parent fluensulfone and the most toxic degradate, MS. 

 1.3. Effects Characterization 

 Fluensulfone is classified as moderately toxic to freshwater and estuarine/marine fish, 

highly toxic to both freshwater and estuarine/marine invertebrates, and very highly toxic to 

molluscs on an acute exposure basis (based on reduced shell deposition). Mortality and sublethal 

effects were observed in most of the acute aquatic animal studies for fluensulfone. 

The available acute toxicity data for the 480EC formulation, which contains 40% 

fluensulfone a.i., show that it is approximately 5-12 times more toxic to fish, 58x more toxic to 

aquatic invertebrates, 2x more toxic to algae, 3-6x more toxic to earthworms, and 2x more toxic 

to birds than the fluensulfone a.i. alone. All available aquatic toxicity data show that metabolites 

of fluensulfone are less toxic to aquatic animals and plants than the parent fluensulfone, with the 

possible exception of MS, which may be of similar toxicity to the parent compound. 

Fluensulfone is classified as slightly toxic to avian species on an acute oral and 

practically non-toxic on a subacute dietary-exposure basis; however, treatment-related 

regurgitation was observed in canaries dosed with fluensulfone technical active ingredient 

(TGAI). The lowest no observed adverse effect (dietary) concentration (NOAEC) in an avian 

reproduction study (255 mg a.i./kg diet) was based on a growth inhibition in mallard ducks. 

Fluensulfone is classified as low to moderately toxic to mammals on an acute oral exposure

basis. A two-generation reproduction study of rats resulted in a no observed adverse effect level 

(NOAEL) of 16.2 mg a.i./kg-bw/day (250 ppm) based on reduced parent and pup weights, 

inhibited weight gain and feed consumption, increased liver and kidney weights, histopathology 

changes in the liver and kidney and increased post-natal pup loss. 

Based on available data, fluensulfone is classified as practically non-toxic to the 

honeybee. Fluensulfone effects on terrestrial invertebrates tested included mortality, weight loss 

and reproduction impairment, with the 480EC formulation being about twice as toxic as the 

TGAI to the honeybee (although the TGAI data was not definitive) and earthworm. Adverse 

effects are possible on terrestrial invertebrates, including pollinators and beneficial insects, from 

exposure to the formulated product in the use areas. Exposure is especially expected for 

earthworms and other under-ground invertebrates due to the mandatory incorporation or dripirrigation into the soil. Other invertebrates may be exposed if present in patches between 

furrows where incorporation does not occur, or alongside in areas reached by spray drift. 

Results of the Tier II seedling emergence and vegetative vigor studies with the 480EC 

formulation show significant effects on onion, ryegrass, cabbage, soybean, wheat and radish. 

The most sensitive monocots were onion and wheat. The most sensitive dicots were cabbage and 

soybean. 
-Page 6 of 117- 

 1.4. Potential Risks to Non-target Organisms 

According to this screening-level ecological risk assessment, the proposed use of 

fluensulfone for nematode control on selected cucurbit and fruiting vegetable crops results in 

LOC exceedances for birds, mammals, aquatic and terrestrial invertebrates, and aquatic plants. 

Additionally, passerine risk could not be fully assessed due to inadequate data; risk to this 

group is uncertain since they can be more sensitive than other test species. 

Potential indirect effects may also occur, including, but not limited to, reduction in food 

resources, decrease in cover, change in water quality parameters, and loss of breeding/nesting 

habitat. Identified potential direct and indirect risks to listed species that may result from the 

proposed uses of fluensulfone are summarized in Table 1.1. In addition, it is possible that 

adverse effects to terrestrial invertebrates, including pollinators and beneficial insects, may 

occur, based on exposure to the 480EC formulated products in and around the use areas of the 

proposed uses of fluensulfone. 

Table 1.1. Potential Direct and Indirect Effects to Federally Listed Taxa from Proposed 

Use of Fluensulfone to Control Nematodes on Cucurbit and Fruiting Vegetable Crops.

Listed Taxon Direct Effects Uses of Concern Indirect 

Effectsc Uses of Concern

Terrestrial and semi-aquatic 

plants - monocots No None No None

Terrestrial and semi-aquatic 

plants - dicots Yes All uses No None

Birds Yes All uses Yes1,2,3 All uses

Terrestrial-phase amphibians Yes All uses Yes1,2,3 All uses

Reptiles Yes All uses Yes1,2,3 All uses

Mammals Yes All uses Yes1,2,3 All uses

Terrestrial invertebrates Yesa All uses Yes1,3 All uses

Aquatic vascular and nonvascular plants Yes All uses No None

Freshwater fish No None Yes2,4 All uses

Aquatic-phase amphibians No None Yes2,4 All uses

Freshwater invertebrates No All uses Yes2,4 All uses

Freshwater mollusks Yesb All uses Yes2,4 All uses

Marine/estuarine fish No None Yes2,4 All uses

Marine/estuarine invertebrates No All uses Yes2,4 All uses

Marine/estuarine molluscs Yesb All uses Yes2,4 All uses

Sediment-dwelling organisms No None Yes2,4 All uses

a

 The LOC exceedance was based on lines of evidence including application rate, toxicity data (both pollinators and 

beneficial insects), and the mode of action of fluensulfone. 

bBased on exposure from spray drift. 

cPotential indirect effects on a taxon attributable to:

1

 Direct acute and chronic effects on birds and mammals. 

2

 Direct acute and chronic effects on aquatic invertebrates. 

3 Direct effects to terrestrial plants (dicots). 

4 Direct effects to aquatic plants. 
-Page 7 of 117- 

Potential measures identified that would reduce environmental exposure or toxicity 

include: 

re-formulation of the end-use product to bring down the formulated product toxicity, 

label specifications for boom height and droplet size, and 

label specifications of a buffer zone. 

For reduction of LOC exceedences based on exposure from spray drift, an estimated 3 to 

49 foot buffer would be needed to remove the presumption of risk to aquatic organisms (see 

Table 5.2). Specifying a low boom and larger droplet size is also a feasible way to reduce risk 

and reduce the size of a protective buffer for aquatic organisms (also see Appendix B):

3 foot buffer would protect aquatic plants1using high boom and fine droplets; no LOCs 

were exceeded with low boom and/or larger droplet sizes; 

49 foot buffer would protect molluscs using high boom and fine droplets; 3 foot buffer if 

low boom used, and no buffer if coarse droplet size used. 

For terrestrial organisms, concern levels are exceeded up to approximately 70 feet from the site 

of application. 

 1.5. Data Gaps and Uncertainties 

Data gaps and uncertainties found in this assessment include: 

data gap in toxicity to passerine bird species; the results of the available avian acute 

oral data are not adequate to assess risk to passerines and rough estimates may 

under- or over-estimate the risk; 

potential for exposure of avian, reptilian, amphibious or mammalian consumers of 

seeds and terrestrial invertebrates in the treatment area is evaluated but the amount 

of seeds and invertebrates entering the treatment area is an unknown and so the 

rough estimates may under- or over-estimate the risk to consumers; and 

degree of above-ground vs. under-ground exposure to terrestrial invertebrates 

entering the treatment area is an unknown and so the rough estimates may under- or 

over-estimate the risk. 

At the time of this assessment, some uncertainty was attributed to the degree of exposure 

to terrestrial organisms in and around the treatment area due to proposed label ambiguities on 

aerial application and time limit for incorporation. However, EFED understands that these label 

ambiguities will be corrected and, therefore, conducted this assessment assuming no aerial 

application and immediate incorporation with an important caveat that without these corrections, 

this risk assessment will underestimate risks. For terrestrial exposure, the only areas assumed to 

 

1

 The listed-species LOC was exceeded for non-vascular aquatic plants. However, no aquatic non-vascular plants 

are presently listed as endangered or threatened species in the US. 
-Page 8 of 117- 

be exposed were areas receiving spray drift and between-furrow and peripheral areas where the 

sprayed area was wider than the incorporated area, and where puddles occur from drip irrigation. 

2. Problem Formulation 

The purpose of this problem formulation is to provide the foundation for the 

environmental fate and ecological risk assessment for the registration of the new chemical 

fluensulfone. This problem formulation sets the objectives for the risk assessment, establishes a 

risk hypothesis and conceptual model depicting risk, and provides a plan for analyzing the data 

and characterizing the risk associated with the proposed uses of fluensulfone (USEPA, 1998a). 

 2.1. Nature of Regulatory Action 

This assessment was prepared to support the new chemical registration of fluensulfone. 

As a new fungicide being proposed for use in the United States, the U.S. Environmental 

Protection Agency (EPA or the Agency) is required under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) to ensure that fluensulfone does not have the potential to cause 

unreasonable adverse effects to the environment. In addition to non-target animals and plants, 

potential effects to listed species (i.e., species on the federal list of endangered and threatened 

wildlife and plants) are also considered under the Endangered Species Act (ESA) in order to 

ensure that the registration of fluensulfone is not likely to jeopardize the continued existence of 

such listed species or adversely modify their critical habitat. In order to meet the requirements of 

FIFRA and the ESA, this assessment follows EPA guidance on conducting ecological risk 

assessments (USEPA, 1998a) and Office of Pesticide Program’s Overview Document, which 

contains guidance for assessing pesticide risks to non-target and listed organisms (USEPA, 

2004).

The end result of the EPA pesticide registration process (i.e., the FIFRA regulatory 

action) is an approved product label. The label is a legal document that stipulates how and where 

a given pesticide may be used. Product labels (also known as end-use labels) describe the 

formulation type (e.g., liquid or granular), acceptable methods of application, approved use sites, 

and any restrictions on how applications may be conducted. Therefore, the use, or potential use, 

described by the pesticide’s labels is considered “the action” being assessed. 

 2.2. Stressor Source and Distribution 

2.2.1. Nature of the Chemical Stressor 

Fluensulfone belongs to the fluoroalkenyle chemical class. It is a pyrazole nematicide 

used mainly to control root-knot (Meloidogyne spp.) and lesion nematodes (Pratylenchus spp.) 

on transplanted crops. The mode of action of fluensulfone is distinct from that of 

organophosphates, carbamates and avermectins. Fluensulfone has a pleiotropic expression of 

activity against nematodes, including weak inhibition of motility in adults, strong inhibition of 

motility in larvae, feeding inhibition and egg-laying, hatching and developmental inhibition. 
-Page 9 of 117- 

Inhibition of larval thrashing and feeding is irreversible after 24 hours of exposure and the 

cuticle does not appear to present a barrier to access. 

Makhteshim Agan of North America, Inc. is applying to register fluensulfone in the 

United States as a technical grade active ingredient (TGAI) and in formulated end-use product, 

respectively. The end-use product currently proposed for registration in the United States is 

fluensulfone 480 EC, which is to be for use on cucurbits and fruiting vegetables under outdoor 

conditions. The proposed use methods include broadcast, banded, and drip irrigation applications 

followed by either mechanical soil incorporation (broadcast, banded ) or delivery via water (drip 

irrigation) to a 6-inch depth at the maximum rate of 3.5 lb a.i./A. No aerial apploication is 

allowed. 

 2.3. Receptors 

 2.3.1. Aquatic and Terrestrial Effects 

Table 2.1 provides examples of taxonomic groups and the surrogate species tested to 

evaluate the potential ecological effects of pesticides to these non-target taxonomic groups. 

Within each of these very broad taxonomic groups, a measure of effect from either acute or 

chronic exposure is selected from the available test data. 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. 

Table 2.1. Example Taxonomic Groups and Surrogate Test Species Evaluated for 

Assessing Potential Ecological Effects of Fluensulfone. 

Taxonomic Group Example(s) of Surrogate Species

Birds, terrestrial-phase amphibians, and reptiles1 Mallard duck (Anas platyrhynchos)

Bobwhite quail (Colinus virginianus)

Zebra finch (Poephila guttata)

Mammals Wistar rat (Ratus norvegicus)

Insects Honey bee (Apis mellifera L.)

Freshwater fish, and aquatic-phase amphibitans2 Bluegill sunfish (Lepomis macrochirus)

Rainbow trout (Oncorhynchus mykiss)

Fathead minnow (Pimephales promelas)

Freshwater invertebrates Water flea (Daphnia magna)

Midge (Chironomus riparius)

Estuarine/marine fish Sheepshead minnow (Cyprinodon variegatus)

Estuarine/marine invertebrates Mysid (Americamysis bahia)

Eastern oyster (Crassostrea virginica)

Terrestrial plants Monocots – corn (Zea mays)

3

Dicots – soybean (Glycine max)

Aquatic plants and algae Duckweed (Lemna gibba) 

Freshwater algae (Pseudokirchneriella subcapita)

1 Birds are surrogates for terrestrial-phase amphibians and reptiles.

2

Freshwater fish are surrogates for aquatic-phase amphibians.

3

Four species of two families of monocots; six species of at least four dicot families.
-Page 10 of 117- 

 2.3.2. Ecosystems Potentially at Risk 

The ecosystems at risk are often extensive in scope; therefore, it may not be possible to 

identify specific ecosystems at the screening level. In general terms, terrestrial ecosystems 

potentially at risk could include the treated site and areas immediately adjacent to the treated site 

that may receive drift or runoff. These areas could include the site itself, other cultivated fields, 

fencerows and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats, 

and other uncultivated areas. 

Aquatic ecosystems potentially at risk include water bodies adjacent to, or down stream 

from, the treated area and might include impounded water bodies (lentic environments) such as 

ponds, lakes and reservoirs, or flowing waterways (lotic environments) such as streams or rivers. 

For uses in coastal areas, aquatic habitat also includes marine ecosystems, including estuaries. 

 2.4. Assessment Endpoints 

Assessment endpoints represent the actual environmental value that is to be protected, 

defined by an ecological entity (species, community, or other entity) and its attribute or 

characteristics (USEPA, 1998a). The ecological entities include the following: birds, 

amphibians, reptiles, mammals, freshwater fish and invertebrates, estuarine/marine fish and 

invertebrates, terrestrial plants, insects, and aquatic vascular and non-vascular plants. The 

attributes for each of these entities may include growth, survival, and reproduction. (See Table 

2.2 in Section 2.6.2, the Analysis Plan, for further discussion). 

 2.5. Conceptual Model 

For a pesticide to pose an ecological risk, it must reach ecological receptors in 

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

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

be complete, it must have a source, a release mechanism, an environmental transport medium, 

and a feasible route of exposure. 

The conceptual model is intended to provide a written description and visual 

representation of the predicted relationships between fluensulfone, potential routes of exposure, 

and the predicted effects for the assessment endpoints. The conceptual model consists of two 

major components: risk hypotheses and a conceptual diagram (USEPA, 1998a).

 2.5.1. Risk Hypotheses 

For fluensulfone, the following ecological risk hypothesis is being employed for this 

baseline-level risk assessment: 

Based on the application methods, mode of action, and the sensitivity of non-target 

aquatic and terrestrial species, the proposed agricultural uses of fluensulfone have the 
-Page 11 of 117- 

potential to reduce survival, reproduction, and/or growth in terrestrial and aquatic 

animals and plants via both direct and indirect adverse effects.

2.5.2. Conceptual Diagram

Fluensulfone is applied pre-planting of seedlings/immature plants by broadcast or banded 

application or drip irrigation. The product is mechanically incorporated into the soil to deliver 

the applied chemical into the root zone (6-8 inches below the soil surface) for pest control. 

Ecological receptors that may potentially be exposed to fluensulfone include terrestrial and semiaquatic wildlife (i.e., mammals, birds, terrestrial-phase amphibians, terrestrial invertebrates, and 

reptiles) and plants. In addition, aquatic receptors, (i.e., freshwater and estuarine/marine fish and 

invertebrates, aquatic-phase amphibians, and plants) may also be exposed as a result of potential 

movement of fluensulfone to aquatic environments via spray drift, runoff, and/or base flow from 

ground water leachate originating at the site of application (no direct applications to water bodies 

are proposed). The potential exposure pathways and effects of the proposed new registration of 

fluensulfone are depicted in Figure 2.1.

Stressor

Fluensulfone applied as broadcast or banded application or 

drip irrigation to agricultural areas

Source/

Transport

Pathways

Direct

Deposition

Spray

Drift

Runoff/

Erosion

Leaching

(Infiltration/

Percolation

Source/

Exposure

Media

Terrestrial Food 

Residues (foliage, 

fruit, insects

Upland

Foliage/Soil

Riparian/

Wetland 

Foliage/Soil

Receiving 

Water Body/ 

Sediment

Groundwater

Exposure

Route

Ingestion Direct contact/

Root Uptake

Direct contact/

Root Uptake

Gill/

Integument 

Uptake

Receptors

Attribute

Changes

Terrestrial Vertebrates

Birds, Mammals,

Reptiles, Terrestrial 

Phase Amphibians

Terrestrial

Upland

Plants

Individual Animals

Reduced survival

Reduced growth

Reduced

reproduction

Aquatic 

Invertebrates

Aquatic 

Vertebrates

Wetland/ 

Riparian

Plants

Individual Plants

Seedling emergence

Vegetative vigor

Individual 

vertebrates and 

invertebrates

Reduced

survival

Reduced

growth

Reduced

reproduction

Plant 

population

Reduced

population

growth

Aquatic 

Plants

Uptake/ 

Adsorption

Figure 2.1. Conceptual Model Depicting Sources of Exposure, Receptors, and Potential 

Adverse Effects from the Proposed Uses of Fluensulfone.1
-Page 12 of 117- 

 2.6. Analysis Plan 

2.6.1. Residues of Concern

The identified degradates of fluensulfone from environmental fate studies include 

thiazole sulfonic acid (TSA), methyl sulfone (MS), butene sulfonic acid (BSA), deschlorofluensulfone, butene sulfinic acid, deschloro thiazole sulfonic acid, and carbon dioxide (chemical 

names and structures are provided in Table 3.3). Available toxicity data for the major organic 

degradates indicate that in general degradates are orders of magnitude less toxic than 

fluensulfone to fish, aquatic invertebrates and algae. However, MS, the most toxic of the tested 

residues, had a somewhat similar toxicity profile compared to that of the parent compound for 

rats (1.3x more toxic) and fish (approximately half as toxic), but for invertebrates, available data 

on the relative toxicity was somewhat varied and much closer for terrestrial (earthworm – the 

LC50 was non-definitive but possibly very close and the NOAEC based on weight was very 

similar, 1.9x more toxic) than aquatic (mysid – MS was 19x less toxic), though the types of tests 

used were quite different and not directly comparable (see Tables 3.42 and 3.45 and Appendix 

F, Tables F.1 and F.2). It was much less toxic to vertebrates and green algae (two orders of 

magnitude less toxic to green algae (Appendix F, Table F.3). Given its persistence, MS was 

deemed a residue of concern; therefore, a total toxic residues (TTR) approach was used in this 

assessment by incorporating exposure to both parent and MS (USEPA, 2011) for aquatic 

organisms but parent alone for terrestrial organisms. MS should not impact plants above the 

ground since it is formed during the degradation reactions in soil and water. 

 2.6.2. Measures of Exposure 

EFED used standard available models to evaluate potential exposures to aquatic and 

terrestrial organisms as described at http://www.epa.gov/pesticides/science/models_db.htm. 

Specifically, in this assessment, aquatic EECs were calculated with the Tier II aquatic exposure 

model PRZM/EXAMS (PE). AgDRIFT was used for assessing off-target spray drift impacts. 

The terrestrial measures of exposure for animals from concentrations on various dietary items 

were estimated with T-REX on a square foot basis, rather than a broadcast basis due to the 

application methods. With either drip irrigation or immediate incorporation, the only aboveground exposure apart from spray drift that is expected is to organisms residing (or blown in) 

between furrows. Exposure of naturally-occurring terrestrial and semi-aquatic (wetland) plant 

species, estimated using TerrPlant (v1.2.2), was assumed to encompass areas outside the 

immediate use site, with exposed areas expected to be patchy, as mentioned above. 

 2.6.3. Measures of Effect 

Measures of effect were obtained from a suite of registrant-submitted OCSPP guidelinecompliant studies that were conducted with a limited number of surrogate test species (Table 

2.1, also see Section 3 and Appendices F and G,). No additional ecotoxicity data on 

fluensulfone were located, based on a July 17, 2013 query of the open literature in the ECOTOX 

database (USEPA, 2012b).
-Page 13 of 117- 

The acute measures of effect used in this baseline-level assessment are the LD50, LC50

(median Lethal Dose or Concentration, respectively) or EC50 (median Effects Concentration). 

These are measures of acute toxicity that result in 50% of the respective effect on tested 

organisms. The endpoints used with sublethal effect measures, mainly from chronic or subchronic exposures, are the NOAEC and the NOAEL (No-Observed Adverse Effect 

Concentration or Level, respectively). Toxicity studies were submitted for freshwater fish and 

invertebrates, estuarine/marine fish and invertebrates, aquatic plants, birds, mammals, bees, and 

other terrestrial invertebrates. The endpoints used for risk characterization were derived from 

studies which underwent review and were classified as “acceptable” (conducted under guideline 

conditions and considered to be scientifically valid) or “supplemental” (conditions deviated from 

guidelines but the results are considered to be scientifically valid). 

Table 2.2 lists the measures of environmental exposure and ecological effects used to 

assess the potential risks of fluensulfone to non-target organisms. The methods used to assess 

the risk are consistent with current policies. 

Table 2.2. Measures of Exposure and Effect Used in Assessing Potential Risks Associated 

with the Proposed Uses of Fluensulfone.

Assessment Endpoint Measures of Ecological Effect1 Measures of Exposure

Birds2

Survival Lowest acute LD50 (single oral dose 

test) and LC50 (subacute dietary test)

Upper-bound residues 

on food items

Reproduction 

and Growth

Lowest NOAEC

(21-week reproduction test)

Mammals

Survival Lowest acute LD50 (single oral dose 

test)

Reproduction 

and Growth

Lowest NOAEC 

(2-generation reproduction test)

Aquatic Animals 

(Freshwater fish and 

invertebrates and 

estuarine/ marine 

invertebrates)3

Survival Lowest tested LC50 or EC50

(acute toxicity test with TGAI)

4 Peak EECs

5

Survival

Lowest tested LC50 or EC50

(acute toxicity test using 

formulation) 4

Spray drift EECs6

Reproduction 

and Growth

Lowest NOAEC

(early life-stage or full life-cycle 

tests)

21-day EECs for 

invertebrates and 60-

day EECs for fish5

Aquatic plants 

(vascular and nonvascular)

Survival and 

growth

Lowest EC25 (for non-listed plants) 

and corresponding NOAEC or EC05

(for listed plants)

Peak EECs

5

1 The most sensitive species tested within taxonomic groups is used for baseline-level risk assessments.

2 Birds are surrogates for terrestrial-phase amphibians and reptiles.

3 Freshwater fish are surrogates for aquatic-phase amphibians.

4 TGAI toxicity endpoints were used for runoff risk calculations and formulation toxicity for spraydrift risk 

calculations due to the unknown differential in long range transport of endproduct constituents; EFED at this time 

lacks the capability to estimate long range transport of adjuvents.

5Aquatic EECs are based on the modeling described in Section 3.2.2.1.

6

Spray drift EECs are based on the modeling described in Section 3.2.2.1
-Page 14 of 117- 

 2.6.4. Integration of Exposure and Effects 

The exposure and toxicity effects data are integrated in order to evaluate the risks of 

adverse ecological effects on non-target species. For the risk assessment of fluensulfone, the RQ 

(Risk Quotient) method is used to compare estimated exposure and measured toxicity values. 

The RQ method involves dividing EECs (Estimated Environmental Concentrations) by acute and 

chronic toxicity values. The resulting RQs are then compared to the Agency’s LOCs (Levels of 

Concern; USEPA, 2004) (Table 2.3). These criteria are used to indicate when applications of 

fluensulfone, as directed on the label, have the potential to cause adverse effects to listed and 

non-listed non-target organisms. 

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

Class.

RISK CLASS RISK DESCRIPTION RQ LOC

Aquatic Animals (fish and invertebrates)

Acute Potential for effects to non-listed animals from acute 

exposures

Peak EEC/LC50

1

0.5

Acute 

Restricted Use

Potential for effects to animals from acute exposures

Risks may be reduced through restricted use classification Peak EEC/LC50

1

0.1

Acute Listed 

Species

Listed species may be potentially affected by acute 

exposures

Peak EEC/LC50

1

0.05

Chronic Potential for effects to non-listed and listed animals from 

chronic exposures

60-day EEC/NOAEC 

(fish)

1

21-day EEC/NOAEC 

(invertebrates)

Aquatic Plants

Non-Listed Potential for effects to non-listed plants from exposures Peak EEC/LC50

1

1

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

Terrestrial Animals (mammals and birds)

Acute Potential for effects to non-listed animals from acute 

exposures

EEC2/LC50 (Dietary)

0.5

EEC/LD50 (Dose)

Acute 

Restricted Use

Potential for effects to animals from acute exposures

Risks may be reduced through restricted use classification

EEC2/LC50 (Dietary)

0.2

EEC/LD50 (Dose)

Acute Listed 

Species

Listed species may be potentially affected by acute 

exposures

EEC2/LC50 (Dietary)

0.1

EEC/LD50 (Dose)

Chronic Potential for effects to non-listed and listed animals from 

chronic exposures EEC2

/NOAEC 1

1 LC50 or EC50. 

2 Based on upper bound Kenega values for foliar exposure.
-Page 15 of 117- 

3. Analysis 

 3.1. Use Characterization 

Fluensulfone 480 EC is an emulsifiable concentrate containing 4 pounds of fluensulfone 

per gallon. No aerial applications are allowed. Applications can be broadcast incorporated, 

banded and incorporated, or applied by drip irrigation. Apply at a rate of 56.0 to 112 fl. oz. per 

acre, a minimum of seven days before transplanting. Do not apply more than one application, 

and no more that 112 fl. oz. of product per acre, per year. For optimal performance, all 

applications must be incorporated by water and/or mechanical means to a depth of 6 – 8 inches. 

The use summaries are presented in Table 3.1.

Table 3.1. Proposed Use Patterns for fluensulfone End-use Products.

Application 

Timing, 

Type, and 

Equip.

Formulation 

[EPA Reg. 

No.]

Max. Single 

Application 

Rate

Max. No. 

Application 

per Season 

Max. Seasonal 

Application Rate 

(lb ai/A)

PHI 

(days)

Use Direction and 

Limitation‡

Cucurbit Vegetables include cucumbers, melons, (cantaloupes, watermelon, honeydew) squash; and 

Fruiting Vegetables include bell pepper, eggplant, groundcherry, hot pepper, pepino, pepper (except black), pimento, 

sweet pepper, tomatilo, and tomatoes for processing

Pre-Plant; 

Drip 

irrigation,

Band 

applicator,

Broadcast 

spray

Fluensulfone 

480 EC

(40% ai)

(4.0 lb ai/gal)

[EPA Reg. No. 

11678-XXX]

1.75-3.5 lb 

ai/A

(56-112 

oz/A)

1 appl. /year 3.5 lb ai/A

(112 oz/A)

N/A Apply with a minimum 

of seven days before

transplanting.

No aerial applications 

allowed.

 3.2. Exposure Characterization 

3.2.1. Environmental Fate and Transport Characterization 

Fluensulfone is not expected to volatilize from water or moist soil but may volatilize in 

dry field conditions. It is moderately mobile in soil (KFOC range of 154-275 L/kgOC). 

Fluensulfone does not undergo hydrolysis. Aqueous photolysis is the fastest route of 

fluensulfone degradation (half-lives of 0.58 and 0.68 days). The compound persists in anaerobic 

soil with a long half-life of 397 days, comparing with the half-life range of 8 to 15 days for 

aerobic soil. For aquatic systems, the aerobic metabolism half-life ranged from 39 to 42 days, 

and the anaerobic metabolism half-life ranged from 23 to 26 days. Terrestrial field dissipation 

study results are relatively consistent with those of the laboratory studies, showing that the 

chemical’s dissipation half-lives range from 7.4 to 10.8 days (laboratory aerobic soil metabolism 

study half-lives ranged from 8 to 15 days). Fluensulfone has an octanol-water partition 

coefficient (KOW) of 91.2 (log Kow = 1.96), for this reason, the fish bioaccumulation study was 

not required. Table 3.2 summarizes the submitted chemical and environmental fate data for 

fluensulfone. 
-Page 16 of 117- 

Table 3.2. Chemical Properties and Environmental Fate Parameters of Fluensulfone. 

Parameter Value Source

Selected Physical/Chemical Parameters

Molecular mass (molecular formula) 291.7 g/mol (C7H5NO2S2ClF3) (Calculated)

Vapor pressure 2.3 x 10-4torr (25 °C) MRID 48574709

Aqueous solubility (20 C) 545.3 mg/L MRID 48574715

Henry’s Law Constant (20°C, pH 7) 1.65 x10-7atm-m

3

/mol MRID 48574710

Log octanol-to-water partition coefficient

(log KOW) (20°C)

1.96 (Kow 91.2) MRID 48574717

Dissociation constant (pKa) No pKa (neutral form from pH 4 to 9) MRID 48574719

Persistence

Hydrolysis half-life (50 C) No substantial degradation

(pH 4, 7, and 9)

MRID 48574718

Aqueous photolysis half-life (25 C) t1⁄2 = 0.68, 0.58 days (dark-control-adjusted) MRID 48574849

Soil photolysis half-life; dark-control adjusted 

half-life (25 C)

t1⁄2 = 38.5 days (dark-control-adjusted) MRID 48574825

Aerobic soil metabolism half-life (20°C) t1⁄2 = 8.05, 11.9 days (SFO*)

 15, 9.53 days (IORE*)

MRID 48574823

Anaerobic soil metabolism half-life (20 C) t1⁄2 = 397 days (SFO*) MRID 48574824

Anaerobic aquatic metabolism half-life (20 C) t1⁄2 = 25.5 days (SFO*)

 23.4 days (IORE*)

MRID 48574840

Aerobic aquatic metabolism half-life (20 C) t1⁄2 = 39, 42 days (IORE*) MRID 48574839

Mobility

Freundlich soil-water partition coefficients 

(Kd); Freundlich organic carbon-normalized 

partition coefficients (KOC)

Kd = 4.06, 1.54, 0.69, 0.87, and 2.47 (mL/g);

KOC = 203, 154, 172, 157 and 275 (mL/goc)

MRID 48574833

Field Dissipation

Terrestrial field dissipation half-life; maximum 

leaching depth of parent

DT50 = 10.1, 8.7, 10.8, 7.4 days.

One trace detection in 30-45 cm.

MRID 48574832

Fish Bioconcentration

Fish bioconcentration factors (steady-state) Study waived due to low log KOW N/A

* SFO = Single First Order; IORE = Indeterminate Order Rate Equation 

3.2.1.1. Transport and Mobility 

 Fluensulfone is not expected to significantly volatilize from soil or water bodies based on 

its water solubility (545.3 mg/L at 20°C), vapor pressure (2.3 x 10-4 torr at 25°C), and Henry’s 

Law Constant (1.65 x 10-7

atm-m3/mol). 
-Page 17 of 117- 

According to the FAO mobility classification, fluensulfone is “moderately mobile” in soil 

with a mean adsorption Koc of 187 mL/goc (range from 154 to 275) and a mean desorption Koc 

of 706 mL/goc (range from 511 to 1058). Both thiazole sulfonic acid (TSA) and butene 

sulfonic acid (BSA) are classified as “highly mobile” with a mean Koc of 7.8 mL/goc, and 6.1 

mL/goc, respectively for TSA and BSA (chemical names and structures of degradates are in 

Table 3.3). MS is classified as “mobile” with a mean Koc of 47.1 mL/goc. There is little 

concern of fluensulfone bioconcentration due to its low Kow value of 91. 

Fluensulfone may be sorbed to residues in or dissolved in runoff feeding surface water 

bodies. The compound may also reach surface water bodies via spray drift and transport of 

dissolved residues in base flow from shallow ground water. 

3.2.1.2. Degradation 

Fluensulfone does not undergo hydrolysis in water bodies over the range of pH 4 to 9. It 

degraded rapidly in an aqueous photolysis study with the dark-control-adjusted half-lives in the 

buffer and natural water of 0.68 and 0.58 days, respectively. In a soil photolysis study, 

fluensulfone degraded moderately with a dark-control-adjusted half-life of 38.5 days at 30-40oN. 

Fluensulfone was degraded to three metabolites in an aerobic soil metabolism study: TSA, MS, 

and BSA. The representative half-lives following the NAFTA degradation kinetics guidance 

ranged from 8 to 15 days. In the anaerobic soil metabolism study, the major degradates were 

TSA and BSA. During the 100-day anaerobic incubation period, fluensulfone degraded slowly, 

with a 397-day half-life. Fluensulfone degraded in aquatic systems with DT50 values of 23-26 

days under anaerobic conditions and DT50 values of 39-42 days under aerobic conditions. The 

major degradates under anaerobic conditions included MS, deschloro-fluensulfone, BSA, and 

butene sulfinic acid. 

3.2.1.3. Field Studies 

The dissipation of fluensulfone in the field was best described by double first order in 

parallel (DFOP) kinetics at the California and Florida fields, single first-order (SFO) kinetics at 

the Texas field, and indeterminate order rate equation (IORE) kinetics for the Ontario field. The 

calculated dissipation rates for fluensulfone across all sites were in close agreement, with an 

estimated DT50 of 10.1, 8.7, 10.8, and 7.4 days at the California, Florida, Texas, and Ontario test 

sites, respectively. The maximum fluensulfone residues occurred in 0 -15 cm soil depth at all four 

sites shortly after the applications (0 – 3 DAA(days after application)) at levels of 2.118, 0.965, 

0.969, and 1.036 mg/kg soil at the California, Florida, Texas, and Ontario test sites, respectively. 

These residues were either at trace levels or below the LOQ (0.01 mg/kg soil) at the end of the 

study. The fluensulfone residues were retained in the top 15 cm soil, with trace levels of 0.025 and 

0.014 mg/kg soil detected in a single sample at 30 – 45 cm soil depth at the California and Florida 

sites on 28 DAA and 1 DAA, respectively. Three transformation products were analyzed for and 

observed (TSA, BSA, MS). The DT50 values for TSA were determined to be 66.7 and 99.9 days 

for the California and Texas test sites, respectively by the SFO model. The DT50 values for TSA 

could not be accurately determined for the Florida and Ontario test sites due to the smaller number 
-Page 18 of 117- 

of samples during the decline phase. Likewise, the DT50 values for BSA were not determined. 

