Page 1 of 43 OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION 

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

March 15 , 2016

PC Code: 03 5503

MEMORANDUM DP Barcode : 430247

SUBJECT: Registration Review

– Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water As sessments for

Fluometuron

TO: Linsey Walsh, Chemical Review Manager

Tr acy Perry, Team Leader Kelly Sherman, Branch Chief Risk Management and Implantation Branch 3

Pesticide Re

- evaluation Division (7508P)

FROM: Ron ald Parker, Ph.D., Senior Environmental Engineer

Christine Hartless

, Ph.D., Wildlife Biologist

Environmental Risk Branch 2 Environmental Fate and Effects Division ( 7507P)

THROUGH: Melissa Panger, Ph.D., Senior Advisor James Lin, Ph.D., Environmental Engineer Mary Clock

- Rust, Acting RAPL Brian Anderson, Branch Chief

Environmental Risk Branch 2 Environmental Fate and Effects Division ( 7507P)

The Environmental Fate and Effects Division (EFED) has completed the preliminary problem formulation (attached) for the ecological risk, environmental fate, endangered species, and drinking water assessments to be conducted as part of the registration revi ew of fluometuron (PC Code 035503)

.

The problem formulation draws on information from both open literature and studies submitted by the technical registrants in response to data requirements. This document is intended to provide an overview of what is c urrently known regarding the environmental fate and ecological

effects associated with fluometuron and outlines uncertainties regarding attributes of the parent compound and its transformation products. It describes the preliminary ecological risk hypothes is and the processes that will be used during the completion of drinking water and ecological risk assessments in support of registration review. This document also recommends

studies that should be included in a data call

- in (DCI) to address uncertainties surrounding the environmental fate and potential ecological effects of fluometuron

.Page 2 of 43 

# Problem Formulation in Support of the Registration Review of Fluometuron

Fluometuron (CAS 2164

- 17

- 2

, PC Code: 035503)

N,N

- dimethyl

- N′

- [3

- (trifluoromethyl)phenyl]urea

March 15 , 2016

Prepared by: Ronald D. Parker, Ph.D., Senior Environmental Engineer Christine Hartless, Ph.D., Wildlife Biologist 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: 

### Melissa Panger, Ph.D., Senior Advisor James Lin, Ph.D., Environmental Engineer
Brian Anderson, Branch Chief

Environmental Risk Branch IIPage 3 of 43 

# Table of Contents

1. Executive Summary

................................ ................................ ................................ ............... 4

2. Introduction

................................ ................................ ................................ ............................ 5

3. Use Characterization

................................ ................................ ................................ .............. 5

4. Conclusions from Previous Risk Assessments

................................ ................................ ...... 7 4.1 Ecological Risk Assessment

................................ ................................ ................................ . 7 4.2 Drinking Water Exposure Assessments

................................ ................................ ................ 7 4.3 Clean Water Act Programs

................................ ................................ ................................ ... 7

5. Environmental Fate and Transport

................................ ................................ ......................... 8

5.1 Transformation Products

................................ ................................ ................................ ..... 10

6. Receptors

................................ ................................ ................................ .............................. 13

7. Exposure Pathways of Concern

................................ ................................ ........................... 16

8. Analysis Plan

................................ ................................ ................................ ....................... 17

8.1 Stressors of Concern

................................ ................................ ................................ ........... 17 8.2 Measures of Exposure

................................ ................................ ................................ ......... 17

8.3 Measures of Effect

................................ ................................ ................................ .............. 18

9. Endangered Species Assessments

................................ ................................ ........................ 18

10. Endocrine Disruptor Screening Program

................................ ................................ ............. 18

11. Preliminary Identification of Data Gaps

................................ ................................ .............. 18

11.1 Environmental Fate

................................ ................................ ................................ ........... 18

11.2 Effects

................................ ................................ ................................ ............................... 19

12. References

................................ ................................ ................................ ............................ 24 12.1 Publically Available Literature

................................ ................................ ......................... 24

12.2 Submitted Environmental Fate Studies

................................ ................................ ............. 24 12.3 Submitted Ecological Toxicity Studies

................................ ................................ ............. 25

Appendix A. SIP Fluometuron Modeling Results

................................ ................................ ........ 30 Appendix B. STIR Fluometuron Modeling Results

................................ ................................ ..... 30 Appendix C. Summary of Fluometuron Environmental Fate Data

................................ .............. 31 Appendix D. Summary of Fluometuron Ecotoxicity Dat a

................................ ........................... 35Page 4 of 43 

# 1. Executive S ummary

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

formulation for the ecological risk, environmental fate, endangered species, and drinking water assessments to be conducted as part of the registration review of flu o met u ron (PC 035503

, CAS

2164

- 17

- 2 ). Fluometuron is a phenylurea herbicide that was first registered in 1974 for control of annual grass and annual broadleaf weeds in cotton and sugarcane , but currently the only Section 3

use is for cotton

. In addition to the cotton use, there is one Section 24(c) special local needs label

in North Carolina for applicatio n to wildflowers for control of annual broadleaf weeds. Its mode of action is a combination of (1) inhibition of photosynthesis at the Photosystem II stage and (2) bleaching and inhibition of carotenoid biosynthesis (unknown target).

The problem formulat ion describes the methods planned to be used during the completion of drinking water and ecological r isk assessments in support of registration review and provide s an

ove rview of the environmental fate, ecological effects , potential risks associated with the use,

and uncertain ties unique to the risk assessment of fluomet u ron

. This document also identifies

additional studies that would be beneficial to the conduct of an ecological risk assessment.

Data needs for ecological effects are:

• Avian acute oral t oxicity test (850.2100), one passerine species

• Seedling Emergence and Seedling Growth (850.4100), 10 species conducted with an end

use product.

• Vegetative Vigor (850.4150), 10 species conducted with an end

- use product.

• T oxicity data are not available with which to assess acute/ chronic exposure to adult honey bees or to larval bees. These exposure routes remain significant uncertainties for the assessment of the impact of fluometuron on pollinators. Studies recommended at this

time are:

o Acute oral toxicity to adult honey bees (OECD Guideline 213)

o Acute oral toxicity to larval honey bees (OECD Guideline 237)

o Chronic oral toxicity to adult honey bees (no guideline number)

o Chronic oral toxicity to larval honey bees (no guideline number)

o Field tria l of residues in pollen and nectar (no guideline number)

o Semi

- field testing for pollinator (OECD Guideline 75)

o Field testing for pollinator (850.3040)

These studies are recommended per the pollinator risk assessment guidance : http://www2.epa.gov/pollinator

- protection/pollinator

- risk

- assessment

- guidance . T he

h oney bee residue on foliage study (850.3030) is not recommended at this time as the

adult bee contact LD 50 

### was greater than 11 μg a.i./bee.

Data needs for fate and exposure assessment are:

• Aerobic Aquatic Metabolism (835.4100)

- There is no aerobic aquatic metabolism study available for fluometuron. This is important because fluometuron is stable to both hydr olysis and aqueous photolysis, the other two possible methods of degradation in

surface water.

• Environmental Chemistry M ethod s in S oil and W ater (850.6100) with an Independent Laboratory Validation. Independently validated analytical methods are important for quantifying environmental residues in offsite soil and water following application.Page 5 of 43 

### Label clarification recommendations are:

• End

- use product labels should be modified to include current recommended drift reduction language. This includes, but is not l imited to, droplet sizes, wind speed, release height, boom height, and boom length.



# 2. Introduction

Fluometuron ([1,1

- dimethyl

- 3

- (alpha, alpha, alpha

- trifluoro

- mtolyl) urea] is a substituted urea

herbicide . Its mode of action is a combination of (1) inhibition of photosynthesis at the Photosystem II stage and (2) bleaching and inhibition of carotenoid biosynthesis (unknown target).

Fluometuron is registered to control large seeded, broadleaf weeds, and annual grasses in cotton.

Fluometuron is effecti ve in the control of annual grass weeds such as barnyardgrass, crabgrass, crowfootgrass, fall panicum, foxtail, goosegrass, ryegrass, and signalgrass. It also controls annual broadleaf weeds such as buttonweed, cocklebur, Florida pusley, groundcherry, jims onweed, lambsquarters, morningglory, pigweed, prickly sida, purslane, ragweed, sesbania, sicklepod, smartweed, and tumbleweed.

EFED evaluated the most recent ecological risk assessments and drinking water assessments for

fluometuron in association with th e updated toxicity, exposure, and usage information to determine if sufficient data are available and if further updates are needed to support registration review. In addition, EFED considered the latest Agency science policies and risk assessment

methodo logies for this evaluation

.



# 3. Use Characterization

The chemical profile produced by Biological and Economic Analysis Division (BEAD), located in this docket, lists the use patterns of maxim um application rates for the current uses of

fluometuron

. BEAD’s chemical profile includes both a summary of labeled uses and rates as well as a summary of available reported usage data. EFED will use application scenarios that result in maximum exposure scenarios for a given use for the risk assessment.

There are c urrently two registered technical products (USEPA Reg. No. ’s 011603

- 31 and

082633

- 19 ) . Currently registered maximum use rates for cotton are provided in Table 1 . The use profile will be re

- evaluated prior to conduct of the risk assessment. The commercial end

- use products for application to cotton include liquid flowables/ emulsifiable concentrates

. These

labels contain soil

- type restrictions ( e.g ., application is not permitted on some soil types and maximum single application rates is reduced in some soil types) , which will be further evaluated

at the time of risk assessment. In 2012, EPA required additional restrictions on fluometuron use near drinking water wells and on vulnerable soils (e.g., karst topographical features) and

removed the county

- specific prohibitions in Louisiana and Georgia

. Some labels have not yet been updated to include this recent language and the Agency is currently working with registrants to either voluntarily cancel or amend these labels. The timing of applications varies

among pr eplant, pre

- emergence, and post

- emergence crop stages

.Page 6 of 43 

### Table 1. Maximum Use Information for Fluometuron on Cotton

Crop (Application type) Max lb ai/A/appl. Max No. of Applications per Year Min Intervals (days) Max lb ai/A/yr

Cotton (aerial or groun d ) 2 2 20 3



### In addition to the cotton use, there is one Section 24(c) special local needs label (EPA SLN No.

NC

- 120002) for application to wildflowers for control of annual broadleaf weeds. The maximum annual and single application rate is 1.0 lb ai/acre. Use of this product is restricted to members of the North Carolina Department of Transportation.

A map of estimated annual use for fluometuron during 2012 is presented in Figure 1

. The USGS Pesticide Usage data extrapolates pesticide usag e from survey data to areas where pesticide usage information is not available. USGS intends these data to be used for broad

- scale assessments, such as at the national or regional level. Therefore, EPA’s assessments will use these data for qualitative pu rposes only, in the form of maps, to provide a geographic footprint of

a pesticide’s use. These data are not suitable for sub

- state quantitative analyses. In addition to the usage map, Figure 1 contains a chart depicting estimated total annual usage from 1992 to

2012.

Figure 1

. Estimated Agricultural Use for Fluometron
( https://water.usgs.gov/nawqa/pnsp/usage/maps/show_map.php? year=2012&map=FLUOMETURON&hilo=H )Page 7 of 43 

# 4. Conclusions from Previous R isk Assessments

4.1 Ecological Risk Assessmen t

The most recent, comprehensive assessment conducted for fluometuron is the RED (USEPA,

2005 ) ; major ecological conclusions are listed in Table 2

. EFED has not conducted any listed species assessments for fluometuron.

Table 2 . Summary of Ecological Risk Concerns Identified for Fluometuron in the 2005 RED

Assessment

Birds Mammals Terr

. Plants Terr

. Inverts Fish BCF

Yes a Yes Yes No Yes a No

Aquatic

Inverts Aquatic Plants Groundwater

Contamination Persistence Degrat es of

Concern

Yes a Yes Yes Yes 

### CGA

- 41686
a No reproduction data were available to allow for a chronic risk assessment ; risk was presumed

Yes = at least one LOC has been exc eeded in previous assessments; No = LOCs have not been exceeded in previous assessments



## 4.2 Drinking Water Exposure Assessments

The most recent drinking water assessment presented EDWCs (Estimated Drinking Water Concentrations) based on cotton and considered both parent fluometuron and the major degradate, CGA

- 41686 (desmethyl

- fluometuron). For details, see also the following docu ment: Refined Fluometuron Percent Crop Treated and Percentage of National Soybean, Corn, and

Wheat Crops Rotated with Fluometuron

- Treated Cotton dated August 9, 2005, and Addendum to Refined Fluometuron Percent Crop Treated

, dated September 21, 2005.

