UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON. D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Date: April 28, 20 15 

PC Code: 028201 

MEMORANDUM DP Barcode: D424442 

SUBJECT: 

FROM: 

THROUGH: 

Registration Review: Preliminary Problem Formulation for Environmental Fate, 

Ecological Ri?k, Endangered Species, and Drinking Water Exposure Assessments 

for Propanil 

Ryan Mroz, Biologist 

He Zhong, Ph.D., Biologist 

Environmental Risk Branch l 

Environmental Fate and Effects Division (7507P) ~ 

;.--J.0\_c~~ Sujatha Sankula, Ph.D., Branch Chief / --\ <~ 

Environmental Risk Branch I 

Environmental Fate and Effects Division (7507P) 

TO: Joel Wolf, Chemical Review Manager 

Dana Friedman, Acting Team Leader 

Kevin Costello, Branch Chief 

Risk Management and Implementation Branch II 

Pesticide Re-Evaluation Division (7508P) 
Contents

1. Executive Summary ............................................................................................................. 3

2. Introduction .......................................................................................................................... 4

3. Use Characterization ............................................................................................................ 4

4. Conclusions from Previous Risk Assessments..................................................................... 6

 a. Ecological Risk Assessment................................................................................................. 6

b. Drinking Water Exposure Assessments.................................................................................7

c. Clean Water Act Programs....................................................................................................7

5. Environmental Fate and Transport....................................................................................... 8

a. Environmental Fate................................................................................................................8

b. Environmental Transport Mechanisms..................................................................................8

6. Receptors............................................................................................................................ 11

a. Effects to Aquatic Organisms..............................................................................................11

b. Effects to Terrestrial Organisms..........................................................................................13

c. Degradates............................................................................................................................16

d. Ecological Incidents.............................................................................................................17

7. Exposure Pathways of Concern.......................................................................................... 18

8. Analysis Plan...................................................................................................................... 18

a. Stressors of Concern ............................................................................................................18

b. Measures of Exposure..........................................................................................................19

c. Measures of Effect ...............................................................................................................20

9. Endangered Species Assessments ...................................................................................... 20

10. Endocrine Disruptor Screening Program............................................................................ 21

11. Preliminary Identification of Data Gaps............................................................................. 21

a. Environmental Fate..............................................................................................................21

b. Ecological Effects................................................................................................................22

12. References.......................................................................................................................... 40

Appendix 1. Propanil Uses and Application Rates....................................................................45

Appendix 2. Previous Actions and Uses of Propanil.................................................................46

Appendix 3. Screening Level Models to Evaluate Potential Importance of Drinking Water and 

Inhalation Exposure Pathways....................................................................................................47

Appendix 4. ECOSAR Output for Propanil and 3,4-DCA........................................................48

2
1. Executive Summary

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

the ecological risk, environmental fate, endangered species, and drinking water assessments to be 

conducted as part of the registration review of propanil. The problem formulation describes the 

methods planned to be used during the completion of the drinking water and ecological risk 

assessments in support of registration review and provides an overview of the environmental fate, 

ecological effects, and potential risks associated with the use of propanil as well as uncertainties

unique to the risk assessment of propanil. This document also identifies additional studies with 

both the parent propanil and/or its major degradate that would be beneficial for conducting an 

ecological risk assessment. Major findings include:

• Propanil has one major degradate of concern; 3,4-DCA. This degradate is also shared 

with two other chemicals, linuron (PC code 035506) and diuron (PC Code 035505), 

although it is formed at a much lower percentage for linuron/diuron. Ecotoxicity and 

environmental fate data gaps for both propanil and 3,4-DCA are included below.