The maximum TSA residues occurred in the 0 -15 cm soil depth at all four sites at levels of 0.254, 

0.116, 0.174 and 0.20 mg/kg soil for the California, Florida, Texas, and Ontario test sites on 14, 28, 

14, and 28 DAA, respectively. The TSA residues in surface soil were below the LOQ (0.01 mg/kg 

soil) at three sites by the end of the study and the fourth site, Ontario, had an average residue just 

slightly higher than the LOQ (0.011 mg/kg soil). Low levels of TSA residues (0.016 – 0.036 mg/kg 

soil) were detected at depths up to 75 – 90 cm later in the study. The maximum MS residues all 

occurred in 0 -15 cm soil depth at the four sites at levels of 0.044 – 0.135 mg/kg soil on 28 – 120 

DAA. No MS residues were detected below 30 cm soil depth at any of the four sites. The 

maximum BSA residues all occurred in 0 -15 cm soil depth at the four sites at levels of 0.031 – 

0.199 mg/kg soil on 7 – 28 DAA. BSA residues were retained in the top 15 cm soil depth at the 

Florida and Ontario sites and were detected at low levels at 75 – 90 cm and 45 – 60 cm soil depths 

at the California and Texas sites, respectively. 

3.2.1.4. Environmental Degradates 

The maximum formation fractions and the molecular structures of major identified 

transformation products are presented in Table 3.3. The transformation products have the 

potential to reach either surface water or ground water as they were either a major degradate in 

the aerobic soil or aerobic aquatic metabolism studies (except one degradate, MS). Three major 

degradates (TSA, MS, and BSA) were also analyzed for and observed in the terrestrial field 

dissipation study. Three degradates, deschloro-fluensulfone, butene sulfinic acid, and deschloro 

thiazole sulfonic acid were only detected in aquatic metabolism studies. 

Table 3.3. Fluensulfone and Its Major Identified Environmental Transformation Products. 

Common, Code, 

and Chemical 

Names

Chemical

Structure Study Type MRID Maximum % Apply (day)

Final % Apply 

(Study End)

Parent

Fluensulfone 

(MCW-2);

5-Chloro-2-

[3,4,4-trifluor-3-

butene-1-

yl)sulfonyl]-

thiazole, CAS 

Number 

318290-98-1

Aerobic soil 

metabolism

48574823 97.56%

(0 day)

2.17%

(120 day)

Aerobic aquatic 

meatbolism

48574839 98.3%

(0 day)

14.2%

(141 day)

Anaerobic soil

metabolism

48574824 97.0%

(0 day)

53.1%

(100 day)

Anaerobic aquatic 

metabolism

48574840 99.6%

(0 day)

17.4%

(103 day)

Soil photolysis 48574825 96.3%

(0 day)

34.4%

(14 day)

Field dissipation 48574832 86%

(0 day)

@ or < LOQ

(363 day)

Major Transformation Products (> 10%)

Thiazole sulfonic 

acid (TSA; M3625);

5-chloro-thiazole2-sulfonic acid

Aerobic soil 

metabolism

48574823 77% 

(50 day)

74%

(120 day)

Aerobic aquatic 

metabolism

48574839 20.4%

(141 day)

20.4%

(141 day)

Anaerobic soil

metabolism

48574824 28.8%

(7 day)

27.3%

(100 day)

Anaerobic aquatic 

metabolism

48574840 5.6%

(29 day)

3.7%

(103 day)

OH S

N

Cl

S

O

O
-Page 19 of 117- 

Common, Code, 

and Chemical 

Names

Chemical

Structure Study Type MRID Maximum % Apply (day)

Final % Apply 

(Study End)

Soil photolysis 48574825 8.6%

(14 day)

8.6%

(14 day)

Field dissipation 48574832 47%

(14 day)

0.011 ppm

(363 day)

Methyl Sulfone 

(MS; M-3626); 

5-chloro-2-methyl 

sulfonyl thiazole

Aerobic soil 

metabolism

48574823 7.45%

(28 day)

0%

(120 day)

Aerobic aquatic 

metabolism

48574839 0.9% 

(141 day)

0.9% 

(141 day)

Anaerobic soil

metabolism

48574824 5.1%

(100 day)

5.1%

(100 day)

Anaerobic aquatic 

metabolism

48574840 28.7%

(29 day)

18.6%

(103 day)

Field dissipation 48574832 20%

(28 day)

< LOQ

(363 day)

Butene Sulfonic 

Acid (BSA M3627) 

3,4,4-trifluorobut-3-ene-1-

sulfonic acid

Aerobic soil 

metabolism

48574823 31%

(90 day)

24%

(120 day)

Aerobic aquatic 

metabolism

48574839 20.8%

(103 day)

20.6%

(141 day)

Anaerobic soil

metabolism

48574824 16.5%

(100 day)

16.5%

(100 day)

Anaerobic aquatic 

metabolism

48574840 13.1%

(103 day)

13.1%

(103 day)

Field dissipation 48574832 29%

(14 day)

< LOQ

(363 day)

Deschlorofluensulfone

2-(3,4,4-trifluoro3-buteny 

sulfonyl) thiazole

Aerobic aquatic 

metabolism

48574839 22.2%

(103 day)

21.5%

(141 day)

Anaerobic aquatic 

metabolism

48574840 20.2%

(103 day)

20.2%

(103 day)

Butene Sulfinic 

Acid

Anaerobic aquatic 

metabolism

48574840 20.3%

(103 day)

20.3%

(103 day)

Deschloro 

Thiazole Sulfonic 

Acid

Aerobic aquatic 

metabolism

48574839 15.2%

(141 day)

15.2%

(141 day)

Carbon Dioxide

O O

Aerobic aquatic 

metabolism

48574839 22.8%

(141 day)

22.8%

(141 day)

Anaerobic aquatic 

metabolism

48574840 13.5%

(61 day)

11.4%

(103 day)

Soil photolysis 48574825 19.9%

(14 day)

19.9%

(14 day)

Aqueous photolysis 48574849 4.4%

(96 hour)

4.4%

(96 hour)

Anaerobic soil

metabolism

48574824 13.3%

(45 day)

12.4%

(100 day)

Aerobic soil 

metabolism

48574823 55.7% 

(50 day)

11.2%

(120 day)

OH

S

O

O

F

F

F
-Page 20 of 117- 

According to the FAO mobility classification, both TSA and BSA are classified as 

“highly mobile” with a mean Koc of 7.8 mL/goc, and 6.1 mL/goc, respectively for TSA and 

BSA. MS is classified as “mobile” with a mean Koc of 47.1 mL/goc. In aerobic soil conditions, 

TSA has an average DT50 of 421 days and MS has an average DT50 of 33 days based on Single 

First Order (SFO) kinetics. The available environmental fate parameters of these degradates are 

presented in Table 3.4. 

Table 3.4. Environmental Fate Parameters of Fluensulfone Transformation Products. 

Parameter Test Compound Value Source

Persistence

Aerobic soil metabolism half-life 

(20°C)

TSA 228, 448, 560 day MRID 48574828

MS 34.2, 41.3, 44 day MRID 48574829

Mobility

Freundlich organic carbonnormalized coefficients (KOC)TSA 7.1, 9.7, 8.0, 8.4, 5.8 mL/gOC MRID 48574834

BSA 3.5, 5.0, 5.3, 10.5 mL/gOC MRID 48574836

MS 31.3, 37.4, 52.2, 55.4, 59.1 mL/gOC MRID 48574834

3.2.2. Measures of Aquatic Exposure 

 Exposure in surface water from the proposed fluensulfone uses due to runoff, erosion, 

and spray drift were assessed with the Tier II screening model, PE. To consider the potential 

effects of the transformation products, the aquatic exposure will address (1) fluensulfone alone, 

(2) MS alone, and (3) the combined residues of fluensulfone plus MS. Exposure for off-target 

spray drift was assessed with AgDRIFT. Only parent fluensulfone was considered for 

AgDRIFT. 

3.2.2.1. Surface Water Exposure 

PE (PRZM/EXAMS) 

(1) Fluensulfone Alone 

The model input parameters for PE based on the general chemical and environmental fate 

data for fluensulfone alone are listed in Table 3.4. 
-Page 21 of 117- 

Table 3.4. PE Chemical Input Parameters for Fluensulfone Alone. 

Input Parameter Value Comment Source (MRID)

Molecular Mass (g/mol) 291.7 Product chemistry data (Calculated)

Henry’s Law Constant

(atm-m

3

/mol)

1.65 x 10-7Product chemistry data 48574710

Solubility in Water (mg/L) 545.3 Represents the value at 20 oC 49574715

Organic Carbon Partition 

Coefficient (KOC) (mL/gOC)

192 Represents the mean KOC of five values (154, 157, 

172, 203, and 275)

48574833

Aerobic Soil Metabolism 

Half-life (days)

11.98 Represents the upper 90% confidence bound on 

the mean of four half-lives (8.05, 9.53, 11.9, and 

15)

48574823

Aerobic Aquatic Metabolism 

Half-life (days)

45.93 Represents the upper 90% confidence bound on 

the mean of two half-lives (39 and 42.4)

48574839

Anaerobic Aquatic 

Metabolism Half-life (days)

27.68 Represents the upper 90% confidence bound on 

the mean of two half-lives (23.4 and 25.5)

48574840

Hydrolysis Half-life (days) 0 Represents hydrolysis stable 48574718

Aqueous Photolysis

Half-life (days)

0.784 Represents the upper 90% confidence bound on 

the mean of two dark-control-adjusted half-lives

(0.58 and 0.68)

48574849

The model input parameters used in PE to simulate fluensulfone application and crop 

management practices are provided in Table 3.5. To reflect the timing with a minimum of 7 

days before transplanting, the application dates were selected before the emergence dates which 

were Oct. 1 for FL cucumber scenario and Oct. 16 for STX vegetable scenario. 

Table 3.5. PRZM Scenario and Input Parameters Describing the Maximum Proposed 

Fluensulfone Use Patterns. 

Use Scenario Application

Date

App. Rate 

(lbs a.i./A)

App. 

per 

Year

Depth, 

cm

CAM 

Input

IPSCND 

Input

Application 

Efficiency/ 

Spray Drift

Fruiting vegetables STX vegetable Aug. 1 3.5 1 15 4 1 0.99/0.01

Cucurbits FL cucumber Sept. 1 3.5 1 15 4 1 0.99/0.01

 Aquatic EECs from PE for fluensulfone alone are presented in Table 3.6 (also see

Appendix A).

Table 3.6. PE 1-in-10-year Aquatic EECs of Fluensulfone Alone

Use Scenario Peak (μg/L) 21-day Mean

(μg/L)

60-day Mean

(μg/L)

Fruiting vegetables STX vegetable 9.60 7.20 4.72

Cucurbits FL cucumber 14.50 13.01 9.16

Sediment Pore Water for parent

Fruiting vegetables STX vegetable 1.49 1.46 1.28

Cucurbits FL cucumber 2.87 2.80 2.51
-Page 22 of 117- 

(2) Methyl Sulfone Alone 

The model input parameters for PE based on the general chemical and environmental fate 

data for methyl sulfone alone are listed in Table 3.7. Degradation rate assumptions were made 

in the absence of data.

Table 3.7. PE Chemical Input Parameters for Methyl Sulfone Alone. 

Input Parameter Value Comment Source (MRID)

Molecular Mass (g/mol) 197.7 Product chemistry data (Calculated)

Henry’s Law Constant

(atm-m

3

/mol)

6.57 x 10-10 EPI Suite

Solubility in Water (mg/L) 29920 EPI Suite

Organic Carbon Partition 

Coefficient (KOC) (mL/gOC)

47.08 Represents the mean KOC of five values (31.3, 

37.4, 52.2, 55.4, and 59.1)

48574834

Aerobic Soil Metabolism 

Half-life (days)

41.91 Represents the upper 90% confidence bound on 

the mean of three half-lives (41.3, 34.2, and 44)

48574823

Anaerobic Soil Metabolism 

Half-life (days)

0 Assume stable Assumption in the 

absence of data

Aerobic Aquatic Metabolism 

Half-life (days)

83.82 Twice of the aerobic soil metabolism half-life 

value

Assumption in the 

absence of data

Anaerobic Aquatic 

Metabolism Half-life (days)

0 Assume stable Assumption in the 

absence of data

Hydrolysis Half-life (days) 0 Assume stable Assumption in the 

absence of data

Aqueous Photolysis

Half-life (days)

0 Assume stable Assumption in the 

absence of data

The model input parameters used in PE to simulate methyl sulfone alone application and 

crop management practices for the degradate methyl sulfone alone are provided in Table 3.8. 

Inputs are the same as for the parent compound, with two exceptions about application rate and 

no spray drift. 

Table 3.8. PRZM Scenario and Input Parameters Describing Methyl Sulfone. 

Use Scenario Application

Date

App. Rate 

(lbs a.i./A)

App. 

per 

Year

CAM 

Input

Depth, 

cm

IPSCND 

Input

Application 

Efficiency/ 

Spray Drift

Fruiting vegetables STX vegetable Aug. 1 0.18* 1 4 15 1 1.0/0

Cucurbits FL cucumber Sept. 1 0.18 1 4 15 1 1.0/0

* 0.18 = 3.5 (application rate of fluensulfone) /291.7 (molecular weight of fluensulfone) * 197.7 (molecular weight 

of methyl sulfone) * 7.45% (max detection of methyl sulfone in the aerobic soil metabolism study) 

 Aquatic EECs from PE for methyl sulfone alone are presented in Table 3.9
-Page 23 of 117- 

Table 3.9. PE 1-in-10-year Aquatic EECs of Methyl Sulfone Alone

Use Scenario Peak (μg/L) 21-day Mean 

(μg/L)

60-day Mean 

(μg/L)

Fruiting vegetables STX vegetable 0.73 0.65 0.55

Cucurbits FL cucumber 1.07 1.02 0.93

Sediment Pore Water for MS

Fruiting vegetables STX vegetable 0.47 0.47 0.46

Cucurbits FL cucumber 0.81 0.80 0.79

(3) Fluensulfone + Methyl Sulfone 

The model input parameters for PE based on the general chemical and environmental fate 

data for fluensulfone plus methyl sulfone are listed in Table 3.10. Since the parent compound is 

expected to exist in a greater amount than MS, the chemical properties of the parent compound 

were used. 

Table 3.10. PE Chemical Input Parameters for Fluensulfone Plus Methyl Sulfone.

Input Parameter Value Comment Source (MRID)

Molecular Mass (g/mol) 291.7 Product chemistry data – parent (Calculated)

Henry’s Law Constant

(atm-m

3

/mol)

1.65 x 10-7Product chemistry data – parent 48574710

Solubility in Water (mg/L) 545.3 Represents the value at 20 oC – parent 49574715

Organic Carbon Partition 

Coefficient (KOC) (mL/gOC)

47.08 Represents the mean KOC of methyl sulfone based 

on five values (31.3, 37.4, 52.2, 55.4, and 59.1)

48574833

Aerobic Soil Metabolism 

Half-life (days)

24.01 Represents the upper 90% confidence bound on 

the mean of five half-lives (6.73, 8.68, 12.8, 20.2, 

and 39 days) for fluensulfone + methyl sulfone

48574823

Anaerobic Soil Metabolism 

Half-life (days)

1353 Single value for fluensulfone + methyl sulfone 48574824

Aerobic Aquatic Metabolism 

Half-life (days)

60.38 Represents the upper 90% confidence bound on 

the mean of two half-lives (52.12 and 56.17 )

48574839

Anaerobic Aquatic 

Metabolism Half-life (days)

59.61 Represents the upper 90% confidence bound on 

the mean of two half-lives (48.4 and 53.9)

48574840

Hydrolysis Half-life (days) 0 Represents hydrolysis stable 48574718

Aqueous Photolysis

Half-life (days)

0.784 Represents the upper 90% confidence bound on 

the mean of two dark-control-adjusted half-lives

(0.58 and 0.68) for fluensulfone

48574849

The model input parameters used in PE to simulate fluensulfone plus methyl sulfone 

application and crop management practices for fluensulfone plus methyl sulfone are the same as 

for fluensulfone alone, as provided in Table 3.11. 
-Page 24 of 117- 

Table 3.11. PRZM Scenario and Input Parameters Describing the Maximum Proposed 

Fluensulfone Use Patterns Based on Fluensulfone Plus Methyl Sulfone. 

Use Scenario Application

Date

App. Rate 

(lbs a.i./A)

App. 

per 

Year

CAM 

Input

Depth, 

cm

IPSCND 

Input

Application 

Efficiency/ 

Spray Drift

Fruiting vegetables STX vegetable Aug. 1 3.5 1 4 15 1 0.99/0.01

Cucurbits FL cucumber Sept. 1 3.5 1 4 15 1 0.99/0.01

 Aquatic EECs from PE for fluensulfone plus methyl sulfone are presented in Table 3.12 . 

Total residue EECs are about 1.21 to 1.59 times greater than parent-only EECs. 

Table 3.12. PE 1-in-10-year Aquatic EECs of Fluensulfone Plus Methyl Sulfone

Use Scenario Peak (μg/L) 21-day Mean

(μg/L)

60-day Mean

(μg/L)

Fruiting vegetables STX vegetable 15.23 12.20 8.69

Cucurbits FL cucumber 17.60 14.80 10.74

Sediment Pore Water for parent + MS

Fruiting vegetables STX vegetable 3.38 3.32 3.12

Cucurbits FL cucumber 7.73 7.09 6.01

3.2.2.2. Spray Drift Only Exposure 

AgDRIFT Tier 1 ground model was used to estimate off-target spray drift amount to the 

standard EPA defined pond (Table 3.13, also see Appendix B). 

Table 3.13. Edge-of-Field Concentration Estimates from Spray Drift using High vs. Low 

Boom and Finest to Coarsest Droplet Size.

Exposure

Edge of Field Concentration

High Boom: Finest 

Droplets

Low Boom: Finest 

Droplets

High Boom: FineMed/Coarse

Droplets

Low Boom: 

Fine-Med/Coarse

Droplets

Aquatic 12.1 μg/L,

0.216 lb/A

5.26 μg/L,

0.0938 lb/A

3.24 μg/L,

0.0577 lb/A

2.14 μg/L,

0.0381 lb/A

Terrestrial 0.0414 mg/cm2

, 

3.69 lb/A

0.0400 mg/cm2, 

3.57 lb/A

0.0397 mg/cm2, 

3.45 lb/A

0.0395 mg/cm2, 

3.53 lb/A

Assuming operation at high boom, with the drop size distribution of ASAS very fine to 

fine at 90th percentile data, with the maximum application rate of 3.5 lb a.i./ac and no buffer 

consideration, the resulting initial average concentration is 12.1 μg/L (Appendix B). Further 

analysis using larger droplet size and lower boom height showed that aquatic exposure could be 

reduced to 2.1 ug a.i./L. However, reductions were not seen for terrestrial exposure; even with 

the largest droplet size and lowest boom, spray drift still produced exposure above the 

application rate of 3.5 lb a.i./A (3.53-3.69 lb a.i./A from spray drift). 
-Page 25 of 117- 

3.2.2.3. Aquatic Bioaccumulation 

Evaluation was not triggered for potential bioaccumulation of fluensulfone residues in a 

freshwater aquatic food web and subsequent risks these residues pose to terrestrial organisms via 

consumption of contaminated aquatic prey (i.e., aquatic invertebrates and fish). This was due to 

fluensulfone’s low Kow of 91. 

3.2.3. Measures of Terrestrial Exposure 

 The application methods for the proposed fluensulfone uses include broadcast and band 

incorporation and drip irrigation, and are considered in the terrestrial exposure assessment. 

3.2.3.1. Terrestrial Wildlife 

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals, 

emphasizing a dietary exposure route for uptake of pesticide active ingredients. Pesticide 

residues on food items are estimated based on the assumption that organisms are exposed to 

pesticide residues in a given exposure use pattern. Birds are used as surrogates for terrestrialphase amphibians and reptiles. 

The T-REX model (v. 1.5, March 22, 2012) was used to calculate dietary and dose-based 

EECs of fluensulfone residues on food items via spray applications for mammals and birds. 

Input values for deriving EECs in T-REX are located in Table 3.22. 

Table 3.22. T-REX Input Parameters for Deriving Terrestrial EECs for Fluensulfone 

Proposed Uses - Maximum single application rate1

Proposed Use 

(Application Method)

Application Rate

(lbs a.i./A)

Number of Applications

(Interval between 

applications)*

Nematode Control Crop Groups 8 and 9:

- broadcast incorporated [6-8 inches]

- banded and incorporated [6-8 inches] 3.5 1 (NA)

Nematode Control Crop Groups 8 and 9:

- applied by drip irrigation

1 Half-life used was the default 35 days. 

Upper-bound Kenaga nomogram values were used to derive EECs for fluensulfone 

exposures to terrestrial mammals and birds. Table 3.23 summarizes the dietary- and dose-based 

EECs, based on the maximum single application rate of fluensulfone for the proposed use (also 

see Appendix C). A 1-year time period is simulated. Consideration is given to different types 

of feeding strategies for mammals, including herbivores, insectivores and granivores. For dosebased exposures, three weight classes of birds (20, 100, and 1000 g) and three weight classes of 

mammals (15, 35, and 1000 g) are considered. All proposed application methods include either 

ground incorporation or drip irrigation. Since the residue studies show that neither fluensulfone 

nor MS are systemic (Health Effects Division email communication) and application is to bare 
-Page 26 of 117- 

ground followed by incorporation, exposure to mammals, birds, reptiles and terrestrial-phase 

amphibians would not be expected to occur through consumption of these constituents. 

Therefore, exposure to animals feeding on plants, fruits or pods is not expected, and, thus, the 

data not discussed in the text. Arthropods and seeds, however, may be present during application 

or enter the treated area and be subsequently consumed, e.g., seeds may be wind-blown into the 

area and then consumed. Due to application methods designed to ensure that the applied 

fluensulfone reaches plant roots, exposure is also estimated using TREX calculations of mg 

a.i./sq. ft. and risk estimates based on LD50/sq. ft (see Section 4.1.2). See Appendix C for 

TREX output. 

Table 3.23. T-REX Calculated EECs of Fluensulfone Proposed Application Methods at 

Maximum Application Rate of 3.5 lbs a.i./A.

Proposed 

Application 

Methods

Food Type

Dietary 

Based

(ppm)

(mammals 

and birds)

Dose Based

(mg/kg-bw)

(birds)

Dose Based

(mg/kg-bw)

(mammals)

All Size 

Classes

Small

(20 g)

Medium

(100 g)

Large

(1000 g)

Small

(15 g)

Medium

(35 g)

Large

(1000 g)

Nematode Control 

Crop Groups 8 and 9:

- broadcast or banded 

and incorporated

or

- applied by drip 

irrigation

Arthropods 329.00 374.70 213.67 95.66 313.68 216.79 50.26

Seeds 52.50 13.29 7.58 3.39 11.12 7.69 1.78

Smaller Scale Exposure Estimate – using TREX Estimates by Square Foot from Broadcast Application.

mg per sq. ft. 5.47 -- -- -- -- -- --

LD50/sq ft -- 0.35 0.05 <0.01 0.25 0.13 0.01

3.2.3.2. Sub-terrestrial Animals 

Fluensulfone exposure to terrestrial wildlife was also evaluated by estimating pesticide 

residues on sub-terrestrial food items in the treatment area. Exposure to fluensulfone was 

assumed to be limited since application is either incorporated or drip-irrigated. Therefore 

terrestrial EECs and acute risks were estimated based on loadings of pesticide per unit area (ft2

) 

and chronic exposure and risk estimated based on direct ingestion of contaminated soil 

invertebrates. In addition, acute risks to terrestrial invertebrates exposed to fluensulfone 

applications were estimated using the concentration of fluensulfone in earthworms and 

earthworm toxicity data, which is used as a surrogate for soil dwelling invertebrates and their 

consumption by the terrestrial vertebrates. The earthworm fugacity evaluation estimated the soil 

concentration at 1-15cm depth immediately after treatment to be 2.2 mg/kg-soil (Appendix D).

3.2.3.3. Terrestrial Plants 

Fluensulfone exposure estimates from TerrPlant for terrestrial plants inhabiting dry and 

wetland treated areas, were derived from combined exposure estimates of runoff and spray drift 

(Table 3.24, also see Appendix E). 
-Page 27 of 117- 

Table 3.24. EECs for Fluensulfone on Terrestrial Plants from Terrplant.

Description EEC, lb a.i./A

Runoff to dry areas 0.029

Runoff to semi-aquatic areas 0.29

Spray drift 0.035

Total for dry areas 0.064

Total for semi-aquatic areas 0.33

The spray drift EEC was 0.35 lb a.i./A (total estimate for fluensulfone a.i.). The total EEC 

estimates for dry and semi-aquatic areas were 0.06 and 0.33 lb a.i./A, respectively. As described 

earlier, with immediate incorporation and drip irrigation for all applications, the exposure is 

expected to be patchy, mostly impacting plants between furrows and those exposed to spray drift. 

3.3. Ecological Effects Characterization 

Ecological effects characterization is based on registrant-submitted toxicity data for 

fluensulfone (also referred to as fluensulfone TGAI, or parent); its formulated product, 

Fluensulfone 480EC; and metabolites of fluensulfone: TSA, MS, BSA, deschloro-fluensulfone, 

butene sulfinic acid and deschloro thiazole sulfonic acid. Appendix F lists these studies, their 

review classifications, and associated deficiencies. In addition, the publicly-available version of 

the ECOTOX database was searched on July 17, 2013 to check for more ecological effects data 

(USEPA, 2012b). The results of this query showed that no additional ecotoxicity data were

available for fluensulfone or its degradates; therefore, all toxicity endpoints were taken from 

registrant-submitted studies. 

 A description of available aquatic and terrestrial toxicity data for fluensulfone, its 

formulated products, and degradates is provided in Section 3.3.1 and 3.3.2, respectively. Given 

that fluensulfone is a new active ingredient with no previous registration in the U.S. or any other 

country, no query of the Agency’s Office of Pesticide Programs Ecological Incident Information 

System (EIIS)2incident database, Aggregate Incidents database3or American Bird Conservancy4

database was completed, and it is assumed that no ecological incidents exist for fluensulfone. 

3.3.1. Aquatic Toxicity Characterization 

A summary of the most sensitive aquatic toxicity data for fluensulfone, including its 

formulated product, Fluensulfone 480EC, based on a current Agency review of all submitted 

data, is provided in Table 3.25 and discussed further in Sections 3.3.2.1 through 3.3.2.4. It 

should be noted that none of the several endpoints for aquatic test species exceed the limit of 

fluensulfone’s solubility in water (545 mg/L, MRID 48574715). EFED has confidence in the 

toxicity values that are being used to estimate risk quotients because the submitted studies did 

not have significant data quality issues and were considered reliable for use in risk assessment. 

 

2

http://www.epa.gov/oppefed1/general/databasesdescription.htm.

3

 EPA Aggragate Incident Reports (version 1.1). 

4 American Bird Conservency database, http://www.abcbirds.org/.
-Page 28 of 117- 

Table 3.25. Summary of the Most Sensitive Acute and Chronic Toxicity Data for Aquatic 

Organisms Exposed to Fluensulfone, based on mean-measured concentrations. 

Aquatic Animals

Most Sensitive 

Test Species 

Test 

Substance1

Acute Toxicity Chronic Toxicity

96-hr 

LC50/EC50/IC50

mg a.i./L

48-hr EC50

mg a.i./L MRID

NOAEC/

LOAEC

mg a.i./L 

(Endpoints)

MRID

Bluegill 

(Lepomis 

macrochirus)

TGAI

480EC

13

2.5

--

48574853

48574929

-- --

Sheepshead 

Minnow

(Cyprinodon 

variegates)

TGAI

480EC

28

5.9

--

48574852

48574928

-- --

Fathead 

Minnow 

(Pimephales 

promelas)

TGAI -- -- --

0.63/1.6

(based on 

post-hatch 

survival and 

small, weak, 

discolored 

fish)

48574854

Daphnid

(Daphnia 

magna)

TGAI

480EC

--

22

0.38

48574855

48574930

(TGAI only) 

0.20/0.39

(based on dry 

weight and 

reproduction)

48574856

Mysid 

(Americamysis 

bahia)

TGAI 1.0 -- 48574864

0.37/0.75

(based on 

growth)

48574857

Eastern oyster

(Crassostrea 

virginica)

TGAI

480EC

7.8

0.077

--

48574865

48574933

-- --

Aquatic Plants

Most Sensitive Test 

Species

Test 

Substance Endpoint, mg a.i./L Effect (MRID)

Nonvascular:

Freshwater Alga 

(Pseudokirchneriella 

subcapitata)

TGAI

96.5 %

480EC

EC50: 0.022 mg a.i./L

EC05: 0.011 mg a.i./L (based on cell density)

EC50: 0.015 mg a.i./L

EC05 = 0.0040 mg a.i./L (based on cell density)

48574858

48574931

Vascular:

Duckweed

(Lemna gibba)

TGAI

96.5 %

EC50: 2.7mg a.i./L (based on biomass yield)

NOAEC: 0.49 mg a.i./L (based on frond number, frond 

yield, frond growth rate, biomass, biomass yield and 

biomass growth rate)

48574863

1

 For risk to aquatic organisms, TGAI toxicity estimates were used for runoff calculations and TEP toxicity for 

spraydrift calculations (Section 2.6.3).
-Page 29 of 117- 

3.3.1.1. Toxicity to Freshwater Fish 

Fluensulfone TGAI 

As shown in Table 3.26, three freshwater fish acute toxicity studies using the TGAI 

(95.7-96.5%) were submitted to evaluate the toxicity of fluensulfone to fish in support of the new 

chemical registration. 

Table 3.26. Freshwater Fish Acute Toxicity to Fluensulfone TGAI.

Test Species/

Test Substance

(Flow-through/Static)

% 

a.i.

96-hour LC50 , mg a.i./L

(95% C.I.)

Slope

Toxicity 

Category MRID Study Classification

Bluegill (L. macrochirus)

Fluensulfone TGAI; 

(Static) 95.7

13

(12-15)

Slope = NA

[Endpoints Affected: mortality 

surfacing, lethargy and lying on 

bottom of vessel]

Slightly 

Toxic 48574853 Acceptable

Rainbow trout

(Oncorhynchus mykiss)

Fluensulfone TGAI; 

(Static) 96.5

38

(27-53)

Slope = NA

[Endpoints Affected: mortality, 

lying on bottom and loss of 

equilibruim]

Slightly 

Toxic 48574740 Acceptable

Common Carp 

(Cyprinus carpio)

Fluensulfone TGAI; 

(Static) 95.7

41

(25-50)

Slope = NA

[Endpoints Affected: mortality, 

lethargy, surfacing, lying on 

bottom and loss of equilibruim]

Slightly 

Toxic 48574851 Acceptable

Slope = NA - Probit slope calculations were not available; binomial method was used as there were less than two 

concentrations with partial mortality 

 All three submitted acute toxicity studies with freshwater fish were classified as acceptable. 

Observed sublethal effects included lethargy, surfacing, lying on the bottom of the test chamber 

and loss of equilibrium. The reported 96-hr LC50 ranged from 13 to 41 mg a.i./L (MRIDs 

48574740, 48574851 and 48574853). Fluensulfone TGAI is classified as slightly toxic to 

freshwater fish on an acute basis.

 A freshwater fish chronic early life stage toxicity test with fathead minnows was submitted 

using fluensulfone TGAI (96.5% a.i.) (Table 3.27). 
-Page 30 of 117- 

Table 3.27. Freshwater Fish Chronic Toxicity to Fluensulfone TGAI.

Test Species

(Flowthrough/Static;

Duration)

% a.i.

NOAEC/LOAEC 

mg a.i./L, meanmeasured

Effect MRID Study 

Classification

Fathead minnow

(P. promelas)

(Flow-through; 33 days)

96.5%

NOAEC = 0.63

LOAEC = 1.6

Based on Survival (Posthatch Larval) and Small, 

Weak and Discolored Fish.

Other Endpoints Affected: 

clinical signs of toxicity, 

total length, wet weight, 

and dry weight

48574854 Acceptable

 A 3- day fish early life-stage study was conducted with the fathead minnow under flowthrough conditions. Post-hatch larval survival was significantly reduced in the 1.6 mg a.i./L 

treatment group compared with control fish (MRID 48574854). Therefore, the NOAEC and 

LOAEC values were 0.63 and 1.6 mg a.i./L, respectively. Observed sublethal effects were also 

observed at all treatments above 1.6 mg ai/L, with increasing frequency of observation with 

increasing concentration level. Clinical signs of toxicity included small, weak, and/or discolored 

fish; fish surfacing; erratic swimming; and cranial swelling and hemorrhage. 

Formulated Product 

Two additional freshwater fish acute static toxicity studies were submitted using the 

formulated product, Fluensulfone 480EC (Table 3.28). 

Table 3.28. Freshwater Fish Acute Toxicity to the MCW2 480EC Formulation.

Test Species

(Flow-through/Static)

% 

a.i.1

96-hour LC50 

mg a.i./L, mean-measured 

concentration [mg 

480EC/L]

(95% C.I., mg a.i./L)

Slope

Toxicity 

Category MRID Study Classification

Rainbow trout

(O. mykiss)

(Static)

45.2

3.2 [7.0 mg 480EC/L]

(2.7-3.7) 

Slope = NA

[Endpoints Affected: mortality 

and loss of equilibrium]

Moderately 

Toxic 48574927 Acceptable

Bluegill (L. macrochirus)

(Static) 45.2

2.5 [5.5 mg 480EC/L]

(2.1-2.9) 

Slope = NA

[Endpoints Affected: mortality, 

loss of equilibrium and lethargy]

Moderately 

Toxic 48574929 Acceptable

Slope = NA - Probit slope calculations were not available; the LC50 and 95% confidence interval were determined 

using Spearman-Karber analysis in CETIS (v. 1.8.6). Neither the probit nor moving average method could be used 

as there were less than two test concentrations at which the percent mortality was between 0 and 100%. 

1

Fluensulfone active ingredient. 
-Page 31 of 117- 

The 480EC formulation was 5-12x more toxic than parent (also see Appendix G, Table 

G.4.) with reported 96-hr LC50 values of 3.2 and 2.5 mg a.i./L, respectively for the rainbow trout 

and bluegill (MRIDs 48574927 and 48574929). Observed sublethal effects included lethargy 

and loss of equilibrium. Based on the formulated product toxicity, fluensulfone is classified as 

moderately toxic to freshwater fish on an acute basis.