EFED will update the drinking water assessment based on the most current methods, data, and

models.



## 4.3 Clean Water Act Programs

Fluomet uron is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of th e Clean Water Act

. No Total Maximum Daily Load (TMDL) criteria have been developed for f luomet uron

. Aquatic life benchmarks have been established for

f luomet uron and are available at http://www.epa.gov/pesticide

- science

- and

- assessing

- pesticide

risks/aquatic

- life

- benchmarks

- pesticide

- registration

. Any data submitted or otherwise located as part of the registration review process may be used to update aquatic life benchmarks if applicable.Page 8 of 43 

# 5

. Environmental Fate and Transport

Table s 3 and 4 summarize the physical properties and environmental fate data of fluometuron and its degradates.

Table 3. Chemical Properties and Environmental Fate Parameters of Fluometuron

Parameter Value Description Source

Selected Physical/Chemical Parameters

Vapor pressure (20°C) 5.0 x 10

- 7 mm Hg Low potential for

volatilization MRID 00262064

Aqueous solubility (20 ° C) 90 mg/L Soluble PPDB

Henry’s Law Constant (20°C) 1.45 x 10

- 10 atm

m 3 /mole Low potential for

volatilization PPDB

Log octanol

- to

- water partition coefficient (log K OW ) 3.2 at 20 o C Moderately hydrophilic MRID 40600608



### Table 4. Summary of Environmental Fate Properties of Fluometuron and Major

D egradates

Study Half

- lives, Days Degradates MRID Study Status

Fluometuron Hydrolysis S table at pH 4, 7 , and 9 @

50 o C none 40864401,

40930601 Acceptable

Direct Aqueous Photolysis S table none 41065101 Acceptable

Soil Photolysis S table none 40930602 Acceptable

Aerobic Soil

Metabolism 181 days (sandy loam) CGA

- 41686 (parent with 1 methyl group removed; 35%, 365 days)

CO 2 (maximum 13.3 %

, 365 days) 42998702 Acceptable

Anaerobic soil

Metabolism 378 days (total system) CGA

- 41686 (parent with 1 methyl group removed; maximum 21%, end of study, total system) 42998703 Acceptable

Anaerobic Aquatic

Metabolism 177 days (total system) CGA

- 41686 (parent with 1 methyl group removed; maximum 7.9%, end of study, total system) 43158901 Acceptable

K d

- ads / K d

- des (mL/g)

K
oc

- ads / K

oc

- des (mL/g) 0.08 / 2.93 (sand), 0.15 / 1.48 (sandy loam), 0.25 / 4.93 (Sandy clay l oam), and 1.13 / 4.25 (clay) 35 /1277 (sand), 57 /561 (sandy loam),

54 / 1075 (Sandy clay loam), and 80 /300 (clay) Not applicable 42643601 Acceptable

Field Dissipation Study 103 days (Georgia Lucy Loamy sand) 40459401

40459402 AcceptablePage 9 of 43 

### Table 4. Summary of Environmental Fate Properties of Fluometuron and Major

D egradates

Study Half

- lives, Days Degradates MRID Study Status 97 days (California Veritas Fine sandy loam)



### CGA

- 41686 (desmethyl

- fluometuron)

K d

- ads / K d

- des (mL/g)

K
oc

- ads / K

oc

- des (mL/g) 0.16 /3.90 (sand), 0.33 /4.55 (sandy loam), 0.57 / 6.44 (Sandy clay loam), and 2.0 /6.25 (clay)

69 /1700 (sand), 125 /1719 (sandy loam), 123 / 1404 (Sandy clay loam), and 141 /441 (clay) Not applicable 42643604 Acceptable



### Fluometuron and its metabolites are both mobile and persistent in the environment. The primary route of degradation of fluometuron and its main degradate CGA

- 41686 (desmethyl

fluometuron) is microbial metabolism. However, since fluom eturon and its degradates are not volatile and these degradative processes are not rapid, these compounds will be available for leaching to ground water and runoff to surface water in many use conditions. Once in ground water or surface water, fluometuron is expected to persist due to its stability to hydrolysis and photolysis.

Parent fluometuron is very stable to abiotic hydrolysis and photolysis in water and on soil. It is also stable to aerobic soil metabolism, anaerobic soil metabolism, and anaerobi c aquatic metabolism, with t 1/2 

### 's of 181, 378, and 177 days, respectively. CGA

- 41686 ( desmethyl

fluometuron ) is the only major degradate identified in acceptable s tudies ( Table 4 ) . The other degradates, CGA

- 41685 (parent with both methyl groups removed), a nd CGA

- 72903 (decarboxylated, demethylated CGA

- 41685) were detected in only small amounts (<10% of the applied radioactivity) in all metabolism studies

.

Adsorption studies using parent compound and the three metabolites showed that fluometuron

residues ar e very mobile to mobile in the environment. In the case of CGA

- 72903, assumed values had to be used to calculate desorption values, which were at best questionable . The

Freundlich K ads 

### values for parent fluometuron were 0.08

- 1.13, with corresponding K ocads 

### values

of 35

- 80 in soils with 0.23

- 1.4 % OC. The Freundlich K ads 

### values for the metabolites CGA

41686, CGA

- 41685, and CGA

- 72903 consistently ranged from low values of 0.16

- 0.23 to higher

values of 1.89

- 2.33, with corresponding K ocads 

### 66

- 164. Adsorption g enerally increased with increasing soil organic carbon and clay content.

Data previously reviewed indicated that fluometuron (1) is stable to hydrolysis; (2) is mobile in (European) sand, sandy loam, loam and clay soils with Kd's 0.15 to 2.8 (leaching appeared to correlate with percent of soil organic matter present in soil.); and (3) has field dissipation half

life of 97 to 193 days in (CA) fine sandy loam soil and (GA) loamy sand soil (v ertical movement of residues appeared to correlate with rainfall )

.Page 10 of 43 

## 5.1 Transformation Products

Fluometuron and its metabolites are both mobile and persistent in the environment. The primary route of degradation of fluometuron and its main degradate, CGA

- 41686, is microbial metabolism. However, since fluometuron and it s degradates are not volatile, and these degradative processes are not rapid, these compounds will be available for leaching to groundwater and runoff to surface water under many use conditions. Once in groundwater or surface water, fluometuron is expected to persist due to its stability to hydrolysis and photolysis.

Fluometuron degradates are detailed in Table 5 below.Page 11 of 43 

### Table 5 . Fluometuron and Its Environmental Transformation Products

Code Name/ Synonym Chemical Name Chemical Structure Study Type MRID Maximum %AR (day) Final %AR (study length)

PARENT


### Fluometuron N,N

- dimethyl

- N′

- [3

- (trifluoromethyl)phenyl]urea

CAS No.: 2164

- 17

- 2

Formula: C 10 H 1 1 F 3 N 2 O

MW: 232.2 g/mol

TRANSFORMATION PRODUCTS 

### Degradate

CGA

- 41686 ( 3

- (3

- trifluoromethylphenyl)

- 1

- methylurea (Fluometuron

- Desmethyl)

CAS No.: 3032

- 40

- 4

Formula: C 9 H 9 F 3 N 2 O

MW: 2 18.18 g/mol A na erobic aquatic ( Pond system) 43158901 7.9% (end of study) 7.9% (end of study)

Aerobic soil 42998702 35% (365 days) 35% (365 days)

Anaerobic soil 42998703 21% (end of study) 21% (end of study)

Terrestrial Field Dissipation 40459401

40459402



### Degradate

CGA

- 41685 1

- ( α,α,α

- trifluoro

- m

- tolyl)urea Anaerobic aquatic (Pond system) 43158901 6.2% ( 6 months )

Aerobic soil 42998702 3.3% (365 days) 3.3 % (365 days)

Anaerobic soil 42998703 < 0.2% ( % (all sampling intervals) < 0.2% (all sampling intervals) )

Terrestrial Field Dissipation 40459401

40459402



### Degradate

CGA

- 72903 Trifluoromethyl aniline (TFMA) Anaerobic aquatic (Pond system) 43158901 ( 1.7% (all sampling

intervals ) (1.7% (all sampling intervals)

Aerobic soil 42998702 1.0% ( 100 days)

Anaerobic soil 42998703 < 0.2% (all sampling intervals) < 0.2% (all sampling intervals)Page 12 of 43 

### Table 5 . Fluometuron and Its Environmental Transformation Products

Code Name/ Synonym Chemical Name Chemical Structure Study Type MRID Maximum %AR (day) Final %AR (study length)

Terrestrial Field Dissipation 40459401

40459402

CO 2 Carbon dioxide O = C = O Aerobic Soil 42998702 13.3% (365 days) 13.3% (365 days)Page 13 of 43 

# 6. Receptors

Table s 6 and 7 and Appendix D provide a summary of the taxonomic groups tested to characterize the potential acute and chronic ecological effects of fluometuron

. In addition, the

table s provide a preliminary overview of the potential acute toxicity of fluometuron by providing

the a cute toxic ity classifications. No eco toxicity data for fluometuron degradates were

identified.

Fluometuron is classified as moderately toxic to practically non

- toxic to freshwater fish and highly toxic to moderately toxic to freshwater invertebrates on an acute exposure basis ( Table

6 ). In addition, fluometuron is classified as slightly toxic to estuarine/marine fish and moderately to slightly toxic to estuarine/marine aquatic invertebrates on an acute exposure basis. In the fathead minnow chronic study , the NOA EC was identified at 3.1 mg ai/L while the LOAEC (based on reductions in length and dry weight ) w as identified at 9.1 mg ai/L. No data

were submitted to evaluate chronic estuarine/marine fish toxicity ; however, an Acute

- to

- Chronic Ratio (ACR) w as calculate d using the fathead minnow acute and chronic data. This ratio was applied to the sheepshead minnow acute LC 50 

### , resulting in a NOAEC ACR 

### = 1.8 mg ai/L. In the daphnid chronic studies, the NOAEC was identified at 1.73 and 1.32 mg ai/L, respectively.
However, since the acute midge data were more sens itive than the daphnid data, an ACR was

also calculated to estimate the chronic NOAEC ACR 

### = 0.038 for freshwater invertebrates. All

NOAEC ACR 

### calculations are provided in Table 6

.

Duckweed ( Lemna gibba ) was sensitive to fluometuron with an IC 50 

### of 0.0 22 mg a

. i

. /L . Non

vascular aquatic plant sensitivity ranged with IC50’s from 0.05 to 0.5 mg a.i./L . EPA does not currently clas sify toxicity to aquatic plants

.