• The following environmental fate data gaps were identified: 

• 835.4100 - An aerobic soil metabolism for parent propanil (TGAI), and 3,4-DCA

• 835.4300 - An aerobic aquatic metabolism study for degradate 3,4-DCA 

• 835.4400 - An anaerobic aquatic metabolism study for degradate 3,4-DCA 

• 850.6100 - ECM/ILVs (water) for both propanil (TGAI) and 3,4-DCA

• The following ecotoxicity data gaps were identified for the parent propanil (see Section 11

for details): 

• 850.2100 – Avian acute oral toxicity with a passerine species (TGAI) 

• Special study (OECD 213) - Acute oral toxicity to adult honey bees (TGAI)

• Special study - Chronic oral toxicity to adult honey bees (TGAI)

• Special study - Chronic oral toxicity to larval honey bees including acute endpoints 

(TGAI)

• Non-Guideline: Residue in pollen and nectar (recommendation pending risks 

identified in Tier I studies) (TEP)

• Non-Guideline: Semi-field testing for pollinators (tunnel and feeding studies) 

(recommendation pending risks identified in Tier I studies) (TEP)

• Guideline 850.3040: Full-field testing for pollinators (recommendation pending 

risk identified in Tier II studies) (TEP)

• The following ecotoxicity data gaps and were identified for the degradate 3,4-DCA (see 

Section 11 for details): 

• 850.2200 – Avian subacute dietary toxicity - bobwhite quail 

• 850.4100 – Seedling emergence (Tier 1) 

• 850.4150 – Vegetative vigor (Tier 1) 

• All labels provide information on the maximum rate (in terms of lb ai/A) per season 

instead of an annual rate. EFED will proceed under the assumption rice is only grown 

once per year in the US as outlined in Appendix 1.

3
2. Introduction

Propanil is a selective post-emergence, contact (requires adequate foliar coverage for good weed 

control), non-residual, broad-spectrum amide herbicide with activity on both broadleaf and grass 

weeds (important target weed is barnyard grass). The mechanism of action of this herbicide is not 

completely understood. Propanil seems to interfere with electron transport in photosystem II of 

photosynthesis. Other reported effects of propanil on susceptible plants include inhibition of 

anthocyanin synthesis, RNA, and protein as well as adverse effects on the plasma membrane. 

Propanil is rapidly absorbed by the foliage. There is limited translocation from treated foliage to 

other areas of the plant. Propanil is most effective when susceptible grasses and broad leaf weeds 

are small and growing actively under favorable soil moisture and weather conditions (USEPA

2014a). 

Propanil was first registered in the United States in 1973 for use as an herbicide in rice. Propanil 

inhibits photosynthesis in a variety of broadleaf and grass plants and kills susceptible weeds by 

direct contact thorough spray coverage. The proper stage of growth for applications is 1-to-3-leaf 

stage (weeds). Application of propanil to susceptible weeds causes foliar desiccation and necrosis 

which can be observed within several days after the herbicide application (Herbicide Handbook, 

2014).

The average number of pounds of propanil applied to rice paddies is 5,300,000 (data from 2004 

through 2012). Average and maximum percent crop treated are 45% and 55%, respectively

(USEPA 2014b).

3. Use Characterization

Propanil is currently only used for the control of weeds in rice paddies. The maximum single 

application rate for rice paddies is 6 lb ai/A with a maximum seasonal rate (assumed 1 per year)

of 8 lb ai/A/season (Appendix 1). Propanil is typically applied as a broadcast treatment with 

ground boom sprayers and aerial equipment during the post-emergent phase (March through 

May) and requires an average temperature of 70oF to be effective (USEPA 2003). 

Propanil currently has 41 active Section 3 registrations. Six registrations are technical products 

and 35 are end-use products formulated as emulsifiable concentrate liquid, water dispersible 

granule (dry flowable), soluble concentrate liquid, and flowable concentrate liquid (USEPA 

2014a). In addition to propanil-only products, propanil is also formulated with other several 

other active ingredients (Table 3.1). 