Degradates 

Three acute freshwater fish toxicity studies using the metabolites TSA, MS and BSA 

were submitted and are summarized in Appendix F. Toxicity to the bluegill ranged from 

slightly toxic to practically non-toxic (96-hr LC50 values of 35 to >122 mg degradate/L, 52 to 

>187 mg a.i./L expressed in terms of parent toxicity by adjusting for molecular weights). Based 

on the results of these tests, all tested fluensulfone metabolites were found to be less toxic than 

the parent TGAI, with the possible exception of MS. Toxicity of MS (LC50 = 35 mg MS/L, 52 

mg a.i./L expressed as parent, MRID 48574874) was similar to parent (LC50 = 11.6 mg a.i./L, 

MRID 48574853). Therefore, TTR includes both parent and MS exposure. 

3.3.1.2. Toxicity to Freshwater Invertebrates 

Fluensulfone TGAI 

Freshwater invertebrate acute toxicity data for the waterflea (Daphnia magna) are 

available for fluensulfone TGAI and are presented in Table 3.29. 

Table 3.29. Freshwater Invertebrate Acute Toxicity to Fluensulfone TGAI.

Test Species

(Flow-through/Static) % a.i.

48-hour EC50, mg a.i./L

(95% C.I.)

Slope

Toxicity 

Category MRID Study Classification

Waterflea

(D. magna)

(Static)

95.7

22

(17-29)

Slope = NA

[Endpoints Affected: Immobility, 

lethargy and surface entrapment]

Slightly 

Toxic 48574855 Acceptable

Slope = NA - Probit slope calculations were not available; the EC50 value was determined using Spearman-Karber 

(CETIS ver. 1.8.7.2). The probit method was not used due to a low goodness of fit probability (<0.001). Due to the 

bimodality of the mortality/immobility data, statistics were checked without data from the lowest test concentration. 

The results did not differ substantially (EC50 of 21, rather than 22 mg a.i./L), so the lack of a clear dose:response 

relationship at the lower three test concentrations did not affect the results substantially. The endpoint used was 

based on Spearman-Karber results using all the data. 

The 48-hr EC50 for Daphnia exposure to fluensulfone TGAI was 22 mg a.i./L (MRID 

48574855), classifying fluensulfone TGAI as slightly toxic to freshwater invertebrates on an 

acute exposure basis. Sublethal effects included lethargy, and surface entrapment. 

A 21-day full life-cycle toxicity test was submitted for aquatic freshwater invertebrates 

using fluensulfone TGAI (MRID 48574856, Table 3.30).
-Page 32 of 117- 

Table 3.30. Freshwater Invertebrate Chronic Toxicity to Fluensulfone TGAI.

Test Species

(Flowthrough/Staticrenewal; 

Duration)

% 

a.i.

NOAEC/LOAEC

mg a.i./L (meanmeasured 

concentration)

Effect MRID Study Classification

Waterflea

(D. magna)

(Flow-through; 21 

days)

96.7 NOAEC = 0.20

LOAEC = 0.39

Based on Dry weight

and Reproduction.

Endpoints affected: 

number of 

neonates/reproductive 

day, length of 

surviving adults, dry 

weight of surviving 

adults

48574856 Supplemental/Quantitative

In the daphnid life-cycle test (MRID 48574856), living offspring per reproductive day 

and dry weight were significantly reduced (p<0.05) in the 0.39 mg a.i./L treatment group

compared with control fish. Therefore, the NOAEC and LOAEC values were 0.20 and 0.39 mg 

a.i./L, respectively. 

One additional 10-day spiked sediment toxicity study was submitted by the registrant to 

assess the potential effects of fluensulfone on the sediment-dwelling freshwater invertebrate 

midge (Chironomus tentans, Table 3.31). 

Table 3.31. Toxicity of Sediment-Dwelling Freshwater Invertebrates to Fluensulfone 

TGAI.

Test Species

(Flow-through/Static; 

Duration)

% 

a.i.

Endpoint 

(Mean Measured 

Concentration)

Effect MRID Study 

Classification

Chironomid

Chironomus tentans

(Spiked sediment; Flowthrough; 10 days)

95.7

Sediment:

LC50: >51 mg ai/kg 

NOAEC = 27 mg a.i./kg 

LOAEC = 51 mg a.i./kg 

Pore Water:

LC50: >157 mg ai/kg TOC1

NOAEC = 66 mg a.i./L

LOAEC = 157 mg a.i./L

Overlying Water:

NOAEC/ LOAEC - values could 

not be determined*

Based on 

Survival248574862

Supplemental 

(non-guideline 

study)/Quantitative 

for survival data 

only

*Overlying water concentrations were <LOQ (<0.500 mg ai/L) for all levels. 

1Total Organic Carbon.

2Though growth was measured (as Ash-free Dry Wt.) these data are not useable due to solvent effects on growth. 
-Page 33 of 117- 

The flow-through study was submitted based on guideline 850.1735 for sediment-water 

chironomid toxicity testing using spiked sediment, with formulated sediment similarly to that 

described in OECD Guideline 218 (2004), except using alpha-cellulose instead of peat moss. 

The study was classified as “Supplemental” because of a solvent effect on the growth parameter, 

and so those results were not reportable (MRID 48574862). Mortality data, however, were 

deemed quantitative; these data showed that the LC50 was >51 mg a.i./kg sediment, and >157 mg 

a.i./kg TOC (total organic carbon, endpoint from pore water analysis). The NOAEC based on 

mortality was 27 mg a.i./kg sediment and 66 mg a.i./L of pore water. Measured concentrations 

in the sediment ranged from 4.0 to 51.1 mg a.i./kg (ppm) and in the pore water from 9.2 to 157 

mg a.i./L (ppm); all over-lying water samples measured <0.500 mg a.i./L. 

Formulated Product 

Toxicity data for daphnia from the 480EC formulation are presented in Table 3.32. 

Table 3.32. Freshwater Invertebrate Acute Toxicity to the MCW2 480EC Formulation.

Test Species

(Flow-through/Static)

% a.i.

1

48-hour EC50

mg a.i./L, mean-measured 

concentration [mg 480EC/L]

(95% C.I., mg a.i./L)

Slope

Toxicity 

Category MRID Study Classification

Waterflea

(D. magna)

(Static)

41.99

0.38 [0.83 mg 480EC/L]

(0.29-0.50)

Slope = 3.19

[Endpoints Affected: immobility and 

lethargy]

Highly Toxic 48574930 Acceptable

1

Fluensulfone active ingredient. 

The available acute data for the D. magna show it to be much more sensitive to the 

480EC formulation than TGAI, the EC50 was 0.38 mg a.i./L (MRID 48574930) for the 

formulation, compared to 22 mg a.i./L (MRID 48574855) for TGAI. According to these data, 

the formulation is 58x more toxic than the fluensulfone a.i. alone to aquatic invertebrates 

classifiying it as highly toxic. 

Degradates 

Three acute mysid toxicity studies using the metabolites TSA, MS and BSA were 

submitted and are summarized in Appendix F. These studies will be used to estimate the 

relative toxicity of freshwater invertebrates as well as estuarine/marine invertebrates and are 

discussed in the estuarine/marine invertebrate section (3.3.1.4).
-Page 34 of 117- 

3.3.1.3. Toxicity to Estuarine/Marine Fish 

Fluensulfone TGAI 

One estuarine/marine fish acute toxicity study with the TGAI was required to evaluate 

the toxicity of fluensulfone to fish in support of the new registration. Results from the submitted 

study are found in Table 3.33 below. 

Table 3.33. Estuarine/Marine Fish Acute Toxicity to Fluensulfone TGAI.

Test Species

(Static/Static-renewal)

% 

a.i.

96-hour LC50 

mg a.i./L, mean-measured 

concentration 

(95% C.I.)

Slope

Toxicity 

Category MRID Study Classification

Sheepshead Minnow

(C. variegatus)

(Static) 95.7

28 (20-38)

Slope = NA

[Endpoints Affected: mortality, 

surfacing and lethargy]

Slightly 

Toxic 48574852 Acceptable

Slope = NA - Probit slope calculations were not available; binomial method was used as there were less than two 

concentrations with partial mortality 

 A submitted acute toxicity study with sheepshead is classified as acceptable (MRID 

48574852). The sheepshead was less sensitive than bluegill (96-hr LC50 = 28 mg a.i./L 

compared to 13 mg a.i./L, respectively) but more sensitive than rainbow trout or carp (LC50 = 38 

and 41, trout and carp, Table 3.26). Observed sublethal effects included lethargy and surfacing. 

 Chronic toxicity data for estuarine/marine fish are not available. It was not feasible to 

derive an acute-to-chronic ratio (ACR) for estuarine/marine fish based from freshwater data 

since acute data was not available for the fathead minnow, the only species with chronic data. 

Formulated Product 

One additional sheepshead acute static toxicity study was submitted using the formulated 

product, Fluensulfone 480EC (Table 3.34). 

Table 3.34. Estuarine/Marine Fish Acute Toxicity to the MCW2 480EC Formulation. 

Test Species

(Static/Staticrenewal)

% a.i. 1

96-hour LC50, mg a.i./L, mean-measured 

concentration [mg 480EC/L]

(95% C.I., mg a.i./L)

Slope

Toxicity 

Categor

y

MRID

Study 

Classificati

on

Sheepshead 

Minnow 

(C. variegatus)

(Static)

45.2

5.9 [13 mg 480EC/L]

(5.0-6.8) 

Slope = NA

[Endpoints Affected: mortality, lethargy and 

surfacing]

Moderate

ly Toxic

485749

28 Acceptable

Slope = NA - Probit slope calculations were not available; the LC50 and 95% confidence interval were determined 

using Spearman-Karber analysis in CETIS (v. 1.8.6). Neither the probit nor moving average methods could be used 

since there was only one concentration at which the percent mortality was between 0 and 100. 

1

Fluensulfone active ingredient. 
-Page 35 of 117- 

The 480EC formulation was 5x more toxic than the technical active ingredient (also see 

Appendix G, Table G.5.) with an 96-hr LC50 of 5.9 mg a.i./L for the sheepshead minnow 

(MRID 48574928). Observed sublethal effects included lethargy and surfacing. Based on the 

formulated product toxicity, fluensulfone is classified as moderately toxic to saltwater fish on an 

acute basis.

3.3.1.4. Toxicity to Estuarine/Marine Invertebrates 

Fluensulfone TGAI 

Estuarine/marine invertebrate acute toxicity data for fluensulfone TGAI is summarized in 

Table 3.35. 

Table 3.35. Estuarine/Marine Invertebrates Acute Toxicity to Fluensulfone TGAI.

Test Species

(Flow-through/Static)

% 

a.i.

96-hour LC/IC50

mg a.i./L, mean-measured 

concentration 

(95% C.I.)

Slope

Toxicity 

Category MRID Study Classification

Mysid

(A. bahia)

(Static) 95.7

LC50 = 1.0

(0.46-1.9)

Slope = NA

[Endpoints Affected: mortality, 

lethargy and erratic swimming]

Highly Toxic 48574864 Suppmemental1

Quantitative

Eastern oyster

(C. virginica)

(Flow-through)

96.5

IC50 = 7.8

(6.3-9.7) [Endpoints Affected: 

shell growth]

Moderately 

Toxic 48574865 Acceptable

Slope = NA - The probit method did not yield statistically sound results. The LC50 and 95% confidence interval 

were calculated using the binomial test via Toxanal statistical software. 

1The negative control had 15% mortality. OCSPP 850.1035 guideline specifies that a static test is not acceptable if 

more than 10% of the control organisms die during the study. However, in this case the two lowest treatments had 

no mortality or sublethal effects, so the weight of evidence indicates that the organisms were reasonably healthy. 

The 96-hr LC50 for mysid shrimp (Americamysis bahia) was 1.0 mg a.i./L (MRID

48574864). Observed sublethal effects included lethargy and erratic swimming. The 96-hr EC50

for the Eastern oyster (Crassostrea virginica), based on mean shell deposition, was 7.8 mg a.i./L

(MRID 48574865). Fluensulfone TGAI was found to be moderately to highly toxic to 

estuarine/marine invertebrates on an acute exposure basis. 

One chronic toxicity study was submitted with estuarine/marine invertebrates (Table 

3.36). 

Table 3.36. Estuarine/Marine Invertebrates Chronic Toxicity to Fluensulfone TGAI.

Test Species

(Flowthrough/Staticrenewal; Duration)% 

a.i.

NOAEC/LOAEC

mg a.i./L (mean-measured 

concentration)

Effect MRID Study 

Classification

Saltwater Mysid (A. 95.92 NOAEC = 0.37 Based on Growth (Total 48574857 Acceptable
-Page 36 of 117- 

Test Species

(Flowthrough/Staticrenewal; Duration)% 

a.i.

NOAEC/LOAEC

mg a.i./L (mean-measured 

concentration)

Effect MRID Study 

Classification

bahia)

(Flow-through; 38 

days)

LOAEC = 0.75 Length of Males).

[Other Endpoints 

Affected: juvenile 

survival, adult survival, 

and total length of 

surviving males]

In the mysid life-cycle test (MRID 48574857), total length of males was significantly 

reduced (p<0.05) at 0.75 mg a.i./L compared with control fish. Other effects observed included 

reduced juvenile and adult survival. Therefore, the NOAEC and LOAEC values were 0.37 and 

0.75 mg a.i./L, respectively. 

Degradates 

Three acute mysid toxicity studies using the metabolites TSA, MS and BSA were 

submitted and are summarized in Appendix F, Table F.4. Toxicity to the mysid ranged from 

slightly toxic to practically non-toxic (96-hr LC50 values of 19 to >123 mg degradate/L, 28 to 

>180 mg a.i./L expressed in terms of parent toxicity by incorporating molecular weights). Based 

on the results of these tests, all tested fluensulfone metabolites were found to be less toxic than 

the parent TGAI, with the possible exception of MS. Though MS had similar toxicity to parent 

for fish (see Section 3.3.1.1) it was 19x less toxic to mysids (LC50 = 19 mg MS/L, 28 mg a.i./L 

expressed in terms of parent toxicity, MRID 48574877 than parent (LC50 = 1.0 mg a.i./L, MRID 

48574864, (see Appendix F, Table F.1). The mysid comparison was somewhat inconsistent 

with terrestrial invertebrate data, which showed similar toxicity between MS and parent, based 

on earthworm data (see Section 3.3.2.3). Therefore, using conservative assumptions, the 

residues of concern for aquatic organisms included both fluensulfone parent and MS. 

3.3.1.5. Toxicity to Aquatic Plants 

 Acute aquatic plant toxicity studies were submitted for non-vascular and vascular plants 

using the fluensulfone TGAI, the 480EC Formulation, and 480EC Formulation formulations. 

The results of these studies are summarized in Table 3.36. 

Fluensulfone TGAI 

Submitted aquatic plant toxicity data with fluensulfone TGAI included studies with five 

algal species and one vascular plant. Data were submitted for freshwater green algae 

(Pseudokirchneriella subcapitata and Desmodesmus subspicatus, formerly, Scenedesmus 

subspicatus), freshwater blue-green (cyanobacteria) algae (Anabaena flos-aquae), freshwater 

diatom (Navicula pellicosa), marine diatom (Skeletonema costatum) and duckweed (Lemna 

gibba) (Table 3.37). 
-Page 37 of 117- 

Table 3.37. Acute Toxicity of Aquatic Plants to Fluensulfone TGAI and the MCW2 480EC 

Formulation.

Test Species

(Test Substance; 

Flow-through/Static; 

Duration)

%

a.i. 1

Endpoint 

mg a.i./L, mean-measured 

concentration

(95% C.I.)

Effect MRID Study 

Classification

Non-vascular Plants: Freshwater Green Algae

Freshwater Algae

P. subcapita

(TGAI; Static; 96 hr)

96.5

96-hr EC50 = 0.022

(0.020-0.024)

NOAEC = <0.0036

EC05 = 0.011 (0.0084-0.013)

Based on Cell 

Density.

Other Endpoint 

Affected: growth rate.

48574858 Acceptable

Freshwater Algae

P. subcapita

(TGAI; Static; 96 hr)

94.4

96-hr EC50 = 0.025

(0.021-0.030)

NOAEC = 0.0089

EC05 = 0.011 (0.0068-0.17)

Based on Cell 

Density.

Other Endpoint 

Affected: growth rate 

and yield.

48575017 Acceptable

Freshwater green 

algae

P. subcapitata

(480EC Formulation; 

Static; 96hr)

39.37

96-hr EC50 = 0.015

(0.011-0.021)

NOAEC = 0.0034

EC05 = 0.0040 (0.0019-

0.0083)

Based on Cell 

Density.

Other Endpoints 

Affected: growth rate 

and yield.

48574931 Acceptable

Non-vascular Plants: Freshwater Blue-Green Algae, Freshwater Diatom, and Marine Diatom

Freshwater Alga 

(Desmodesmus 

subspicatus, formerly, 

Scenedesmus 

subspicatus) (TGAI; 

Static, 96 hr)

94.4

96-hr EC50 = 0.026

(0.014-0.050)

NOAEC = <0.0018

EC05 = 0.0013 (0.0003-

0.0057)

Based on Cell 

Density.

Other Endpoints 

Affected: growth rate 

and yield.

48575019 Acceptable

Freshwater bluegreen algae

Anabaena flos-aquae

(TGAI; Static, 96 hr)

96.7

96-hr EC50 = 6.9

(2.9-17)

NOAEC = 2.8

EC05 = 0.60 (0.067-5.5)

Based on Yield.

Other Endpoints 

Affected: growth rate 

and cell density.

48574859 Acceptable

Freshwater diatom

Navicula pelliculosa

(TGAI; Static, 96 hr)

96.7

96-hr EC50 = 13

(9.9-17)

NOAEC = 7.4

EC05 = 4.7 (2.6-8.2)

Based on Cell 

Density.

Other Endpoints 

Affected: growth rate 

and yield.

48574860 Acceptable

Marine diatom

Skeletonema costatum

(TGAI; Static, 96 hr) 96.7

96-hr EC50 = 2.6

(2.2-3.0)

NOAEC = 1.2

EC05 = 1.1 (0.83-1.5)

Based on Cell 

Density.

Other Endpoints 

Affected: growth rate 

and yield.

48574861 Acceptable

Vascular Plants: Duckweed

Duckweed

L. gibba

(TGAI; StaticRenewal; 7 days) 96.57-d EC50 = 2.7

(1.7-4.3)

NOAEC = 0.49

EC05 = 0.13 (0.03-0.54)

Based on Biomass 

Yield.

Other Endpoints 

Affected: frond 

number, frond yield, 

frond growth rate, 

biomass, biomass 

growth rate

48574863 Acceptable

1

Fluensulfone active ingredient. 
-Page 38 of 117- 

Non-Vascular Aquatic Plants

 Results of acute non-vascular plant data show the following sensitivity rank for 

fluensulfone TGAI of the species tested: freshwater green algae > marine diatom > freshwater 

blue-green algae > freshwater diatom (Table 3.37). Two submitted studies were available for 

the freshwater green algae (P. subcapitata), the most sensitive species tested; the 96-hr EC50 and 

NOAEC values were 0.022 and <0.0036 (EC05 = 0.011) mg a.i./L and 0.025 and 0.0089 mg 

a.i./L, respectively, based on cell density (MRIDs 48574858 and 48575017). The freshwater 

green algae (D. subspicatus) had 96-hr EC50 and NOAEC values of 0.026 and <0.0018 mg a.i./L 

based on cell density (MRID 48574931), very similar sensitivity to P. subcapitata. The marine 

diatom (S.costatum) had 96-hr EC50 and NOAEC values of 2.6 and 1.2 mg a.i./L based on 

decreased cell density (MRID 48574861). For the freshwater blue-green algae (A. flos-aquae) 

and the freshwater diatom (N. pellicosa) the 96-hr EC50 and NOAEC values were 6.9 and 2.8 mg 

a.i./L and 13 and 7.4 mg a.i./L, respectively, based on yield and cell density (MRIDs 48574859 

and 48574861). 

Vascular Aquatic Plants

 The 7-day EC50 and NOAEC values for duckweed were 2.4 and 0.49 mg a.i./L, 

respectively, based on biomass yield (MRID 48574863, Table 3.37). 

Formulated Product 

Non-Vascular Aquatic Plants

 One study was submitted for non-vascular plant (green algae P. subcapitata) toxicity 

using the 480EC formulation. The formulation had similar toxicity to parent (1.6x more toxic) 

with 96-hr EC50 and NOAEC values of 0.015 and 0.0034 mg a.i./L for the formulation (MRID 

48574931) compared to 0.022-0.025 and <0.0036-0.0089 mg a.i./L for TGAI (MRIDs 48574858 

and 48575017, Table 3.37). 

Vascular Aquatic Plants

 No vascular plant toxicity studies were submitted for the formulation. 

Degradates 

Four acute non-vascular plant studies were submitted for four of the metabolites of 

fluensulfone (TSA, MS, BSA and Deschloro-Fluensulfone); these data are summarized in 

Appendix F (Table F.3). Based on the results of these tests, all four metabolites tested were 

found to be greater than two orders of magnitude less acutely toxic to green algae than the parent 

compound. The EC50 ranged from 2.5 to >4.4 mg/L (3.7 to >6.8 mg a.i./L expressed in terms of 

parent) for transformation products compared to 0.022 mg a.i./L for the parent compound. 

Therefore, parent-only exposure was used to calculate risk to aquatic plants. 
-Page 39 of 117- 

 3.3.2 Terrestrial Effects Characterization 

A summary of the most sensitive terrestrial animal toxicity data for fluensulfone TGAI 

and its formulated products is provided in Table 3.38 and discussed further in Sections 3.3.2.1

through 3.3.2.3. The available Tier II terrestrial plant toxicity data for fluensulfone TGAI are 

provided in Section 3.3.2.4.

Table 3.38. Summary of the Most Sensitive Acute and Chronic Toxicity Data for 

Terrestrial Organisms Exposed to Fluensulfone.

Species/

Chemical

Acute Toxicity Chronic Toxicity

48-hr LD50

mg a.i./bee

(95% C.I.)

(Toxicity 

Classification)

14-day LD50

mg a.i./kg-bw

(95% C.I.) 

(Toxicity 

Classification)

8-day LC50

mg a.i./kg-diet

(95% C.I.)

(Toxicity 

Classification)

MRID

NOAEC/LOAEC

(95% C.I.)

mg a.i./kg-diet 

(Endpoints)

MRID

Northern 

bobwhite quail

(Colinus 

virginianus)

NA

1510

(Slightly 

Toxic) 1

-- 48574842 -- --

Mallard duck

(Anas 

platyrhynchos)/

(TGAI)

NA --

>5760 (NA)

(Practically 

Non-toxic)1

48574845

255//511

(Based on male weight 

gain inhibition)

48574846

Wistar rat

(Ratus 

norvegicus) /

(TGAI)

NA

671

(Low to 

Moderate 

Toxicity)

-- 48574745

Offspring and Parental 

NOAEL = 250 ppm

(♂16.2 and ♀23.0

mg/kg-bw/day)

Parental LOAEL = 

1880 ppm

(Based on weight, 

food consumption 

and histopathology).2

48574769

Honey Bee

(Apis mellifera)/

(TGAI)

0.167

(0.141-0.210)

(Practically 

Nontoxic)

NA NA 48574879 NA NA

Honey Bee

(A. mellifera)/

(Formulation: 

MCW2 480 EC)

>0.200 (NA)

(Practically 

Nontoxic)

NA NA 48574934 NA NA
-Page 40 of 117- 

Species/

Chemical

Acute Toxicity Chronic Toxicity

48-hr LD50

mg a.i./bee

(95% C.I.)

(Toxicity 

Classification)

14-day LD50

mg a.i./kg-bw

(95% C.I.) 

(Toxicity 

Classification)

8-day LC50

mg a.i./kg-diet

(95% C.I.)

(Toxicity 

Classification)

MRID

NOAEC/LOAEC

(95% C.I.)

mg a.i./kg-diet 

(Endpoints)

MRID

Terrestrial Plant Endpoints, lb a.i./A

Most Sensitive Test Species NOAEC EC25 Effect

Tier II Seedling Emergence - using 480EC Formulation (MRID 48574945)

Monocots:

Onion (Allium cepa)

1.21 2.50 Reduced Height

Dicots:

Soybean (Glycine max) 0.141 >3.77

Reduced Emergence and 

Survival

Tier II Vegetative Vigor - using 480EC Formulation (MRID 48574972)

Monocots:

Wheat (Triticum aestivum) 0.0415 >3.49 Reduced Height 

Dicots:

Cabbage (Brassica oleracea) 0.419 1.31 Reduced Dry Weight

NA - Not Applicable; -- No Data 

1

Passerine studies were inconclusive, but indicate that the toxicity is possibly greater. NOAEL for regurgitation in 

the canary was <155 mg a.i./kg-bw (MRID 48574843). 

2

 Based on reduced pup weights and spleen weights and an increase in post-natal pup loss between days 0 and 4 in 

the F1 and F2 offspring; also adult reduced body weight, body weight gain, food consumption and increased liver 

and kidney weights and histopathology changes in the liver and kidney. 

3.3.2.1. Toxicity to Birds 

Fluensulfone TGAI 

Avian acute oral toxicity studies using fluensulfone TGAI. were submitted for bobwhite 

quail (Colinus virginianus) and the canary (Serinus carania). Avain acute dietary toxicity 

studies using TGAI were submitted for bobwhite (C. virginianus), mallard (Anas platyrhynchos) 

and zebra finch (Poephila guttata). Results of these tests are presented in Tables 3.39 and 3.40

below. 

Table 3.39. Avian Acute Oral Toxicity to Fluensulfone Technical.

Test Species % 

a.i. 1

LD50 

mg/kg-bw

(95% C.I.)

Slope

Toxicity 

Category MRID Study Classification

Northern bobwhite quail

(C. virginianus)

(TGAI)

96.5

1510 

(1220-1880)

Slope = 8.035

Slightly Toxic 48574842 Acceptable
-Page 41 of 117- 

Test Species % 

a.i. 1

LD50 

mg/kg-bw

(95% C.I.)

Slope

Toxicity 

Category MRID Study Classification

Canary (Serinus carania)

(TGAI) 96.5

LD50: Not 

determined2

NOAEL: <155 

mg ai/kg-bw 

based on 

regurgitation

ND 48574843

Supplemental

Quantitative 

(for upperbound of 

NOAEL) 

Regurgitation

Requested

Passerine 

Dietary Study

ND – Not determined.

1

Fluensulfone active ingredient. 

2Due to regurgitation at all treatment levels, an accurate LD50 (lethal dose) could not be determined. An EC50 for 

regurgitation was estimated to be 540 mg a.i./kg-bw (310-1340 mg a.i./kg-bw; slope 1.7) for use in risk description.

The bobwhite oral LD50 for TGAI was 1510 mg/kg-bw (body weight) (MRID 48574842), 

classifying fluensulfone as slightly toxic to upland avian species on an acute oral exposure basis. 

No treatment related mortality was observed in 292, 486, or 810 mg ai/kg-bw treatment groups. 

The NOAEL was >1506 mg ai/kg-bw for mortality. Clinical signs of toxicity were observed in 

the 810, 1350, and 2250 treatment groups, including lethargy, ruffled appearance, depression, 

loss of coordination, prostrate posture and lower limb weakness. Gross necropsy in the 2250 mg 

ai/kg treatment group showed thinness with loss of muscle mass and a slightly mottled liver, 

enlarged gall bladder, and slightly distended ceca. The LD50 was 1510 mg ai/kg-bw with 95% 

confidence interval of 1220 to 1880 mg ai/kg. The NOAEL based on mortality was 810 mg 

ai/kg-bw. The NOAEL based on male and female body weight gain was 810 mg ai/kg-bw. The 

NOAEL based on clinical signs of toxicity was 486 mg ai/kg-bw. 

Due to regurgitation in the canary study at all treatment levels, (20% at 155 mg ai/kg, 

30% at 259 mg ai/kg, 40% at 432 mg ai/kg, 50% at 720 mg ai/kg, and 80% at 1200 mg ai/kg) no 

useable endpoints for calculating risk were determined apart from the regurgitation NOAEL of 

<155 mg ai/kg-bw (MRID 48574843). However, an estimated EC50 for regurgitation of 540 mg 

a.i./kg-bw (310-1340 mg a.i./kg-bw; slope 1.7) is useable for risk description. No treatment 

related mortality was observed in the 155, 259, 432, or 720 mg ai/kg treatment groups. Clinical 

signs of toxicity were observed in the 259, 720, and 1200 treatment groups and included slight 

ruffled appearances. Clinical signs observed for the 1200 mg ai/kg treatment group also included 

reduced reaction to external stimuli and lethargy. Regurgitation within an hour of being dosed 

was observed at all treatment levels. A passerine dietary study was subsequently requested. 

Avian sub-acute dietary toxicity tests were required for upland game and waterfowl bird 

species, as well as passerines. Results of the three submitted tests are listed in Table 3.40 below. 

 
-Page 42 of 117- 

Table 3.40. Avian Subacute Dietary Toxicity to Fluensulfone TGAI.

Test Species % 

a.i.

8-Day LC50

mg a.i./kg-diet, meanmeasured 

concentration

(95% C.I.)

Slope

Toxicity 

Category MRID Study Classification

Northern bobwhite 

quail

(C. virginianus)

96.5

>5930 

(NA)

Slope = NA

Practically 

Nontoxic 48574844 Acceptable

Mallard duck

(A. platyrhynchos) 96.5

>5760 

(NA)

Slope = NA

Practically 

Nontoxic 48574845 Acceptable

Zebra Finch 

(Poephila guttata)

97.56 LD50: Not determined2ND 49138701 Supplemental/ 

Qualitative

NA – Confidence intervals and probit slope calculations were not available; no effects were observed.

2Due to regurgitation in the earlier passerine study (MRID 48574843) with the canary, this study was modified for a 

one day exposure to avoid starvation of test subjects. 

The LC50 values for the bobwhite quail and mallard duck are greater than the highest 

mean-measured treatment level of 5930 mg a.i./kg-diet (MRIDs 48574844 and 48574844); 

therefore, fluensulfone TGAI is classified as practically non-toxic to avian species on a subacute 

dietary exposure basis. In the bobwhite study, 10% mortality occurred at the 3390 mg ai/kg 

treatment group. Clinical signs of toxicity for the 3390 and 5930 mg ai/kg treatment groups 

included ruffled appearance, lethargy, and wing droop, loss of coordination. Statistically 

significant reductions in mean body weight gain were measured in the 1870 mg ai/kg treatment 

group and above, as compared to the control, from days 0-5. Based on mean-measured 

concentrations, the LC50 was >5930 mg/kg diet and the NOAEC based on feed consumption and 

exposure-period weight gain was 1060 mg ai/kg. The NOAEC based on clinical signs of toxicity 

was 1870 mg ai/kg. The NOAEC based on mortality and post-exposure weight gain was 5930 

mg/kg diet. 

In the mallard study, no test substance mortality was observed in the control group or any 

of the treatment groups throughout the 8-day test period. The 8-day acute dietary LC50 was 

>5760 mg/kg diet. Clinical signs of toxicity for the 3220 and 5760 mg ai/kg treatment groups 

included lethargy and loss of coordination. Statically significant reductions (p<0.05) in mean 

body weight gain were observed for the 1030, 1840, 3220, and 5760 mg ai/kg treatment groups 

from Days 0-5. Reductions in feed consumption were observed for the 5760 mg ai/kg treatment 

groups from Days 0-5 and Days 6-8. The LC50 was >5760 mg/kg diet and the NOAEC was 571 

mg/kg diet, based on reductions in exposure period weight gain. Fluensulfone is classified as 

practically non-toxic to upland game and waterfowl bird species. 

To assess toxicity to passerine bird species, an acute dietary toxicity study of fluensulfone 

TGAI was conducted using adult zebra finches (Taeniopygia guttata) in a modified study (MRID 

49138701) designed to reduce complications caused by regurgitation and feed avoidance in the 

earlier canary oral dosing study (MRID 48574843). Due to the likelihood of avoidance of or 
-Page 43 of 117- 

aversion to the treated diet, the standard five-day dietary exposure was shortened to 24-h. 

However, this study did not fulfill current EFED recommendations for a five-day dietary study 

with the same species that regurgitated in the oral test, or a new oral study with a different 

species.5 The results from this study could not be quantifiably extrapolated to a 5-day exposure 

endpoint and therefore, may be used only qualitatively to describe risk (for more information see 

footnote to Table G.1, Appendix G). 

Two avian reproduction tests using the TGAI were submitted to establish the chronic 

toxicity of fluensulfone to birds. Results from these studies are summarized in Table 3.41

below.

Table 3.41. Avian Chronic Toxicity (over 20 weeks) to Fluensulfone TGAI.

Test Species % 

a.i.

NOAEC/LOAEC

mg a.i./kg-diet, 

mean-measured 

concentrations

Effect MRID Study 

Classification

Northern bobwhite 

quail

(C. virginianus)

96.5

NOAEC = 1010

LOAEC = >1010

No Effect at Highest 

Concentration Tested 48574847

Supplemental 

(small cages)/ 

Quantitative

Mallard duck

(A. platyrhynchos) 96.5

NOAEC = 255

LOAEC = 511

Based on Growth (Male 

Weight Gain Inhibition).

Other Endpoint Affected: 

eggshell thickness.

48574846 Acceptable

For the bobwhite quail study a single mortality was observed in the 519 mg ai/kg 

treatment group; the mortality was not considered related to the treatment (MRID 48574847). No 

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

significant differences in feed consumption or in adult body weight gain and hatchling 

bodyweight at any treatment level. There were no statistically significant differences in any of 

the reproductive parameters measured in the 519 or 1010 mg ai/kg treatment groups. At the 256 

mg ai/kg treatment group, there were slight but statistically significant (p<0.05) increases in the 

number of viable embryos and hatchlings as percentages of eggs set, but these were not 

considered to be adverse treatment-related effects. No statistically significant differences upon 

egg shell thickness were observed at any treatment level (p>0.05). The NOAEL for parental 

toxicity and reproduction endpoints was 1010 mg ai/kg diet. This study was deemed sound but 

supplemental due to a small cage size, adding an element of uncertainty in the reproductive 

behavior due to overcrowding. The results are quantitatively useable, however, since control 

performance was adequate and the uncertainty is not likely to affect the risk conclusions. 