Table 6. Summary of the Most Sensitive Endp oints from Aquatic Toxicity Studies for Fluometuron

Taxonomic

Group Study Type Tested Species Toxicity Value s ( mg a.i./L) Acute Toxicity

Classification Source (Study Classification)

Comments

Freshwater

fish 1 Acute Rainbow trout ( Oncorhynchus mykiss ) LC 50 = 2.96 Moderately toxic 40098001 (Supplemental, raw data not found)

Chronic Fathead minnow ( Pimephales promelas) NOAEC = 3.1

LOAEC = 9.1 -- 46565702 (Acceptable) Reductions in growth (length and dry weight)

Freshwater

invertebrates Acute Midge ( Chironomus

plumosus ) LC 50 = 0.22 Highly toxic 40098001 Supplemental (96

- hr study, not recommended species, 4 th instar tested)

Chronic Acute

- to

- Chronic Ratio (ACR) NOAEC ACR = 0 .038 -- Utilized data from acute

and chronic daphnid

studies to calculate the ACR. Applied the ACR

to t he acute midge

LC 50

. 2Page 14 of 43 

### Table 6. Summary of the Most Sensitive Endp oints from Aquatic Toxicity Studies for Fluometuron

Taxonomic

Group Study Type Tested Species Toxicity Value s ( mg a.i./L) Acute Toxicity

Classification Source (Study Classification)

Comments

Estuarine/

marine fish Acute Sheepshead

Minnow ( Cyprinodon variegatus ) LC 50 = 38 Slightly toxic 42498004 (Supplemental

, Undissolved test

material at all

concentrations

, analytical samples not centrifuged or filtered )

Chronic Acute

- to

- Chronic Ratio (ACR) NOAEC ACR = 1.8 -- Utilized data from acute

and chronic fathead

minnow studies to

calculate the ACR. Applied the ACR to the acute sheepshead

minnow LC 50

. 3

Estuarine/

marine

invertebrates Acute,

crustacean Mysid shrimp (Americamysis bahia) LC 50 = 3.8 Moderately toxic 42568501 (Acceptable)

Acute,

mollusk Eastern oyster,

Crassostrea

virginica IC 50 = 6.53 Moderately toxic 43848101 (Acceptable)

Chronic Mysid shrimp NOAEC = 1.32

LOAEC = 2.68 -- 48080701 (Acceptable)

Most sensitive

e ndpoints: F 0 Day 13 survival (before pairing)

and F 0 male body lengths on Day 28

Aquatic plants and algae Vascular Duckweed ( Lemna gibba ) IC 50 = 0.22

NOAEC = 0.225 -- 43421601 (supplemental, fewer

than recommended initial number of fronds)

Non

vascular Green Algae ( Selenastrum capricornutum ) IC 50 = 0.030

NOAEC < 0.007

IC 05 = 0.0016 -- 42498007 (supplemental, no definitive NOAEC)

1 Freshwater fish may be surrogates for aquatic

- phase amphibians.

2 NOAEC ACR = 0.22 mg a.i./L * (1.73 mg a.i./L / 9.9 mg a.i./L) = 0.038 mg a.i./L (Endpoints obtained from MRIDs

40098001

, 46565701, 47978401 , and 0024180 ).

3 NOAEC ACR = 38 mg a.i./L * (3.1 mg a.i./L / 65 mg a.i./L) = 1.8 mg a.i./L (Endpoints obtained from MRIDs

42498004

, 46565702 , and 607401 )



### Fluometuron is practically non

- toxic to b irds on an acute oral basis and slightly toxic to birds on a dietary basis , and it is slightly toxic to mammals on an acute oral exposure basis ( Table 7 ). Mammalian acute inhalation toxicity is low. For birds, number of eggs laid and hatchling weights were reduced at 102 mg a.i./kg

- diet in the chronic study using mallards (NOAEC = 60.4 mg a.i./kg

- diet). For mammals, no reproductive or growth effec ts were identified in the 2

- generation rat reproduction study. The most sensitive developmental toxicity study was conducted with rabbits, resulting in a NOAEL = 10 mg a.i./kg

- bw and LOAEL = 100 mg a.i./kg

bw based on increased incidence of stool variation s and abortions, reduced food consumption, decreased maternal body weight gain. The equivalent NOAEC and LOAEC are 189 and 1890Page 15 of 43 

### mg a.i./kg

- diet , respectively (calculation approach provided in Table 7 ). Acute co ntact toxicity

to bees was low

.

Terrestrial plants were sensitive to fluometuron at both the seedling emergence and vegetative vigor stages of growth. EFED recommends requesting new terrestrial plant studies conducted

with an end

- use product to reduce uncertainty in estimating the effects of end

- us e product drift to

non

- target plants. EPA does not currently classify toxicity to terrestrial plants.

Table 7. Summary of the Most Sensitive Endpoints from Terrestrial Toxicity Studies for

Fluometuron

Taxonomic

Group Study Type Tested Species Toxicity Value Acute Toxicity

Classification Source (Study Classification)

Comments

Birds 1 Acute Mallard duck ( Anas platyrhynchos) LD 50 = 2974 mg ai/kg

- bw Practically

non

- toxic 00019221 (Acceptable)

Sub

- acute dietary Ring

- necked pheasant ( Phasianus

colchicus ) LC 50 = 3150 mg ai/kg

- diet Slightly toxic 00019222 (Acceptable)

Sublethal toxic effects included huddling, lethargy, and reduced weight gain.

Chronic Mallard duck NOAEC= 60.4 mg ai/kg diet

LOAEC = 102 mg ai/kg diet -- 47896201 ( Acceptable) At 102 mg a.i./kg

- diet (highest tested concentration), reduced number of eggs laid and reduced hatchling weight.

Mammals Acute Oral Laboratory rat ( Rattus norvegicus ) LD 50 between

1000 and 1500 mg a.i./kg Slightly toxic 41216802 (Acceptable) Females: 0% mortality at 1000 mg a.i./kg

- bw and 100% mortality at 1500 mg a.i./kg

- bw and above.

Males LD 50 = 3800 mg a.i./kg

- bwt.

Acute

Inhalation Laboratory rat LC 50 > 0.6 mg

a.i./L HED Tox Category III 40409304 (Acceptable)

Chronic Laboratory rabbit NOAEL= 10 mg/kg

- bw ( NOAEC = 189 mg a.i./kg

- diet ) 2

LOAEL= 1 00 mg/kg

- bw ( LOAEC = 1890 mg a.i./kg

- diet ) -- 00163774

00147 55 4

42397602 (acceptable) LOAEL

based on increased

incidence of stool

variations and

a bortions, reduced food consumption, decreased maternal body wt. gain

Insects Acute

contact Honey bee ( Apis mellifera L. ) LC 50 > 11 μg

a.i./bee Practically

non

- toxic 00006653 and 00028772 AcceptablePage 16 of 43 

### Table 7. Summary of the Most Sensitive Endpoints from Terrestrial Toxicity Studies for

Fluometuron

Taxonomic

Group Study Type Tested Species Toxicity Value Acute Toxicity

Classification Source (Study Classification)

Comments

Terrestrial plants Seedling Emergence Dicot

– Lettuce (Lactuca sativa) IC 25 = 0.006 lbs

ai/acre

NOAEC =

0.00021 lbs

ai /acre -- 42718802 (Acceptable) Technical (97.2%) was tested. Dry weight most sensitive parameter. Monocot

– Corn (Zea mays) IC 25 = 0.026 lbs

ai/acre

NOAEC =

0.0019 lbs ai/acre --

Vegetative vigor Dicot

– Cucumber ( Cucumis sativus ) IC 25 = 0.0008 lb

ai/acre

NOAEC =

0 .0021 lbs ai /acre -- 42718803 (Acceptable) Technical (97.2%) was tested. Dry weight most sensitive parameter. Monocot

– Oat ( Avena sativa ) IC 25 = 0.035 lbs

ae/acre

NOAEC = 0.019

lbs ai /acre --

1 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

2 NOAEC and LOAEC calculated as follows: Female rabbits in study ranged in weight from 3.045 to 4.491 kg; average of minimum and maximum weights was used to estimate food consumption (3.768 kg). Da ily food consumption was estimated using the following allometric equation in USEPA (1993): kg

- diet/day = 0.067 * (rabbit wt, kg) 0.822 = 0.199 kg

- diet/day Daily consumption of fluometuron at NOAEL:

NOA EL * bw = 10 mg ai./kg

- bw/day * 3.768 kg = 37.68 mg a.i./day NOAEC = daily consumption of fluometuron at NOAEL / daily food consumption = 37.67 mg a.i./day / 0.199 kg

- diet/day = 189 mg a.i./kg

- diet



### A review of the EIIS database for ecological incidents involving fluometuron was completed on January 12, 2016. There were two fluometuron incidents in the database, both involving cotton. The first incident occurred in Martin County, NC

, on 7/15/98 and in volved 45 adversely affected acres of cotton out of a total acreage of 80. The seco nd incident occurred on 10/14/98 in Northampton County, NC

, and involved a registered use of liquid formulation fluometuron.

Three out of 26 acres were adversely affected. No additional incidents were identified in the Aggregate Incident Database component of the Office of Pesticide Programs Incident Database System (OPP IDS) search completed in January 12, 2016.

The Avian Incident Monitoring System (AIMS) 1 

### database will b e examined at the time of registration review for fluometuron

.



# 7. Exposure Pathways of Concern

The environmental fate properties and use patterns of fluometuron indicate that direct spray, spray drift, leaching to ground water, atmospheric deposition, and runoff represent potential

transport mechanisms to aquatic and terrestrial organisms. Drinking water and inhalation exposure pathways for birds and mammals were evaluated using the SIP (Screening Imbibition

1 http://www.abcbirds.org/abcprograms/policy/pesticides/aims/aims/index.cfmPage 17 of 43 

### Program) and STIR (Screening Tool for Inhal ation Risk) screening methods ( Appendices 1 and

2 )

. Drinking water alone was not identified as a potential acute concern for birds and mammals; however, it was identified as a potential chronic concern for both birds and mammals. Inhalation was found to be an exposure pathway of low concern for both birds a nd mammals. SIP and STIR

are described in detail at: http://www.epa.gov/pesticide

- science

- and

- assessing

- pesticide

risks/model s

- pesticide

- risk

- assessment#terrestrial

.



# 8. Analysis Plan

8.1 Stressors of Concern

Fluometuron and its major degradate

, desmethyl

- fluometuron , are the stressors of concern for both the ecological and drinking water risk assessments for registration review. For the

ecol ogical risk assessment, fluomet uron and desmethyl

- fluometuron will be assume d to have equal toxicity as the chemicals have very similar structures ( desmethyl

- fluometuron has the same structure as fluometuron with the exception of one le ss methyl group).



## 8.2 Measures of Exposure

8.2.1 Modeling of Exposure

EFED will use standard available models to evaluate potential exposures to aquatic and terrestrial organisms as described at http://www.epa.gov/pesticide

- science

- and

- assessing

pesticide

- risks/models

- pesticide

- risk

- assessment . Both a cute and chronic exposure will be

a ssessed with modeling inputs based on fluometuron and its major metabolite, desmethyl

fluometuron, environmental fate and transport properties. The Pesticide in Water Calculator (PWC), previously known as the Surface Water Concentration Calculator (SWCC), is currently the model typically used to estimate aquatic exposure. T

- REX and TerrPlant are currently models typically used to estimate terrestrial exposure.

Screening level calculations suggested that drinking water pathway may be significant chronic

exp osures for terrestrial organisms. This exposure pathway may be further considered at the time of the risk assessment ( Appendix B ).

8.2. 2 Available Monitoring Data

EFED currently has monitoring data on the concentrations of fluometuron in surface water. The US Geological Survey (USGS) National Water Quality Assessment Program (NAWQA) 2


### analyzed pesticide occurrence and concentrations for major streams, showed fluometuron with a maximum concentration of 37.8 μg/L. Even though, the surface water monitoring d ata collected by NAWQA are from sites considered typical for use areas, the frequency of sampling and the length of sampling period were not sufficient to represent the temporal and spatial requirements for regulatory purposes.

2 

### http://waterqualitydata.us/portal/Page 18 of 43 

### The US Geological Survey (U SGS) National Water Quality Assessment Program (NAWQA)

also analyzed pesticide occurrence and concentrations for major aquifers and shallow ground water in agricultural areas showed fluometuron with a maximum concentration of 4.7 μg/L. Even though the grou ndwater monitoring data collected by NAWQA are from sites considered typical for use areas, the frequency of sampling and the length of sampling period were not sufficient to represent the temporal and spatial requirements for regulatory purposes

.

EFED has targeted monitoring data on the concentrations of fluometuron in gro undwater. According to the US EPA Pesticides in Ground Water Database (USEPA 1992) , the concentrations of fluometuron in a total of 530 well samples collected in A R , CA, FL, GA, LA, MO, and MS, ranged from 0.8 to 5.00 μg/L.