Table 3.1. Other Registration Products Formulated with Propanil

Registration 

Number Product Status Other Active 

Ingredient

71085-9 DUET HERBICIDE Conditionally Registered 

(20-Feb-1996) Bensulfuron-methyl

4
71085-16 DUET DF RICE 

HERBICIDE

Conditionally Registered 

(21-Sep-2000)

71085-23 DUET 60DF Conditionally Registered 

(08-Sep-2003)

71085-25 RICEMAX Conditionally Registered 

(20-Dec-2006) Clomazone

71085-31 RICEEDGE Conditionally Registered 

(01-Apr-2010)

Halosulfuron-methyl

71085-32 RICEEDGE 60 DF Registered (01-Dec-2010)

5905-495 SETRE PROWL 

HERBICIDE + PROPANIL

Conditionally Registered 

(06-Mar-1986) Pendimethalin

71085-26 RICEPRO Registered (13-Mar-2007) Quinclorac

71085-30 RICEBEAUX Registered (10-Apr-2008) Thiobencarb

71085-29 RICEPYR Conditionally Registered 

(23-Aug-2007)

Triclopyr, 

triethylamine salt

The chemical profile produced by BEAD, located in the docket, lists the use patterns for the 

current uses of propanil.

For propanil, a few label issues were identified. Appendix 1 has more details on missing 

information and assumptions which may be made in the absence of information:

• Seasonal, rather than yearly, application information is provided, and a minimum retreatment interval is missing for most of the uses. The number of applications and the 

maximum application rate should be reported on an annual basis. In the absence of yearly 

information, EFED will assume one crop season per year when performing the risk 

assessment. 

• The Propanil RED lists a maximum seasonal application rate of 8 lbs. ai/A per season 

(from two 4 lbs. ai/A applications) or a single 6 lb ai/A emergency treatment; however, 

this is not explicit on the labels. The labels should clarify if a single application at 6 lb 

ai/A is the only allowable application that year. If multiple applications are to be made the 

interval between those applications should be specified on the label. EFED may assume 

multiple applications made up to the maximum allowable annual rate, i.e. 2 applications at 

4 lb ai/A, 2 applications with one at 6 lb ai/A, and one at 2 lb ai/A, etc in modeling 

scenarios.

5
4. Conclusions from Previous Risk Assessments

a. Ecological Risk Assessment

The Agency has conducted several ecological risk assessments (Appendix 2) on propanil that 

serve as a basis for this problem formulation, including a Reregistration Eligibility Decision 

(RED) (USEPA 2001 D275423, USEPA 2003, Docket: EPA-HQ-OPP-2003-0348-0002, and 

USEPA 2006, Amendment Docket: EPA-HQ-OPP-2003-0348-0024) and a California red-legged 

frog (CRLF) endangered species assessment (USEPA 2009). The RED was completed in 2003 

and amended in 2006 for usage on rice, turf, and small grains and the CRLF assessment was 

completed in 2009 for propanil use on rice. The registrations for small grains have been 

voluntarily canceled and the registration for turf was canceled due to non-payment of 

maintenance fees. 

The assessments identified the following potential direct risk concerns from the rice use:

• acute risk to birds (including endangered species); 

• acute and chronic risk to mammals (including endangered species); 

• risk to non-target aquatic nonvascular plants; and 

• risk to non-target terrestrial plants.

Based on the RED the following EFED relevant mitigations were implemented:

• A 7-day water holding (discharge) interval for the Mississippi Delta (Arkansas, 

Mississippi, Missouri and Northern Louisiana) and California was established to address 

concerns for both endangered and non-endangered aquatic species. 

• Spray drift management practices were made consistent with best management practices 

for rice. Likewise, all labels with use directions on rice were amended to specify 

restrictions against application to fields where catfish farming is practiced and draining 

water from treated fields into areas where catfish farming is practiced. 

Data gaps for propanil and/or the degradate 3,4 dichloroaniline (3,4-DCA) from the 2003/2006 

RED and their status are below:

Table 4.1. Guideline Studies Requested and Their Status for Propanil and 3,4-DCA

Guideline Study Substance Status DP Barcode(s)