In the mallard study there were no treatment-related mortalities overt signs of toxicity or 

treatment-related effects on adult body weight or feed consumption during the study (MRID 

48574846). There was a significant reduction (p<0.05) in the proportion of eggs not cracked to 

eggs laid at the 511 and 991 mg a.i./kg treatment levels. Additional adverse effects on egg 

 

5

 Internal Memo from Donald J. Brady, Director of Environmental Fate and Effects Division, dated April 9, 2012, 

“Guidance for Use When Regurgitation is Observed in Avian Acute Toxicity Studies with Passerine Species.” 
-Page 44 of 117- 

quality were noted for eggs shell thickness, as a slight (i.e., 5%) significant (p=0.010) reduction 

at the 991 mg ai/kg treatment level, relative to the negative control. Male weight gain was 

significantly reduced (p=0.029) at the 511 mg ai/kg treatment level, but not significantly reduced 

(p=0.122) at the 991 mg ai/kg level; however, using a weight of evidence approach, it was 

reasoned that both levels at which birds exhibited weight loss over the course of the study were 

affected by fluensulfone. Overall food consumption during Week 1 of the test, as well as 

reductions in reproductive performance including a delay in the onset of egg production (most 

noticeable during the first six weeks of egg-laying) and decrease in embryo viability at the 991 

mg ai/kg treatment level were noted though not significantly different from the control group 

(p>0.05). Based on adverse effects on adult male weight gain at the 511 and 991 mg ai/kg 

treatment levels, the NOAEC in this study was determined to be 255 mg ai/kg; this is supported 

by reduced egg quality. 

Formulated Product 

An avian acute oral toxicity study was submitted using 480EC formulation (Table 3.42). 

Table 3.42. Avian Acute Oral Toxicity to the MCW2 480EC Formulation.

Test Species % a.i. 1

LD50

mg/kg-bw

(95% C.I.)

Slope

Toxicity 

Category MRID Study Classification

Northern bobwhite 

quail

(C. virginianus)

41.99

998

(791-1260)

Slope = 6.08 (3.10-9.07)

[Endpoints Affected: 

mortality and weight 

gain]

Slightly Toxic 48574951 Acceptable

1

Fluensulfone active ingredient. 

The LD50 value for the bobwhite quail exposed to the 480EC formulation was 998 mg 

a.i./kg-bw (MRID 48574951). Clinical signs of toxicity in higher treatment groups included 

depression, reduced reaction to external stimuli, loss of coordination, prostrate posture, ruffled 

appearance, lower limb weakness, and lethargy. Weight gain was significantly reduced in males 

in the 810 mg ai/kg-bw dosage group. Toxicity was slightly enhanced (1.5x) by exposure to the 

formulation (LD50 of 998 compared with 1510 mg a.i./L-diet, MRIDs 48574951 and 48574842, 

for parent and 480EC studies, respectively). 

3.3.2.2. Toxicity to Mammals 

Five mammalian acute oral toxicity studies using the TGAI, 480EC formulation and three 

metabolites (TSA, MS and BSA) were submitted to establish the toxicity of fluensulfone to 

mammals. Results of these tests are presented in Table 3.43 below. 
-Page 45 of 117- 

Table 3.43. Mammalian Acute Oral Toxicity to Fluensulfone TGAI and Metabolites (TSA, 

MS and BSA).

Test Species

(Test Substance) % a.i.

LD50 

mg/kg- bw

Slope

Toxicity 

Category1 MRID Study Classification

Wistar rat (R. norvegicus)

(TGAI) 96.5 671 mg a.i./kg-bwSlope = NA

Low to 

Moderate 

Toxicity2

48574745 Acceptable 

(fully reliable)

Wistar rat (R. norvegicus)

(Thiazole sulfonic acid) 93.6 >2000 mg tsa/kg-bwSlope = NA Low Toxicity3

48574783 Acceptable 

(fully reliable)

Wistar rat (R. norvegicus)

(Methyl sulfone)

98.1

500 mg ms/kg-bw

(300-2000)

Slope = NA

Low to 

Moderate 

Toxicity4

48574787 Acceptable 

(fully reliable)

Wistar rat (R. norvegicus)

(Butene sulfonic acid) 99.5 >2000 mg bsa/kg-bwSlope = NA Low Toxicity3

48574792 Acceptable 

(fully reliable)

Wistar rat (R. norvegicus)

(MCW-2 480 EC 

formulation)

473.6 

g/L5

>2000 mg 480EC/kgbw

(>947 mg a.i./kgbw)5

Slope = NA

Low Toxicity348574924 Acceptable 

(fully reliable)

1 Based on guidance within the OECD 423 test guideline for acute oral toxicity testing, the guideline allows the classification of 

the test substance into a series of toxicity classes that are defined by a fixed cut-off LD50 value. 

2According to the acute toxicity classification criteria for PMRA, MCW-2 tech. (fluensulfone) is of moderate toxicity via the oral 

route and based on the EPA classification criteria falls under Category III for acute oral toxicity. Under OCS criteria for acute 

toxicity endpoints, the test material is considered to be of low acute oral toxicity. 

3Based on PMRA’s acute toxicity classification system, thiazole sulfonic acid, butene sulfonic acid and the 480EC formulation 

are considered to be of low acute toxicity via the oral route. Based on the EPA classification criteria, they fall under Category III 

for acute oral toxicity. Under OCS criteria for acute toxicity endpoints, they are considered to be of low acute oral toxicity. 

4Based on PMRA’s acute toxicity classification system, methyl sulfone is considered to be of moderate toxicity via the oral route. 

Based on the EPA classification criteria, methyl sulfone falls under Category II for acute oral toxicity. Under OCS criteria for 

acute toxicity endpoints, methyl sulfone is considered to be of low to moderate acute oral toxicity. 

5The test material was formulated at a concentration of 20% (weight:weight); dosing was 10 mL/kg-bw. Therefore, 473.6 g a.i./L 

*0.2 *10ml/kg-bw * L/1000ml *1000 mg/g = 947.2 mg/kg-bw. 

The acute mammalian oral LD50 was 671 mg a.i./kg-bw based on TGAI toxicity to the 

wistar rat (MRID 48574745). One metabolite, MS, was slightly more toxic (1.3x) than parent 

with an LD50 of 500 mg TS./kg-bw (MRID 48574787), but the other two (TSA and BSA) had 

lower toxicity (>2000 mg/kg-bw, MRIDs 48574783 and 48574792). The 480EC formulation 

was also less toxic than parent with an LD50 of >947 mg a.i./kg-bw (MRID 48574924). 

Therefore, fluensulfone and its metabolites are classified as having low to moderate toxicity to 

mammals on an acute oral exposure basis. 

A 2-generation wistar rat reproduction study using the TGAI was submitted to establish 

the toxicity of fluensulfone to mammals over prolonged periods. Results from this test are listed 

in Table 3.44 below. 
-Page 46 of 117- 

Table 3.44. Mammalian Chronic Toxicity of Fluensulfone TGAI*

Test 

Species % a.i.

NOAEL/

LOAEL

(mg a.i./kg-diet; ppm)

Effect MRID

Study 

Classificati

on

Wistar rat

(R.

norvegicus)

96.67-

96.78

Parental NOAEL = 250 ppm

(♂16.2 and ♀23.0 mg/kg-bw/day) 

Parental LOAEL = 1880 ppm

(♂122.0 and ♀169.1 mg/kg-bw/day)

Reproductive NOAEL = 1800 ppm

(♂122.0 and ♀169.1 mg/kg-bw/day)

Reproductive LOAEL = >1880 ppm

Offspring NOAEL = 250 ppm

(♂16.2 and ♀23.0 mg/kg-bw/day) 

Offspring LOAEL = 1880 ppm

(♂122.0 and ♀169.1 mg/kg-bw/day)

Reduced body weight, body 

weight gain, food 

consumption and increased 

liver and kidney weights and 

histopathology changes in the 

liver and kidney.

Increase in post-natal pup loss 

between days 0-4 in both P 

and F1 generations.

Reduced pup weights and 

spleen weights and an 

increase in post-natal pup loss 

between days 0 and 4 in the 

F1 and F2 offspring.

48574769

Acceptable 

(fully 

reliable)

Wistar rat

(R. 

norvegicus)

96.1-

97.0 

Maternal and Developmental 

NOAELs were 48.6 mg/kg bw/day; 

LOAELs were 292 mg/kg bw/day

Fluensulfone was not 

teratogenic in rats. Based on 

decreased body weight gain 

and food consumption in 

dams and on lower body 

weight of female pups

48574771

Acceptable 

(fully 

reliable)

* Bolded values will be used in risk calculations. 

The NOAEL for wistar rat reproduction was 250 ppm (overall study intake of 16.2 mg/kg 

bw/day in males and 23.0 mg/kg bw/day in females; premating intake of 18.3 mg/kg bw/day in 

males and 20.3 mg/kg bw/day in females) based on decreased body weight, body weight gain, 

food consumption and increased liver and kidney weights and histopathology changes in the 

liver and kidney as well as decreased pup weights and spleen weights and an increase in postnatal pup loss between days 0 and 4 in the F1 and F2 offspring (MRID 48574769) at 1880 ppm, 

the LOAEL. At 1880 ppm, cumulative premating body weight gain was reduced by 21% and 

12% for P males and females, respectively. Body weight gain was also lower for P (8%) and F1 

(10%) females during gestation. Increased kidney and liver weights were seen in the 1800 ppm 

treatment group animals of both generations and adrenal weights were reduced in the P females. 

Relative (to body weight) testes and epididymides weights were increased in the 1800 ppm F1 

males. The reproductive NOAEL in males and females was 1800 ppm (overall study intake of 

122.0 mg/kg bw/day in males and 169.1 mg/kg bw/day in females; premating intake of 137 

mg/kg bw/day in males and 149 mg/kg bw/day in females) based on an increase in post-natal pup 

loss between days 0-4 in both P and F1 generations. The reproductive LOAEL was not 

determined as no treatment-related effects on reproductive performance were observed.
-Page 47 of 117- 

3.3.2.3. Toxicity to Terrestrial Invertebrates and Beneficial Insects 

Honeybees

Acute contact toxicity data bees was required, and 48-hr acute contact toxicity studies 

using fluensulfone TGAI, and the 480EC formulation were submitted to establish the toxicity of 

fluensulfone to young adult honeybees (Apis mellifera). In addition, non-guideline honeybee 

acute oral and bumblebee drip irrigation toxicity studies were submitted for the 480EC 

formulation (Table 3.45).

Table 3.45. Honeybee Acute Toxicity to Fluensulfone TGAI and to the MCW2 480EC 

Formulation.

Test Species/ 

Test Substance

Exposure 

Route

% 

a.i.1

Endpoint

(95% C.I.)

Slope

Toxicity 

Category MRID Study Classification

Honeybee

(A. mellifera)

(TGAI)

Acute 

contact 96.5

48-hr LD50 = 167 μg a.i./bee

(141-210 μg a.i./bee)

Slope = 4.73 (2.80-6.66)

[Endpoints Affected: mortality 

and moving and coordination 

problems]

Practically 

Nontoxic 48574879 Supplemental2Quantitative

Honeybee

(A. mellifera)

(MCW-2 480 EC 

Formulation)

Acute 

contact 41.99

48-hr LD50 = >200 μg a.i./bee3

(NA)

Slope = NA

[Endpoints Affected: no 

mortality or behavioral 

abnormalities]

Practically 

Nontoxic

48574934

Supplemental2

Quantitative

Acute oral 41.99

48-hr LD50 = 83.7 μg a.i./bee

(42.0-97.8 μg a.i./bee)

Slope = 4.69 (3.25-6.14)

[Endpoints Affected: no 

behavioral abnormalities]

Practically 

Nontoxic

Supplemental

Quantitative

Bumble Bee 

(Bombus sp.)

(MCW-2 480 EC 

Formulation)

Drip 

Irrigation 40.4

NOAEL: 3.5 lb a.i./A

(3930 g a.i./hectare).

LOAEL: >3.5 lb a.i./A

(>3930 g a.i./hectare).

[Endpoints Affected: no 

observed effects.]

--

4

48574910

Supplemental/ 

Quantitative

Non-Guideline2

Slope = NA – Confidence intervals and probit slope calculations were not available; no endpoints were affected. 

1

Fluensulfone active ingredient. 

2

 Some uncertainty exists due to a lack of confirmation that the test organisms were randomly assigned to 

treatments, although described catching method may have produced some randomization. 

3 Mortality was 23% in the 200 ug a.i./bee treatment; no behavioral abnormalities were observed. 

4

 No effects seen at maximum label allowance. 

The 48-hr LD50 was 167 μg a.i./bee from fluensulfone TGAI exposure (MRID 

48574879). Mortality was 16.7% and 63.3%, respectively, for 100 and 200 g/bee treatments. 

Behavioral abnormalities, including moving and coordination problems, were observed for bees 

treated at 100 and 200 g/bee after 4 hours. For all surviving bees no behavioral differences were 

observed compared to control bees, at the 24 and 48 hour assessments. 
-Page 48 of 117- 

The 480EC formulation was less toxic than parent to the honeybee on an acute contact 

exposure basis (MRID 48574934, also see Appendix G, Table G.5.). From both TGAI and 

480EC studies, fluensulfone is classified as practically non-toxic to bees.

Information from non-guideline acute oral bee data shows a 48-hr LD50 of 83.7 μg 

a.i./bee (MRID 48574934); the non-guideline bumble-bee drip-irrigation study shows a NOAEL 

of 3.5 lb a.i./A based on no observed effects at the concentration tested (MRID 48574910). 

Other Terrestrial Invertebrates and Beneficial Insects 

As shown in Table 3.46, additional terrestrial invertebrate toxicity studies were 

submitted for earthworms (Eisenia fetida), the parasitic wasp (Aphidius rhopalosiphi), the 

predatory mite (Typhlodromus pyri), the predatory minute pirate bug (Orius laevigatus), and the 

green lacewing (Chrysoperla carnea). 

Table 3.46. Toxicity to Other Terrestrial Invertebrates and Beneficial Insects using 

Fluensulfone TGAI and the MCW2 480EC Formulation.

Test Species / 

Test Substance Purity1 Endpoint Effect MRID Study Classification

Studies with Technical Active Ingredient:

Earthworm

Eisenia fetida

(TGAI)

96.5% a.i.

14-day LC50 = 148 (133-163) 

mg a.i./kg soil dw

Slope = NA

NOAEC = 48.3 mg a.i./kg 

soil dw

Mortality/ Weight

(NOAEC based on 

weight)

48574880

Supplemental

(non-guideline 

study)

Studies with Degradates:

Earthworm

E. fetida

(Degradate –

Thiazole Sulfonic 

Acid)

99.6% TS 

Acid

14-day LC50 >300 mg TS 

Acid /kg soil dw

Slope = NA

NOAEC = 300 mg TS Acid 

/kg soil dw (nominal)

No Effects 48574881

Supplemental

(non-guideline 

study)

Earthworm

E. fetida

(Degradate – Butene 

Sulfonic Acid)

99.5% BS 

Acid

14-day LC50 >300 mg BS 

Acid /kg soil dw

Slope = NA

NOAEC = 75.0 mg BS Acid 

/kg soil dw (nominal)

Mortality/ Weight

(NOAEC based on 

weight)

48574882

Supplemental

(non-guideline 

study)

Earthworm

E. fetida

(Degradate – Methyl 

Sulfone)

98.7% MS

14-day LC50 >50 mg MS /kg 

soil dw

Slope = NA

NOAEC = 25.0 mg MS /kg 

soil dw (nominal)

Weight248574883

Supplemental

(non-guideline 

study)

Studies with Formulation:

Earthworm

E. fetida

(MCW-2 480 EC)

492.7 g 

a.i./L

14-day LC50 = 57.4 (53.1-

62.2) mg a.i./kg soil dw

Slope = NA

NOAEC = 10.5 mg a.i./kg 

soil dw 

Mortality/ Weight

(NOAEC based on 

weight)

48574939

Supplemental

(non-guideline 

study)

Earthworm

E. fetida

492.7 g 

a.i./L

56-d EC50 = 23.0 (22.0-24.0) 

mg a.i./kg soil dw 

Mortality and 

Reproduction: 48574940 Supplemental (non-guideline 
-Page 49 of 117- 

Test Species / 

Test Substance Purity1 Endpoint Effect MRID Study Classification

(MCW-2 480 EC) NOAEC = 10.5 mg a.i./kg 

soil dw

Weight and 

Number of 

Juveniles

study)

Parasitoid wasp

Aphidius 

rholaposiphi

(MCW-2 480 

EC) 

492.7 g 

a.i./L

48-hr LR50 = 0.0145 lb 

a.i./A (nominal) (16.2 g 

a.i./ha, 33.7 [27.4-39.2] ml 

480 EC/ha)

NOAEL = >0.0086 lb 

a.i./A (nominal) (>9.6 g 

a.i./ha, >20 ml 480 EC/ha)

Survival/

No Effects in 

Reproduction

48574936

Supplemental 

(non-guideline 

study)

Predatory mite, 

Hypoaspis 

aculeifer

(MCW-2 480 

EC)

492.7 g 

a.i./L

The 14-day EC50 = 86.5 

(79.5-93.7) mg a.i./kg soil dw 

(205.9 mg 480 EC/kg soil 

dw) 

NOEC = 55.4 mg a.i./kg soil 

dw (132 mg 480 EC/kg soil 

dw)

Reproduction: 

Number of 

progeny

48574937

Supplemental 

(non-guideline 

study)

Predaceous mite

Typhlodromus 

pyri

(MCW-2 480 

EC)

492.7 g 

a.i./L

7-day LR50 = 0.892 lb a.i./A 

(nominal) (1000 g a.i./ha, 

2080 (1780-2310) ml 480 

EC/ha) 

14-day ER50: >0.892 lb 

a.i./A (nominal) (>1000 g 

a.i./ha, >2080 ml 480 

EC/ha) 

Mortality/

Reproduction 48574935

Supplemental 

(non-guideline 

study)

Springtail, 

Folsomia 

candida

(MCW-2 480 

EC)

492.7 g 

a.i./L

28-day EC50 = 20.9 (16.2-

28.2) mg a.i./kg soil dw 

(49.8 [38.5-67.2] mg 480 

EC/kg soil dw)

NOEC = 15.5 mg a.i./kg 

soil dw (37 mg 480 EC/kg 

soil dw)

Reproduction: 

Number of 

progeny

48574941

Supplemental 

(non-guideline 

study)

Ground-active 

beetle

Aleochara 

bilineata 

(MCW-2 480 

EC)

492.7 g 

a.i./L

ER50 = 6.8 mg a.i./kg soil dw 

(13.8 μl 480 EC/kg soil dw12.7-15.2 μl /kg soil)

NOAEC = 1.49 mg a.i./kg 

soil dw (3.02 μl 480 EC/kg 

soil dw)

Reproduction /

Parasitisation 

success

48574938

Supplemental 

(non-guideline 

study)

NA = Not available; dw = dry weight; LR50 = median lethal rate. 

1

Fluensulfone active ingredient unless otherwise specified. 

2Three worms out of ten died in the 25 mg/kg treatment; however, none died in the 50 mg/kg treatment. Therefore, 

this was not assumed to be treatment related. 

Earthworms 

The results of the 14-day earthworm acute soil exposure toxicity tests with fluensulfone 

TGAI, and the 480EC formulation, show 480EC to be about twice as toxic as parent (LC50 = 

47.4 and 148 mg a.i./kg soil dw (dry weight) (MRIDs 48574939 and 48574880). The NOAEC 

based on weight and mortality was 10.5 and 48.3 mg a.i./kg soil dw (respectively) for 480EC and 
-Page 50 of 117- 

TGAI. An earthworm reproduction and growth toxicity study with 480EC resulted in a 56-d 

EC50 of 23.0 mg a.i./kg soil dw and an NOAEC of 10.5 mg a.i./kg soil dw based on mortality and 

reproduction (weight and number of juveniles, MRID 48574940). 

Earthworm acute toxicity studies using the metabolites TSA, BSA and MS show TSA 

and BSA to be less toxic than parent (MRIDs 48574881 and 48574882), but show MS to 

possibly have similar toxicity to parent a.i. (14-d LC50 >50 mg MS/kg soil dw, compared to 57.4-

148 mg a.i./kg soil dw, MRIDs 48574883, 48574939 and 48574880, also see Appendix F). The 

NOAECs from these studies based on mortality and weight are 25.0 mg MS/kg soil dw 

compared to 10.5-48.3 mg a.i./kg soil dw). 

Beneficial Insects 

Effects on two sensitive species, the parasitic wasp, and the predatory mite, were studied 

using the emulsifiable concentrate 480EC Formulation (40% fluensulfone a.i.). The LR50 values 

(lethal rate to 50% of the test population) were equivalent to an application rate of 0.0145 lbs 

a.i./A for the parasitic wasp (MRID 48574936), and 0.892 lbs a.i./A for the predatory mite

(MRID 48574935). For the wasp, the NOAEL was 0.0086 lb a.i./A based on survival and 

reproductive performance and for the predatory mite. For the predatory mite (T. pyri), the 7-day 

ER50 based on mortality and reproduction was >0.892 lb a.i./A. 

In addition, extended laboratory studies were completed on the predatory mite (H. 

aculeifer), the green lacewing and the ground-active beetle to examine the effects of fluensulfone 

on mortality and reproduction (fecundity and fertility) with the emulsifiable concentrate 480EC 

formulation (40% fluensulfone). The 14-day reproduction study with the predatory mite 

produced an EC50 of 86.5 mg a.i./kg soil dw and an NOAEC of 55.4 mg a.i./kg soil dw based on 

number of progeny (MRID 48574937). A 28-day reproduction EC50 for the springtale was 20.9 

mg a.i./kg soil dw and the NOAEC was 15.5 mg a.i./kg soil dw based on number of progeny

(MRID 48574941). In the ground-active beetle reproduction study, the ER50 was 6.8 mg a.i./kg 

soil dw and the NOAEC was 1.49 mg a.i./kg soil dw based on parasitisation success (MRID 

48574938). 

3.3.2.4. Toxicity to Terrestrial Plants 

 Two Tier I terrestrial non-target plant studies were submitted for the 480EC formulation to 

assess the toxicity of fluensulfone to terrestrial plants. The results of the non-target terrestrial 

plant studies are summarized in Tables 3.47 and 3.48. 
-Page 51 of 117- 

Table 3.47. Summary of Tier I Toxicity of Fluensulfone WCW2 480EC Formulation 

(41.99% a.i.) to Non-target Terrestrial Plants.

Test Species

Seedling Emergence 

(MRID 48574944)

Vegetative vigor 

(MRID 48574943)

1

Test level 

lb a.i./A Endpoint(s) Affected Test level lb a.i./A Endpoint(s) Affected

Monocots

Corn (Zea mays) 3.44 None 2.78 Dry weight (7% reduction)

Onion (Allium cepa)

3.44

Survival (22% reduction)*

Emergence (11% reduction)

Dry weight (19% reduction)

& Height (18% reduction)*

2.78 Dry weight (17% reduction)

& Height (13% reduction)*

Ryegrass (Lolium 

perenne)

3.44

Survival (63% reduction)*

Emergence (36% reduction)*

Dry weight (83% 

reduction)*

& Height (70% reduction)*

2.78 Dry weight (24% reduction)

Wheat (Triticum 

aestivum)

3.44 Dry weight (28% reduction)

& Height (9% reduction)* 2.78 None

Dicots

Cabbage (Brassica 

oleracea) 3.44

Survival (8% reduction)

Emergence (5% reduction)

& Dry weight (16% reduction)

2.78

Dry weight (70% 

reduction)*

& Height (10% reduction)*

Lettuce (Lactuca 

sativa) 3.44 Dry weight (33% reduction) 2.78 None

Radish (Raphanus 

sativus)

3.44 None 2.78 Dry weight (34% 

reduction)*

Soybean (Glycine 

max) 3.44 Dry weight (6% reduction)

& Height (5% reduction) 2.78

Dry weight (50% 

reduction)*

& Height (15% reduction)*

Sugarbeet (Beta 

vulgaris) 3.44

Survival (8% reduction)

Emergence (14% reduction)

Dry weight (14% reduction)

& Height (5% reduction)

2.78 Dry weight (12% reduction)

Tomato

(Lycopersicon 

esculentum)

3.44 None 2.78 Dry weight (11% reduction)

* These species exhibited statistically significant reductions at the limit concentration relative to the negative 

control; therefore, Tier II toxicity studies will be required for these species and the respective studies. 

Bold Endpoints = >25% effect, triggering Tier II data need. 

1

Signs of phytotoxicity included: chlorosis, leaf curl, necrosis, and stem curl.

2

Signs of phytotoxicity included: necrosis, chlorosis, leaf curl, and unshed seed coat.

Based on the results of the submitted Tier I seedling emergence toxicity test (MRID 

48574944), application of 480EC Formulation at the nominal maximum label rate of 3.5 lbs 

a.i./A (3920 g a.i./ha), (measured rate of 3.44 lbs a.i./A, 3860 g a.i./ha), resulted in the following 

adverse effects: 63% reduction in survival, 36% reduction in emergence, 83% reduction in dry 

weight and 70% reduction in height of ryegrass (Lolium perenne), 28% reduction in dry weight 

(also a non-significant 9% reduction in height) of wheat (Triticum aestivum), and 33% reduction 

in dry weight of lettuce (Lactuca sativa). Onions (Allium cepa), cabbage (Brassica oleracea), 
-Page 52 of 117- 

soybeans (Glycine max) and subargeets (Beta vulgaris) also had observed effects in survival, 

emergence, weight and height, though not statistically significant (as compared to controls) nor 

greater than 25%. For other observed phytotoxic effects, onion effects were categorized as 

slight to moderate and ryegrass was the most affected, with severe phytotoxic effects. 

Based on the results of the submitted Tier I vegetative vigor toxicity test (MRID 

48574943), application of 480EC Formulation at the nominal maximum label rate of 3.5 lbs 

a.i./A (3920 g a.i./ha), (measured rate of 2.78 lbs a.i./A, 3120 g a.i./ha), resulted in adverse 

effects on dry weight of cabbage, radish (Raphanus sativus) and soybean, with reductions of 

70%, 34% and 50%, respectively. Cabbage and soybeans also showed some reduction in height 

(10% and 15%, respectively). Corn (Zea mays), onion, ryegrass and sugarbeet also had reduced 

weight and/or height, though not statistically significant (as compared to controls) nor greater 

than 25%. 

 Since greater than 25% inhibitory effects were measured in both seedling emergence and 

vegetative vigor, Tier II studies were required. Results are summarized in Table 3.48. 

Table 3.48. Summary of Tier II Toxicity of Fluensulfone WCW2 480EC Formulation 

(41.99% a.i.) to Non-target Terrestrial Plants, lbs a.i./A (g a.i./ha).

Study Species Most sensitive parameter NOAEC EC25

Seedling Emergence (MRID 48574945)

Monocots

Corn (Z. mays) None 4.04 (4530) >4.04 (>4530)

Onion (A. cepa) Height 1.21 (1360) 2.50 (2800)

Ryegrass (L. perenne) Height 1.21 (1360) 3.21 (3600)

Wheat (T. aestivum) None 4.04 (4530) >4.04 (>4530)

Dicots

Cabbage (B. oleracea) None 4.04 (4530) >4.04 (>4530)

Lettuce (L. sativa) None 3.77 (4230) >3.77 (>4230)

Radish (R. sativus) Survival 1.22 (1370) >3.77 (>4230)

Soybean (G. max) Emergence & survival 0.141 (158) >3.77 (>4230)

Sugarbeet (B. vulgaris) None 3.77 (4230) >3.77 (>4230)

Tomato (L. esculentum) None 3.87 (4340) >3.87 (>4340)

Vegetative Vigor (MRID 48574972)

Monocots

Corn (Z. mays) None 3.49 (3910) >3.49 (3910)

Onion (A. cepa) Height 1.11 (1250) >3.49 (3910)

Ryegrass (L. perenne) None 3.49 (3910) >3.49 (3910)

Wheat (T. aestivum) Height 0.0415 (46.5) >3.49 (3910)

Dicots

Cabbage (B. oleracea) Dry Weight 0.419 (470) 1.31 (1470)

Lettuce (L. sativa) Dry Weight 1.19 (1340) >3.66 (4100)

Radish (R. sativus) Dry Weight 0.396 (444) 3.02 (3390)

Soybean (G. max) Dry Weight 0.419 (470) 1.15 (1290)

Sugarbeet (B. vulgaris) None 3.66 (4110) >3.66 (4100)

Tomato (L. esculentum) Dry Weight 1.11 (1250) >3.49 (3910)

Bold Endpoints were the most sensitive and used for risk calculations.
-Page 53 of 117- 

 In the Tier II seedling emergence study (MRID 48574945), the most sensitive monocot 

species was onion, based on height, with NOAEC and EC25 values of 1.21 and 2.50 lb a.i./A, 

respectively. Height was significantly affected in ryegrass, as well, along with emergence and 

survival. Dry weight was also significantly affected in the onion. The most sensitive dicot was 

soybean, based on emergence and survival, with NOAEC and EC25 values of 0.141 and >3.77 lb 

a.i./A, respectively. Survival was significantly affected in the radish. For radish, the % 

inhibition in seedling emergence compared to control ranged from -6 to 38%. An EC25 of 5.92 

lbs a.i./A was calculated for radish; however this estimation was extrapolated beyond the range 

of concentrations tested and should be interpreted with caution..

Phytotoxic effects included necrosis, chlorosis, leaf curl, and stem curl. Instances of 

these effects were scattered and did not follow a dose response relationship. There were slight 

effects for corn, onion, tomato, sugarbeet, lettuce, soybean, and radish, though for lettuce there 

was a slightly higher level of phytotoxicity expressed in the control as compared to the treatment 

groups. Wheat and cabbage had ratings lower than those categorized as slight effects. Ryegrass 

experienced moderate phytotoxic effects. 

In the Tier II vegetative vigor study the most sensitive monocot was wheat with an 

NOAEC and EC25 of 0.0415 and >3.49 lb a.i./A, respectively (46.5 and >3910 g a.i./ha), based 

on height (MRID 48574972). The most sensitive dicot was cabbage with an NOAEC and EC25

0.419 and 1.31 lb a.i./A, respectively (470 and 1470 g a.i./ha) based on dry weight. Plant height 

was significantly affected in onion, wheat and soybean. Dry weight was significantly affected in 

onion, cabbage, lettuce, soybean, tomato and radish. There was no effect on survival for any 

species. 

Signs of toxicity included adventitious growth, chlorosis, leaf curl, necrosis, plant death, 

stem curl and wilt. Based on the phytotoxicity rating used by the study author, ryegrass 

experienced little to no effects; corn, onion, wheat, tomato, sugarbeet, and lettuce experienced 

slight effects; and cabbage, soybean, and radish experienced moderate effects. 

The study was classified as supplemental due to damage to control radishes and 

soybeans. In radishes, control damage included necrosis, wilt and plant death; therefore, some 

uncertainty is acknowledged. However, since plant sensitivities tend to run in plant families and 

since cabbage data is available (same plant family as the radish) an assumption can be made that 

the radish would exhibit similar sensitivity and, therefore, this is not likely to impact the risk 

assessment conclusions. Necrotic effects were also seen in soybean controls, though less severe 

(but possibly more widespread). The soybean data are still useable, but the control necrosis adds 

to the uncertainty of the soybean results. Soybean was the most sensitive dicot (as well as 

overall) based on dry weight, though the results for the radish and cabbage (where only 1 plant of 

30 suffered necrosis in the controls) are closely similar. Thus the impact of rejecting the soybean 

part of the test would seem to have limited impact on the final endpoint for vegetative vigor. 

The cabbage data, with almost identical endpoints were used, being deemed slightly more 

reliable; the impact on the risk picture from chosing cabbage or radish as the most sensitive dicot 

was insignificant. It is also noted that in the related Tier I Vegetative Vigor study (MRID 
-Page 54 of 117- 

48574943), no necrosis was noted in the controls for either radish or soybean (also true for 

cabbage). It is also noted that again cabbage, radish and soybean were the most sensitive plants, 

the only species where reductions of >25% relative to the control were noted. There therefore 

seems to have been some unique problems with the radish and soybean controls in the Tier II 

study, but even if both results were rejected the final endpoint based on the cabbage results are 

very similar and unlikely to be a significant issue in the terrestrial plant risk assessment. 

Therefore, no new data are needed at this time. 

4. Risk Characterization 

 4.1 Risk Estimation

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

ecological effects on non-target species. As discussed previously, this baseline-level assessment 

of fluensulfone relies on the deterministic RQ method to provide a metric of potential risks. The 

RQ provides a comparison of exposure estimates to toxicity endpoints (i.e., the estimated 

exposure concentrations are divided by acute and chronic toxicity values). The resulting RQs are 

compared to the Agency’s LOCs, as shown in Table 2.3. LOCs are used by the Agency to 

indicate when the use of a pesticide, as directed by the label, has the potential to cause adverse 

effects to non-target organisms. 

 

 4.1.1. Aquatic Organisms 

The highest baseline-level aquatic EECs were used to derive RQs. These exposure 

estimates were based on the proposed uses of fluensulfone to control nematodes on Crop Groups 

8 (fruiting vegetables) and 9 (cucurbits) using PRZM/EXAMS (Appendix A). Peak EECs are 

used to represent acute exposure to fish, aquatic invertebrates, and aquatic plants, and the highest 

21-day and 60-day average EECs represent chronic exposure to aquatic invertebrates and fish, 

respectively. In addition, to evaluate the acute risk to non-target aquatic organisms resulting 

from exposure to the 480EC formulation via spray drift, EECs were calculated using AgDRIFT 

(Table 3.13 and Appendix B). 

4.1.1.1. Aquatic Animals 

Table 4.1 lists RQs calculated for aquatic animals exposed to fluensulfone, based on the 

highest PE-calculated EECs listed in Table 3.12, for Crop Groups 8 and 9. These EECs are 

based on the TTR exposure from both fluensulfone and the degradate of concern, MS (Appendix 

A). 

The acute RQs based on the highest TTR EECs (parent + MS degradate) for the proposed 

use patterns of fluensulfone for Crop Groups 8 and 9 were all <0.01. No fish or aquatic 

invertebrate taxon had an RQ above the Agency’s acute risk LOC (0.05) for listed species, based 

on fluensulfone TGAI toxicity. 
-Page 55 of 117- 

Table 4.1. Aquatic Animal RQs (Risk Quotients) for Exposure to Fluensulfone TTR 

(TGAI plus MS) Resulting from Runoff and Drift from Proposed Uses on Transplanted 

Crop Groups 8 and 9.