## 8 .3 Measures of Effect

Toxicity data presented in Section 6 of this problem formulation will be used to calculate risk quotients. Any t oxicity data identified for the major degradate

, desmethyl fluometuron

, may also

be used. A dditional information submitted by the registrant or found in the open literature prior

to con duct of the risk assessment will also be considered. The open literature studies are identified using EPA’s E COTOXicology database ( ECOTOX) (USEPA, 2007), which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The evaluation of both sources of data can also provide insight into the direct a nd indirect effects of pesticides on biotic communities from loss of species that are sensitive to the chemicals and from changes in structure and functional characteristics of the affected

communities.



# 9

. Endangered Species Assessments

Consistent with t he Agency’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally threatened and/or endangered (listed) species from registered uses of pesticides in registration review . The process for evaluating potential risks to listed species is further described at http://www.epa.gov/oppfead1/endanger/litstatus/riskasses.htm

.



# 10. Endocrine Disruptor Screening Program

Fluometuron was not included in the first group or the second group of chemicals issued an order to conduct Tier 1 EDSP testing. For additional information the EDSP program, visit http://www2.epa.gov/endocrine

- disrupti on

.



# 11

. Preliminary Identification of Data Gaps

11.1 Environmental Fate

Table 8 identifies environmental fate studies by MRID that offer data for each guideline requirement, as well as study classifications and whether or not further data are needed in order to support risk assessment.Page 19 of 43 

### Table 8. Summary of Submitted Environmental Fate Data for Fluometuron

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classifications Are Additional

Data Needed to

Conduct Risk

Assessment?

835.2120 Hydrolysis 40864401 and

40930601 Acceptable No

835.2240 Aqueous photolysis 41065101 Acceptable No

835.2410 Soil photolysis 40930602 Acceptable No

835.4100 Aerobic soil metabolism 42998702 Acceptable No

835.4200 Anaerobic soil metabolism 42998703 Acceptable No

835.4300 Aerobic aquatic metabolism No available data NA Yes

835.4400 Anaerobic aquatic metabolism 43158901 Acceptable No

835.1230

835.1240 Adsorption/ desorption and leaching 42643601 Acceptable No

835.6100 Terrestrial field dissipation 40459401

40459402 Acceptable No

850.1730 Fish bioconcentration 42017304 Acceptable No

850.6100 Analytical method in soil No available data NA Yes Analytical method in water No available data NA



## 11.2 Effects

Tables 9 and 10 identify ecological effects studies by MRID that offer data for each guideline requirement, as well as study classifications and whether or not further data are needed in order to support risk assessment.

Although fluometuron is categorized as practica lly non

- toxic to adult honeybees on an acute contact exposure basis, and by extension, to other beneficial terrestrial invertebrates on an acute exposure basis, there is considerable uncertainty regarding the potential effects of the compound on honeybee l arval development and survival as well as potential for chronic effects. Therefore,

additional data on honeybees is needed to fully characterize the risk associated with fluometuron use to all developmental stages of honeybees, as sensitivity may vary acco rding to life

- stage and length of exposure (adult vs. larval and acute vs. chronic, respectively). It is unknown if fluometron is systemic in plants so exposure via pollen and nectar is possible; and therefore, residues of pollen and nectar of crops are an additional data need. D ata are needed to help better characterize some uncertainties regarding potential effects to bees. H igher tier effects toxicity tests ( i.e., semi

- field and/or field studies

– Tier II and Tier III, respectively) may be needed,

based on the results of the larval and chronic adult toxicity studies. Higher tier studies are

recommended if the ratio of the EEC and larval or adult bee acute LD50> 0.4 or the ratio of the

EEC and the chronic NOAEC> 1 . Incident data and/or open literature studie s can also be used to support the need for higher tier studies. Should the screening level risk assessment identify that there are risk concerns to bees, mitigation measures may need to be considered or the registrant may need to conduct Tier II or Tier II I effects studies ( e.g. OECD Guideline 75 and/or 850.3040 guideline studies) that reduce uncertainty by characterizing fluometuron’s effects at the whole

colony level ( http://www2.epa.gov/pollinator

- protection/pollinator

- risk

- assessment

- guidance ). These additional pollinator protection studies are listed in Table 9

.Page 20 of 43 

### Table 9 . Available ecological effects data for terrestrial organisms exposed to fluometuron

and r emaining data gaps.

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classifications Are data

needed for

risk

assessment? Current Additional Data Need

850.2100 Avian oral toxicity 160000 Supplemental Yes Data are required for a vian acute oral with passerine 00019221 Acceptable

850.2200 Avian dietary toxicity 42498001 Acceptable No

--

42597401 Acceptable

00019222 Supplemental (Japanese quail)

00019222 Supplemental (Mallard)

00019222 Acceptable (ring

- necked pheasant)

850.2300 Avian reproduction 47984401 Supplemental No

--

46565703 Invalid

47896201 Acceptable

Non

guideline Avian inhalation (None)

-- No A data gap was not identified as

inhalation concerns were not raised

based on the STIR screen.

850.3020 Honey bee acute contact toxicity 00006653 and

00028772 Acceptable No

--

850.3030 Honey bee residue on foliage (None)

-- No Data are not requested at this time

as the adult bee contact LD 50 was greater than 11 μg a.i./bee.

Non

guideline,

OECD TG

213 Acute oral toxicity to adult honey

bees (None)

-- Yes Recommend that PRD request data

per: http://www2.epa.gov/pollinator

protection/pollinator

- risk

assessment

- guidance

Non

guideline,

OECD TG

237 Acute oral toxicity to larval honey

bees (None)

-- Yes Recommend that PRD request data

per: http://www2.epa.gov/pollinator

protection/pollinator

- risk

assessment

- guidance

Non

guideline Chronic oral toxicity to adult honey bees (None)

-- Yes Recommend that PRD request data

per: http://www2.epa.gov/pollinator

protection/pollinator

- risk

assessment

- guidance

Non

guideline Chronic oral toxicity to larval honey bees (None)

-- Yes Recommend that PRD request data

per: http://www2.epa.gov/pollinator

protection/pollinator

- risk

assessment

- guidancePage 21 of 43 

### Table 9 . Available ecological effects data for terrestrial organisms exposed to fluometuron

and r emaining data gaps.

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classifications Are data

needed for

risk

assessment? Current Additional Data Need

Non

guideline Field t rial of residues in pollen

and nectar (None)

-- Yes Recommend that PRD request data

per: http://www2.epa.gov/pollinator

protection/pollinator

- risk

assessment

- guidance

Non

guideline,

OECD

Guidance 75 Semi

- field testing for pollinator (None)

-- Yes Recommend that PRD request data

per: http://www2.epa.gov/pollinator

protection/pollinator

- risk

assessment

- guidance

850.3040 Field testing for pollinator (None)

-- Yes Recommend that PRD request data

per: http://www2.epa.gov/pollinator

protection/pollinator

- risk

assessment

- guidance

850.3100 Earthworm

Subchronic Toxicity Test (None)

-- No Data have not been submitt ed to fulfill this guideline. A data gap

was not identified as these data are not necessary for risk assessment at

this time.

850.4100 Seedling Emergence and Seedling Growth 42718802 Supplemental Yes Submitted study utilized technical grade fluometuron, not an end

- use product. Given the likelihood of increased toxicity when exposed to the formulated product, and exposure to the formulated product is likely given drift during application, additional dat a are recommended for 10 species utilizing an end

- use product

.

850.4150 Vegetative Vigor 42718802 Supplemental Yes Submitted study utilized technical grade fluometuron, not an end

- use product. Given the likelihood of increased toxicity when exposed to the formulated product, and exposure to the formulated product is likely given drift during application, additional dat a are recommended for 10 species utilizing an end

- use product

.Page 22 of 43 

### Table 10 . Available ecological effects data for aquatic organisms exposed to fluometuron and remaining data gaps.

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classifications Are data

needed to

conduct risk

assessment? Current Additional Data Need

850.1010 Freshwater

invertebrate acute toxicity 0024180 Acceptable No

--

40098001 Acceptable

40098001 Supplemental

40098001 Supplemental

40098001 Supplemental

850.1025

850.1035

850.1045

850.1055 Saltwater

invertebrate acute toxicity 42568501 Acceptable No

--

42498006 Acceptable

42498005 Supplemental

43848101 Acceptable

42560101 Invalid

850.1075 Freshwater fish acute toxicity 161088 Supplemental No

--

42498002 Acceptable

40098001 Acceptable

40098001 Supplemental

42498003 Acceptable

42505001 Acceptable

40098001 Supplemental

40098001 Acceptable

40098001 Supplemental

47607401 Supplemental

40098001 Invalid

40098001 Acceptable

40098001 Supplemental

850.1075 Saltwater fish acute toxicity 42498004 Supplemental No

--

42505002 Acceptable

850.1300 Freshwater

invertebrate life cycle 46565701 and

47978401 Acceptable No

--

850.1350 Saltwater

invertebrates life cycle 48080701 Acceptable No

--

850.1400 Freshwater fish early

- life stage 46565702 Acceptable No

--Page 23 of 43 

### Table 10 . Available ecological effects data for aquatic organisms exposed to fluometuron and remaining data gaps.

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classifications Are data

needed to

conduct risk

assessment? Current Additional Data Need

850.1400 Saltwater fish early

- life stage (None)

-- No Data have not been submitted to fulfill this guideline. A data gap

was not identified as these data are not necessary for risk assessment

at this time as utilized data from

acute and chronic fathead minnow

studies to calculate the ACR and applied the ACR t o the acute sheepshead minnow LC 50

.

850.1500 Fish life cycle (None)

-- No Data have not been submitted to fulfill this guideline. A data gap

was not identified as these data are not necessary for risk assessment

at this time.

850.4400 Aquatic plant Toxicity Test using Lemna spp. 42564102 Supplemental No

--

43421601 Supplemental

850.4500 Algal toxicity 43025601 Supplemental No

--

42498007 Supplemental

42564101 Supplemental

42568502 Acceptable

850.4550 Cyanobacteria 42568503 Supplemental No

--

43421602 AcceptablePage 24 of 43 

# 12. References

12.1 Publically Available Literature

US EPA. 1992. Pesticides in Ground Water Database

- A compilation of Monitoring Studies: 1971

- 1991. Office of Prevention, Pesticides, and Toxic Substances, EPA 734

- 12

- 92

- 001.

USEPA. 1993. Wildlife Exposure Factors Handbook (vol. I and II). EPA/600/R

- 93/187b. http://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=2799



## 12.2 Submitted Environmental Fate Studies

161

- 1: Hydrolysis Das, Y.T. 1988. Hydrolysis of [Phenyl (U)

- 14 C]

- Fluometuron in Aqueous Solutions Buffered at pH 5, 7, and 9.