850.1010 Freshwater Invertebrate Acute 

Toxicity 3,4-DCA Waived -12/9/2011

339060, 339061, 339063, 

339065, 339069

850.1035 Mysid Acute Toxicity 3,4-DCA Waived -

12/9/2011

339060, 339061, 339063, 

339065, 339069

850.1075 Freshwater and Estuarine/Marine 

Fish Acute Toxicity 3,4-DCA Waived -12/9/2011

339060, 339061, 339063, 

339065, 339069

850.1300 Early-Life Stage in Freshwater and 

Estuarine/Marine Fish 3,4-DCA Waived -

12/9/2011

339060, 339061, 339063, 

339065, 339069

850.1350 Life Cycle in Freshwater and 

Estuarine/Marine Invertebrates 3,4-DCA Waived -12/9/2011

339060, 339061, 339063, 

339065, 339069

850.2200 Avian Subacute Dietary Toxicity 

(bobwhite quail) 3,4-DCA Waiver denied -12/9/2011

339060, 339061, 339063, 

339065, 339069

850.2300 Avian Reproduction (bobwhite 

quail) Propanil Data received -Acceptable study 382979

850.2300 Avian Reproduction (bobwhite 

quail) 3,4-DCA Waived -12/9/2011

339060, 339061, 339063, 

339065, 339069

6
850.2300 Avian Reproduction (mallard 

duck) Propanil Data received -Acceptable study 405966, 387605

850.2300 Avian Reproduction (mallard 

duck) 3,4-DCA Waived -12/9/2011

339060, 339061, 339063, 

339065, 339069

850.4100 Seedling Emergence (Tier 1) 3,4-DCA Waiver denied -

12/9/2011

339060, 339061, 339063, 

339065, 339069

850.4150 Vegetative Vigor (Tier 1) 3,4-DCA Waiver denied -

12/9/2011

339060, 339061, 339063, 

339065, 339069

850.4150 Vegetative Vigor (Tier 2) Propanil Data received -

Acceptable study 343057

b. Drinking Water Exposure Assessments

The most recent drinking water assessment for propanil and its major degradate 3,4-DCA was 

conducted to support the Reregistration Eligibility Decision (RED) for the propanil uses in three 

rice growing regions (USEPA 2001; D275423). Table 4.2 lists the estimated drinking water 

concentrations (EDWC) in surface water sources for propanil and 3,4-DCA .

Table 4.2. Estimated Drinking Water Concentrations (EDWC) (ppb) of Propanil and 3,4-

DCA in Surface Water from Two Applications to Three Different Rice-Growing Scenarios.

Propanil (μg/L) 3,4-DCA (μg/L)

Scenario Acute (peak) Chronic Acute (peak) Chronic 

California 0.7 0.02 106 6.2

Gulf Coast 236 5.9 1007 59

Mississippi Valley 

(flooded release; day 21)1

489 12.2 1022 60

Mississippi Valley 

(normal release; day 78)

0.65 0.02 118 6.9

1 The peak concentration represents pre-mature release of the paddy water due to rainfall. 

In addition, EFED reported the peak EDWCs of propanil and 3,4-DCA by SCIGROW modeling 

in ground water sources as 0.001 μg/L and 0.35 μg/L, respectively. 

c. Clean Water Act Programs

Propanil is not identified as a cause of impairment for any water bodies listed as impaired under 

section 303(d) of the Clean Water Act1. No Total Maximum Daily Load (TMDL) criteria have 

been developed for propanil. Aquatic benchmarks have been established for propanil and are 

available at http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm. Any data 

submitted or otherwise located as part of the registration review process may be used to update 

aquatic life benchmarks, if applicable. 

1 http://water.epa.gov/lawsregs/lawsguidance/cwa/tmdl/

7

 
5. Environmental Fate and Transport

a. Environmental Fate

Propanil is stable to both hydrolysis, and aqueous photolysis. While degradation by soil 

photolysis is reported (MRID 42820401; t1/2 = 11 days), it appears to be microbially mediated. 

Aerobic aquatic (MRID 41848701) and soil (MRID 41538701) metabolisms of the parent 

propanil are rapid (t1/2 =2 days and t1/2 =0.5 days, respectively). Anaerobic soil and aquatic 

metabolism (t1/2 =2 - 3 days) are also rapid (MRID 41872601). The aerobic and anaerobic 

aquatic metabolism of propanil are the important routes of degradation for the rice use pattern.

Propanil is considered moderately mobile in the environment (Kd= 0.54 – 11.7, MRID 

42780401), and has limited potential to leach to groundwater. Vapor pressure is low enough 

(9.08 X 10-7 mm Hg) to preclude volatilization as a major route of dissipation for propanil in the 

open environment. 