Taxa

Surface Water EEC

μg/L

Endpoint 

Used

μg a.i./L

(MRID)

RQ values

Fruiting 

Veg. Cucurbits Based on Fruiting Vegetable (Group 8)

Based on Cucurbit 

(Group 9)

Acute Exposure

Freshwater Fish Peak/ 15.2 Peak/ 17.6 LC50 = 130001<0.01 <0.01

Estuarine/Marine Fish Peak/ 15.2 Peak/ 17.6 LC50 = 280002<0.01 <0.01

Freshwater Invertebrates Peak/ 15.2 Peak/ 17.6 EC50 = 2200

3

<0.01 <0.01

Estuarine/Marine 

Invertebrates Peak/ 15.2 Peak/ 17.6 EC50 = 78004

<0.01 <0.01

Chronic Exposure

Freshwater Fish 60-d/ 8.7 60-d/ 10.7 NOAEC = 

6305

0.01 0.01

Estuarine/Marine Fish 60-d/ 8.7 60-d/ 10.7 0.01 0.01

Freshwater Invertebrates 21-d/ 12.2 21-d/ 14.8 NOAEC = 

2006 0.06 0.07

Estuarine/Marine 

Invertebrates 21-d/ 12.2 21-d/ 14.8 NOAEC = 3707 0.03 0.04

Sediment-Dwelling 

Organisms

Peak/ 3.4 Peak/ 7.7 10-d NOAEC 

= 660008

<0.01 <0.01

21-d/ 3.3 21-d/ 7.1 <0.01 <0.01

Bolded and shaded values indicate RQs that exceed the Agency’s acute risk LOC (0.05 - listed species; or 0.5 - 

non-listed species) or chronic risk LOC (1.0). Asterisk (*) indicates that only the listed species LOC was exceeded. 

1Based on bluegill mortality (MRID 48574853). 

2Based on sheepshead mortality (MRID 48574852). 

3Based on daphnid mortality and lethargy (MRID 48574855). 

4Based on oyster shell-growth inhibition (MRID 48574865). 

5 Based on fathead minnow NOAEC = 630 (48574854) – used for both freshwater and saltwater calculations. 

6Based on daphnid NOAEC = 200 (MRID 48574856). 

7Based on mysid NOAEC = 370 (MRID 48574857). 

8Based on chironomid 10-day survival NOAEC, using pore water concentration (MRID 48574862). 

As shown in Table 4.1, chronic RQ values for aquatic taxa (including sediment-dwelling 

organsims) were less than the Agency’s chronic LOC (1.0) based on TTR exposure. 

Further characterization of the available fish and aquatic invertebrate acute and chronic toxicity 

data for the fluensulfone formulated products is also provided as part of the risk description in 

Section 4.2.1.1.
-Page 56 of 117- 

Table 4.2 lists the RQs that were calculated to characterize the risk potential relating to 

non-target aquatic organisms exposed to the 480EC formulation via spray drift. RQs were based 

on the spray drift EECs that were calculated using AgDRIFT (Table 3.13 and Appendix B). 

Table 4.2. Aquatic Organism RQs for Exposure (via Spray Drift) to the MCW2 480EC 

Formulation. 

Taxa

Study Type

Spray 

Drift 

EEC1

μg/L

Formulation

Endpoint Used

μg a.i./L

RQ values*

1

Buffer 

Distance 

Needed to 

Remove 

Presumption 

of Risk, 2ft

Freshwater Fish: 

 Bluegill Acute

12.1

LC50 = 25003<0.01 0

Estuarine/Marine Fish:

 Sheepshead Acute LC50 = 59004

<0.01 0

Freshwater Invertebrates: 

 Daphnid Acute EC50 = 38050.03 0

Estuarine/Marine Invertebrates:

 Oyster Shell Deposition Acute EC50 = 776

0.16* 49

Non-Vascular Aquatic Plants: 

 Listed Species7 NOAEC = 3.47

3.56 62

Bolded and shaded values indicate RQs that exceed the acute risk LOC (0.05 - listed animal species; 0.5 - nonlisted animal species; 1.0 for aquatic plants) or chronic risk LOC (1.0). Asterisk (*) indicates that only the listed 

species LOC was exceeded. N/A = Not Applicable. 

1

 Based on the highest calculated spray drift EEC value using AgDRIFT for application by high boom and very fine 

to fine droplet size - using the maximum proposed single agriculture application rate of 3.5 lbs a.i./A. 

2 Removal of presumption of risk is defined by the endpoint times the acute LOC for listed species (0.05). 

3

 MRID 48574929. 

4

 MRID 48574928. 

5

 MRID 48574930. 

6 Based on oyster shell-growth inhibition (MRID 48574933). 

8

 No non-vascular aquatic plant species are currently listed in the US. 

7 Based on P. subcapitata cell density and yield (MRID 48574931).

Due to the higher toxicity of the formulated product and the use of these data as the basis 

for calculating risk from spray drift, the risk calculations were greater than for runoff. The RQ 

for estuarine/marine invertebrates exceeds the listed species LOC (0.05). The RQ for nonvascular aquatic plants exceeds the LOC (1.0) based on the listed species RQ estimate. An 

estimate buffer of 49 feet is estimated for removal of the presumption of risk to estuarine/marine 

invertebrates, but the risk is readily reduced by specifying either a low boom and 3 foot buffer or 

use of coarse droplet size (Appendix B). 

4.1.1.2. Aquatic Plants 

Table 4.3 summarizes RQ values and LOC exceedences for aquatic and terrestrial plants 

based on exposure to TTR (parent plus MS) and parent alone. 
-Page 57 of 117- 

Table 4.3. Aquatic Plant RQs for Exposure to Fluensulfone at maximum proposed 

application rate of 3.5 lb a.i./A for nematode control in Crop Groups 8 and 9. 

Taxa

Surface Water 

EEC

μg a.i./L Endpoint 

Used

μg a.i./L

RQ values

Fruiting 

Veg. Cucurbits

Based on Fruiting 

Vegetable 

(Group 8)

Based on 

Cucurbit 

(Group 9)

Aquatic vascular 

plants1

NonListed Peak/ 9.6 Peak/ 14.5

EC50 = 2700 <0.01 <0.01

Listed NOAEC = 490 0.020 0.030

Aquatic nonvascular plants2

NonListed Peak/ 9.6 Peak/ 14.5

IC50 = 22 0.436 0.659

Listed IC05 = 11 0.872 1.318

Bolded and shaded values indicate RQs that exceed the LOC (1.0) for listed and/or non-listed aquatic plants. 

1

 Based on L. gibba biomass yield (MRID 48574863). 

2

 Based on P. subcapitata cell density (MRID 48574858).

RQ values for listed non-vascular plants based on fluensulfone exposure exceed the 

Agency’s listed species LOC for non-vascular plants from the proposed use on Crop Group 9 

only (Table 4.3). A 3-foot buffer or specification of low boom or coarse droplet size readily 

reduces this risk (Appendix B).

 4.1.2. Terrestrial Organisms 

Table 4.4 through 4.6 summarize RQs and LOCs for avian (also surrogate for reptiles 

and terrestrial-phase amphibians) and mammalian exposure to fluensulfone based on residue on 

food as estimated using TREX and on spray-drift residue as estimated using AGDRIFT, as well 

as the distance from the application site to which risk no longer exceeds concern levels. 

Table 4.4. Avian RQs for Acute Exposure to Fluensulfone at maximum proposed 

application rate of 3.5 lb a.i./A for nematode control in Crop Groups 8 and 9.

Avian Dose-based Acute RQs

Type of Food 20 g bird 100 g bird 1000 g bird

Arthropods 2.84 1.27 0.40*

Seeds 0.45* 0.20* 0.06

Grains 0.10* 0.05 0.01

Mammalian Dose-based RQs

Type of Food 15 g mammal 35 g mammal 1000 g mammal

Acute Chronic Acute Chronic Acute Chronic

Arthropods 0.21* 7.80 0.18* 6.66 0.10*

1

3.57

Seeds 0.03 1.24 0.03 1.06 0.02 0.57

Grains <0.01 0.28 <0.01 0.24 <0.01 0.13

Avian and Mammalian Dietary-based RQs
-Page 58 of 117- 

Type of Food EECs (ppm)

Kenaga Values

Avian Mammalian 

Acute RQs Chronic 

RQs3 Acute RQs3 Chronic RQs

Seeds 53 <0.012

0.21 0.21

Arthropods 329 <0.0621.29 1.32

Bolded and shaded values indicate RQs that exceed the Agency’s acute risk LOC (0.1 - listed species; or 0.5 - nonlisted species) or chronic risk LOC (1.0). Asterisk (*) indicates that only the listed species LOC was exceeded. 

1

Please note that an RQ matching the LOC is considered to exceed the LOC.

2Definitive sub-acute dietary toxicity data were unavailable due to low toxicity and so RQ calculations are presented 

as less than (<) values – these are not definitive RQs but constitute an upper bounding of the true RQs.

Table 4.5. Terrestrial RQs for Exposure (via Spray Drift) to the MCW2 480EC 

Formulation. 

Taxa

RQ and Spray Drift Fraction of Applied to 

Remove Presumptin of Risk1

Distance From Application 

Site From Which LOCs are 

no Longer Exceeded,

2

ft

Acute Chronic

Acute Chronic

RQ3 Fraction RQ3 Fraction

Both Birds and Mammals Consuming the Following Items:

Arthropods NA – N/A4,5 1.29 - 1.32 0.775-0.758 NA – N/A 3.3

Bolded and shaded values indicate RQs that exceed the acute risk LOC (0.1 - listed species; or 0.5 - non-listed species). 

Asterisk (*) indicates that only the listed species LOC was exceeded. 

NA = Information Not Available; N/A = Not Applicable. 

1 Target is LOC/RQ. 

2 Defined as the endpoint times the acute LOC for listed species (0.05). 

3 RQs from TREX were based on dietary toxicity data presented in Table 3.28: mallard LC50 (MRID 48574845), Mallard 

NOAEC (MRID 48574846) and rat NOAEL (MRID 48574769).

4The bird acute dietary toxicity endpoint was non-definitive; however this was due to low toxicity; therefore acute dietary toxicity 

is potentially exceeded for birds eating short grass due to applied safety factors. 

5 For Acute Dietary RQs, bird RQs were below the LOC with the exception of short grass consumers; dietary acute toxicity 

information for mammals was not available. 

Table 4.6. Characterization of Minimum Foraging Area Needed to Allow for Ingestion of 

Sufficient Mass of a.i. to Achieve LOC Exceedance 

Mammalian Assessment1

Foraging area (square feet) needed to achieve LOC exceedance assuming 100% 

feeding efficiency 2.28

Foraging area (square feet) needed to achieve LOC exceedance assuming 50% 

feeding efficiency 4.55

Foraging area (square feet) needed to achieve LOC exceedance assuming 10% 

feeding efficiency 22.75

1Avian assessment was unavailable due to lack of chronic dose-based data. 

4.1.2.1. Birds 

As shown in Table 4.4, acute LOCs based on dose-based toxicity estimates are exceeded 

for non-listed small and medium birds feeding on arthropods. Listed species LOCs are also 

exceeded for small granivores, small and medium seed eaters and large birds feeding on 
-Page 59 of 117- 

arthropods. Chronic LOCs are exceeded based on dietary toxicity for birds feeding on 

arthropods. The chronic LOC is also exceed for birds consuming arthropods (RQ of 1.3) from 

spray drift exposure for a distance of up to 3-72 feet from an application site (Table 4.5; also see 

Appendix B). Specifying low boom and/or coarse droplets reduces the spatial extent of the LOC 

exceedances to 7-10 feet from an application site for medium and small birds feeding on 

arthropods. 

An estimated EC50 for regurgitation of 540 mg a.i./kg-bw (310-1340 mg a.i./kg-bw; slope 

1.7) generated from the canary study (Table 3.39) was deemed useable for risk description. The 

EEC’s generated by TREX (Table 3.23) show that birds in the study area may be exposed to 

fluensulfone levels between 96 and 375 mg a.i./kg-bw on arthropod food items and between 3 

and 13 mg a.i./kg-bw on seeds. According to this screening, the exposure levels are less than the 

EC50 for regurgitation, but some are above levels known to cause regurgitation (NOAEC of <155 

mg a.i./kg-bw). None of the EECs can be discounted as possibly producing regurgitation, since 

the NOAEC is not definitive. Therefore, arthropods and seeds in the study area may produce 

regurgitation which may lead to adverse effects. Since this exposure is expected to be patchy 

rather than widespread (assuming no aerial spray and immediate incorporation), this may not be 

a problem on a population scale; however, the extent of the effect is unknown. 

4.1.2.2. Mammals 

Similar to birds, acute LOCs based on dose-based toxicity estimates are exceeded for 

listed small, medium and large mammals feeding on arthropods. Chronic LOCs are exceeded 

based on both dose-based and dietary toxicity for mammals feeding on arthropods (Table 4.4). 

The chronic LOC is also exceed for mammals consuming arthropods (RQ of 1.3) up to an 

estimated 3.3 feet from the application site (Table 4.5). A further breakdown of distances 

associated with LOC exceedances is found in Appendix B. TREX calculations show that only a 

small foraging area is needed (2-23 sq. ft., depending on feeding efficiency) for a mammal to 

consume enough fluensulfone to exceed the LOC (Table 4.6). 

4.1.2.3. Terrestrial Invertebrates 

Fluensulfone is classified as practically non-toxic to honey bees on an acute contact and 

oral exposure basis, based on available data for the TGAI and the 480EC formulation. Using the 

arthropod EEC of 329 mg ai/kg-diet (from TREX calculations above) and a bee weight estimate 

of 0.128g, a risk quotient can be estimated at 0.25 which exceeds the endangered species LOC 

(0.05). Additional characterization of the potential effects of fluensulfone on terrestrial 

invertebrates, and beneficial insects, including consideration of non-guideline laboratory studies 

with non-target arthropods, is provided as part of the risk description in Section 4.2.2.2. 

Additionally, Appendix B presents a breakdown of distances from application sites associated 

with LOC exceedances for listed terrestrial invertebrates; risk extends up to 3 feet with low 

boom and coarse droplets to 16 feet with high boom and fine droplets. 
-Page 60 of 117- 

4.1.2.4. Terrestrial Plants 

RQ values for listed semi-aquatic dicots exceed the Agency’s LOC of 1.0 based on 

fluensulfone exposure from the proposed use (RQ of 2.3). No other LOCs were exceeded for 

terrestrial plants (Table 4.7).

Table 4.7. Terrestrial Plant RQs for Exposure to Fluensulfone at maximum proposed 

application rate of 3.5 lb a.i./A for nematode control in Crop Groups 8 and 9. 

Taxa

EECa

lb a.i./A

Endpoint Used

Seedling Emergence/ 

Vegetative Vigor

lb a.i./A

RQ values*

Dry SemiAquatic

Spray 

Drift Dry SemiAquatic

Spray 

Drift

Fluensulfone Alone 

Monocots

Non-Listed

0.064 0.327 0.035

EC25 = 2.501/>3.492

<0.1 0.13 <0.1

Listed NOAEC = 1.211 /0.04152

<0.1 0.27 <0.1

Dicots

Non-Listed EC25 = >3.773/ 1.314

<0.1 <0.1 <0.1

Listed NOAEC = 0.1413/0.4194

0.46 2.32 <0.1

* RQs that exceed the LOC (1.0) for listed or non-listed terrestrial plants are bolded and shaded. 

1

 Based on onion height (MRID 48574945).

2

 Based on wheat height (MRID 48574972).

3

 Based on soybean emergence and survival (MRID 48574945).

4

 Based on cabbage dry weight (MRID 48574972).

 4.2. Risk Description 

Fluensulfone is characterized as intermediate volatilie under field conditions and 

moderately mobile in soil. Fluensulfone does not undergo hydrolysis. Aqueous photolysis is the 

fastest route of fluensulfone degradation (half-life of 0.58 and 0.68 days). It is quite mobile and 

persists in anaerobic soil. For aerobic aquatic systems, the half-life is slightly longer (39 to 42 

days) than in anaerobic systems (23 to 26 days). Terrestrial field dissipation half-lives are less 

than aquatic (7.4 to 10.8 days) and fluensulfone is not expected to bioaccumulate. 

Based on the effects assessment, fluensulfone is classified as moderately toxic to fish 

(also surrogate for aquatic-phase amphibians) and highly toxic to aquatic invertebrates, on an 

acute basis, based on toxicity of the 480EC formulation. Fluensulfone TGAI alone is only 

slightly toxic to fish and freshwater invertebrates, though highly toxic to mysids and moderately 

toxic to oysters. Chronic exposure of aquatic organisms to fluensulfone resulted in reduced 

survival and growth (weight and length) and an observed sign of toxicity, such as small, weak 

and discolored fish. Fluensulfone is practically non-toxic to birds based on dietary data, and 

ranges from slightly to moderately toxic to birds based on oral dosing data. Fluensulfone has 

low to moderate toxicity to rats. Fluensulfone is practically non-toxic to bees (the 480EC 

formulation being less toxic than TGAI to this taxon). 

 The results of this baseline-level risk assessment indicate that the proposed use of 

fluensulfone for nematode control on Crop Groups 8 and 9 has the potential for direct adverse 
-Page 61 of 117- 

acute effects on listed birds, mammals, terrestrial invertebrates, aquatic invertebrates (except 

sediment-dwellers) and aquatic and semi-aquatic plants. All proposed uses of fluensulfone result 

in potential direct adverse chronic effects on listed and non-listed mammals. Based on the 

results of the baseline-level assessment, the risk hypothesis [...the proposed fluensulfone uses 

have the potential to reduce survival, reproduction, and/or growth in terrestrial and aquatic 

organisms] is supported. These results are based on all application rates for the proposed 

fluensulfone use on both crop groups. Although direct adverse effects to fish and sedimentdwelling organisms from fluensulfone use are not expected, indirect effects to these taxa are 

possible, given the effects on aquatic invertebrates and non-vascular aquatic plants, which could 

indirectly impact the aquatic organisms that feed on these species. 

4.2.1. Risks to Aquatic Organisms 

4.2.1.1. Risks to Aquatic Animals 

Acute RQs for fish and freshwater invertebrates did not exceed the Agency’s listed 

species LOC (0.05) for the proposed use to control nematodes on Crop Groups 8 and 9. 

Additionally (Table 5.2), the probability for acute direct effects (i.e., mortality) to individual 

listed fish at the highest derived RQ value is likely very low, ~>1 in 8.86E+18. The probability 

for acute direct effects to individual listed freshwater invertebrates at the highest derived RQ 

value is 1 in 1.69E+06. Marine invertebrates were the only taxa that had an RQ above the 

Agency’s acute risk to listed species LOC of 0.05 (RQ = 0.16 from spray drift). The probability 

for acute direct effects to individual listed estuarine/marine invertebrates ranges was low (~1 in 

4.18E+08) for mysids exposed at the listed species LOC. 

For chronic risk, the Agency’s chronic LOC (1.0) was not exceeded for freshwater 

invertebrates based on TTR exposure 

4.2.1.2. Risks to Aquatic Plants 

Listed non-vascular aquatic plants were determined to be at risk if exposure occurs. 

However, no non-vascular aquatic plant species are currently listed in the US. 

4.2.2. Risks to Terrestrial Organisms 

4.2.2.1. Birds, Terrestrial-Phase Amphibians and Reptiles 

Acute LOCs based on dose-based toxicity estimates were exceeded for non-listed small 

and medium birds feeding on arthropods. Listed species LOCs were also exceeded for small 

granivores, and large birds feeding on arthropods. Chronic LOCs are exceeded based on dietary 

toxicity for birds feeding on arthropods. The chronic LOC is also exceed for birds consuming 

arthropods (RQ of 1.3) from spray drift exposure; an estimated 3.3 feet is needed to remove the 
-Page 62 of 117- 

presumption of risk. The probability for acute direct effects to individual listed birds (also 

reptiles and terrestrial-phase amphibians) at the highest derived RQ value range from 1 in 1 to 1 

in 1.05E+17. 

As previously discussed in Section 3.3.2.1, avian acute oral data are now required for 

passerine species, as well as either waterfowl or upland game species. Two passerine studies 

were submitted, one with the canary and one with the zebra finch. Due to regurgitation in the 

canary study at all treatment levels, no useable endpoints were determined apart from a nondefinitive regurgitation NOAEL. A single mortality was observed, but not thought to be 

treatment related. A passerine dietary study was subsequently requested. In response, a zebra 

finch dietary study was submitted. This study was designed to reduce complications caused by 

regurgitation and feed avoidance in the earlier canary oral dosing study. Due to the likelihood of 

avoidance of or aversion to the treated diet, the standard five-day dietary exposure was shortened 

to 24-h. Study authors cited preliminary method work suggesting that in five–day exposures 

starvation threshold existed between 1.2 and 2.3 g/day food consumption per bird. Data were 

not available to confirm the starvation feeding level. By reducing exposure to 24-h in this study, 

however, even birds that ate less than 1.0 grams had good (90 %) survival. With such a short 

exposure, the resulting endpoint calculations were not useable for risk assessment without 

substantiating the starvation level or the trend over more than one day (i.e., birds feeding above 

the starvation rate on the first day might reduce feed consumption subsequently, thus possibly 

underestimating effects). A significant reduction in feed consumption was measured, but, again 

the results could not be quantifiably extrapolated to a 5-day exposure endpoint and therefore, the 

results may be used only qualitatively to describe risk. As described above (Section 4.1.2.1), 

arthropods and seeds in the study area may induce regurgitation and/or food avoidance which 

may lead to lower food intake. Since this exposure is expected to be patchy, rather than 

widespread (assuming no aerial spray and immediate incorporation), this may not be a problem 

on a population scale; however, the extent of the effect is unknown. 

An earthworm fugacity evaluation was conducted to further analyze risks to birds, 

reptiles and terrestrial-phase amphibians through consumption of terrestrial invertebrates 

inhabiting the treated sites or indirect consumption through consuming other vertebrates that 

have consumed tainted invertebrates from the treatment sites (see Appendix D). These 

calculations showed that food-borne uptake exposure does not produce LOC exceedences. 

4.2.2.2. Mammals 

Similar to birds, acute LOCs based on dose-based toxicity estimates were exceeded for 

listed small, medium and large mammals feeding on arthropods. Chronic RQs based on dosebased toxicity were exceeded for all sizes of mammals feeding on arthropods. Chronic LOCs 

were exceeded based on dietary toxicity for mammals feeding on arthropods. The chronic LOC 

is also exceeded for mammals consuming arthropods from spray drift exposure. The probability 

for acute direct effects to individual listed mammals at the highest derived RQ value range from 

1 in 1 to 1 in 1.05E+17. An estimated 3.3 foot buffer is needed to remove the presumption of 
-Page 63 of 117- 

risk. Therefore, labeling language that would preclude spraying within 5 feet of a known feeding 

ground for listed mammals that consume seeds or arthropods is suggested. 

An earthworm fugacity evaluation was conducted to further analyze risks to mammals 

through consumption of terrestrial invertebrates inhabiting the treated sites or indirect 

consumption through consuming other vertebrates that have consumed tainted invertebrates from 

the treatment sites (see Appendix D). These calculations showed that food-borne uptake 

exposure does not produce LOC exceedences. 

4.2.2.3. Terrestrial Invertebrates 

Honeybees 

Fluensulfone is classified as practically non-toxic to honey bees on an acute contact and 

oral exposure basis, based on available data for the TGAI and the 480EC formulation. The 

probability for acute direct effects to individual listed invertebrates at the highest derived RQ 

value was 1 in 1. 

Earthworms

The mandatory soil incorporation for two of the proposed application methods likely 

increases fluensulfone exposure to the earthworm. A very rough comparison of exposure from 

TREX dietary EECs show fluensulfone to be in various parts of the environment in 

concentrations from about 50-850 ppm. With acute toxicity to the earthworm occurring at 

roughly 50-150 ppm and chronic around 10-50 ppm, this line of reasoning indicates potential for 

toxicity to earthworms from the proposed use. Additionally, the target taxon, nematodes, has a 

somewhat similar life history to that of the annelids. 

An earthworm fugacity evaluation was conducted to further analyze risks to terrestrial 

invertebrates inhabiting the treated sites (see Appendix D). These calculations indicated that 

exposure through incorporation or drip-irrigation from 1-15 cm down into the soil does not 

exceed Agency LOC for listed invertebrates (0.05). 

Conclusions from TREX and fugacity evaluations were not consistent. The major 

uncertainty seems to be the concentrations within the soil to which earthworms are exposed. 

TREX calculations represent exposure at the top of the soil column and the fugacity model 

within the soil column to a depth of 15cm. The fugacity model likely better estimates exposure 

to earthworms, and the TREX model exposure to above ground invertebrates. 

Beneficial insects 

If the TREX estimate of the EEC for arthropods (52 ppm) is compared to the toxicity 

endpoints for beneficial insects, reproduction was impaired in the predatory mite, green lacewing 

and ground-active beetle at soil concentrations of about 10-100 ppm. The acute endpoints for the 

predatory mite and parasitic wasp were expressed as lbs a.i./A and ranged from 0.0145 to 0.892 

lb a.i./A. With the application rate of 3.5 lb a.i./A exceeding these endpoints by roughly 4 to 

200x, clearly, above-ground beneficial insects in the treatment area are at risk. 
-Page 64 of 117- 

4.2.2.4. Terrestrial Plants 

Terrestrial plants inhabiting dry areas were not determined to be at any significant risk 

from the proposed use of fluensulfone to control nematodes on Crop Groups 8 and 9. Semiaquatic dicots were determined to be at risk if exposure occurs. However, since spray-drift 

exposure does not pose a significant risk, exposure is unlikely unless by either aerial application 

or failure to incorporate soon enough to prevent runoff. Therefore, label statements preventing 

aerial application and ensuring immediate incorporation would likely reduce this risk. 

5. Federally Threatened and Endangered (Listed) Species 

Concerns

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all 

federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and 

anadromous listed species, and/or the United States Fish and Wildlife Service (USFWS, 2011) 

for listed wildlife and freshwater organisms, if they are proposing an "action" that may affect 

listed species or their designated critical habitat. Each federal agency is required under the Act 

to ensure that any action they authorize, fund, or carry out is not likely to jeopardize the 

continued existence of a listed species or result in the destruction or adverse modification of 

designated critical habitat. To jeopardize the continued existence of a listed species means "to 

engage in an action that reasonably would be expected, directly or indirectly, to reduce 

appreciably the likelihood of both the survival and recovery of a listed species in the wild by 

reducing the reproduction, numbers, or distribution of the species" (50 C.F.R. § 402.02). 

To facilitate compliance with the requirements of the Endangered Species Act 

(subsection (a)(2)), the Office of Pesticide Programs has established procedures to evaluate 

whether a proposed registration action may directly or indirectly appreciably reduce the 

likelihood of both the survival and recovery of a listed species in the wild by reducing the 

reproduction, numbers, or distribution of any listed species (USEPA, 2004). After the Agency’s 

screening level risk assessment is conducted, if any of the Agency’s listed species LOCs are 

exceeded for either direct or indirect effects, an analysis is conducted to determine if any listed 

or candidate species may co-occur in the area of the proposed pesticide use or areas downstream 

or downwind that could be contaminated from drift or runoff/erosion. If listed or candidate 

species may be present in the proposed action area, further biological assessment is undertaken. 

The extent to which listed species may be at risk is considered, which then determines the need 

for the development of a more comprehensive consultation package, as required by the 

Endangered Species Act. 

The federal action addressed herein is the proposed new registration of fluensulfone on 

agricultural and non-agricultural use sites. Given that fluensulfone can be used on both Crop 

Groups 8 and 9, it is expected that its use could occur nationwide. 
-Page 65 of 117- 

 5.1. Action Area

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

affected directly or indirectly by fluensulfone use and not merely the immediate area where 

fluensulfone is applied. At the initial screening-level, the risk assessment considers broadly 

described taxonomic groups and conservatively assumes that listed species within those broad 

groups are co-located with the pesticide treatment area. This means that listed terrestrial plants 

and wildlife are assumed to be located on or adjacent to the treated site and listed aquatic 

organisms are assumed to be located in a surface water body adjacent to the treated site. The 

assessment also assumes that the listed species are located within an assumed area, which has the 

relatively highest potential exposure to the pesticide, and that exposures are likely to decrease 

with distance from the treatment area. Section 3.1 of this risk assessment presents the proposed 

pesticide use sites that are used to establish initial co-location of species with treatment areas. 

 5.2. Taxonomic Groups Potentially at Risk 

 

If the assumptions associated with the screening-level action area result in RQs that are 

below the listed species LOCs, a "no effect" determination conclusion is made with respect to 

listed species in that taxa, and no further refinement of the action area is necessary. Furthermore, 

RQs below the listed species LOCs for a given taxonomic group indicate no concern for indirect 

effects on listed species that depend upon the taxonomic group for which the RQ was calculated. 

However, in situations where the screening assumptions lead to RQs in excess of the listed 

species LOCs for a given taxonomic group, a potential for a "may affect" conclusion exists and 

may be associated with direct effects on listed species belonging to that taxonomic group or may 

extend to indirect effects upon listed species that depend upon that taxonomic group as a 

resource. In such cases, additional information on the biology of listed species, the locations of 

these species, and the locations of use sites are considered to determine the extent to which 

screening assumptions regarding an action area apply to a particular listed organism. These 

subsequent refinement steps will consider how this information would impact the action area for 

a particular listed organism and potentially include areas of exposure that are downwind and 

downstream of the pesticide use site. 

Assessment endpoints, exposure pathways, and the conceptual models addressing 

proposed new fluensulfone uses, and the associated exposure and effects analyses conducted for 

the fluensulfone screening-level risk assessment are in Sections 2 to 3. The assessment 

endpoints used in the screening-level risk assessment include those defined operationally as 

reduced survival and reproductive impairment for both aquatic and terrestrial animal species and 

survival, reproduction, and growth of aquatic and terrestrial plant species from both direct acute 

and chronic exposures. These assessment endpoints are intended to address the standard set 

forth in the Endangered Species Act requiring federal agencies to ensure that any action they 

authorize does not appreciably reduce the likelihood of both the survival and recovery of a listed 

species in the wild by reducing the reproduction, numbers, or distribution of the species. Risk 

estimates (RQs) which, integrating exposure and effects, are calculated for broad based 

taxonomic groups in the screening-level risk assessment presented in Section 4.
-Page 66 of 117- 

Both acute listed species and chronic risk LOCs are considered in the screening-level risk 

assessment to identify direct and indirect effects to taxa of listed species. This section identifies 

direct effect concerns, by taxa, that are triggered by exceeding endangered LOCs in the 

screening-level risk assessment, with an evaluation of the potential probability of individual 

effects for exposures that may occur at the established endangered species LOC. Data on 

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

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

species. Additionally, the results of the screen for indirect effects to listed species, using direct 

effect acute and chronic LOCs for each taxonomic group, is presented and evaluated. Identified 

potential direct and indirect risks to listed species that may result from the proposed uses of 

fluensulfone are summarized in Table 5.1. 

Table 5.1. Potential Direct and Indirect Effects to Federally Listed Taxa from Proposed 

Use of Fluensulfone to Control Nematodes on Crop Groups 8 and 9.

Listed Taxon Direct 

Effects Uses of Concern Indirect Effectsc Uses of Concern

Terrestrial and semiaquatic plants -

monocots

No None No None

Terrestrial and semiaquatic plants - dicots Yes All uses No None

Birds Yes All uses Yes1,2,3 All uses

Terrestrial-phase 

amphibians Yes All uses Yes1,2,3 All uses

Reptiles Yes All uses Yes1,2,3 All uses

Mammals Yes All uses Yes1,2,3 All uses

Terrestrial invertebrates Yesa All uses Yes1,3 All uses

Aquatic vascular and 

non-vascular plants Yes All uses No None

Freshwater fish No None Yes2,4 All uses

Aquatic-phase 

amphibians No None Yes2,4 All uses

Freshwater 

invertebrates No All uses Yes2,4 All uses

Freshwater mollusks Yesb All uses Yes2,4 All uses

Marine/estuarine fish No None Yes2,4 All uses

Marine/estuarine 

invertebrates No All uses Yes2,4 All uses

Marine/estuarine 

molluscs Yesb All uses Yes2,4 All uses

Sediment-dwelling 

organisms No None Yes2,4 All uses

a

 The LOC exceedance was based on lines of evidence including application rate, toxicity data (both pollinators and 

beneficial insects), and the mode of action of fluensulfone. 

b

.Based on exposure from spray drift. 

cPotential indirect effects on a taxon attributable to: 

1

 Direct acute and chronic effects on birds and mammals. 

2

 Direct acute and chronic effects on aquatic invertebrates. 

3 Direct effects to terrestrial plants (dicots). 

4 Direct effects to aquatic plants. 
-Page 67 of 117- 

 5.2.1. Probit Dose-Response Analysis 

The Agency uses the probit dose-response relationship as a tool for providing additional 

information on the potential for acute direct effects to individual listed species and aquatic 

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 (i.e., mortality or immobilization) should exposure at the EEC actually occur for a species 

with sensitivity to fluensulfone 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 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 fluensulfone, a summary of the probit dose-response analysis is provided in Table 6.2. If no 

dose response information is available to estimate a slope for this analysis, a default slope 

assumption of 4.5 (with lower and upper bounds of 2 to 9) (Urban and Cook, 1986) is used. 

Individual effect probabilities are calculated based on an Excel spreadsheet tool IECV1.1 

(Individual Effect Chance Model Version 1.1) developed by the U.S. EPA, OPP, Environmental 

Fate and Effects Division (June 22, 2004). The model allows for such calculations by entering 

the mean slope estimate (and the 95% confidence bounds of that estimate) as the slope parameter 

for the spreadsheet. The desired threshold for the probability of an individual effect is entered as 

the listed species LOC. In addition, the probability of an individual effect is also derived based 

on the calculated acute RQ, if available. 

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

(Based on the Proposed Use on Crop Groups 8 and 9)

Taxa (study 

type)

Acute Effect

Slope (95% C.I.)1

Associated 

RQs

Chance of Individual 

Effect at Listed Species 

LOC (95% C.I.)1

Chance of Individual 

Effect at Derived 

Acute RQ (95% C.I.)