Innovative Scientific Serv ices, Inc., for Ciba Geigy Corporation. Laboratory Study ISSI No. 88020. (40864401)

Das, Y.T. 1988. A Supplement to Hydrolysis of [Phenyl (U)

- 14 C]

- Fluometuron in Aqueous Solutions Buffered at pH 5, 7, and 9. Innovative Scientific Services, Inc., fo r Ciba Geigy Corporation. Laboratory Study ISSI No. 88020. (40930601)

161

- 2: Photolysis in Water Das, Y.T. 1988. Photodegradation of [Phenyl (U)

- 14 C]

- Fluometuron in Aqueous Solutions Buffered at pH 5, 7, and 9 under Natural Sunlight. Innovative Scienti fic Services, Inc., for Ciba Geigy Corporation. Laboratory Study ISSI No. 88011. (41065101)

161

- 3: Photolysis on soil Das, Y.T. 1988. Photodegradation of [Phenyl (U)

- 14 C]

- Fluometuron on Soil under Natural Sunlight. Innovative Scientific Services, Inc., for Ciba Geigy Corporation. Laboratory Study ISSI No. 88031. (40930602)

162

- 1: Aerobic soil metabolism Spare, W.C. 1993a. Aerobic soil metabolism of 14 C

- fluometuron. Agrisearch Project No. 12196; Ciba

- Geigy Study

No. 112

- 90. Unpublished study performed by Agrisearch Incorporated, Frederick, MD, and submitted by Ciba

Geigy Corporation, Greensboro, NC. (42998702)

162

- 2: Anaerobic soil metabolism Spare, W.C. 1993b. Anaerobic soil metabolism of 14 C

- fluometuron. Agrisearch Project No. 12197; Ciba

- Geigy Study No. 111

- 90. Unpublished study performed by Agrisearch Incorporated, Frederick, MD, and submitted by

Ciba

- Geigy Corporation, Greensboro, NC. (42998703)

162

- 3: Anaerobic aquatic metabolism Spare, W.C. 1994. Anaerobic aquatic metabolism of 14 C

- fluometuron. Agrisearch Project No. 12204; Ciba

- Geigy Study No. 44

- 92. Unpublished study performed by Agrisearch Incorporated, Frederick, MD, and submitted by

Ciba

- Geigy Corporation, Greensboro, NC. (43158901)

163

- 1: Mobility/ Adsorption/ Desorption Spare, W.C. 1992d. Adsorption/desorption of 14 C

- fluometuron. Agrisearch Project No. 12200; Ciba

- Geigy Study

No. 19

- 92. Unpublished study performed by Agrisearch Incorporated, Frederick, MD, and submitted by Ciba

- Geigy Corporation, Greensboro, NC. (4264 3601)

Spare, W.C. 1992c. Adsorption/desorption of 14 C

- CGA

- 72903. Agrisearch Project No. 12203; Ciba

- Geigy Study

No. 22

- 92. Unpublished study performed by Agrisearch Incorporated, Frederick, MD, and submitted by Ciba

- Geigy Corporation, Agricultural Divi sion, Greensboro, NC. (42643602)Page 25 of 43 Spare, W.C. 1992a. Adsorption/desorption of 14 C

- CGA

- 41685. Agrisearch Project No. 12202; Ciba

- Geigy Study

No. 20

- 92. Unpublished study performed by Agrisearch Incorporated, Frederick, MD, and submitted by Ciba

- Geigy

Cor poration, Agricultural Division, Greensboro, NC. (42643603)

Spare, W.C. 1992b. Adsorption/desorption of 14 C

- CGA

- 41686. Agrisearch Project No. 12201; Ciba

- Geigy Study

No. 21

- 92. Unpublished study performed by Agrisearch Incorporated, Frederick, MD, and submitted by Ciba

- Geigy Corporation, Agricultural Division, Greensboro, NC. (42643604)

164

- 1: Terrestrial Field Dissipation White, S.M. 1987. Field Dissipation Study on Fluometuron for Terrestrial Uses on Cotton, Donalsonville, Georgia. Ciba Geigy Corpor ation, Greensboro, NC. (40459401)

White, S.M. 1987. Field Dissipation Study on Fluometuron for Terrestrial Uses on Cotton, Ripton, California. Performed by Landis Associates, Inc., Valdosta, Georgia. Submitted by Ciba Geigy Corporation, Greensboro, NC

. (40459402)

165

- 4: Bioacccumulation in Fish Shortelle, A.B., C.V. Manning, and G.C. Ward. 1990. 14 C

- Fluometuron: Accumulation and Depuration of 14C

Residues by Bluegill Lepomis macrochirus. Performed by Hunter/ESE, P.O. Box 1703, Gainesville, Florid a. Laboratory Project ID #88311

- 0200

- 2130. Completed 2/9/90. Submitted by Ciba

- Geigy Corporation, Agricultural Division, Greensboro, N.C. (42017304)

Cruz, S.M. 1992. Bioacccumulation of 14 C

- Fluometuron in Bluegill Sunfish: Response to the January 10 , 1992 EPA Review of Fluometuron Environmental Fate Studies. Performed by Ciba Geigy Corporation, Greensboro, NC. (42413502)

166

- 1,2: Ground Water Monitoring

Demartinis J. 1991. Small

- Scale Retrospective Ground Water Monitoring Study for Cotoran TM

- Fin al Report, Volumes 1 and 2. Ciba Geigy, Greensboro, NC. (41931501)



## 1 2.3 Submitted Ecological Toxicity Studies

Guideline: 850.1010 Daphnid acute toxicity test

M RID: 24180 Citation: Vilkas, A.G. (1977) The Acute Toxicity of Technical Fluometuron to the Water Flea,~Daphnia magna~ Straus: UCES Proj. # 11506

- 04

- 07. (Unpublished study received Jun e 22, 1978 under 100

- 561; prepared by Union Carbide Environmental Services, submitted by Ciba

- Geigy Corp., Greensboro, N.C.;

CDL:234176

- E)

MRID: 40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and Data Base for 410 Chemicals and 66 Species of Freshwater Animals. US Fish & Wildlife Service, Resource Publication 160. 579 p.

Guideline: 850.1025 Oyster Acut e

– Shell deposition

MRID: 42498005 Dionne, E. (1992) Fluometuron: Acute Toxicity to Eastern Oyster (Crassotrea virginica) Under

Flow

- Through Conditions: Lab Project Number: 1781.0292.6298.504: 92

- 6

- 4275. unpublished study prepared by Springborn Laborat ories Inc. 59 p.

MRID: 42560101 Lintott, D.; Ward, G. (1992) Fluometuron: Acute Effect on New Shell Growth of the Eastern Oyster, Crassostrea virginica: Lab Project Number: J9201011E. Unpublished study prepared by Toxikon Environmental Sciences. 27 p.

MRID: 43075902 Peters, G. (1993) Response to Review of Fluometuron Estuarine/Marine Mollusk Toxicity Test. Unpublished study prepared by Ciba

- Geigy Corp. 6 p.

MRID: 43848101 Cunningham, F.; Davis, J. (1995) Fluometuron: Acute Effects on New Shell Growth of the Eastern Oyster (Crassostrea virginica): Lab Project Number: J9501009: J9201001B. Unpublished study prepared by Toxikon Environmental Sciences. 46 p.Page 26 of 43 Guideline: 850.1035 Mysid acute toxicity test

MRID: 42568501 Lintott, D. (1992) Fluometuron: Acute Toxicity to the Mysid, Mysidopsis bahia, under Flow

through Test Conditions: Lab Project Number: J9201001C. Unpublished study prepared by Toxikon Environmental Sciences. 24 p.

MRID: 42498006 Machado, M. (1992) Fluometuron: Acute T oxicity to Mysid Shrimp (Mysidopsis bahia) Under

Flow

- Through Conditions: Lab Project Number: 92

- 6

- 4301: 1781.0292.6297.515. Unpublished study prepared by Springborn Laboratories Inc. 63 p.

Guideline: 850.1075 Fish acute toxicity test, freshwater and marine

M RID: 68507 Hughes, J.S.; Davis, J.T. (1964?) Effects of Selected Herbicides on Bluegill Sunfish. (Louisiana,

Wild Life and Fisheries Commis

- sion; unpublished study; CDL:231131

- A)

MRID: 19220 Bathe, R.; Ullmann, L.; Sachsse, K. (1972) D etermination of the Toxicity of Pesticides to Fish. (Unpublished study received Jun 22, 1978 under 100

- 561; prepared by Ciba

- Geigy, AG, submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:234176

- B)

MRID: 109024 Bathe, R.; Ullmann, L.; Sachsse, K.; et al. (1975) Relationship between Toxicity to Fish and to Mammals: A Comparative Study under Defined Laboratory Conditions. (Unpublished paper pre

- sented at the 17th Meeting of the European Society of Toxicol

- ogy; Jun 16

- 18, 1975, Montpellier, Fr.; unpub lished study re

- ceived Oct 11, 1977 under 100

- 524; prepared by Ciba

- Geigy, Ltd., Switz., submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL: 232008

- B)

MRID: 161088 Swigert, J.; Bowman, J. (1986) Acute Toxicity of Fluometuron to Bluegill Sunfish (Lepom is macrochirus): Static Acute Toxicity Report #34522. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 14 p.

MRID: 40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and Data Base for 410

Chemi cals and 66 Species of Freshwater Animals. US Fish & Wildlife Service, Resource Publication 160. 579 p.

MRID: 42498002 Machado, M. (1992) Fluometuron: Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus)

Under Flow

- Through Conditions: Lab Project Number: 92

- 7

- 4327: 1781.0292.6300.105. Unpublished study prepared by Springborn Laboratories Inc. 70 p.

MRID: 42498003 Machado, M. (1992) Fluometuron: Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss)

Under Flow

- Through Conditions: Lab Project Number: 92

- 6

- 4297: 1781.0292.6299.108. Unpublished study prepared by Springborn Laboratories Inc. 67 p.

MRID: 42505001 Mc Elwee, C.; Lintott, D. (1992) Fluometuron: Acute Toxicity to Rainbow Trout, Oncorhynchus mykiss, under Static Test Conditions: Lab Project Number: J9208001. Unpublished study prepared by Toxikon Environmental Sciences. 24 p.

MRID 47607401 Soucy, K. (2 008) Acute Toxicity to Fathead Minnow (Pimephales promelas) Under Static Conditions, following OPPTS Draft Guidelines: (Fluometuron). Project Number: 13929/6101, 032708/OPPTS/ST/FHM/. Unpublished study prepared by Springborn Smithers Laboratories. 53 p.

MRID: 42498004 Machado, M. (1992) Fluometuron: Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under Flow

- Through Conditions: Lab Project Number: 92

- 6

- 4304: 1781.0292.6301.505. Unpublished study prepared by Springborn Laboratories Inc. 67 p.

MRID: 42505002 Lintott, D. (1992) Fluometuron: Acute Toxicity to Sheepshead Minnow, Cyprinodon variegatus, under Static Test Conditions: Lab Project Number: J9206006. Unpublished study prepared by Toxikon Environmental Sciences. 23 p.

MRID: 4307 5901 Peters, G. (1993) Response to Review of Fluometuron Estuarine/Marine Fish Toxicity Test. Unpublished study prepared by Ciba

- Geigy Corp. 6 p.Page 27 of 43 Guideline: 850.1300 Daphnid chronic toxicity test

MRID: 46565701 Firth, K. (2002) Fluometuron Technical: Prolonged Toxicity to Daphnia magna. Project Number: AGM/159/023724, 90005120. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 47 p.

MRID: 47978401 Citation: Jenkins, C. (2010) Fluometuron Technical: Prolonged Toxicity to Dap hnia magna. Project Number: AGM0159/023724. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 3 p.

Guideline: 850.1350 Mysid chronic toxicity test

MRID: 48080701 Hicks, S. (2010) Fluometuron: Life

- Cycle Toxicity Test of the Saltwater Mysid, Americamysis bahia, Conducted Under Flow

- Through Conditions. Project Number: 65181, 90012757. Unpublished study prepared by ABC Laboratories, Inc. 81 p.

Guideline: 850.1400 Fish early

- life stage toxicity test

MRID: 46565702 Albuquerque, R. (2003) Fluometuron Technical: Fish Early Life Stage Toxicity Test for Fathead Minnow. Project Number: AGM/158, AGM/158/023687, 90005271. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 58 p.