The major degradate of propanil is 3,4-DCA, which is formed at 76%, 78% and 65% in the 

aerobic aquatic metabolism (MRID 41848701), anaerobic aquatic metabolism (MRID 41872601) 

and aerobic soil metabolism (MRID 41538701) studies, respectively. 3,4-DCA is also a minor 

degradate for other chemicals such as diuron and linuron. The minor degradates (< 2%) include

3,4-dichloronitrobenzene, and 3,3’,4,4’-tetra chloroazobenzene. A separate batch equilibrium 

study (MRID 47165602) reports that 3,4-DCA is less mobile (Kd = 1.38 – 32.8) than the parent 

propanil.

In aquatic field dissipation studies conducted in Arkansas clay loam (MRID 42200401) and 

Louisiana loam soils (MRID 42200501), propanil dissipated with half-lives of 1.5 and 1.3 days, 

respectively. The major degradate, 3,4-DCA, dissipated in the same plots with half-lives of 9.5 

and 11.6 days, respectively. These studies were conducted in paddies with aqueous outflow 

where each paddy was separated by a bank of earth used as a barrier between them (berms), and 

thus may be compared qualitatively to laboratory studies.

b. Environmental Transport Mechanisms

AIR

Propanil is applied by broadcast directly to the foliage in the paddy using ground or aerial 

equipment, suggesting that there is a possibility of drift. Propanil is relatively non-volatile, as 

indicated by its low vapor pressure of 9.08 X 10-7 mm Hg, and a low Henry’s law constant of 4.5 

x 10-9 atm m3 mol-1. These properties indicate that propanil is unlikely to be dispersed in air over 

a large area, and has a low tendency to volatilize from water or moist soils. Volatilization is 

insignificant except when propanil is exposed on the soil surface for several days or weeks under 

hot, dry conditions (Hess and Warren, 2002). However, its major degradate, 3,4-DCA, is a semivolatile compound, as indicated by the vapor pressure of 6.32 E-3 mmHg @ 25°C and Henry’s 

law constant of 1.46E-5 atm-m3/mol (Table 5.2). 3,4-DCA has the tendency to volatilize from 

the water or soils and disperse to a wide-area through the re-settlement. 

WATER

8
Propanil is applied directly to water to control the weeds in the rice paddy and exposure in water 

is expected. Monitoring data indicate that both propanil and its degradate 3,4-DCA are frequently 

detected in rice paddy and receiving waters from overflow of the paddy water. 

SOIL

Soil runoff to terrestrial habitats does not appear to be a major route of transportation for parent 

propanil based on the short half-lives of aerobic aquatic metabolism (t1/2 = 2 days, MRID 

41848701) and soil metabolism (t1/2 = 0.5 days, MRID 41538701). The most likely transportation 

route to terrestrial plants and animals is via spray drift. As a result, the only propanil residues on 

soils outside the rice paddy are expected to occur from spray drift during application. However, 

soil runoff to terrestrial habitats may be a major route of transportation for the major degradate 

3,4-DCA, which is formed 76% in aerobic aquatic metabolism (MRID 41848701), 78% in

anaerobic aquatic metabolism (MRID 41872601) and 65% in aerobic soil metabolism (MRID 

41538701). Therefore, aquatic metabolism studies are recommended to clarify the transportation 

pathway. 

Physical/chemical property and fate data for propanil and 3,4-DCA are presented in Tables 5-1 

and 5-2. 

Table 5-1 Summary of Physical/Chemical and Environmental Fate and Transport 

Properties of Propanil.