Bird (oral dose)

Bobwhite LD50 = 998

(791-1260)

Slope: 6.08 (3.10-

9.07) 

48574951

Weight Gain 

Inhibition

Mallard NOAEC = 

255

48574846

7.25-0.40

3.29-1.29

1 in 1.66E+09

(1 in 1.03E+03 to 1 in 

1.68E+19)1

1 in 1.00

(1 in 1.00

to 1 in 1.00)

to

1 in 1.05E+17

(1 in 1.36E+05

to 1 in 2.60E+36)

Bird (dietary)2

Bobwhite LC50 >5930 

mg a.i./kg-diet

48574844

>0.15 1 in 2.94E+05

(1 in 4.40E+01 to 1 in 

8.86E+18)

>1 in 9.56E+03

(>1 in 2.01E+01 to >1 

in 1.65E+13)

Mammal (oral Rat LD50 671 mg 0.54-0.10 1 in 2.94E+05 1 in 8.75-2.94E+05
-Page 68 of 117- 

Taxa (study 

type)

Acute Effect

Slope (95% C.I.)1

Associated 

RQs

Chance of Individual 

Effect at Listed Species 

LOC (95% C.I.)1

Chance of Individual 

Effect at Derived 

Acute RQ (95% C.I.)

dose) a.i./kg-bw

48574745

(1 in 4.40E+01 to 1 in 

8.86E+18)

Honeybee

48-hr LD50 = 167 μg 

a.i./bee (766 mg ai/kgbw)

(141-210 μg a.i./bee, 

647-963 mg ai/kg-bw)

Slope = 4.73 (2.80-

6.66)

48574879

Arthropod 

EEC = 329 

mg ai/kgdiet 

bee=0.218g; 

Est RQ:0.43 

(0.34 -

0.51)

1 in 8.91E+05

(1 in 3.91E+02 to 1 in 

7.30E+10)

1 in 1.00

(1 in 1.00

to 1 in 1.00)

Freshwater fish 

(acute)

Bluegill LC50 2.5 mg 

a.i./L1

48574929

<0.01 (no 

exc)

1 in 4.18E+08

(1 in 2.16E+02 to 1 in 

1.75E+31)

<1 in 8.86E+18

Freshwater 

invertebrates 

(acute)

Immobilization and 

sublethal effects

Slope 

Daphnia magna 0.38 [

Slope = 3.19

95% C.I.: 2.18-4.19

48574930

0.026-0.030 

(not exceed)

1 in 6.02E+04 (1 in 

4.38E+02 to 1 in 4.00E+07)

1 in 4.68E+06 to 1 in 

1.69E+06

Estuarine/marine 

fish (acute)

SheepsheadLC50 5.9 

mg a.i./L1

Use Default Slope

48574928

<0.01 (no 

exc) 1 in 4.18E+08

(1 in 2.16E+02 to 1 in 

1.75E+31)

>1 in 8.86E+18

Estuarine/marine 

invertebrates 

(acute)

Mysid Mortality

LC50 = 0.24 mg a.i./L1

48574932

Mysid

1 in 4.18E+08

(1 in 2.16E+02 to 1 in 

1.75E+31)

--

1

 The chance of individual effect at the listed species was calculated using the default slope of 4.5 (2 – 9) (unless 

another slope is listed), and the threshold of 0.05 (the listed species LOC). 

2

 Does not include the passerine data due to inadequacy. 

As shown in Table 5.2, the probability for acute direct effects (i.e., mortality) to 

individual listed fish at the highest derived RQ value is very low, <1 in 8.86E+18. The 

probability for acute direct effects (i.e., mortality) to individual listed estuarine/marine 

invertebrates is 1 in 4.18E+08 for the mysids exposed at the listed species LOC. The probability 

for acute direct effects (i.e., mortality) to individual listed freshwater invertebrates at the highest 

derived RQ value is 1 in 1.69E+06. The probability for acute direct effects to individual listed 

birds, mammals and bees at the highest derived RQ value range from 1 in 1 to 1 in 1.05E+17. 

 5.2.2. Conclusions, Uncertainties and Potential Reduction Measures 

According to this screening-level ecological risk assessment, the proposed use of 

fluensulfone for nematode control on Crop Groups 8 and 9 resulted in LOC exceedances for: 
-Page 69 of 117- 

acute exposure of listed estuarine/marine invertebrates from runoff plus spraydrift, 

acute and chronic exposure of aquatic invertebrates and algae from runoff and spray 

drift; 

acute exposure of small and medium birds feeding on arthropods and contaminated 

drinking water; 

chronic exposure of birds and mammals consuming arthropods; 

acute exposure of listed small, medium and large mammals feeding on arthropods and 

contaminated drinking water; 

exposure of beneficial insects and other terrestrial invertebrates; and 

exposure of listed aquatic non-vascular plants and semi-aquatic dicots. 

Additionally: 

passerine risk could not be fully assessed due to inadequate data; risk to this group is 

uncertain since they can be more sensitive than other test species. 

Potential indirect effects may also occur, including, but are not limited to, reduction in 

food resources, decrease in cover, change in water quality parameters, and loss of 

breeding/nesting habitat. Identified potential direct and indirect risks to listed species that may 

result from the proposed uses of fluensulfone are summarized in Table 5.1. In addition, it is 

possible that adverse effects to terrestrial invertebrates, including pollinators and beneficial 

insects, may occur, based on exposure to the 480EC formulated products in and around the use 

areas of the proposed uses of fluensulfone. 

Potential measures identified that would reduce environmental exposure or toxicity 

include: 

re-formulation of the end-use product to bring down the formulated product toxicity, 

label specifications of low boom height and/or coarse droplet size and

label specifications of buffer zones. 

For reduction of LOC exceedences based on exposure from spray drift, an estimated 3 to 

49 foot buffer would be needed to remove the presumption of risk to aquatic organisms (see 

Table 5.2). Specifying a low boom and larger droplet size is also a feasible way to reduce risk 

and reduce the size of a protective buffer for aquatic organisms (also see Appendix B):

3 foot buffer would protect aquatic plants6using high boom and fine droplets; no LOCs 

were exceeded with low boom and/or larger droplet sizes; 

49 foot buffer would protect molluscs using high boom and fine droplets; 3 foot buffer if 

low boom used, and no buffer if coarse droplet size used. 

 

6

 The listed-species LOC was exceeded for non-vascular aquatic plants. However, no aquatic non-vascular plants 

are presently listed as endangered or threatened species in the US. 
-Page 70 of 117- 

 5.2.3. Listed Species Occurrence Associated with Fluensulfone Use 

The goal of the co-location analysis is determine whether sites of pesticide use are 

geographically associated with known locations of listed species [following the convention of the 

Services, the word ‘species’ in this assessment may apply to a ‘species’, ‘subspecies’, or an 

Evolutionary Significant Unit (ESU)]. At the screening level, this analysis is accomplished 

using the LOCATES database (version 2.2.1). The database uses location information for listed 

species at the county level and compares it to agricultural census data (from 2007) for crop 

production at the same county level of resolution. The product is a listing of Federally-listed 

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

used. 

The results of this baseline-level risk assessment indicate that the proposed uses of 

fluensulfone have the potential for direct adverse acute effects on listed and non-listed freshwater 

fish (a surrogate for aquatic-phase amphibians); acute effects on listed freshwater invertebrates, 

estuarine/marine fish and invertebrates; chronic effects to freshwater fish and estuarine/marine 

invertebrates; acute effects on listed estuarine/marine fish and invertebrates (via spray drift from 

480EC Formulation formulated product); and chronic effects on listed and non-listed mammals 

based on all proposed use patterns. Due to effects seen at the single application rate for both 

terrestrial monocot and dicot plant species in the seedling emergence and vegetative vigor 

toxicity tests, risk to terrestrial plants and animals with obligate relationships with plants are 

assumed. Although direct adverse effects to birds, terrestrial-phase amphibians, and reptiles, 

from fluensulfone use are not expected, indirect effects to these taxa are possible, given the 

chronic effects on mammals could indirectly impact terrestrial organisms that feed on these 

species. Therefore, all listed species occurring nationwide may potentially be affected by the 

proposed new registration of fluensulfone. Because there is a potential for indirect effects to all 

listed taxa and all proposed uses of fluensulfone may occur anywhere in the United States or its 

territories, state and county-level summaries from LOCATES are not provided. However, based 

on the U.S. Fish and Wildlife Services Endangered Species Program there are a total of 71 

mammalian, 83 avian, 22 amphibian, 34 reptilian, 23 crustacean, 81 bivalve, 44 gastropod, 12 

arachnid, 63 insect, 714 dicot, 28 fern, 3 conifers/cycads, 2 coral and 2 lichen listed species in 

the United States that may be directly or indirectly affected by the proposed new uses of 

fluensulfone (http://www.fws.gov/endangered/species/us-species.html). Listed fish species that 

may be indirectly affected were not tallied and the list was not culled for only birds and 

mammals in the feeding groups that are likely to be exposed (i.e., those feeding on arthropods in 

the treated area and/or seeds or grains that drift into the treated area). 

This preliminary analysis indicates that there is a potential for fluensulfone use to overlap 

with listed species. 
-Page 71 of 117- 

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Documentation. Revision G. EPA/600/R-00/081. National Exposure Research 

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USFWS, U.S. Fish and Wildlife Services (2011). Endangered Species Program, U.S. Listed 

Species. Last updated September 1, 2011. Online at: 

http://www.fws.gov/endangered/species/us-species.html. 

Urban, D.J. and N.J. Cook, 1986. Hazard Evaluation Division Standard Evaluation Procedure 

Ecological Risk Assessment. EPA 540/9-85-001. U.S. Environmental Protection Agency, 

Office of Pesticide Programs, Washington D.C. 

Willis, G.H., and L.L. McDowell. 1987. Pesticide Persistence on Foliage in Reviews of 

Environmental Contamination and Toxicology. 100: 23-73. 

 6.1. Submitted Product Chemistry and Environmental Fate Studies 

MRID Citation

MRID 48574709. Weissenfield, M. 2008d. MCW-2: Determination of the vapour pressure. 

Harlan Laboratories Ltd, Zelgliweg 1, 4452 Itingen, Switzerland. Makhteshim Chemical Works 

Ltd, Harlan Laboratories Study C00382, R-23313

MRID 48574710. Weissenfield, M. 2009. MCW-2: Henry’s Law constant – Expert statement. 

Harlan Laboratories Ltd, Zelgliweg 1, 4452 Itingen, Switzerland. Makhteshim Chemical Works 

Ltd, Harlan Laboratories Study C00516, R-23313A

MRID 48574715. Weissenfield, M. 2008a. MCW-2: Determination of water solubility. Harlan 

Laboratories Ltd, Zelgliweg 1, 4452 Itingen, Switzerland. Makhteshim Chemical Works Ltd, 

Harlan Laboratories Study C00415, R-23316

MRID 48574717. Weissenfield, M. 2008b. MCW-2: Determination of the partition coefficient 

(n-octanol / water). Harlan Laboratories Ltd, Zelgliweg 1, 4452 Itingen, Switzerland. 

Makhteshim Chemical Works Ltd, Harlan Laboratories Study C00426, R-23318 

MRID 48574719. Weissenfield, M. 2008c. MCW-2: Calculation of dissociation constant. 

Harlan Laboratories Ltd, Zelgliweg 1, 4452 Itingen, Switzerland. Makhteshim Chemical Works 

Ltd, Harlan Laboratories Study C00527, R-23321
-Page 73 of 117- 

 

MRID 48574823. Moser F. 2011. Fluensulfone: Aerobic Degradation in Soils. Smithers 

Viscient AG Seestrasse 21, Postfach CH-9326 Horn, Switzerland. Makhteshim Chemical 

Works, Smithers Viscient AG Study 1026.014.760, R-27436, 

MRID 48574824. Schick, M. 2011a. Anaerobic Soil Metabolism of [14C]MCW-2. PTRL West, 

Inc., 625-B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim Chemical Works, Ltd. PTRL 

West Report Number 1860W-1. Sponsor Study Code: R-23370 

MRID 48574825. Ponte, M. 2012. Photodegradation of [14C]MCW-2 in/on Soil by Artificial 

Light. PTRL West, Inc., 625-B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim 

Chemical Works, Ltd. PTRL West Report Number 1856W 1, R-23320 

MRID 48574823. Moser F. 2011. Fluensulfone: Aerobic Degradation in Soil. Smithers 

Viscient AG Seestrasse 21, Postfach CH-9326 Horn, Switzerland. Makhteshim Chemical 

Works, Smithers Viscient AG Study 1026.014.760, R-27436, 

MRID 48574828. Brands, Ir. C. 2011a. Determination of the aerobic degradation rate of TSA 

in three soils. NOTOX B.V., Hambakenwetering 7, 5231 DD 's-Hertogenbosch, The 

Netherlands. Makhteshim Chemical Works, Ltd. Notox Project 496681, R-28470 

MRID 48574829. Brands, Ir. C. 2011b. Determination of the aerobic degradation rate of MS in 

three soils. NOTOX B.V., Hambakenwetering 7, 5231 DD 's-Hertogenbosch, The Netherlands. 

Makhteshim Chemical Works, Ltd. Notox Project 496894, R-28472 

MRID 48574824. Schick, M. 2011a. Anaerobic Soil Metabolism of [14C]MCW-2. PTRL West, 

Inc., 625-B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim Chemical Works, Ltd. PTRL 

West Report Number 1860W-1. Sponsor Study Code: R-23370 

MRID 48574832. Newcombe, A.C., Negley, T. And Everich, R. 2012. Dissipation of MCW-2 

(Fluensulfone) in Soil under Bare Soil Conditions at Multiple Sites Across North America. 

ARCADIS, 3382 Capital Circle NE. Tallahassee, FL 32308. Makhteshim Chemical Works, Ltd. 

ARCADIS Rep No., R-23393.

MRID 48574833. LaMar J. and Quistad G.B. 2011a. Soil Adsorption/Desorption of 

[

14C]Fluensulfone (MCW-2) by the Batch Equilibrium Method. PTRL West, Inc., 625-B Alfred 

Nobel Drive, Hercules, CA 94547. Makhteshim Chemical Works, Ltd. PTRL West Report 

Number 1844W-1, R-23337.

MRID 48575039. LaMar J. and Quistad G.B. 2011b. Soil Adsorption/Desorption of 

[

14C]Fluensulfone (MCW-2) by the Batch Equilibrium Method. PTRL West, Inc., 625-B Alfred 

Nobel Drive, Hercules, CA 94547. Makhteshim Chemical Works, Ltd. PTRL West Report No. 

2081W: R23333
-Page 74 of 117- 

MRID 48574834. Brands, Ir. C. 2011c. Adsorption/Desorption of TSA on five soils. NOTOX 

B.V., Hambakenwetering 7, 5231 DD 's-Hertogenbosch, The Netherlands. Makhteshim 

Chemical Works, Ltd. NOTOX Project 496682, R-28473 

MRID 48574835. Brands, Ir. C. 2011d. Adsorption/Desorption of MS on five soils. NOTOX 

B.V., Hambakenwetering 7, 5231 DD 's-Hertogenbosch, The Netherlands. Makhteshim 

Chemical Works, Ltd. NOTOX Project 496850, R-28475 

MRID 48574836. Brands, Ir. C. 2011e. Adsorption/Desorption of BSA on five soils. NOTOX 

B.V., Hambakenwetering 7, 5231 DD 's-Hertogenbosch, The Netherlands. Makhteshim 

Chemical Works, Ltd. NOTOX Project 496851, R-28474 

MRID 48574718. Shepler K. 2010. Hydrolysis of [14C]MCW-2 (Fluensulfone) at pH 4, 7 and 9. 

PTRL West, Inc. 625-B Alfred Nobel Drive Hercules, CA 94547. Makhteshim Chemical 

Works, Ltd. PTRL West Report No. 1843-001, R-23319 

MRID 48574840. Quistad G. B and Bronner B. 2011. Anaerobic Aquatic Metabolism of 

[

14C]MCW-2. PTRL West, Inc., 625-B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim 

Chemical Works. PTRL West Report Number 1855W-1, R-23381 

MRID 48574839. Hiler T. and. Duncan T. M. 2011. Aerobic Aquatic Metabolism of 

[

14C]MCW-2. PTRL West, Inc., 625-B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim 

Chemical Works. PTRL West Report Number 1857W-1, R-23380 

MRID 48575016. Feil, N. 2011. Ready biodegradability of MCW-2 in a closed bottle test. 

Institute für Biologische Analytic und Consulting IBACON GmbH. Arheilger Weg 17, 64380 

Rossdorf, Germany. Makhteshim Chemical Works, Ltd. Report No. 63711161. R-23406. 

MRID 48574849. Schick M, 2011. Photodegradation of [14C]MCW-2 in Sterilized pH 7 Buffer 

and Natural Water by Artificial Sunlight. PTRL West, Inc. 625-B Alfred Nobel Drive Hercules, 

CA 94547. Makhteshim Chemical Works, Ltd. Report No.: Report no. 1843W-001, R-23322

 6.2. Submitted Ecotoxicity Studies 

MRID Citation

MRID 48574842 Hubbard, P.M., Beavers, J.B. MCW-2 Technical: An acute oral toxicity study 

with the Northern Bobwhite Wildlife International, LTD, 8598 Commerce Drive, Easton, 

Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife 

International Ltd Project No. 234-104. R-23384 

MRID 48574843 Hubbard, P.M.; Beavers, J.B. MCW2 Technical: An acute oral toxicity study 

with the canary (serinus canaria) Wildlife International, LTD, 8598 Commerce Drive, Easton, 

Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife 

International Ltd Project No. 234-110. R-23437 
-Page 75 of 117- 

MRID 48574844 Hubbard, P.M., Martin, K.H., Beavers, J.B. MCW-2 Technical: A dietary 

LC50 study with the Northern Bobwhite Wildlife International, LTD, 8598 Commerce Drive, 

Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife 

International Ltd Project No. 234-102. R-23387 

MRID 48574845 Hubbard, P.M.; Martin, K.H.; Beavers, J.B. MCW-2 Technical: A dietary 

LC50 study with the Mallard. Wildlife International, LTD, 8598 Commerce Drive, Easton, 

Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife 

International Ltd Project No. 234-103. R-23388 

MRID 48574846 Temple, D.L.; Martin, K.H.; Beavers, J.B.; Jaber, M. MCW-2 Technical: A 

reproduction study with the Mallard. Wildlife International, LTD, 8598 Commerce Drive, 

Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife 

International Ltd Project No. 234-115. R-23439 

MRID 48574847 Temple, D.L.; Martin, K.H.; Beavers, J.B.; Jaber, M. MCW-2 Technical: A 

reproduction study with the Northern Bobwhite. Wildlife International, LTD, 8598 Commerce 

Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America 

Wildlife International Ltd Project No. 234-114. R-23438 

MRID 48574850 Gallagher, S.P. MCW-2 Technical: A 96-Hour static acute toxicity test with 

the rainbow trout (Oncorhynchus mykiss) Wildlife International, LTD, 8598 Commerce Drive, 

Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America. Wildlife 

International Ltd Project No. 234A-104. R-23440. 

MRID 48574851 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour 

static acute toxicity test with Common Carp (Cyprinus carpio). Wildlife International, LTD, 

8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of 

North America Wildlife International Ltd Project No. 234A-116. R-23374. 

MRID 48574852 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour 

static acute toxicity test with Sheepshead Minnow (Cyprinodon variegatus) Wildlife 

International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. 

Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-105. R-23390 

MRID 48574853 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour 

static acute toxicity test with Bluegill (Lepomis macrochirus). Wildlife International, LTD, 8598 

Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North 

America Wildlife International Ltd Project No. 234A-103. R-23391 

MRID 48574854 Gallagher, S. P. MCW-2 Technical: An early life-stage toxicity test with 

Fathead Minnow (Pimephales promelas) Wildlife International, LTD, 8598 Commerce Drive, 

Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife 

International Ltd Project No. 234A-118. R-23392 
-Page 76 of 117- 

MRID 48574855 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW2 Technical: Results of a 

48-hour static acute toxicity test with Daphnia magna Definitive Trial 2 (Definitive test results 

not audited by Quality Assurance). Wildlife International, LTD, 8598 Commerce Drive, Easton, 

Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife 

International Ltd Project No. 234A-102A. R-23409 

MRID 48574856 Gallagher, S.P.; Minderhout, T.; Kendall, T.Z.; Krueger, H.O. MCW-2 

Technical: A flow-through Life-cycle toxicity test with the cladoceran (Daphnia magna). 

Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-

8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-117. R23394 

MRID 48574857 Claude, M.B.; Kendall, T.Z.; Krueger, H.O. MCW2 technical: A flowthrough life-cycle toxicity test with the saltwater mysid (Americamysis bahia). Wildlife 

International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. 

Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-120. R-23447 

MRID 48574858 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour 

toxicity test with the freshwater alga. (Pseudokirchneriella subcapitata) Wildlife International, 

LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim 

Agan of North America Wildlife International Ltd Project No. 234A-109. R-23441 

MRID 48574859 Porch, J.R.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour 

toxicity test with the freshwater alga. (Anabaena flos-aquae) Wildlife International, LTD, 8598 

Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North 

America Wildlife International Ltd Project No. 234A-121. R-23460 

MRID 48574860 Porch, J.R.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour 

toxicity test with the freshwater diatom (Navicula pelliculosa) Wildlife International, LTD, 8598 

Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North 

America Wildlife International Ltd Project No. 234A-122. R-23445 

MRID 48574861 Porch, J.R.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour 

toxicity test with the marine diatom (Skeletonema costatum) Wildlife International, LTD, 8598 

Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North 

America Wildlife International Ltd Project No. 234A-123. R-23446 

MRID 48574862 Thomas, S.T.; Kendall, T.Z.; Krueger, H.O. MCW2 Technical: a 10-day 

survival and growth sediment toxicity test with Chironomus tentans using spiked sediment 

Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-

8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-119. R23413. 
-Page 77 of 117- 

MRID 48574863 Gallagher, S.P. MCW-2 Technical: A 7-day static-renewal toxicity test with 

Duckweed (Lemna gibba G3) Wildlife International, LTD, 8598 Commerce Drive, Easton, 

Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife 

International Ltd Project No. 234A-108. R-23443. 

MRID 48574864 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour 

static acute toxicity test with Saltwater Mysid (Americamysis bahia). Wildlife International, 

LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim 

Agan of North America Wildlife International Ltd Project No. 234A-106. R-23405 

MRID 48574865 Gallagher, S.P. MCW-2 Technical: A 96-hour shell deposition test with the 

Eastern oyster (Crassostrea virginica) Wildlife International, LTD, 8598 Commerce Drive, 

Easton, Maryland 21601 USA, Makhteshim Agan of North America Wildlife International Ltd 

Project No. 234A-107. R-23408. 

MRID 48574866 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. Thiazole sulfonic acid: a 96-

hour static acute toxicity test with the bluegill. (Lepomis macrochirus) Wildlife International, 

LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North 

America Wildlife International Ltd Project No. 234A-137. R-27469 

MRID 48574868 Jacobs, A.M.; Porch, J.R.; Kendall, T.Z.; Krueger, H.O. Thiazole sulfonic 

acid: A 96-hour toxicity test with the freshwater alga (Pseudokirchneriella subcapitata) Wildlife 

International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of 

North America Wildlife International Ltd Project No. 234A-132. R-27470 

MRID 48574869 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. Thiazole sulfonic acid: a 96-

hour static acute toxicity test with the saltwater mysid (Americamysis bahia) Wildlife 

International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of 

North America Wildlife International Ltd Project No. 234A-138. R-27468 

MRID 48574870 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. Butene sulfonic acid: a 96-hour 

static acute toxicity test with the bluegill. (Lepomis macrochirus) Wildlife International, LTD, 

8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America 

Wildlife International Ltd Project No. 234A-136. R-23493 

MRID 48574872 Butene sulfonic acid: A 96-hour toxicity test with the freshwater alga 

(Pseudokirchneriella subcapitata) Wildlife International, LTD, 8598 Commerce Drive, Easton, 

Maryland 21601 USA Makhteshim Agan of North America Wildlife International Ltd Project 

No. 234A-126. R-23494 

MRID 48574873 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. Butene sulfonic acid: a 96-hour 

static acute toxicity test with the saltwater mysid (Americamysis bahia) Wildlife International, 

LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North 

America Wildlife International Ltd Project No. 234A-125. R-23492 
-Page 78 of 117- 

MRID 48574874 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. Methyl sulfone: A 96-hour 

static acute toxicity test with the bluegill. (Lepomis macrochirus) Wildlife International, LTD, 

8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America 

Wildlife International Ltd Project No. 234A-139. R-27464 

MRID 48574876 Porch, J.R.; Kendall, T.Z.; Krueger, H.O. Thiazole methyl sulfone: A 96-hour 

toxicity test with the freshwater alga (Pseudokirchneriella subcapitata) Wildlife International, 

LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North 

America Wildlife International Ltd Project No. 234A-135. R-27465 

MRID 48574877 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. Methyl sulfone: A 96-hour 

static acute toxicity test with the saltwater mysid (Americamysis bahia) Wildlife International, 

LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North 

America Wildlife International Ltd Project No. 234A-140. R-27463 

MRID 48574878 Jacobs, A.M.; Porch, J.R.; Kendall, T.Z.; Krueger, H.O. Deschlorofluensulfone: A 96-hour toxicity test with the freshwater alga (Pseudokirchneriella subcapitata) 

Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim 

Agan of North America Wildlife International Ltd Project No. 234A-134. R-27472 

MRID 48574879 Zenker, K. Acute toxicity of MCW-2 TECH to the honeybee Apis mellifera 

L. Under laboratory conditions. Makhteshim Agan of North America BioChem agrar, Labor für 

biologische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, Germany. 

BioChem Project No: 09 10 48 011 B, R-23398 

MRID 48574880 Friedrich, S. Acute toxicity of MCW-2 technical to the earthworm Eisenia 

fetida in artificial soil with 5% peat. Makhteshim Agan of North America BioChem agrar, Labor 

für biologische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, Germany. 

BioChem Project No: 09 10 48 030 S, R-23401. 

MRID 48574881 Sindermann, A.B.; Porch, J.R.; Krueger, H.O. Thiazole sulfonic acid: an 

acute toxicity study with the earthworm in an artificial soil substrate Makhteshim Agan of North 

America Wildlife International, Ltd., 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-

410-822-8600. Wildlife International Ltd. Project No: 234-122. R-27471 

MRID 48574882 Sindermann, A.B.; Porch, J.R.; Krueger, H.O. Butene sulfonic acid: an acute 

toxicity study with the earthworm in an artificial soil substrate Makhteshim Agan of North 

America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-

410-822-8600. Wildlife International Ltd Project No. 234-121. R-23495 

MRID 48574883 Sindermann, A.B.; Porch, J.R.; Krueger, H.O. Methyl sulfone: An acute 

toxicity study with the earthworm in an artificial soil substrate Makhteshim Agan of North 

America Wildlife International, Ltd., 8598 Commerce Drive, Easton, Maryland 21601 Wildlife 
-Page 79 of 117- 

International Ltd. Project No: 234-123. R-27466 

MRID 48574910 Grande, A. Determination of the non target effects on the bumble bees 

Bombus sp. [Hymenoptera: Aphidae] following a single application of MCW-2 EC (by drip 

irrigation before seedlings transplanting) or following two applications of Nemacur 240 CS (by 

drip irrigation before and after seedlings transplanting) on tomato – one trial in southern Europe 

(Italy) - 2010 Makhteshim Agan of North America SAGEA Centro di Saggio s.r.l., Via S. 

Sudario, 13-12050 Castagnito d’Alba (CN), Italy SAGEA Project No.: 3446610, R-29571 

MRID 48574927 Gallagher, S.P. MCW-2 480 EC: A 96-hour static acute toxicity test with 

Rainbow Trout (Oncorhynchus mykiss) Wildlife International, LTD, 8598 Commerce Drive, 

Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife 

International Ltd Project No. 234A-112. R-23363 

MRID 48574928 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 480 EC: A 96-hour 

static acute toxicity test with Sheepshead Minnow (Cyprinodon variegatus) Makhteshim Agan of 

North America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 

USA, 1-410-822-8600. Wildlife International Ltd Project No. 234A-113. R-23364 GLP, not 

published. 

MRID 48574929 Gallagher, S.P. MCW-2 480 EC: A 96-hour static acute toxicity test with the 

Bluegill (Lepomis macrochirus). Makhteshim Agan of North America Wildlife International, 

LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Wildlife 

International Ltd Project No. 234A-111. R-23368. GLP, not published. 

MRID 48574930 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O MCW-2 480 EC: A 48-hour 

static acute toxicity test with the cladoceran (Daphnia magna) Wildlife International, LTD, 8598 

Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North 

America Wildlife International Ltd Project No. 234A-110. R-23367 

MRID 48574931 Jacobs, A.M., Porch, J.R.,Kendall,T.Z., Krueger, H.O. Fluensulfone 480EC: 

A 96-hour toxicity test with the freshwater alga (Pseudokirchneriella subcapitata) Wildlife 

International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. 

Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-133C. R23499 

MRID 48574932 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 480 EC: A 96-hour 

static acute toxicity test with Saltwater Mysid (Americamysis bahia) Makhteshim Agan of North 

America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-

410-822-8600. Wildlife International Ltd Project No. 234A-114A. R-23365. 

MRID 48574933 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 480 EC: A 96-hour 

shell deposition test with the Eastern oyster (Crassostrea virginica) Makhteshim Agan of North 

America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-
-Page 80 of 117- 

410-822-8600. Wildlife International Ltd Project No. 234A-115. R-23378. 

MRID 48574934 Zenker, K. Acute toxicity of MCW-2 480 EC to the honeybee Apis mellifera 

L. Under laboratory conditions. Makhteshim Agan of North America BioChem agrar, Labor für 

biologische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, Germany. 

BioChem Project No: 09 10 48 010 B, R-23371. 

MRID 48574935 Fallowfield, L. A rate-response laboratory bioassay to determine the effects of 

fresh residues of MCW-2 480 EC on the predatory mite, Typholodromus pyri (Acari: 

Phytoseiidae) Makhteshim Agan of North America Mambo-Tox Ltd., 2 Venture Road, 

Chilworth Science Park, Southampton SO16 7NP Study No. MAK-09-1, R-23399 

MRID 48574936 Stevens, J. A rate-response extended laboratory bioassay to determine the 

effects of fresh residues of MCW-2 480 EC on the parasitic wasp, Aphidus rhopalosophi 

(Hymenoptera, Braconidae) Makhteshim Agan of North America Mambo-Tox Ltd., 2 Venture 

Road, Chilworth Science Park, Southampton SO16 7NP Study No. MAK-09-2, R-23400 

MRID 48574937 Vinall, S. A rate-response laboratory bioassay to determine the effects of 

fresh residues of MCW-2 480 EC on predatory mite, Hypoaspis aculeifer (Acari, Laelapidae) 

Makhteshim Agan of North America Mambo-Tox Ltd., 2 Venture Road, Chilworth Science 

Park, Southampton SO16 7NP Study No. MAK-09-3, R-23359 

MRID 48574938 Spincer, D. A rate-response extended laboratory bioassay to determine the 

effects of fresh residues of MCW-2 480 EC on the ground-active beetle, Aleochara bilineata 

(Coleoptera; Staphylinidae) Makhteshim Agan of North America Mambo-Tox Ltd., 2 Venture 

Road, Chilworth Science Park, Southampton SO16 7NP Study No. MAK-09-5, R-23361 

MRID 48574939 Friedrich, S. Acute toxicity of MCW-2 480 EC to the earthworm Eisenia 

fetida in artificial soil with 5% peat. Makhteshim Agan of North America BioChem agrar, Labor 

für biologische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, Germany. 

BioChem Project No: 09 10 48 032 S, R-23377 

MRID 48574940 Friedrich, S. Sublethal toxicity of MCW-2 480 EC to the earthworm Eisenia 

fetida in artificial soil with 5% peat. Makhteshim Agan of North America BioChem agrar, Labor 

für biologische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, Germany. 

BioChem Project No: 09 10 48 031 S, R-23402 

MRID 48574941 Vinall, S. A rate-response laboratory bioassay to determine the effects of 

fresh residues of MCW-2 480 EC on springtail, Folsomia candida (Collembola, Isotomidae 

Makhteshim Agan of North America Mambo-Tox Ltd., 2 Venture Road, Chilworth Science 

Park, Southampton SO16 7NP Study No. MAK-09-4, R-23360 

MRID 48574942 Schulz, L. MCW-2 480EC. Effects on the activity of soil microflora 

(Nitrogen and carbon transformation tests) Makhteshim Agan of North America BioChem agrar, 
-Page 81 of 117- 

Labor für biologische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, 

Germany. BioChem Project No: 09 10 48 017 C/N, R-23403 

MRID 48574943 Porch, J.R.; Krueger, H.O.; Kendall, T.Z. MCW-2 480 EC: A toxicity test to 

determine the effects of the test substance on vegetative vigour of ten species of plants 

Makhteshim Agan of North America Wildlife International, LTD, 8598 Commerce Drive, 

Easton, Maryland 21601 USA, 1-410-822-8600. Wildlife International Ltd Project No. 234-109. 

R-23436 

MRID 48574944 Porch, J.R.; Martin, K.H.; Krueger, H.O. MCW-2 480 EC: A toxicity test to 

determine the effects of the test substance on seedling emergence of ten species of plants. 

Makhteshim Agan of North America Wildlife International, LTD, 8598 Commerce Drive, 

Easton, Maryland 21601 USA, 1-410-822-8600. Wildlife International Ltd Project No. 234-108. 

R-23435 

MRID 48574945 Porch, J.R.; Krueger, H.O.; Kendall, T.Z. MCW-2 480 EC: A toxicity test to 

determine the effects of the test substance on seedling emergence of ten species of plants. 

Makhteshim Agan of North America Wildlife International, LTD, 8598 Commerce Drive, 

Easton, Maryland 21601 USA, 1-410-822-8600. Wildlife International Ltd Project No. 234-116. 

R-23448 

MRID 48574951 Hubbard, P.M.; Beavers, J.B. MCW-2 480 EC: An acute oral toxicity study 

with the Northern Bobwhite Wildlife International, LTD, 8598 Commerce Drive, Easton, 

Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife 

International Ltd Project No. 234-107. R-23450 

MRID 48574957 Qingli Ma, Polakoff, B and Schocken, M. Fluensulfone (MCW-2): US 

Ecological Risk Assessments, Exponent, Inc. 1150 Connecticut Avenue, NW, Suite 1100, 

Washington, D.C. 20036 Makhteshim Chemical Works Report WD01184.002 EWC 100. 

MRID 48574958 Qingli Ma, Polakoff, B and Schocken, M. Fluensulfone (MCW-2): 

Ecological Risk Assessments for Canada, Qingli Ma, Polakoff, B and Schocken, M, Exponent, 

Inc. 1150 Connecticut Avenue, NW, Suite 1100, Washington, D.C. 20036 Makhteshim 

Chemical Works Report WD01184.002 EWC 110. 