MRID: 18645 Lawrence, J.M. (1964) The Effe ct of C

- 2059, Tenoran, C

- 3126, and C

- 3095 on Fathead Minnows. (Unpublished study received Oct 8, 1964 under 100

- 548; prepared by Auburn Univ., submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:023178

- L)

MRID: 18646 Takeda Chemical Ind., Limited (1 963) Test on Fish Toxicity of C

- 1936, C

- 1983, and C

- 2059. (Unpublished study received Oct 8, 1964 under 100

- 548; submitted by Ciba

- Geigy Corp., Greensboro, N.C.;

CDL:023177

- L)

MRID: 19162 Lawrence, J.M. (1964) The Effect of C

- 2059, Tenoran, C

- 3126, a nd C

- 3095 on Fathead Minnows: Research Report CF

- 70. (Unpublished study received Oct 8, 1964 under 100

- 549; prepared by Auburn Univ., submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL: 007070

- S)

Guideline: 850.2100 Avian Single Dose Oral Toxicity

MRID: 19221 Beavers, J.B.; Brown, R.; Fink, R. (1977) Final Report: Acute Oral LD50

-- Mallard Duck: Project

No. 108

- 133. (Unpublished study re

- ceived Jun 22, 1978 under 100

- 561; prepared by Wildlife Interna

- tional, Ltd. in cooperation with Was hington College, submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:234176

- C)

Guideline: 850.2200 Avian Dietary Toxicity

MRID: 19222 Robinson, D.; Shillam, K.W.G. (1970) Acute Toxicity of Fluometuron to the Japanese Quail, Ring

Necked Pheasant a nd Mallard Duck. (Unpublished study received Jun 22, 1968 under 100

- 561; prepared by Huntingdon Research Centre, submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:234176

- D)

MRID: 42498001 Campbell, S.; Lynn, S. (1992) Fluometuron: A Dietary LC50 Stu dy with the Northern Bobwhite: Lab Project Number: 108

- 353. Unpublished study prepared by Wildlife International Ltd. 39 p.

MRID: 42597401 Pedersen, C.; Mumper, J. (1992) Fluometuron Technical: 8

- day Acute Dietary LC50 Study in Bobwhite Quail: Lab Pro ject Number: 130

- 001

- 01. Unpublished study prepared by Bio

- Life Associates, Ltd. 67 p.

Guideline: 850.2300 Avian reproduction test

MRID: 46565703 Mitterer, K. (2003) Study on Reproduction in Birds (Bobwhite Quail) with Fluometuron by Oral

Admin istration via the Diet. Project Number: 90003450, 14750/01. Unpublished study prepared by Laboratorium fuer Pharmakologie und Tox. 279 p.

MRID: 47896201 Frey, L.; Martin, K.; Beavers, J.; et al. (2009) Fluometuron: A Reproduction Study with the

Malla rd: Final Report. Project Number: 234/111. Unpublished study prepared by Wildlife International, Ltd. 153

p.Page 28 of 43 MRID: 47984401 Leuschner, J. (2010) Study on Reproduction in Birds (Bobwhite Quail) with Fluometuron by

Oral Administration via the Diet. Pr oject Number: 14750/01/AMENDMENT/NO/1. Unpublished study prepared by Laboratorium fuer Pharmakologie und Tox. 291 p.

Guideline: 850.4100 Seedling emergence

MRID: 43530301 Kranzfelder, J. (1995) Fluometuron: Seed Germination/Seedling Emergence: La b Project Number: J9403004A: J9201001H. Unpublished study prepared by Toxikon Environmental Sciences. 99 p.

MRID: 42695801 Kegley, M. (1993) Fluometuron: Seed Germination/Seedling Emergence: Lab Project Number: J9201001F. Unpublished study prepared by Toxikon Environmental Sciences. 30 p.

MRID: 42718801 Chetram, R. (1993) Tier 2 Seed Germination Nontarget Phytotoxicity Study Using Fluometuron: Lab Project Number: 92060. Unpublished study prepared by Pan Agricultural Labs, Inc. 111 p.

MRID: 42 718802 Chetram, R. (1993) Tier 2 Seedling Emergence Nontarget Phytotoxicity Study Using Fluometuron: Lab Project Number: 92061. Unpublished study prepared by Pan

- Agricultural Labs, Inc. 283 p.

Guideline: 850.4150 Vegetable Vigor

MRID: 42795001 Kegley, M. (1993) Fluometuron: Vegetative Vigor: Lab Project Number: J9201001G. Unpublished study prepared by Toxicon Environmental Sciences. 29 p.

MRID: 43530302 Kranzfelder, J. (1995) Fluometuron: Vegetative Vigor: Lab Project Number: J9403004B: J9201001H. Unpublished study prepared by Toxikon Environmental Sciences. 65 p.

MRID: 42718803 Chetram, R. (1993) Tier 2 Vegetative Vigor Nontarget Phytotoxicity Study Using Fluometuron: Lab Project Number: 92062. Unpublished study prepared by Pan

- Agricultural Labs, Inc. 287 p.

Guideline: 850.4400 Aquatic plant growth using Lemna spp.

MRID: 43421601 Jones, F. (1994) Fluometuron: Acute Toxicity to Duckweed, Lemna gibba G3, under Static Test Conditions: Lab Project Number: J9403004D. Unpublished study prepared by Toxikon Environmental Sciences. 26 p.

MRID: 42564102 Ward, G.; Lintott, D . (1992) Fluometuron: Acute Toxicity to Duckweed, Lemna gibba G3, under Static Test Conditions: Lab Project Number: J9201001K. Unpublished study prepared by Toxikon Environmental Sciences. 27 p.

Guideline: 850.4500 Aquatic plant growth using algae

MRID: 42498007 Hoberg, J. (1992) Toxicity to the Freshwater Green Alga, (Selenastrum capricornutum): Lab Project Number: 92

- 5

- 4273: 1781.0292.6296.430. Unpublished study prepared by Springborn Laboratories Inc. 61

p.

MRID: 43075903 Peters, G. (199 3) Response to Review of Fluometuron Aquatic Plant Growth Test. Unpublished study prepared by Ciba

- Geigy Corp. 10 p.

MRID: 42564101 Ward, G.; Lintott, D. (1992) Fluometuron: Acute Toxicity to the Saltwater Diatom, Skeletonema

costatum under Static Te st Conditions: Lab Project Number: J9201001M. Unpublished study prepared by Toxikon Environmental Sciences. 29 p.

MRID: 42568502 Lintott, D. (1992) Fluometuron: Acute Toxicity to the Freshwater Diatom, Nitzschia palea,

under Static Test Conditions: L ab Project Number: J92010010. Unpublished study prepared by Toxikon Environmental Sciences. 30 p.

MRID: 43025601 Ward, G.; Lintott, D. (1992) Fluometuron: Acute Toxicity to the Freshwater Green Alga, Selenastrum capricornutum, Under Static Test Condi tions: Lab Project Number: J9201001L. Unpublished study prepared by Toxikon Environmental Sciences. 30 p.

Guideline: 850.4500 Aquatic plant growth using cyanobacteriaPage 29 of 43 MRID: 43421602 Jones, F. (1994) Fluometuron: Acute Toxicity to Freshwater Blue

- G reen Alga, Anabaena flos

aguae, under Static Test Conditions: Lab Project Number: J9403004C. Unpublished study prepared by Toxikon Environmental Sciences. 25 p.

MRID: 42564103 Juarovisech, K.; Lintott, D. (1992) Fluometuron: Acute Toxicity to the Fre shwater Blue

- Green Alga, Anabaena flos

- aquae, under Static Test Conditions: Lab Project Number: J9201001N. Unpublished study prepared by Toxikon Environmental Sciences. 29 p.

MRID: 42568503 Juarovisech, K.; Lintott, D. (1992) Fluometuron: Acute Toxic ity to the Freshwater Blue

- green Alga, Anabaena Flos

- aquae, under Static Test Conditions: Lab Project Number: J9201001N. Unpublished study prepared by Toxikon Environmental Sciences. 29 p.Page 30 of 43 

# Appendix A. SIP Fluometuron Modeling Results

Table 1. Inputs

Parameter Value

Chemical name fluometuron

Solubility (in water at 25 o C; mg/L) 90

Mammalian LD 50 (mg/kg

- bw) 1000

Mammalian test species laboratory rat

Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg

- bw) 10

Mammalian test species Other

- rabbit

Body weight (g) of "other" mammalian species 3768

Avian LD 50 (mg/kg

- bw) 2974

Avian test species mallard duck

Body weight (g) of "other" avian species

Mineau scaling factor 1.15

Mallard NOAEC (mg/kg

- diet) 60.4
Bobwhite quail NOAEC (mg/kg

- diet) 0
NOAEC (mg/kg

- diet) for other bird species 0

Body weight (g) of other avian species

NOAEC (mg/kg

- diet) for 2nd other bird species 0

Body weight (g) of 2nd other avian species

Table 2. Mammalian Results

Parameter Acute Chronic

Upper bound exposure (mg/kg

- bw) 15.4800 15.4800
Adjusted toxicity value (mg/kg

- bw) 769.1606 13.9325

Ratio of exposure to toxicity 0.0201 1.111

Conclusion* Drinking water exposure alone is NOT a potential concern for

mammals Exposure through drinking water alone is a potential concern for mammals

Table 3. Avian Results

Parameter Acute Chronic

Upper bound exposure (mg/kg

- bw) 72.9000 72.9000
Adjusted toxicity value (mg/kg

- bw) 1544.1764 2.9966

Ratio of exposure to acute toxicity 0.0472 24.3276

Conclusion* Drinking water exposure alone is NOT a potential concern for birds Exposure through drinking water alone is a potential concern for birds

*Conclusion is for drinking water exposure alone. This does not combine all routes of exposure. Therefore, when aggregated with other routes ( i.e ., diet, inhalation, dermal), pesticide exposure through drinking water may contribute to a total exposure that has potential for effects to non

- target animals. 

# Appendix B. STIR Fluometuron Modeling Results

This tool is designed to provide the risk assessor with a rapid method for determining the potentialPage 31 of 43 significance of the inhalation exposure route to birds and mammals in a risk assessment. 

# Input

Application and Chemical Information

Enter Chemical Name fluometuron

Enter Chemical Use herbicide Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) air Enter Chemical Molecular Weight (g/mole) 232 Enter Chemical Vapor Pressure (mmHg) 5.00E

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

Toxicity Properties

**Bird**

Enter Lowest Bird Oral LD 50 (mg/kg bw) 2974 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 1.58

**Mammal**

Enter Lowest Rat Oral LD 50 (mg/kg bw) 1000

Enter Lowest Rat Inhalation LC 50 (mg/L) 0.6 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35



# Output

Results Avian (0.020 kg )

Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 6.24E

- 03

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 7.85E

- 04

Adjusted Inhalation LD 50 7.17E+00

Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.09E

- 04 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 1.92E

- 01

Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 2.68E

- 02 Exposure not Likely Significant



### Results Mammalian (0.015 kg )

Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 6.24E

- 03

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 9.86E

- 04

Adjusted Inhalation LD 50 3.57E+01

Ratio of Vapor Dose to Adjusted Inhalation LD 50 2.76E

- 05 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 2.42E

- 01

Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 6.76E

- 03 Exposure not Likely Significant



# Appendix C . Summary of Fluometuron Environmental Fate

DataPage 32 of 43 

### 161

- 1: Hydrolysis : Fluometuron is stable to hydrolysis at pH 5, 7 and 9 aqueous buffer solutions

incubated at 25 o 

### C. This data requirement is fulfilled (GLN 161

- 1, MRID's 40864401, 40930601).

161

- 2: Photolysis in Water : Fluometuron is stable to aqueous photolysis in pH 5, 7, and 9 buffer

solutions at 25 o 

### C irradiated with natural sunlight and in dark controls This data requirement is fulfilled (GLN 161

- 2); MRID's 41065101).

161

- 3: Photolysis on soil : Fluometuron is stable to photolysis on sandy loam soil irradiated with natural sunlight and in dark c ontrols. This data requirement is fulfilled (GLN 161

- 3, MRID 40930602).

162

- 1: Aerobic soil metabolism : Fluometuron slowly degraded with a calculated half

- life of 181 days in aerobic sandy loam soil. The identified major degradate was CGA

- 4 1686 (parent with 1 methyl group removed). The minor d egradates were CGA

- 41685 (parent with 2 methyl groups removed) and CGA

- 72903 (decarboxlated, demethylated parent compound). This data requirement is fulfilled (GLN 162

- 1, MRID 42998702).

162

- 2: Anaerob ic soil metabolism : Fluometuron slowly degraded in anaerobic soil with a

calculated half

- life of 378 days following 30 days of aerobic incubation plus 60 days of anaerobic incubation. The identified major degradate was CGA

- 41686 (parent with 1 methyl grou p removed). The minor degradates were CGA

- 41685 (parent with 2 methyl groups removed) and

CGA

- 72903 (decarboxlated, demethylated parent compound). This data requirement is fulfilled (GLN 162

- 2, MRID 42998703).