MRID 48575017 Porch, J.R.; Kendall, T.Z.; Krueger, H.O. Fluensulfone TGAI: A 96-hour 

toxicity test with the freshwater alga (Pseudokirchneriella subcapitata) Wildlife International, 

LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim 

Agan of North America Wildlife International Ltd Project No. 234A-131. R-23496 

MRID 48575019 Jacobs,A., Proch, R., Kendall, T., Kreueger, H. Fluensulfone TGAI: A 96-

hour toxicity test with the freshwater alga (Scenedesmus subspicatus) Wildlife International, 

LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim 

Agan of North America Wildlife International Ltd Project No. 234A-130. R-23497.
-Page 82 of 117- 
-Page 83 of 117- 

Appendix A. Aquatic Model Input/Output Data. 

Example Input/Output Data for Individual Simulations 

PE5 (PRZM-EXAMS) Output File for Parent (surface water)

stored as FlFLCUn.out 

Chemical: Fluensulfone 

PRZM environment: FLcucumberSTD.txt modified Tueday, 26 August 2008 at 06:16:38 

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

Metfile: w12844.dvf modified Tueday, 26 August 2008 at 06:14:22 

Water segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1961 2.681 2.54 2.13 1.653 1.336 0.3633

1962 3.827 3.714 3.079 2.296 1.914 0.5746

1963 4.638 4.409 3.816 2.891 2.321 0.7152

1964 7.321 7.081 6.175 4.723 3.791 1.116

1965 1.964 1.862 1.604 1.317 1.082 0.4198

1966 20.29 19.56 17.69 12.21 9.593 2.626

1967 3.791 3.609 3.03 2.433 1.988 0.8398

1968 7.791 7.402 6.674 4.929 3.939 1.145

1969 5.082 4.928 4.457 3.248 2.613 0.8587

1970 5.223 4.989 4.238 2.933 2.419 0.7659

1971 5.064 4.812 4.134 2.989 2.384 0.7346

1972 4.624 4.373 3.5 2.395 1.901 0.5745

1973 6.763 6.414 5.695 4.077 3.199 0.9119

1974 7.268 6.884 5.657 3.927 3.122 0.9274

1975 5.759 5.468 4.568 3.226 2.65 0.8194

1976 8.706 8.368 6.944 5.088 4.075 1.212

1977 43.74 42.28 35.43 24.04 18.82 5.208

1978 7.901 7.512 6.186 4.239 3.347 1.479

1979 14.75 14.34 13.36 9.428 7.401 2.09

1980 12.28 11.81 9.866 6.764 5.289 1.649

1981 8.778 8.347 7.232 4.986 3.96 1.245

1982 3.358 3.197 2.692 2.035 1.613 0.5675

1983 3.582 3.396 2.788 2.368 1.916 0.5695

1984 4.314 4.142 3.806 2.954 2.38 0.7106

1985 5.292 5.06 4.302 3.36 2.678 0.7986

1986 7.862 7.434 5.965 3.951 3.082 0.9044

1987 5.62 5.329 4.479 3.375 2.732 0.82

1988 2.012 1.899 1.609 1.249 1.018 0.3676

1989 3.876 3.695 3.169 2.502 1.993 0.57

1990 6.314 5.98 5.247 4.016 3.204 0.9228

Sorted results 

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

0.032258064516129 43.74 42.28 35.43 24.04 18.82 5.208 

0.0645161290322581 20.29 19.56 17.69 12.21 9.593 2.626 

0.0967741935483871 14.75 14.34 13.36 9.428 7.401 2.09 

0.129032258064516 12.28 11.81 9.866 6.764 5.289 1.649 

0.161290322580645 8.778 8.368 7.232 5.088 4.075 1.479

0.193548387096774 8.706 8.347 6.944 4.986 3.96 1.245 

0.225806451612903 7.901 7.512 6.674 4.929 3.939 1.212 

0.258064516129032 7.862 7.434 6.186 4.723 3.791 1.145 

0.290322580645161 7.791 7.402 6.175 4.239 3.347 1.116 

0.32258064516129 7.321 7.081 5.965 4.077 3.204 0.9274 

0.354838709677419 7.268 6.884 5.695 4.016 3.199 0.9228 

0.387096774193548 6.763 6.414 5.657 3.951 3.122 0.9119 
-Page 84 of 117- 

0.419354838709677 6.314 5.98 5.247 3.927 3.082 0.9044 

0.451612903225806 5.759 5.468 4.568 3.375 2.732 0.8587 

0.483870967741936 5.62 5.329 4.479 3.36 2.678 0.8398 

0.516129032258065 5.292 5.06 4.457 3.248 2.65 0.82 

0.548387096774194 5.223 4.989 4.302 3.226 2.613 0.8194 

0.580645161290323 5.082 4.928 4.238 2.989 2.419 0.7986 

0.612903225806452 5.064 4.812 4.134 2.954 2.384 0.7659 

0.645161290322581 4.638 4.409 3.816 2.933 2.38 0.7346 

0.67741935483871 4.624 4.373 3.806 2.891 2.321 0.7152 

0.709677419354839 4.314 4.142 3.5 2.502 1.993 0.7106 

0.741935483870968 3.876 3.714 3.169 2.433 1.988 0.5746 

0.774193548387097 3.827 3.695 3.079 2.395 1.916 0.5745 

0.806451612903226 3.791 3.609 3.03 2.368 1.914 0.57 

0.838709677419355 3.582 3.396 2.788 2.296 1.901 0.5695 

0.870967741935484 3.358 3.197 2.692 2.035 1.613 0.5675 

0.903225806451613 2.681 2.54 2.13 1.653 1.336 0.4198 

0.935483870967742 2.012 1.899 1.609 1.317 1.082 0.3676 

0.967741935483871 1.964 1.862 1.604 1.249 1.018 0.3633 

0.1 14.503 14.087 13.0106 9.1616 7.1898 2.0459 

 Average of yearly averages: 1.08353666666667 

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run: 

Output File: FlFLCUn 

Metfile: w12844.dvf 

PRZM scenario: FLcucumberSTD.txt 

EXAMS environment file: pond298.exv 

Chemical Name: Fluensulfone 

Description Variable Name Value Units Comments 

Molecular weight mwt 291.7 g/mol

Henry's Law Const. henry 1.65e-7 atm-m^3/mol 

Vapor Pressure vapr torr

Solubility sol 545.3 mg/L

Kd Kd mg/L 

Koc Koc 192 mg/L

Photolysis half-life kdp 0.784 days Half-life

Aerobic Aquatic Metabolism kbacw 45.93 days Halfife 

Anaerobic Aquatic Metabolism kbacs 27.68 days Halfife 

Aerobic Soil Metabolism asm 11.98 days Halfife 

Hydrolysis: pH 7 0 days Half-life

Method: CAM 4 integer See PRZM manual 

Incorporation Depth: DEPI 15 cm

Application Rate: TAPP 3.92 kg/ha

Application Efficiency: APPEFF 0.99 fraction 

Spray Drift DRFT 0.01 fraction of application rate applied to pond 

Application Date Date 01-09 dd/mm or dd/mmm or dd-mm or dd-mmm

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) 

PE5 (PRZM-EXAMS) Output File for Parent (sediment pore water)

stored as FlFLCUnben.out 

Chemical: Fluensulfone 
-Page 85 of 117- 

PRZM environment: FLcucumberSTD.txt modified Tueday, 26 August 2008 at 06:16:38 

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

Metfile: w12844.dvf modified Tueday, 26 August 2008 at 06:14:22 

Benthic segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1961 0.5137 0.5133 0.5055 0.461 0.4153 0.1203

1962 0.7458 0.7453 0.733 0.6783 0.6258 0.2159

1963 0.901 0.9005 0.887 0.8128 0.7395 0.2878

1964 1.486 1.486 1.463 1.336 1.203 0.4184

1965 0.6226 0.6082 0.5494 0.4286 0.3529 0.2025

1966 3.7 3.698 3.648 3.318 3.007 0.9186

1967 1.573 1.528 1.352 1.043 0.8625 0.4431

1968 1.516 1.515 1.494 1.38 1.268 0.4405

1969 1.018 1.018 1.001 0.9104 0.8326 0.371

1970 0.9477 0.947 0.9312 0.8591 0.7891 0.3141

1971 0.9223 0.9216 0.9066 0.8198 0.7344 0.291

1972 0.7283 0.7277 0.7147 0.6392 0.568 0.2139

1973 1.231 1.23 1.212 1.095 0.9743 0.3273

1974 1.197 1.196 1.178 1.078 0.9738 0.3518

1975 1.063 1.062 1.045 0.9545 0.8645 0.3198

1976 1.626 1.625 1.601 1.464 1.328 0.4687

1977 7.331 7.327 7.236 6.624 5.936 1.864

1978 2.825 2.764 2.516 2.03 1.712 0.8198

1979 2.879 2.877 2.832 2.566 2.297 0.7495

1980 2.053 2.051 2.023 1.827 1.638 0.6838

1981 1.57 1.569 1.543 1.408 1.286 0.5156

1982 0.7486 0.729 0.6511 0.5441 0.4866 0.2567

1983 0.7249 0.7244 0.7132 0.6531 0.5973 0.2164

1984 0.9371 0.9364 0.9211 0.8359 0.7537 0.2748

1985 1.039 1.038 1.018 0.9056 0.8023 0.2985

1986 1.194 1.193 1.174 1.05 0.9189 0.3335

1987 1.072 1.071 1.055 0.9597 0.8619 0.3124

1988 0.4566 0.4452 0.3993 0.3285 0.3021 0.1674

1989 0.7504 0.7499 0.7388 0.6728 0.6059 0.2044

1990 1.226 1.225 1.202 1.08 0.9663 0.3263

Sorted results 

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

0.032258064516129 7.331 7.327 7.236 6.624 5.936 1.864 

0.0645161290322581 3.7 3.698 3.648 3.318 3.007 0.9186 

0.0967741935483871 2.879 2.877 2.832 2.566 2.297 0.8198 

0.129032258064516 2.825 2.764 2.516 2.03 1.712 0.7495 

0.161290322580645 2.053 2.051 2.023 1.827 1.638 0.6838 

0.193548387096774 1.626 1.625 1.601 1.464 1.328 0.5156 

0.225806451612903 1.573 1.569 1.543 1.408 1.286 0.4687 

0.258064516129032 1.57 1.528 1.494 1.38 1.268 0.4431 

0.290322580645161 1.516 1.515 1.463 1.336 1.203 0.4405

0.32258064516129 1.486 1.486 1.352 1.095 0.9743 0.4184 

0.354838709677419 1.231 1.23 1.212 1.08 0.9738 0.371 

0.387096774193548 1.226 1.225 1.202 1.078 0.9663 0.3518 

0.419354838709677 1.197 1.196 1.178 1.05 0.9189 0.3335 

0.451612903225806 1.194 1.193 1.174 1.043 0.8645 0.3273 

0.483870967741936 1.072 1.071 1.055 0.9597 0.8625 0.3263 

0.516129032258065 1.063 1.062 1.045 0.9545 0.8619 0.3198 

0.548387096774194 1.039 1.038 1.018 0.9104 0.8326 0.3141 

0.580645161290323 1.018 1.018 1.001 0.9056 0.8023 0.3124 

0.612903225806452 0.9477 0.947 0.9312 0.8591 0.7891 0.2985 

0.645161290322581 0.9371 0.9364 0.9211 0.8359 0.7537 0.291 

0.67741935483871 0.9223 0.9216 0.9066 0.8198 0.7395 0.2878 
-Page 86 of 117- 

0.709677419354839 0.901 0.9005 0.887 0.8128 0.7344 0.2748 

0.741935483870968 0.7504 0.7499 0.7388 0.6783 0.6258 0.2567 

0.774193548387097 0.7486 0.7453 0.733 0.6728 0.6059 0.2164 

0.806451612903226 0.7458 0.729 0.7147 0.6531 0.5973 0.2159 

0.838709677419355 0.7283 0.7277 0.7132 0.6392 0.568 0.2139 

0.870967741935484 0.7249 0.7244 0.6511 0.5441 0.4866 0.2044 

0.903225806451613 0.6226 0.6082 0.5494 0.461 0.4153 0.2025 

0.935483870967742 0.5137 0.5133 0.5055 0.4286 0.3529 0.1674 

0.967741935483871 0.4566 0.4452 0.3993 0.3285 0.3021 0.1203 

0.1 2.8736 2.8657 2.8004 2.5124 2.2385 0.81277 

 Average of yearly averages: 0.42426 

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run: 

Output File: FlFLCUn 

Metfile: w12844.dvf 

PRZM scenario: FLcucumberSTD.txt 

EXAMS environment file: pond298.exv 

Chemical Name: Fluensulfone 

Description Variable Name Value Units Comments 

Molecular weight mwt 291.7 g/mol

Henry's Law Const. henry 1.65e-7 atm-m^3/mol 

Vapor Pressure vapr torr

Solubility sol 545.3 mg/L

Kd Kd mg/L 

Koc Koc 192 mg/L

Photolysis half-life kdp 0.784 days Half-life

Aerobic Aquatic Metabolism kbacw 45.93 days Halfife 

Anaerobic Aquatic Metabolism kbacs 27.68 days Halfife 

Aerobic Soil Metabolism asm 11.98 days Halfife 

Hydrolysis: pH 7 0 days Half-life

Method: CAM 4 integer See PRZM manual 

Incorporation Depth: DEPI 15 cm

Application Rate: TAPP 3.92 kg/ha

Application Efficiency: APPEFF 0.99 fraction 

Spray Drift DRFT 0.01 fraction of application rate applied to pond 

Application Date Date 01-09 dd/mm or dd/mmm or dd-mm or dd-mmm

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) 
-Page 87 of 117- 

Appendix B. AGDRIFT v.2.01 Output. 

Aquatic:

High Boom, Smallest Droplets 

Fraction of Applied at Edge of Field. 

Distance Needed to Remove Presumption of Risk –as defined by endpoint divided 

by LOC (0.05 for Listed Animals; 1.0 for plants): 

 For listed molluscs: For listed invertebrates: For Aquatic Plants: 

Oyster estimate (77000*0.05 = 3850). Mysid estimate (1000000*0.05 = 50000). Algae estimate (11000*1).
-Page 88 of 117- 

Buffer Needed using Daphnid Chronic Toxicity Data: 

Low Boom: Smallest Droplets 

Buffer Needed Based on Oyster Acute: Buffer Needed Based on Daphnid Chronic: 
-Page 89 of 117- 

High Boom: Largest Droplets 

Distance needed to remove Presumption of Risk: 

Oysters: 
-Page 90 of 117- 

Low Boom: Largest Droplets 

Summary of AgDrift Calculations and Buffer Needed to Reduce the Presumption of Risk to 

Below the LOC (0.05) for Listed Aquatic Species 

Taxon and Type 

of Toxicity Data 

Used as Basis

Concentration 

Estimate to 

Remove 

Presumption of 

Risk for Listed 

Species, as 

defined by the 

High Boom: Finest 

Droplets

Low Boom: Finest 

Droplets

High Boom: FineMed/Coarse

Droplets

Low Boom: 

Fine-Med/Coarse

Droplets

Edge of 

Field 

Conc.

Buffer 

Needed, 

ft

Edge of 

Field 

Conc.

Buffer 

Needed, 

ft

Edge of 

Field 

Conc.

Buffer 

Needed, 

ft

Edge of 

Field 

Conc.

Buffer 

Needed, 

ft
-Page 91 of 117- 

Endpoint*LOC

Aquatic 

Invertebrates:

Oyster Acute 

Data

Mysid Acute 

Data

Daphnid 

Chronic

77000 * 0.05 = 

3850 ppt 12100 

ppt, 

0.216 

lb/A

49

5260 

ppt, 

0.0938 

lb/A

3

3240 

ppt,

0.0577 

lb/A

0

2140 

ppt,

0.0381 

lb/A

1000000 * 0.05 

= 50000 ppt 0

96000 ppt (*1) 0

Aquatic Plants:

Algal EC05 11000 ppt (*1) 3 0

ppt = parts per trillion. 

Note: Calculated EECs (edge of field concentrations) based on parent compound a.i. but assuming equal toxicity 

with MS, calculations represent both. 

Terrestrial: 

High Boom: Smallest Droplets 

Low Boom: Smallest Droplets 
-Page 92 of 117- 

High Boom: Largest Droplets 

Low Boom: Largest Droplets 
-Page 93 of 117- 

Exposure to Terrestrial Animals From Varying Boom Heights and Droplet Sizes. 

Taxon and 

Type of 

Toxicity Data 

Used as Basis

Concentration Estimate 

to Remove Presumption 

of Risk for Listed 

Species, as defined by 

the Endpoint*LOC

High Boom: 

Finest 

Droplets

HB/FD

Low Boom: Finest 

Droplets

LB/FD

High Boom: FineMed/Coarse

Droplets

HB/CD

Low Boom: 

Fine-Med/Coarse

Droplets

LB/CD

Birds:

Acute

Chronic

1510 mg/kg-bw*0.1 = 

151.0 mg/kg-bw

>5760 mg/kg-diet*0.1 = 

>576.0 mg/kg-diet

0.0414 

mg/cm2, 

3.69 lb/A

0.0400 mg/cm2,

3.57 lb/A

0.0397 mg/cm2, 

3.54 lb/A

0.0395 mg/cm2, 

3.53 lb/A

255 mg/kg-diet*0.1 = 25.5 

mg/kg-diet

Mammals:

Acute

Chronic

671 mg/kg-bw*0.1 – 67.1 

mg/kg-bw

16.2 mg/kg-bw*0.1=1.62 

mg/kg-bw

250 ppm*0.1=25 ppm

Bees1

0.167 mg/bee (0.139 

mg/cm2) *0.05 = 0.00695 

mg/ cm

2

0.0414 

mg/cm2 0.0400 mg/cm2

0.0397 mg/cm20.0395 mg/cm2

Note: Calculated EECs (edge of field concentrations) based on parent compound a.i.; bird and mammal toxicity 

data based on most conservative, including consumers of grasses and other plants because even with incorporation 

and drip irrigation application, spray drift is one exposure route that may result in such exposure. 

1Assumed average honeybee to be approximately 90 to 140 mm2

 calculated from information from Smithsonian 

website: http://www.issg.org/database/species/ecology.asp?si=325&fr=1&sts=sss. Used honeybee worker body 

length of 19 mm and ratio of body length to width of 3.0x (from average ratio of two bees measured in photos): 

19mm * 6.3mm (19/3.0) = 119.7 mm2 or 1.20 cm2. 

2 EEC in mg/bee * bee/1.20 cm2

 (conversion) = EEC in mg/ cm2-- Example: 0.167 mg/bee * bee/1.20 cm2= 0.139 mg/cm2.

HB/FD: 
-Page 94 of 117- 

LB/CD: 
-Page 95 of 117- 

Distance Needed to Reduce the Presumption of Risk to Below the LOC (0.1) for Listed Species For Feeding 

Groups with LOC Exceedances Using Avian Dose-Based Toxicity Data.

Size, g

Avian Consumers of Fruits/Pods/Seeds Avian Consumers of Arthropods

EEC, 

mg/kg-bw RQ Allowable Fraction

Feet to 

Fraction

HB/FD

LB/CD1

EEC, 

mg/kgbwRQ Allowable 

Fraction

Feet to 

fraction

HB/FD

LB/CD1

20 59.8 0.45 22% 13

3

375 2.84 3.5% 72

10

100 34.1 0.20 -- -- 214 1.27 7.9% 33

7

Distance Needed to Reduce the Presumption of Risk to Below the LOC (1) for Feeding Groups with LOC 

Exceedances Using Chronic Avian Dietary-Based Toxicity Data.

All Size Classes 52.5 0.21 -- -- 329 1.29 78% 3

3

Size class not used for dietary risk quotients

1HB/FD = High Boom/Fine Droplets; LB/CD = .Low Boom/Coarse Droplets.

Distance Needed to Reduce the Presumption of Risk to Below the LOC (0.1) for Listed Species For Feeding 

Groups with LOC Exceedances Using Acute Mammalian Dose-Based Toxicity Data.

Size Class

(grams)

EECs and RQs

Consumers of Arthropods

EEC RQ

Allowable Fraction

Feet to Fraction

HB/FD

LB/CD1

15 314 0.21 48%

7

3

35 217 0.18 56%

7

3

1HB/FD = High Boom/Fine Droplets; LB/CD = .Low Boom/Coarse Droplets. 

Terrestrial Invertebrates: 

HB/FD: 

LB/CD: 
-Page 96 of 117- 

Buffer Needed to Reduce the Presumption of Risk to Below the LOC (0.05) for Listed Terrestrial 

Invertebrates.

Taxon and Type 

of Toxicity Data 

Used as Basis

Concentration 

Estimate to 

Remove 

Presumption of 

Risk for Listed 

Species, as defined 

by the 

Endpoint*LOC

Edge of Field 

EEC, mg/cm2

HB/FD

LB/CD1

Estimated RQ1 Allowable Fraction

Buffer Needed, 

Feet to Fraction

HB/FD

LB/CD

Honeybee 0.139 mg/cm2

*0.05 

= 0.00695 mg/ cm

2

0.0414

0.0395

0.298

0.284

17%

18%

16

3

RQ estimate is EEC/Endpoint, in this case, edge-of-field EEC ÷ honeybee LC50 expressed as mg/cm2 of honeybee 

surface (see table above for calculations). . 

Allowable fraction is fraction of EEC to achieve concentration below listed spp. LOC (0.05). 

Bolded and shaded mean exceed Agency listed species LOC (0.05). 
-Page 97 of 117- 

Appendix C. T-REX and Terrplant Output for Fluensulfone. 

TREX MODEL INPUTS Assumed broadcast and 85% incorporation

These values will be used in the calculation of exposure estimates for foliar, granular, liquid and/or 

seed applications of pesticides.

Chemical Identity and Application Information

Chemical Name: Fluensulfone

Seed Treatment? (Check if yes)

FALSE

 Use: Transplanted Crops - Groups 8 and 9

Product name and form: 480EC (40% but all calcs in a.i.)

% A.I. (leading zero must be entered 

for formulations <1% a.i.): 100.00%

Application Rate (lb ai/acre) 3.5

Half-life (days): 35

Application Interval (days):

Number of Applications: 1

Are you assessing applications with 

variable rates or intervals? no

Summary of Risk Quotient Calculations Based on Upper Bound Kenaga EECs

Table X. Upper Bound Kenaga, Acute Avian Dose-Based Risk Quotients

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds Arthropods Granivore

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

20 131.88 956.68 7.25 438.48 3.32 538.13 4.08 59.79 0.45 374.70 2.84 13.29 0.10

100 167.89 545.54 3.25 250.04 1.49 306.86 1.83 34.10 0.20 213.67 1.27 7.58 0.05

1000 237.16 244.24 1.03 111.95 0.47 137.39 0.58 15.27 0.06 95.66 0.40 3.39 0.01

Table X. Upper Bound Kenaga, Subacute Avian Dietary Based Risk Quotients

LC50 EECs and RQs
-Page 98 of 117- 

Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds Arthropods

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

5760 840.00 0.15 385.00 0.07 472.50 0.08 52.50 0.01 329.00 0.06

Size class not used for dietary risk quotients 

Table X. Upper Bound Kenaga, Chronic Avian Dietary Based Risk Quotients

NOAEC 

(ppm)

EECs and RQs

Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds Arthropods

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

255 840.00 3.29 385.00 1.51 472.50 1.85 52.50 0.21 329.00 1.29

Size class not used for dietary risk quotients

Table X. Upper Bound Kenaga, Acute Mammalian Dose-Based Risk Quotients 

Size Class

(grams)

Adjusted

LD50

EECs and RQs

Short Grass Tall Grass Broadleaf 

Plants Fruits/Pods/Seeds Arthropods Granivore

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 1474.74 800.88 0.54 367.07 0.25 450.49 0.31 50.05 0.03 313.676 0.2127 11.123 0.0075

35 1193.23 553.51 0.46 253.69 0.21 311.35 0.26 34.59 0.03 216.792 0.1817 7.6877 0.0064

1000 516.11 128.33 0.25 58.82 0.11 72.19 0.14 8.02 0.02 50.2641 0.0974 1.7824 0.0035

Table X. Upper Bound Kenaga, Acute Mammalian Dietary Based Risk Quotients

LC50 

(ppm)

EECs and RQs

Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds Arthropods

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

0 840.00 #DIV/0! 385.00 #DIV/0! 472.50 #DIV/0! 52.50 ##### 329.00 #DIV/0!

Size class not used for dietary risk quotients
-Page 99 of 117- 

Table X. Upper Bound Kenaga, Chronic Mammalian Dietary Based Risk Quotients

NOAEC 

(ppm)

EECs and RQs

Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds/Large 

Insects Arthropods

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

250 840.00 3.36 385.00 1.54 472.50 1.89 52.50 0.21 329.00 1.32

Size class not used for dietary risk quotients 

Table X. Upper Bound Kenaga, Chronic Mammalian Dose-Based Risk Quotients

Size 

Class

(grams)

Adjusted 

NOAEL

EECs and RQs

Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds Arthropods Granivore

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 40.22 800.88 19.91 367.07 9.13 450.49 11.20 50.05 1.24 313.68 7.80 11.12 0.28

35 32.54 553.51 17.01 253.69 7.80 311.35 9.57 34.59 1.06 216.79 6.66 7.69 0.24

1000 14.08 128.33 9.12 58.82 4.18 72.19 5.13 8.02 0.57 50.26 3.57 1.78 0.13
-Page 100 of 117- 

Appendix D. Earthworm Fugacity Model 

Terrestrial Chronic Exposure Estimates for Birds and Mammals Exposed to Incorporated 

or Drip Irrigated Applications of Fluensulfone 

Terrestrial Acute Exposure Estimates for Earthworms Exposed to Incorporated or Drip 

Irrigated Applications of Fluensulfone 

Fluensulfone exposure to terrestrial wildlife from non-granular applications was evaluated by 

estimating pesticide residues on food items that enter the treatment area, including insects and 

seeds. For the purposes of this assessment, terrestrial wildlife is assumed to include birds, which 

are also used as a surrogate for reptiles and terrestrial-phase amphibians, and mammals. Since 

exposure to fluensulfone through these types of applications is likely to be limited since it is 

either incorporated or drip-irrigated (assuming no aerial application and immediate 

incorporation, e.g., within 24 hours) terrestrial EECs and acute risks were also derived based on 

an estimation of loadings of pesticide per unit area (ft2) for a more refined assessment. The 

following chronic exposure estimation and risk characterization for terrestrial wildlife considers 

the exposure route of direct ingestion of soil invertebrates that have ingested granules of soil. In 

addition, acute risks to terrestrial invertebrates exposed to applications of fluensulfone are 

estimated using the concentration of fluensulfone in earthworms and earthworm toxicity data, 

which is used as a surrogate for terrestrial invertebrates and their consumption by the terrestrial 

vertebrates. 

Direct Ingestion of Soil Invertebrates

An estimation of fluensulfone concentrations potentially accumulated in the tissues of 

earthworms was calculated using a fugacity-based (equilibrium partitioning) approach based on 

the work of Trapp and McFarlane (1995) and Mackay and Paterson (1981). Earthworms 

dwelling within the soil are exposed to contaminants in both soil pore water and via the ingestion 

of soil (Belfroid et al. 1994). The concentration of fluensulfone in earthworms was calculated as 

a combination of uptake from soil pore water and gastrointestinal absorption from ingested soil: 

Cearthworm = [(Csoil)(Zearthworm/Zsoil]+[(Csoil water)(Zearthworm/Zwater)]

where: Csoil is the concentration of chemical in bulk soil (note: a chemical 

concentration averaged over a 1-15 cm soil depth was used to reflect a 

concentration across the earthworm occupied area of soil, MRID 

48574832, using the California soil type concentration of 2.118 mg/kg 

soil, because it had the greatest concentration of the four soils tested.) 

 Zearthworm is the fugacity capacity of chemical in earthworms = 

 (lipid)(Kow)(ρearthworm)/H

 Zsoil is the fugacity capacity of chemical in soil = (Kd)(ρsoil)/H 

 Zwater is the fugacity capacity of chemical in water = 1/H 

 Csoil water is the concentration of chemical in soil water = Csoil/Kbw

 Kbw is the bulk soil-to-water partitioning coefficient = 

 (ρsoil)(Kd)+θ+(ε-θ)(Kaw) 
-Page 101 of 117- 

 Kaw is the air-to-water partitioning coefficient = H/RT 

 H = Henry’s Constant specific to fluensulfone (1.65E-7) 

R = universal gas constant, 8.31 Joules-m3/mole-oK 

 T = temperature oK, assumed to be 298 oK 

 Kd = soil partitioning coefficient for fluensulfone (mean value of 1.93, 

used in PRZM/EXAMS calculations, MRID 48574833) 

 ρsoil = bulk density of soil, assumed to be 1.3 g/cm3

 θ = volumetric fraction of the soil, assumed to be 0.30 

ε = volumetric total porosity of the soil, assumed to be 0.50 

 lipid = fraction of lipid in organism 0.01 (Cobb et al. 1995) 

Kow = the octonal to water partitioning coefficient for fluensulfone (91.2, 

MRID 48574717) 

ρearthworm = the density of the organism, assumed to be 1 g/cm3

Table E-1 summarizes the estimated immediate post-treatment soil concentrations of 

fluensulfone, assuming 1 cm averaging depth, a soil density of 1.3 g/cm3

, and the granular 

application rate of fluensulfone (3.5 lb a.i./acre, nematode treatment to Crop Groups 8 and 9). 

Table G-1 Estimated Soil Concentration for Fluensulfone (Immediately Posttreament)

Application Rate (lb a.i./acre) Soil Concentration (mg/kg-soil) at 1-15 cm depth

3.5 2.118

Table G-2 summarizes the model inputs and exposure estimates (i.e., earthworm concentrations 

in ppm) for insectivorous birds (used as a surrogate for reptiles terrestrial-phase amphibians that 

consume invertebrates) and mammals based on the fluensulfone application incorporated or dripirrigated (3.5 lb a.i./acre). 

Table G-2 Model Input Parameters and Dietary Exposure Estimates for Avian and 

Mammalian Receptors (for Soil Concentrations Immediately Post-treatment)

Parameter Application Rate: 3.5 lb a.i./acre

Csoil (mg/kg @ 1-15 cm depth) 2.118

Cearthworm (mg/kg) 1.46

Kd (L/kg) 1.93

Zwater (1/H or moles/Pa-m

3

) 6.06E+06

Zsoil ((Kd)(ρsoil)/H) 1.52E+07

Zearthworm ((lipid)(Kow)(ρearthworm)/H) 5.53E+06

ρsoil (g/cm3) 1.3

ρearthworm (g/cm3) 1

θ (unitless) 0.3

ε (unitless) 0.5

Kaw (H/RT) 5.92E-06

Kbw ((ρsoil)(Kd)+θ+(ε-θ)(Kaw)) 2.804
-Page 102 of 117- 

Risk Characterization for Terrestrial Wildlife

Chronic risks for birds and mammals that consume terrestrial invertebrates as the majority of 

their diet were estimated based on comparison of the concentration of fluensulfone in earthworm 

tissue (Cearthworm) with chronic toxicity values for birds and mammals. Although earthworms are 

likely to be present in the top six inches of soil, a 1-15 cm soil depth was used because 

fluensulfone is incorporated or drip-irrigated into the soil and soil concentration estimation is 

immediately post-treatment. It is important to note that this estimation of risk assumes that 100% 

of the diet is comprised of terrestrial soil invertebrates. In addition, the model assumes that no 

metabolism or elimination of the chemical has occurred. 

Direct Effects: Insectivorous Mammals, Birds, Reptiles or Terrestrial-Phase 

Amphibians

Chronic risks for insectivorous mammals were estimated by comparing the Cearthworm in ppm to 

the mammalian chronic NOAEC for fluensulfone (250 mg/kg-diet, based on growth effects, food 

consumption and histopathology, 48574769). Estimated earthworm residues for insectivorous 

mammalian receptors (1.46 mg/kg) are less than the mammalian chronic endpoint for 

fluensulfone applications at the rate of 3.5 lb a.i./acre. Therefore, the chronic RQ value (<0.01) 

mammals associated with ingestion of terrestrial invertebrates (i.e., earthworms) that have 

bioaccumulated fluensulfone does not exceed the chronic LOC. 

Chronic risks for insectivorous birds (also surrogate for reptiles and terrestrial-phase amphibians) 

were estimated by comparing the Cearthworm in ppm to the avian chronic NOAEC for fluensulfone 

(255 mg/kg-diet, based on mallard growth effects, 48574846). Estimated earthworm residues for 

insectivorous avian receptors (1.46 mg/kg) are less than the avian chronic endpoint for 

fluensulfone applications at the rate of 3.5 lb a.i./acre. Therefore, the chronic RQ value (<0.01) 

birds associated with ingestion of terrestrial invertebrates (i.e., earthworms) that have 

bioaccumulated fluensulfone does not exceed the chronic LOC. 

However, it is unclear whether other routes of fluensulfone exposure (i.e., direct consumption of 

fluensulfone, ingestion of fluensulfone that adheres to soil invertebrates, partitioning of dissolved 

fluensulfone to on-site sources of wildlife drinking water, and dermal exposure to soil and onsite puddles) or combined routes of exposure would result in chronic risk concerns for mammals, 

birds, reptiles and terrestrial-phase amphibians. 

Indirect Effects: Consumption of Insectivorous Mammals, Birds, Reptiles or 

Terrestrial-Phase Amphibians 

Chronic risks for insectivorous animals were estimated by considering both dietary-based and 

dose-based exposures and effects. In the dietary method, risks were estimated by comparing the 

Cearthworm to the mammalian and avian chronic NOAEC for fluensulfone (250 and 255 ppm, 

respectively, MRIDs 48574769 and 48574846). In the dose-based method, the residue 

concentration in earthworms was converted to a daily oral dose based on the fraction of body 

weight consumed as estimated through mammalian and avian allometric relationships. The dose 
-Page 103 of 117- 

was then compared to the NOAEL (for rats, 16.2 mg/kg-bw/day, based on male rat weight, 

MRID 48574769, for mallards, 31.2 mg/kg-bw/day, based on male bird weight, MRID 

48574846) for bird and mammalian receptors. 

Based on the dietary method and the fluensulfone granular application rate of 3.5 lb a.i./acre, the 

chronic RQ value (<0.01) does not exceed the chronic LOC for insectivorous mammals because 

the earthworm residue concentration (1.46 mg/kg) is less than the NOAECs (250 and 255 mg 

a.i./kg-diet, mammal and bird). The earthworm residue concentration, derived based on the dose 

method, is first converted to a daily dose by multiplying the dietary Cearthworm by the percentage 

body weight consumed, e.g. for the small mammals (15 g), this is 95% body weight (this is also 

used as a default value for small birds). In addition, the NOAEL value (16.2 and 32.2 mg/kgbw/day, mammal and bird, respectively) is adjusted to account for the size of the mammals 

according to the following equation: 

Adjusted NOAEL = NOAEL (TW/AW)(0.25) 

where: 

 TW = body weight of tested animal (350 g rat); and 

 AW = body weight of assessed animal (15 g). 

As shown in Table G-3, the estimated chronic dose for insectivorous mammals and birds, based 

on the 3.5 lb a.i./acre application rate and adjusted NOAELs for small mammals and birds does 

not exceed the chronic LOC (1.0) with respective RQ values of 0.04 and 0.02. The results of the 

assessment indicate that, when growth and reproduction effect risks for mammals and birds are 

assessed on the basis of daily ingested dietary dose, the accumulation of fluensulfone in 

terrestrial invertebrates does not represent, by itself, a biologically significant pathway for 

exposure. Other size classes were not assessed since the smallest size classes come the highest 

rates of food and this screening showed that the risk was biologically significant. 

Table G-3 Dose-based Chronic RQ Values for Insectivorous Mammals and Birds at 

an Application Rate of 3.5 lb a.i./A.

Taxon Body Weight (g) Dose-adjusted EECw

(mg/kg)a

Adjusted NOAEL 

(mg/kg-bw/day)b

Chronic 

RQc

Mammals 15 1.39 35.6 0.039

Birds 20 1.39 85.9 0.016

aDose-adjusted EECw = Dietary EECw (ppm) * (%BW consumed/100).

bAdjusted NOAEL = NOAEL(TW/AW)0.25; weight of rats used in calculations was a FDA standard 350g, 

for mallards, weight data was derived from the study.

cChronic RQ = Dose-adjusted EECw/Adjusted NOAEL.

Bolded and Shaded if exceeds chronic risk level of concern (RQ ≥ 1.0); no exceedences were found.

Indirect Effects: Earthworms

Acute risks for earthworms (used as a surrogate for terrestrial invertebrates for quantifying risk) 

exposed to incorporated and drip-irrigation applications of fluensulfone (also serving as food for 
-Page 104 of 117- 

some mammals, birds, reptiles and terrestrial-phase amphibians) were estimated based on 

comparison of the concentration of fluensulfone in earthworm tissue (Cearthworm) with the LC50 for 

earthworms. The estimated earthworm residue (1.46 mg/kg) divided by the LC50 = 148 mg 

a.i./kg-dry soil results in an acute RQ value of <0.01, which does not exceed the acute LOC 

(Table G-4). 

Table G-4 Acute RQ Estimation for Terrestrial Invertebrates

Application Rate Cearthworm 

(mg/kg @ 1-15 cm depth)

LC50

1

(mg a.i./kg-dry soil) Acute RQ

3.5 lb a.i./acre 1.46 148 <0.01

1Estimation based on earthworm 14-d LC50 (MRID 48574880).

*Does not exceed acute LOC (RQ ≥ 0.05).

Uncertainties 

There are a number of uncertainties associated with the fugacity model used to estimate 

fluensulfone concentrations in earthworm tissue and subsequent risks to insectivorous terrestrial 

wildlife. It may be possible to further refine this assessment with additional information that 

addresses the following uncertainties: 

The fugacity-based model assumes equilibrium partitioning between bulk soil and soil pore 

water. In addition, the model assumes a fixed value for soil density, earthworm density, 

temperature, pore space, organic carbon, and the lipid content of the earthworm. Resulting 

concentrations of fluensulfone in earthworm tissue may be either underestimated or 

overestimated depending on the soil type, temperature, and size/lipid content of the earthworm at 

the time of exposure. This assessment considers only one route of exposure (i.e., ingestion of 

terrestrial invertebrates that have bioaccumulated fluensulfone from granules in the soil) for 

insectivorous birds and mammals. In addition, it is assumed that 100% of the diet is comprised of 

terrestrial soil invertebrates. Given species-specific feeding habits and dietary requirements, this 

assumption may overestimate risk associated with ingestion of soil invertebrates that have 

accumulated fluensulfone. Other potential routes of exposure including direct ingestion of 

fluensulfone, ingestion of fluensulfone adhering to soil invertebrates, partitioning of dissolved 

fluensulfone to sources of wildlife drinking water, and dermal exposure of granules released to 

surrounding soil and puddles or combined routes of exposure were not considered. 

References 

Belfroid, A., M. Sikkenk, W. Seinen, K.V. Gestel, J. Hermens. 1994. The toxicokinetic behavior 

of chlorobenzenes in earthworm (Eisenia andrei) experiments in soil. Environ. Toxicol. Chem. 

13:93-99. 

Mackay, D. and S. Paterson. 1981. Calculating fugacity. Environ. Sci. Technol. 15: 1006-1014. 

Trapp, S. and J.C. McFarlane (eds.). 1995. Plant Contamination Modeling and Simulation of 

Organic Chemical Processes. Lewis Publishers. Boca Raton, Florida. 
-Page 105 of 117- 

Appendix E. TerrPlant Output 

Table 1. Chemical Identity.

Chemical Name Fluensulfone1

PC code 50410

Use Nematode Treatment Trans Crops Groups 8 and 9

Application Method Broadcast and Incorp

Application Form Spray 

Solubility in Water (ppm) 545

Table 2. Input parameters used to derive EECs.

Input Parameter Symbol Value Units

Application Rate A 3.5 y

Incorporation I 6 none

Runoff Fraction R 0.05 none

Drift Fraction D 0.01 none

Table 3. EECs for Fluensulfone. Units in y.

Description Equation EEC

Runoff to dry areas (A/I)*R 0.029166667

Runoff to semi-aquatic areas (A/I)*R*10 0.291666667

Spray drift A*D 0.035

Total for dry areas ((A/I)*R)+(A*D) 0.064166667

Total for semi-aquatic areas ((A/I)*R*10)+(A*D) 0.326666667

Table 4. Plant survival and growth data used for RQ derivation. Units are in y.

Seedling Emergence Vegetative Vigor

Plant type EC25 NOAEC EC25 NOAEC 

Monocot 2.5 1.21 >3.491

0.0415

Dicot >3.771

0.141 1.31 0.419

1Non-Definitive Endpoint - Used.as lower-bound of risk estimate.

Table 5. RQ values for plants in dry and semi-aquatic areas exposed to Fluensulfone through runoff 

and/or spray drift.*

Plant Type Listed Status Dry Semi-Aquatic Spray Drift

Monocot non-listed <0.1 0.13 <0.1

Monocot listed <0.1 0.27 <0.1

Dicot non-listed <0.1 <0.1 <0.1

Dicot listed 0.46 2.32 <0.1

Assume exposure based on both parent + MS; if run based on MS solubility, results are the same. 

Therefore, EECs represent both fractions.

*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.
-Page 106 of 117- 

Appendix F. Fluensulfone Degradate Toxicity Summary. 

Comparative Ecotoxicity of Transformation Products 

No ecotoxicity concerns were found for the major transformation products: TSA, MS, BSA, 

deschloro-fluensulfone, butene sulfinic acid and deschloro thiazole sulfonic acid. Studies are 

available for TSA, MS and BSA regarding toxicity to aquatic animals and plants and for deschloro-fluensulfone toxicity to aquatic plants. Tables E-1 to E-3 display available aquatic 

ecotoxicity study data and QSAR estimates for transformation products compared to the parent 

compound. 

Table F-1. Available Aquatic Invertebrate Transformation-Product Toxicity Data 

Compared with Parent.

Test 

Substance

Acute Endpoint, 96-h LC/EC50 (95% C.I.), mg/L1 Chronic Endpoint, NOAEC or EC05, mg/L1

Available Acute Laboratory Study 

Data

QSAR (EPIWEB 

4.1) Estimate

[Based on Neutral 

Organics and 

Neutral OrganicAcid]

2

Available Chronic 

Laboratory Study 

Data

QSAR (EPIWEB 4.1) 

Estimate – Chronic 

Value

Daphnid 

(Daphnia 

magna)

Mysid 

(Americamysis 

bahia)

Parent 

Technical 

Grade Active 

Ingredient

22 (15-25)

[MRID 

48574864]

1.0 (0.46-1.9)

[MRID 48574864]

Daphnid - 118

Mysid - 197*

Daphnid: 0.20

(dry wt. and 

offspring/repro. day)

[MRID 48574856]

Mysid: 0.37 (male 

length)

[MRID 48574857]

Daphnid - 13.8

Mysid - 16.7

TSA --

3 >123 (NA)

[MRID 48574869]

Daphnid-6.46e+005

Mysid - 2.37e+007* --

Daphnid - 42900

Mysid - 5.81e+006*

MS --

19 (16-22)

[MRID 48574877]

Daphnid - 2490

Mysid - 20600 --

Daphnid - 217

Mysid - 3030

BSA --

>114 (NA)

[MRID 48574873]

Daphnid-2.38e+005

Mysid - 5.66e+006* --

Daphnid - 17100

Mysid -1.2e+006*

DeschloroFluensulfone -- --

Daphnid - 836

Mysid –3720*

--

Daphnid - 82

Mysid - 442

Butene 

Sulfinic Acid -- --

Daphnid - 21900

Mysid –5.21e+005* --

Daphnid - 1580

Mysid -1.1e+005

Deschloro 

Thiazole 

Sulfonic Acid

-- --

Daphnid1.79e+006*

Mysid-1.14e+008*

--

Daphnid-1.07e+005

Mysid - 3.4e+007*

TSA - thiazole sulfonic acid; MS - methyl sulfone; BSA - butene sulfonic acid. 

1

Parent results are in mg a.i./L; TSA results are in mg TSA/L; MS results are in mg MS/L; and BSA results are in mg BSA/L. 

2

 For deschloro-fluensulfone, since Ecosar does not assess charged particles, used smiles O=S(=O)(CCC(F)=C(F)F)c1nccs1 

3 

-- No Data; NA – information not available; * = asterisk designates: Chemical may not be soluble enough to measure this effect. 
-Page 107 of 117- 

Table F-2. Available Fish Transformation-Product Toxicity Data Compared with Parent.

Test Substance

Acute Endpoint, 96-h LC/EC50 (95% C.I.), mg/L1 Chronic Endpoint, NOAEC or EC05, 

mg/L1

Available Acute Laboratory 

Study Data QSAR (EPIWEB 

4.1) Estimate

[Based on Neutral 

Organics and 

Neutral OrganicAcid]2

Available Chronic 

Laboratory Study 

Data

QSAR (EPIWEB 

4.1) Estimate –

Chronic Value Bluegill (Lepomis 

macrochirus)

Sheepshea

d Minnow 

(Cyprinodo

n 

variegatus)

Parent Technical 

Grade Active 

Ingredient

MCW2 Technical

11.6 (9.0-15.4)

[MRID 48574853]

28 (20-38) 

[MRID 

48574852]

FW – 207*

SW – 286*

Fathead Minnow 

(Pimephales promelas)

0.63 (post-hatch 

survival and signs of 

toxicity)

FW - 21.7

SW - 31.3

TSA >121 (NA)

[MRID 48574866] --

3 FW – 1.93e+006 *

SW – 3.5e+006 * --

FW - 1.59e+005

SW - 37100

MS 35 (28-44)

[MRID 48574874] --

FW – 5760

SW – 9170

--

FW - 532

SW - 299

BSA >122 (NA)

[MRID 48574870] --

FW – 6.6e+005 *

SW – 1.15e+006 * --

FW - 56200

SW - 16700

DeschloroFluensulfone -- --

FW – 1740

SW – 2620

--

FW - 169

SW - 137

Butene Sulfinic 

Acid -- --

FW – 60700

SW – 1.06e+005 --

FW – 517

SW - 1560

Deschloro 

Thiazole Sulfonic 

Acid

-- --

FW – 5.88e+006 *

SW – 1.12e+007 * --

FW - 4.64e+005

SW - 78200

TSA - thiazole sulfonic acid; MS - methyl sulfone; BSA - butene sulfonic acid. 

1

Parent results are in mg a.i./L; TSA results are in mg TSA/L; MS results are in mg MS/L; and BSA results are in mg BSA/L. 

2

 For deschloro-fluensulfone, since Ecosar does not assess charged particles, used smiles O=S(=O)(CCC(F)=C(F)F)c1nccs1 

3

-- No Data; NA – information not available; * = asterisk designates: Chemical may not be soluble enough to measure this effect. 

Table F-3. Available Aquatic Plant Transformation-Product Toxicity Data Compared with Parent Using the 

Green Alga (Pseudokirchneriella subcapitata).

Test Substance

EC50 (95% C.I.),

lb a.i./A1,2 

[Reference]

EC05 (95% C.I.) and NOAEC, 

mg a.i./L 1,3

[Reference]

QSAR (EPIWEB 

4.1) Estimate

[Based on Neutral 

Organics and 

Neutral OrganicAcid]4

Parent Technical Grade 

Active Ingredient

MCW2 Technical

0.022 (0.020-0.024)

[MRID 48574858]

Cell Density: EC05: 0.011 (0.0068 - 0.017)

NOAEC: 0.0089 

[MRID 48575017]

96-hr EC50 57.5

ChV 22.2

TSA >4.4 (NA)5

[MRID 48574868]

Growth Rate (Yield): EC05: 0.090 (NA)

NOAEC: 4.4 

[MRID 48574868]

96-hr EC50 66400

ChV14100

MS 2.5 (1.7-3.7)

[MRID 48574876]

Cell Density: EC05: 1.1 (0.47 - 2.6)

NOAEC: 1.3

[MRID 48574876]

96-hr EC50 543

ChV 154

BSA >4.4 (NA)

[MRID 48574872]

Cell Density, Growth Rate and Yield:

EC05: >4.4 (NA), NOAEC: 4.4

[MRID 48574872]

96-hr EC50 30500

ChV 7060

Deschloro-Fluensulfone >4.5 (NA)

[MRID 48574878]

Cell Density, Growth Rate and Yield:

EC05: 0.036 (3.7x10-4 - 3.5)

NOAEC: 0.43 

[MRID 48574878]

96-hr EC50 249

ChV 79.7
-Page 108 of 117- 

Butene Sulfinic Acid -- --

96-hr EC50 2810

ChV 648

Deschloro Thiazole 

Sulfonic Acid -- --

96-hr EC50 

1.39e+005

ChV 26600

TSA - thiazole sulfonic acid; MS - methyl sulfone; BSA - butene sulfonic acid. 

1

Parent results are in lb a.i./A; TSA results are in lb TSA/A; MS results are in lb MS/A; BSA results are in lb BSA/A; and 

Deschloro-fluensulfone results are in lb Deschloro-fluensulfone/A. 

2

For plants this is the endpoint of fifty percent effect used to assess risk to non-listed species. 

3

For plants this is the no-observed effect endpoint or five percent effect endpoint used to assess risk to listed species. 

4

 For deschloro-fluensulfone, since Ecosar does not assess charged particles, used smiles O=S(=O)(CCC(F)=C(F)F)c1nccs1 

5

-- No Data; NA – information not available; ChV = Chronic Value – QSAR chronic endpoint estimate. 

Laboratory studies showed that for aquatic invertebrates, all transformation products were 

greater than two orders of magnitude less acutely toxic to mysids than the parent compound 

(Table F-1). The 96-h LC50 ranged from 19 to >123 mg/L for transformation products compared 

to 1.0 mg a.i./L for the parent compound. For freshwater fish, all transformation products were 

less acutely toxic by at least half to the bluegill than the parent compound (Table F-2). The 96-h 

LC50 ranged from 35 to >122 mg/L for transformation products compared to 12 mg a.i./L for the 

parent compound. For aquatic plants, all transformation products were greater than two orders of 

magnitude less acutely toxic to green algae than the parent compound (Table F-3). The EC50

ranged from 2.5 to 13 mg/L for transformation products compared to 0.022 mg a.i./L for the 

parent compound. 

Toxicity estimates using EPISuite 4.1 were also run to fill data gaps for transformation products 

that did not have available toxicity data (Tables F-1 to F-3). These estimates showed all 

transformation products to be less toxic than parent. However, a comparison of available 

toxicity data with the estimates showed that EPISuite was not populated with sufficient data on 

compounds similar to these to be a good predictor of toxicity for these compounds – making 

these estimates unreliable. Most estimates were one to two orders of magnitude (or more) less 

sensitive than measured endpoints. Uncertainty exists for the ecological impact of the 

transformation products without toxicity data. This analysis did not suggest that any of the major 

degradates were likely to be more toxic than the parent compound, but did not offer any 

quantifiable certainty that they are not. 

Aquatic Organisms Toxicity Comparisons of Fluensulfone TGAI and its Metabolites 

Acute aquatic toxicity data (fish, aquatic invertebrates, and algal studies) are available for three 

degradates of fluensulfone and algal data only available for a fourth. 

Table F.4. Comparison of Degradate and Parent Compound Toxicity* 

Test Material Test Species

LC/EC50

Toxicity Value

(mg/L)

Molecular 

weight

(g/mol)

Degradate toxicity 

(mg/L) 

expressed in terms of 

the parent compound1

Fluensulfone Parent

5-Chloro-2-[3,4,4-trifluor-3-

butene-1-yl)sulfonyl]-thiazole

Mysid (Americamysis 

bahia)

1.0 

[MRID 48574864]

291.7 

--

Bluegill (Lepomis 

macrochirus)

11.6

[MRID 48574853] --

Green algae

(Pseudokirchneriella 

0.022

[MRID 48574858] --
-Page 109 of 117- 

Test Material Test Species

LC/EC50

Toxicity Value

(mg/L)

Molecular 

weight

(g/mol)

Degradate toxicity 

(mg/L) 

expressed in terms of 

the parent compound1

subcapitata)

TSA (Thiazole Sulfonic Acid)

5-chloro-thiazole-2-sulfonic 

acid

Mysid (A. bahia)

>123

[MRID 48574869]

199.5

>180

Bluegill (L. 

macrochirus)

>121

[MRID 48574866] >177

Green algae (P. 

subcapitata)

>4.4

[MRID 48574868] >6.43

MS (Methyl Sulfone)

5-chloro-2-methyl sulfonyl 

thiazole

Mysid (A. bahia)

19

[MRID 48574877

197.7

28.0

Bluegill (L. 

macrochirus)

35

[MRID 48574874] 51.6

Green algae (P. 

subcapitata)

2.5

[MRID 48574876] 3.69

BSA (Butene Sulfonic Acid)

3,4,4-trifluoro-but-3-ene-1-

sulfonic acid

Mysid (A. bahia)

>114

[MRID 48574873]

190

>175

Bluegill (L. 

macrochirus)

>122

[MRID 48574870] >187

Green algae (P. 

subcapitata)

>4.4

[MRID 48574872] >6.76

Deschloro-Fluensulfone

2-(3,4,4-trifluoro-3-buteny 

sulfonyl) thiazole Green algae (P. 

subcapitata)

>4.5

[MRID 48574878] 257 >5.11

1

[(MW parent/MW degradate) * (toxicity endpoint degradate (mg/L))] = LC/EC50 of degradate as parent, mg a.i./L.

* Bold values indicates potentially equal degradate toxicity when compared to the parent, fluensulfone TGAI.

 Degradates were less toxic than parent, with the possible exception of MS, which had 

somewhat similar toxicity to parent when tested on the mysid and bluegill. Based on toxicity 

expressed as parent (see Table F.4), the mysid LC50 was 28 and 1 mg a.i./L for MS and parent, 

respectively. The bluegill LC50 was 52 and 12 mg a.i./L, for MS and parent, respectively. The 

only available plant data was with green algae and this showed MS to be about 2 orders of 

magnitude less toxic than parent (EC50 of 3.7 and 0.022 mg a.i./L for MS and parent, 

respectively). 

Table F.5. Comparison of Toxicity of 480EC Formulation to the Fluensulfone Technical 

Active Ingredient. 

Taxa

(Study) Test Species

Test Substance

(Flowthrough/Static)

Endpoint 

(95% C.I.)

(mg a.i./L, meanmeasured)

Toxicity 

Enhancement 

of 

Formulation

MRID

Freshwater 

Fish Acute

Rainbow trout (O. 

mykiss)

TGAI Static LC50 = 38 (27-53)

11.9x 48574740

480EC Static LC50 = 3.2 (2.7-3.7) 48574927

Bluegill (L. 

macrochirus)

TGAI Static LC50 = 13 (12-15)

5.2x 48574853

480EC Static LC50 = 2.5 (2.1-2.9) 48574929
-Page 110 of 117- 

Estuarine/ 

Marine 

Fish Acute

Sheepshead 

Minnow (C. 

variegatus)

TGAI Static LC50 = 28 (20-38)

4.7x

48574852

480EC Static LC50 = 5.9 (5.0-6.8) 48574928

Daphnid

Acute

Waterflea

(D. magna)

TGAI Static EC50 = 22 (17-29) 58x 48574855

480EC Static EC50 = 0.38 (0.29-0.50) 48574930

Avain 

Acute

Northern 

bobwhite quail

(C. virginianus)

TGAI Oral Dose LD50 = 1510 (1220-1880)

1.5x

48574842

480EC Oral Dose LD50 = 998 (791-1260) 48574951

Rat Acute Wistar rat

(R.norvegicus)

TGAI Dietary 

Dose LD50 = 671 mg a.i./kg-bw

Less Toxic

48574745

480EC Dietary 

Dose

LD50 = >947 mg a.i./kgbw 48574924

Bee 

Contact 

Acute

Honey Bee

(A. mellifera)

TGAI Contact LD50 0.167 (0.141-0.210) 

mg a.i./bee

LD50 >0.200 mg a.i./bee

Less Toxic 48574879

480EC Contact 48574934

Earthworm 

Acute

Earthworm

(E. fetida) TGAI Soil LC50 = 148 mg a.i./kg soil dw 2.6x

48574880

480EC Soil LC50 = 57.4 mg a.i./kg soil 

dw 48574939

Algal 

Acute

Green algae

(P. subcapitata)

TGAI Static EC50 = 0.022 (0.020-0.024)

EC50 = 0.025 (0.021-0.030) 1.6x

48574858

48575017

480EC Static EC50 = 0.015 (0.011-0.021) 48574931

The available acute toxicity data for the 480EC formulation, which contains 40% 

fluensulfone a.i., show that it is approximately 5-12 times more toxic to fish, 58x more toxic to 

aquatic invertebrates, 2x more toxic to algae, 3x more toxic to earthworms, and 2x more toxic to 

birds than the fluensulfone a.i. alone,; however, the formulation was less toxic to rats and 

honeybees than the a.i. alone. 
-Page 111 of 117- 

Appendix G. Submitted Ecological Effects Studies for Fluensulfone and 

Remaining Data Gaps. 

Fluensulfone Global EPs: Active substance; Emulsifiable Concentrate Formulation 480EC.

Primary Reviewer: 

 Donna R. Judkins, US EPA 

 Date: January 10, 2013

Secondary Reviewers: (PMRA and APVMA) 

Derek Francois, PMRA 

Date: March 20, 2013

 Jack Holland, APVMA 

 Date: June 10, 2013

 

Please Note: The study reviews were written in both US EPA DER (Data Evaluation Report) 

and standard global monograph formats. The US EPA contractor initially used the DER format 

to write the study reviews and due to time constraints, US EPA and PMRA decided to use those 

reviews rather than taking the time to re-write them. Later, however, APVMA joined the review 

and used the monograph format for their review. All major comments were addressed and 

reviewers agreed that either format was useable depending on the preference, rather than spend 

time merging the documents. No reporting table was constructed because no major issues came 

about -- PMRA stated that no reporting table would be needed since there were no issues of 

contention between US EPA and PMRA in the DERs 7

and APVMA suggested that given the 

lack of major issues, they proceed with the summaries from the monograph and the US 

EPA/PMRA proceed with the DERs.8

Beneficials Fluensulfone Global EPs: Active substance; Emulsifiable Concentrate Formulation 

480EC.

Primary Reviewer: 

 Derek François, PMRA, Canada 

 Date: April 30, 2012

Secondary Reviewers: (APVMA, PMRA, and US EPA) 

 Donna R. Judkins, US EPA

 Date: August 13, 2013 

 

7

 Per February 21, 2013 email note from Derek Francois to Donna Judkins.

8

 Per July 18, 1013 email from Kahli Weir (APVMA) to Donna Judkins (US EPA) and Derek Francous (APVMA). 
-Page 112 of 117- 

Table G.1. Submitted Ecological Effects Studies for Fluensulfone and Identification of 

Additional Data Needs (Beige Shading Indicates Formulated Product Toxicity). 

OCSPP 

Guideline

Data 

Requirement

Submitted 

Studies 

(MRID)

Study Issues Review Classification

Sufficient 

for Risk 

Assessment?

Current 

Additional 

Data Need

850.1010

Daphnid 

Acute 

Toxicity

48574855 N/A Acceptable Yes No

850.1010

Daphnid 

Acute 

Toxicity with 

Formulated 

Product

48574930 N/A Acceptable Yes No

850.1035

Mysid Acute 

Toxicity

48574864

Negative control had 

15% mortality; 

however two lowest 

treatments had no 

mortality.

Suppmemental

Quantitative Yes No

850.1035

Mysid Acute 

Toxicity with 

Formulated 

Product

48574932 N/A Acceptable Yes No

850.1025 Oyster Acute 

Toxicity 48574865 N/A Acceptable Yes No

850.1025

Oyster Acute 

Toxicity with 

Formulated 

Product

48574933 N/A Acceptable Yes No

850.1075

Fish Acute 

Toxicity

48574740 N/A Acceptable Yes No

850.1075 48574851 N/A Acceptable Yes No

850.1075 48574852 N/A Acceptable Yes No

850.1075 48574853 N/A Acceptable Yes No

850.1075 Fish Acute 

Toxicity with 

Formulated 

Product

48574927 N/A Acceptable Yes No

850.1075 48574928 N/A Acceptable Yes No

850.1075 48574929 N/A Acceptable Yes No

850.1300

Life-Cycle 

Toxicity 

Daphnid

48574856

– no NOAEC for 

reproduction or dry 

weight.

Supplemental

Quantitative Yes No

850.1350

Life-Cycle 

Toxicity 

Mysid

48574857 N/A Acceptable Yes No

850.1400

Fish Early 

Life-Stage 

Toxicity

48574854 N/A Acceptable Yes No

850.1735 Sediment 

Acute Toxicity 48574862 – quantitative for survival data only. Supplemental Quantitative Yes No

850.4400 Aquatic Plant 

Toxicity 48574863 N/A Acceptable Yes No
-Page 113 of 117- 

OCSPP 

Guideline

Data 

Requirement

Submitted 

Studies 

(MRID)

Study Issues Review Classification

Sufficient 

for Risk 

Assessment?

Current 

Additional 

Data Need

using Lemna

850.5400

Algal 

Toxicity

48574858 N/A Acceptable Yes No

850.5400 48575017 N/A Acceptable Yes No

850.5400 48575019 N/A Acceptable Yes No

850.5400 48574859 N/A Acceptable Yes No

850.5400 48574860 N/A Acceptable Yes No

850.5400 48574861 N/A Acceptable Yes No

850.5400

Algal 

Toxicity with 

Formulated 

Product

48574931 N/A Acceptable Yes No

850.2100

Avian Acute

Toxicity

48574842 N/A Acceptable Yes No

850.2100 48574843

Regurgitation -

requested passerine 

dietary study

Supplemental

Qualitative No Yes1

850.2100

Avian Acute

Toxicity with 

Formulated 

Product

48574951 N/A Acceptable Yes No

850.2200 Avian Subacute Dietary 

Toxicity

48574844 N/A Acceptable Yes No

850.2200 48574845 N/A Acceptable Yes No

850.2200

Modified

Not 

Assigned

Only one day 

exposure and five 

days recovery; need 

longer exposure for 

feeding birds.

Supplemental

Qualitative No Yes

850.2300 Avian 

Reproduction

48574847 Small cages. Supplemental 

Quantitative Yes No

850.2300 48574846 N/A Acceptable Yes No

850.3020 

& NonGuideline

OECD 

213

Honeybee 

Acute 

Contact 

Toxicity

48574879 N/A Supplemental

Quantitative Yes No

850.3020 

& NonGuideline

Honeybee 

Acute 

Contact 

Toxicity with 

Formulated 

Product

48574934 N/A Supplemental

Quantitative Yes No

NonGuideline

Bumble Bee 

Drip Irrigation 

Study

48574910 N/A Supplemental

Quantitative Yes No

850.4100 Terrestrial 

Plant 48574944 – no definitive 

endpoints

Supplemental

Quantitative

No -

Incomplete No
-Page 114 of 117- 

OCSPP 

Guideline

Data 

Requirement

Submitted 

Studies 

(MRID)

Study Issues Review Classification

Sufficient 

for Risk 

Assessment?

Current 

Additional 

Data Need

Toxicity 

(Seedling 

Emergence)

Toxicity with 

Formulated 

Product

850.4150

Terrestrial 

Plant 

Toxicity 

(Vegetative 

Vigor)

Toxicity with 

Formulated 

Product

48574943

– no definitive 

endpoints for four

plants; requested Tier 

II data for radish,

soybean, cabbage 

and onion

Supplemental

Quantitative

No -

Incomplete No

850.4225

Tier II 

Seedling 

Emergence

48574945 N/A Acceptable Yes No

850.4150

Tier II 

Vegetative 

Vigor 48574972

Did not get a 

definitive endpoint 

for all plants, but did 

for the most 

sensitive; no further 

data needed.

Supplemental

Quantitative Yes No

NA

None; 

Beneficial 

Insects -

Effects on the 

Parasitic Wasp 

with 

Formulated 

Product

48574936 N/A Supplemental (nonguideline studies) Yes No

NA

None; 

Beneficial 

Insects -

Effects on the 

Predatory Mite 

with 

Formulated 

Product

48574937 N/A Supplemental (nonguideline studies) Yes No

NA

None; 

Beneficial 

Insects -

Effects on the 

Predceous 

Mite

with 

Formulated 

Product

48574935 N/A Supplemental (nonguideline studies) Yes No
-Page 115 of 117- 

OCSPP 

Guideline

Data 

Requirement

Submitted 

Studies 

(MRID)

Study Issues Review Classification

Sufficient 

for Risk 

Assessment?

Current 

Additional 

Data Need

NA 

None; 

Beneficial 

Insects -

Effects on the 

Ground-active 

Beetle with 

Formulated 

Product

48574938 N/A Supplemental (nonguideline studies) Yes No

NA 

None; 

Beneficial 

Insects -

Effects on the 

Springtail with 

Formulated 

Product

48574941 N/A Supplemental (nonguideline studies) Yes No

NA

OECD 

207

None; Acute 

Toxicity to 

Earthworms

- with TGAI

- with 

Formulated 

Product

48574880 N/A

Supplemental (nonguideline studies) Yes No

48574939 N/A

NA

None; 

Subchronic 

Earthworm 

Toxicity with 

Formulated 

Product

48574940 N/A Supplemental (nonguideline studies) Yes No

1To assess toxicity to passerine bird species, an acute dietary toxicity study of fluensulfone TGAI was conducted 

using adult zebra finches (Taeniopygia guttata) in a modified study (MRID NEED A NUMBER) designed to reduce 

complications caused by regurgitation and feed avoidance in the earlier canary oral dosing study (MRID 48574843). 

Due to the likelihood of avoidance of or aversion to the treated diet, the standard five-day dietary exposure was 

shortened to 24-h. Study authors cited preliminary method work suggesting that in five–day exposures starvation 

threshold existed between 1.2 and 2.3 g/day food consumption per bird. Data were not available to confirm the 

starvation feeding level. By reducing exposure to 24-h in this study, however, even birds that ate less than 1.0 

grams had good (90 %) survival. However, the resulting endpoint calculations were deemed not useable for risk 

assessment without substantiating the starvation level or the trend over more than one day (i.e., birds feeding above 

the starvation rate on the first day might reduce feed consumption subsequently, thus possibly missing some effects). 

A significant reduction in feed consumption was measured at 1590 mg a.i./kg-diet; such a reduction is likely to 

affect growth and reproduction, but the degree of environmental significance was not fully quantifiable. Clinical 

signs of toxicity were also observed in the two highest treatment groups (5070 and 8890 mg a.i./kg-diet), including 

ruffled appearance and loss of coordination. Necropsy results showed pale kidneys and liver and enlarged kidneys 

at the end of the test for birds exposed to treatments of 1590 mg a.i./kg-diet and above. Statistically significant 

reductions in feed consumption and mean body weight were observed in all except the lowest treatment group, 891 

mg ai/kg-diet, during exposure Days 0-1. The results could not be quantifiably extrapolated to a 5-day exposure 

endpoint and therefore, the results may be used only qualitatively to describe risk. 
-Page 116 of 117- 

Table G.2. Submitted Ecological Effects Studies for Degradates of Fluensulfone and 

Identification of Additional Data Needs.

OCSPP 

Guideline

Data 

Requirement

Submitted 

Studies 

(MRID)

Study Issues Review

Classification

Sufficient 

for Risk 

Assessment?

Current 

Additional 

Data Need

850.1035

Mysid Acute 

Toxicity

48574869 N/A Acceptable Yes No

850.1035 48574873 N/A Acceptable Yes No

850.1035 48574877 N/A Acceptable Yes No

850.1075

Fish Acute 

Toxicity

48574866 N/A Acceptable Yes No

850.1075 48574870 N/A Acceptable Yes No

850.1075 48574874 N/A Acceptable Yes No

850.5400

Algal Toxicity 

Test

48574868 EC50 non-definitive. Supplemental

Quantitative

Yes

Partially

No, not at 

this time.

850.5400 48574872 EC50 non-definitive. Supplemental

Quantitative

Yes

Partially

No, not at 

this time.

850.5400 48574876 N/A Acceptable Yes No

850.5400 48574878 N/A Supplemental

Quantitative

Yes

Partially

No, not at 

this time.

NA

OECD 207

None; Acute 

Toxicity to 

Earthworms with 

48574881 N/A Supplemental 

(non-guideline 

studies)

Yes No 48574882 N/A

48574883 N/A

NA

None; 

Subchronic 

Earthworm 

Toxicity with 

Formulated 

Product

48574940 N/A

Supplemental 

(non-guideline 

studies)

Yes No