162

- 3: Anaerobic aquatic metabolism : Fluomet uron slowly degraded with a half

- life of 177 days following 365 days of anaerobic i ncubation plus nitrogen atmosphere. The identified major degradate was CGA

- 41686 (parent with 1 methyl group removed). There were several minor degradates that ranged in con centration from <1.7 to 6.2 % of applied. This data requirement is fulfilled (GLN 162

- 3, MRID 43158901).

Leaching

- adsorption

- desorption (163

- 1) Unaged Batch Equilibrium of Parent Fluometuron Parent fluometuron is very mobile in Sassafras sand (Maryland, 0 .23 % OC), Hesperia sandy loam (California, 0.26 % OC), Sesquatchie sandy clay loam (Maryland, 0.45 % OC), and Sharkey clay (Mississippi, 1.40 % OC) soils with Freundlich Kads values of 0.08, 0.15, 0.25, and 1.13, respectively. Freundlich Kdes values were 2.93, 1.48, 4.93, and 4.25, respectively. Kocads were 35, 57, 54, and 80 and Kocdes values were 1277, 561, 1075, and 300, respectively. The N values were 1.15, 1.16, 1.15, and 1.08 for adsorption and 1.00, 1.19, 0.99, and 1.08 for desorption, respectively. The unaged portion of the data requirement is fulfilled (GLN 163

- 1, MRID 42643601).

Batch Equilibrium of Three Metabolites The primary degradate (CGA

- 41686) was very mobile in Sassafras sand (Maryland, 0.23 % OC), Hesperia sandy loam (California, 0.26 % OC), Sesquatchie sandy clay loam (Maryland, 0.45 % OC), and Sharkey clay (Mississippi, 1.40 % OC) soils with Freundlich Kads values ofPage 33 of 43 

### 0.16, 0.33, 0.57, and 2.00, respectively. Freundlich Kdes values were 3.90, 4.55, 6.44, and 6.25, respectively. Kocads were 69, 125, 123, and 141 and Kocdes values were 1700, 1719, 1404, and 441, respectively. The N values were 1.14, 1.11, 1.21, and 1.14 for adsorption and 1.05, 1.02, 1.03, 1.10 for desorption, respectively. The aged portion of the data requirement is fulf illed (163

- 1, MRID 42643604).

CGA

- 41685 (parent with both methyl groups removed) was very mobile in Sassafras sand (Maryland, 0.23 % OC), Hesperia sandy loam (California, 0.26 % OC), Sesquatchie sandy clay loam (Maryland, 0.45 % OC), and Sharkey clay (Mississippi, 1.40 % OC) soils with Freundlich Kads values of 0.20, 0.27, 0.48, and 1.89, respectively. Freundlich Kdes values were 2.56, 2.38, 3.33, and 6.78, respectively. Kocads were 88, 101, 104, and 133 and Kocdes values were 1119, 900, 725, and 478, respectively. The N values were 1.13, 1.06, 1.26, and 1.15 for adsorption and 1.15, 1.14, 1.32, 1.11 for desorption, respectively. The aged portion of the data requirement is fulfilled (163

- 1, MRID 42643603).

CGA

- 72903 (decarboxylated parent fluometuron) was very mobile in Sassafras sand (Maryland, 0.23 % OC), Hesperia sandy loam (California, 0.26 % OC), Sesquatchie sandy clay loam (Maryland, 0.45 % OC), and Sharkey clay (Mississippi, 1.40 % OC) soils with Freundlich Kads values of 0.23, 0.23, 0.30, and 2 .33, respectively. Freundlich Kdes values were <30, 6.77, <30, and 20.68, respectively. Kocads were 102, 87, 66, and 164 and Kocdes values were <13,100, 2559, <6536, and 1459, respectively. The N values were 1.28, 1.40, 1.65, and 1.21 for adsorption

and 1. 0 (assumed), 1.63, 1.0 (assumed), and 1.33 for desorption, respectively. The aged portion of the data requirement is fulfilled (163

- 1, MRID 42643602).

Terrestrial Field Dissipation (164

- 1 ); MRID 40459401, 40459402, 41931501, 5/9/88. The

calculated half

- li ves of fluometuron were 103 days in Georgia Lucy loamy sand (0.9 % OM) and 97 days in Veritas fine sandy loam (1.3 % OM). Even with below average rainfall, detectable levels of parent fluometuron and the primary degradate CGA

- 41686 reached 24 inches of dep th.

Bioaccumulation in Fish (165

- 4 ); MRID 42017304, reviewed on 9/14/87, and MRID 42413502. The calculated bioconcentration factors were 6.88x for edible, 861.5x for non

- edible, and 51.7x for whole fish. Dealkylated fluometuron and hydroxylated and conjug ated metabolites were present in fish.

Small

- Scale Retrospective (166

- 2); MRID 41931501, 10/2/91. Fluometuron and its main

metabolite CGA

- 41686 were repeatedly found in shallow ground water monitoring wells (<5 feet in depth), piezometers, and loamy sand/ sandy loam (maximum of 1.6 % OM) soil samples in North Carolina. Maximum concentrations of parent fluometuron were 99 ppb in ground water, 23 ppb in piezometers, and 19 ppb in soil (12

- 24 inch depth). Maximum concentrations of CGA

41686 were 34 ppb in grou nd water, 21 ppb in piezometers, and 21 ppb in soil (12

- 24 inch depth). In Mississippi, there were no detections in ground water above the detection limit of 0.1 ppb.

Fluometuron and its main metabolite CGA

- 41686 were found in lysimeters at low levels with maximum concentrations of 0.7 and 1.7 ppb, respectively. CGA

- 41686 was found in very fine sandy loam soil (0.8 % OM) down to the 24

- 36 inch soil depth at 13 ppb.Page 34 of 43Page 35 of 43 

# Appendi x D

. Summary of Fluometuron Ecotoxicity Data

Acute Toxicity of Fluometuron to Freshwater Fish

Species % ai 96

- hr LC 50 (95%CI) (mg a.i./L) Toxicity Category Comments MRID Study Classification

Bluegill sunfish ( Lepomis

macrochirus ) 97.2 >100 Practically

non

- toxic Uncertainties since precipitate at all test concentrations (12.5 to 100 mg a.i./L), nominal concentrations reported 161088 Supplemental (precipitate at all test concentrations)

97.2 48 (41, 57) slope = 5.7 Slightly

toxic Slight precipitate in mixing chamber, none in test aquaria, test

concentrations were

measured 42498002 Acceptable

96.2 42.5 Slightly

toxic Nominal concentrations 40098001 acceptable

80 (WP) 13.5 Slightly

toxic Nominal concentrations, precipitate at test concentration of 100 mg

a.i./L 40098001 Supplemental (end

- use

product, precipitate noted)

Rainbow trout ( Oncorhynchus mykiss ) 97.2 30 (26, 34) Slope = 10.0 Slightly

toxic Slight precipitate in mixing chamber and highest test concentration,

test concentrations were

measured 42498003 Acceptable

97.5 26 (19, 37) Slightly

toxic No precipitate noted 42505001 Acceptable

98.7 2.96 Moderately

toxic Nominal concentrations 40098001 Supplemental (raw data not found)

96.2 14.5 Slightly

toxic Nominal concentrations 40098001 Supplemental

80 (WP) 4.3 Moderately

toxic Nominal concentrations 40098001 Supplemental (end

- use product)

Fathead minnow ( Pimephales promelas ) 97.8 65 (49, 95)

Binomial

method Slightly

toxic Precipitate at highest test concentration; solutions were not centrifuged or filtered prior to chemical analysis 47607401 Supplemental (precipitate at highest

test concentration)

Channel catfish

Ictalurus

punctatus -- -- -- Water temperature at 18oC; 850.1075 guideline temp is 22 o ± 2.0 40098001 (invalid, water temp

below recommended)

96.2 22.5 Slightly

toxic Nominal concentrations 40098001 supplemental

80 (WP) 11.5 Slightly

toxic Nominal concentrations 40098001 Supplemental ( end

- use product , raw data not found)Page 36 of 43 Acute Toxicity of Fluometuron to Estuarine/Marine Fish Species/Static

or Flow

- through % ai LC 50 (mg a.i./L) Toxicity Category MRID Study Classification

Sheepshead minnow (Cyprinodon variegatus) 97.2 38 Slightly toxic 42498004 (Supplemental;

undissolved test material at all concentrations, analytical samples not centrifuged or filtered,

measured concentrations were 97 to 121% of nominal)

97.5 55.3 Slightly toxic 42505002 (Acceptable)

Acute Toxicity of Fluometuron to Freshwater Invertebrates Species % ai EC 50 (95% CI) (mg a.i./L) Toxicity Category Comments MRID Study

Classification Daphnid ( Daphnia

magna ) Tech 9.9 mg a.i./L (8.3, 11.9) Moderately

toxic Nominal concentrations;

48

- hr study 0024180 Acceptable

96.2 >1.0 Moderately

toxic Nominal concentrations; 1/10 mortalities at 1.0 mg a.i./L; 96

- hr study 40098001 supplemental

80 (WP) >1.0 Moderately

toxic Nominal concentrations; 3/10 mortalities at 1.0 mg a.i./L; 96

- hr study 40098001 Supplemental (end

- use product) Midge ( Chironomus plumosus ) 96.2 0.22 Highly toxic Nominal concentrations;

96

- hr study 40098001 Supplemental (not

recommended species)

80 (WP) >1.0 Moderately

toxic Nominal concentrations;

96

- hr study 40098001 Supplemental (not

recommended species, end

- use product)

Acute Toxicity of Fluometuron to Estuarine/Marine Invertebrates Species % ai. Toxicity Endpoint Toxicity Category MRID Study Classification Mysid ( Americamysis

bahia ) 97.5 LC 50 = 3.8 mg a.i./L Moderately

toxic 42568501 (Acceptable)

97.2 LC 50 = 6.8 mg a.i./L Moderately

toxic 42498006 (Acceptable)

Oyster Shell Deposition: Mollusk, Crassostrea virginica 97.2 IC 50 = 22 mg a.i./L Slightly toxic 42498005 (Supplemental, average control shell deposition less than 2 mm)

97.6 IC 50 = 6.53 mg a.i./L Moderately

toxic 43848101 (Acceptable)

-- -- -- 42560101 (Invalid; Low flow rate, lack of food, dissolved oxygen <60% throughout study)Page 37 of 43 Chronic Toxicity of Fluometuron to Aquatic Animals

Species % a.i. Endpoints (mg ai/L) Effects MRID (Study Classification)

Fathead minnow

( Pimephales promelas) 98.3% NOAEC = 3.1

LOAEC = 9.1 Reductions in growth (length and dry weight) 46565702 (Acceptable)

-- -- -- 18645 (Invalid, study

not conducted under Agency guidelines)

-- -- -- 18646 (Invalid, study

not conducted under Agency guidelines)

-- -- -- 19162 (Invalid, study

not conducted under Agency guidelines)

Water flea ( Daphnia magna ) 98.3% NOAEC = 1.73

LOAEC = 2.52 Reduced number of young per reproductive day. 46565701 and 47978401 (Acceptable)

Mysid ( Americamysis bahia) 98.4% NOAEC = 1.32

LOAEC = 2.68 Most sensitive endpoints:

F 0 Day 13 survival (before pairing) and F 0 male body lengths on Day 28 48080701 (Acceptable)

Acute Oral Toxicity of Fluometuron to Birds Species % ai LD 50 (95% confidence interval) (mg a.i./kg

- bwt) Toxicity Category Comments MRID Study

Classification

Mallard duck (Anas platyrhynchos) 80% TEP >2000 Practically non

toxic No mortalities, only 3 birds used. Toxic signs were ataxia, wing drop or cross over back, etc; persisted for a

week. 160000 Supplemental

Mallard duck (Anas platyrhynchos) Technical (purity not specified) 2974 (2060, 4269) Practically non

toxic 00019221 AcceptablePage 38 of 43 Subacute Dietary Toxicity of Fluometuron to Birds Species % ai 5

- Day LC 50 (95% confidence interval) (mg a.i./kg

- diet) Toxicity Category Comments MRID Study

Classification

Northern bobwhite quail (Colinus virginianus) 97.8 >5620 Practically

non

- toxic One mortality at 3160 mg a.i./kg

- diet. Sub

lethal toxic effects at ≥ 1000 mg a.i./kg

- diet (wing droop, lethargy, reduced weight gain) 42498001 Acceptable

97.5 >3474 Slightly

toxic One mortality at 3474 mg a.i./kg

- diet. 42597401 Acceptable Japanese quail ( Coturnix japonica ) Technical (purity not specified) 4620 (3250, 6550) Slightly

toxic Sublethal toxic effects included huddling, lethargy, and reduced weight gain. 00019222 Supplemental

Mallard duck Technical (purity not specified) 4500 (3400, 5960) Slightly

toxic Sublethal toxic effects included huddling, lethargy, and reduced weight gain. 00019222 Acceptable

Ring

- necked pheasant ( Phasianus

colchicus ) Technical (purity not specified) 3150 (1750, 5670) Slightly

toxic Sublethal toxic effects included huddling, lethargy, and reduced weight gain. 00019222 AcceptablePage 39 of 43 Chronic Toxicity of Fluometron to Birds

Species % A.I. Toxicity Endpoints Affected Endpoints MRID and Status

Bobwhite quail 98.7% NOAEC = 477 mg ai/kg diet LOAEC > 477 mg ai/kg diet No statistically significant reductions in endpoints at any test concentration. 47984401 Supplemental (concentrations in

diet were increased three

- fold five weeks into the study, from 14.7, 50. and 146 mg a.i./kg

- diet

to 43, 150, and 477 mg ai.i/kg

diet )

Bobwhite quail

--- --- --- 46565703 Invalid (non

- reproducing pairs

were removed data analysis)

Mallard duck 97.8% NOAEC: 60.4 mg ai/kg diet

LOAEC: 102 mg ai/kg diet At 102 mg a.i./kg

- diet (highest tested concentration), reduced number of eggs laid and reduced hatchling weight. 47896201 Acceptable

Acute Oral Toxicity of Fluometuron to Mammals Species % ai LD 50 (95% CI) (mg a.i./kg

- bw) Toxicity Category Comments MRID Study

Classification Laboratory

rat ( Rattus norvegicus ) 80% LD 50 between 1000 and 1500 mg a.i./kg

bw Slightly

toxic Female: 0% mortality at 1000 mg a.i./kg

- bw and 100% mortality at 1500 mg a.i./kg

- bw and above.

Male LD 50 = 3880 mg a.i./kg

- bwt (3020, 4980) 41216802 (Acceptable)

Laboratory

rat 80% LD 50 = 5223 (4111, 6636) Practically

non

- toxic Males and females

combined 40409302 (Acceptable) Laboratory

rat 80% LD 50 = 3949 (male)

LD 50 = 3209 (female) Practically

non

- toxic 00142844 (Acceptable)

Acute Inhalation Toxicity of Fluometuron to Mammals Species % ai LC 50 (mg a.i./L) HED Toxicity Category MRID Study Classification Laboratory rat 80% LC 50 > 0.6 III 40409304 (Acceptable) Laboratory rat 80% LC 50 > 2.25 III 41216804 (Acceptable) Laboratory rat 80% LC 50 > 6.16 III 00145431 (Acceptable)Page 40 of 43 Chronic Toxicity of Fluometuron to Mammals Species/

Guideline Toxicity

Value Affected Endpoints Study

Classification Laboratory rat Developmental Toxicity

870.3700 NOAEL = 10 mg/kg/day

LOAEL = 100 mg/kg/day Doses tested: 0, 10, 100, 1000 mg/kg/day from days 6 thru 15 of presumed gestation. Maternal NOAEL= 10 mg/kg; Maternal LOAEL= 100 mg/kg, based on the reduction of food consumption and on the increased darkened spleen. Developmental NOAEL= 10 mg/kg Developmental LOAEL= 100 mg/kg, based on an increased delayed urinary system development (shortened renal papillae). Females at 1000 mg/kg/day also ex hibited: reduced body weight, reduced viability, lethargy & salivation. Fetal abnormalities at 1000 mg/kg/day included reduced fetal weight, increased resorptions & postimplantation loss, and skeletal abnormalities. 00163710

42397601 (acceptable)

Rabbit

D evelopmental Toxicity

870.3700 NOAEL = 10 mg/kg/day

LOAEL = 100 mg/kg/day

NOAEC = 189 mg a.i./kg

- diet a LOAEC = 1890 mg a.i./kg

- diet Doses tested 0, 1, 10, 100 mg/kg on days 7

- 19 of gestation, inclusively. Maternal toxicity NOAEL= 10 mg/kg

Maternal toxici ty LOAEL= 100 mg/kg, based on

increased incidence of stool variations and abortions, reduced food consumption, decreased maternal body wt. gain. Developmental toxicity NOAEL= 100 mg/kg (HDT) No developmental toxicity was observed. 00163774

00147 55 4

42397602 (acceptable)

Laboratory rat.

2

- Generation Reproduction.

870.3800 NOAEL= 0.5 mg/kg (10 ppm) LOAEL= 15 mg/kg (300 ppm) Doses tested: 10, 300, 1000 ppm (0, 0.5, 15, 50 mg/kg) Systemic (Maternal &Paternal) NOAEL= 0.5 mg/kg (10 ppm) Systemic LOAEL= 15 mg/kg (300 ppm), based on spleen effects (extramedullary hematopoiesis, and

an increase in hemosiderin

- laden macrophages). Reproductive NOAEL= Study not rigorous enough

to base a conclusion on whether f luometuron has the potential to affect reproductiv e performance. RfD Committee concluded study is adequate for risk assessment purposes. (TXR 010710 b ) 00163773 (acceptable)

a NOAEC and LOAEC calculated as follows: Female rabbits in study ranged in weight from 3.045 to 4.491 kg; average of minimum and maximum weights was used to estimate food consumption (3.768 kg). Daily food consumption was estimated using the following allometric equation in USEPA (1993): kg

- diet/day = 0.067 * (rabbit wt, kg) 0.822 = 0.199 kg

- diet/day Daily consumption of fluometuron at NOAEL: NOAEL * bw = 10 mg ai./kg

- bw/day * 3.768 kg = 37.68 mg a.i./day

NOAEC = daily consumption of fluometuron at NOAEL / daily food consumption = 37.67 mg a.i./day / 0.199 kg

- diet /day = 189 mg a.i./kg

- diet

b Ghali, G. (1993). Fluometuron: RfD/Peer Review Report, dated December 9, 1993; TXR No. 010710Page 41 of 43 

### Acute Contact Toxicity of Fluometuron to Nontarget Insects

Species % ai LD 50 NOEC Toxicity Category MRID Study Classification Honey bee (Apis mellifera) NA LD 50 > 11 μg

a.i./bee 3.80 % mortality at 193.38 μg

a.i./bee Practically

non

- toxic 00006653 and 00028772 Acceptable

Toxicity of Fluometuron to Nontarget Terrestrial Plants (Seedling Emergence, Tier II) a

Species Plant Height Dry Weight Survival

NOAEC (lbs a.i./A) IC 25 (lbs a.i./A) NOAEC (lbs a.i./A) IC 25 (lbs a.i./A) NOAEC (lbs a.i./A) EC 25 (lbs a.i./A)

Monocot

Corn (Zea mays) 0.019 0.47 0.019 0.026 1.5 2.5

Onion (Allium cepa) 0.019 0.11 0.019 0.031 0.17 0.15

Ryegrass (Lolium perenne) 0.019 0.071 0.019 0.042 0.51 0.45

Oat ( Avena sativa ) 0.019 0.10 0.019 0.038 0.17 0.34

Dicot

Cucumber ( Cucumis sativus ) 0.019 0.046 0.0063 0.020 0.064 0.076

Cabbage (Brassica oleracea) 0.006 0.012 0.019 0.038 0.019 > 0.019

Lettuce (Lactuca sativa) 0.019 0.041 0.0021 0.006 0.019 0.031

Radish (Raphanus sativus) 0.057 0.010 0.019 0.045 0.11 0.21

Soybean (Glycine max) 0.17 0.24 0.019 0.069 1.5 >1.5

Tomato (Solanum lycopersicum) 0.019 0.090 0.019 0.033 0.17 0.16

a MRID 42718802. Test material was the technical, 97.2% a.i. Study classified as Supplemental

.Page 42 of 43 Toxicity of Fluometuron to Nontarget Terrestrial Plants (Vegetative Vigor, Tier II) a

Species Plant Height Dry Weight Survival

NOAEC (lbs a.i./A) EC 25 (lbs a.i./A) NOAEC (lbs a.i./A) EC 25 (lbs a.i./A) NOAEC (lbs a.i./A) EC 25 (lbs a.i./A)

Monocot

Corn (Zea mays) 0.057 0.29 0.057 0.086 0.51 1.3

Onion (Allium cepa) 0.019 0.10 0.019 0.056 0.51 0.43*

Ryegrass (Lolium perenne) 0.057 0.11 0.019 0.051 0.51 0.43*

Oat ( Avena sativa ) 0.019 0.078 0.019 0.035 0.17 0.12*

Dicot

Cucumber ( Cucumis sativus ) 0.019 0.087 0.0021 0.0088 0.057 0.10

Cabbage (Brassica oleracea) 0.019 0.065 0.0063 0.010 0.019 >0.019

Lettuce (Lactuca sativa) 0.0063 0.087 0.0063 0.014 0.0063 0.11

Radish (Raphanus sativus) 0.019 0.26 0.019 0.014 0.019 0.39

Soybean (Glycine max) 0.019 0.072 0.019 0.31 0.17 0.29

Tomato (Solanum lycopersicum) 0.019 0.086 0.019 0.026 0.17 0.12*

a MRID 42718803. Test material was the technical, 97.2% a.i. Study classified as Supplemental

. * Estimated EC 25 endpoint was less than the NOAEC. Reviewer did not re

- calculate as survival was not the most sensitive endpoint.Page 43 of 43 Toxicity of Fluometuron to Aquatic Plants

Species % a.i. Endpoint (mg ai/L) Effects MRID (Study Classification)

Duckweed ( Lemna gibba ) 97.5 IC 50 = 0.59

NOAEC not

determined Frond number was measured endpoint (14

- day test) 42564102 (supplemental, solvent effect, no definitive NOAEC)

96.4 IC 50 = 0.22

NOAEC = 0.115 Frond number was measured endpoint (14

- day test) 43421601 (supplemental,

fewer than recommended initial number of fronds)

Green algae ( Selenastrum capricornatum ) 97.5 IC 50 = 0.306

NOAEC = 0.180 Cell density was measured endpoint

(120 hour test) 43025601 ( supplemental,

solvent effect )

97.2 IC 50 = 0.030

NOAEC < 0.007

IC 05 = 0.0016 Cell density was measured endpoint

(120 hour test) 42498007 (supplemental, no definitive NOAEC)

Freshwater

diatom, Nitzschia palea 97.5 IC 50 = 0.312

NOAEC = 0.107 Cell density was measured endpoint

(120 hour test) 42568502 (acceptable)

Marine diatom,

Skeletonema

costatum 93.4 IC 50 = 0. 62

NOAEC = 0. 41 Cell density was measured endpoint (96 hour test) 42564101 ( supplemental,

solvent effect )

Cyanobacteria

, Anabaena flos

aquae 97.5 IC 50 = 0.29

NOAEC = 0.22 Cell density was measured endpoint

(120 hour test) 42568503 * ( supplemental,

solvent effect )

97.5 IC 50 = 0.13

NOAEC = 0.07 Cell density was measured endpoint

(120 hour test) 43421602 ( acceptable )

* Please refer to the DER for MRID 42568503. Same study also submitted to the Agency and reviewed as MRID 42564103; however, the DER for MRID 42564103 contains errors.