Parameter Value(s) (units) Source Comment

Chemical Name Propanil (3,4-dichloropropionanilide)

SMILES CCC(=O)NC1=CC(Cl)=C(Cl)C=C1

Structure

Molecular Formula C9H9Cl2N1O1 EPI Suite (v4.11)

Molecular Weight 218.08 EPI Suite (v4.11)

Log Kow 3.07 EPI Suite (v4.11)

Aqueous Solubility (25o C) 152 mg/L EPI Suite (v4.11)

Vapor Pressure (25o C) 9.08 X 10-7 mm Hg EPI Suite (v4.11)

Henry’s Law constant 4.5 x 10-9 atm m3 mol-1

EPI Suite (v4.11)

Hydrolysis Half-life t1/2 = stable MRID 41066601

MRID 00111395

Stable at 30 days 

(pH 5, 7, 9)

9
Parameter Value(s) (units) Source Comment

Aqueous Photolysis Halflife t1/2 = 103 days 

(12-h light / 12-h dark)

t1/2 = 61 days 

(Continuous Irradiation)

MRID 41070701

MRID 47165603

Stable for 30 days

Soil Photolysis Half-life t1/2 = 11 days MRID 42820401 t1/2 = 2 days in dark control

Aerobic Soil Metabolism 

Half-life

t1/2 = 0.5 days MRID 41538701 Only sandy loam soil tested,

Degradate 3,4-DCA (44%),

Bound material 65% at 360 

days

Anaerobic Aquatic 

Metabolism 

t1/2 = 2-3 days MRID 41872601 3,4-DCA formed 78% at 14 

days 

Aerobic Aquatic 

Metabolism 

t1/2 = 2 days (parent only) MRID 41848701 3,4-DCA reached 76% at 7 

days and 72% at 30 days. 

Organic Carbon Partition

Coefficient (KOC) mL/g

306; 239; 703; 800; and 

389 

MRID 42780401

Soil Partition Coefficient 

(Kd) mL/g

0.54; 2.3; 5.8; 8.0; and 11.7 MRID 42780401 

Aquatic Field Dissipation t1/2 = 1.5 days (soil)

t1/2 = 1.3 days (soil)

MRID 42200401

MRID 42200501

Table 5-2 Physical-Chemical and Fate Properties of 3,4-dichloroaniline (3,4-DCA)

Property Value Source Comment

Chemical Name 3,4-DCA (3,4-

dichloroaniline)

SMILES NC1=CC(Cl)=C(Cl)C=C1

Structure

Molecular formula C6H5Cl2N

Molecular weight (g/mol) 162.02 EPI Suite (v4.11)

Log Kow 2.69 EPI Suite (v4.11)

Aqueous solubility 92 mg/L @ 20°C EPI Suite (v4.11)

Vapor Pressure 6.32 E-3 mmHg @ 25°C EPI Suite (v4.11)

Henry’s Law Constant 1.46E-5 atm-m3/mol EPI Suite (v4.11)

10
Hydrolysis

(5 day test at pH 4 ,7, and 

9 and temperature 50oC)

Stable MRID 47165601

Aerobic Soil Metabolism 

Half-life

t1/2 = 30 days MRID 41538701

Organic Carbon Partition 

Coefficient (Koc)

1,182; 488; and 883 MRID 47165602

Soil Partition Coefficient 

(Kd) mL/g

35.2; 1.4; and 3.0 MRID 47165602

Aquatic Field Dissipation t1/2 = 9.5 days (soil)

t1/2 = 11.6 days (soil)

MRID 42200401

MRID 42200501

6. Receptors

Table 6.1 and 6.2 provide a summary of the aquatic and terrestrial taxonomic groups, 

respectively, and the most sensitive surrogate species tested to characterize the potential acute and 

chronic ecological effects of propanil. All endpoints are based on TGAI test substance unless 

otherwise indicated. In general, propanil is moderately toxic to fish and aquatic invertebrates, 

with the exception of being highly toxic to the saltwater mysid. Propanil is moderately toxic to 

birds on an acute oral toxicity basis, and slightly toxic or practically non-toxic to birds on an acute 

dietary basis depending on the species. Aquatic groups have different sensitivities to propanil.

The most sensitive freshwater invertebrate (daphind) is less sensitive to propanil than the most 

sensitive estuarine/marine invertebrate (mysid) while conversely the estuarine/marine fish 

(sheepshead minnow) is less sensitive than the most sensitive freshwater fish (trout). No chronic 

data are available for estuarine/marine fish or invertebrates; however acute to chronic ratios can 

be calculated based on available endpoints to estimate chronic toxicity for these taxa. Honeybee 

data suggest propanil is practically non-toxic to adults on a contact basis, but based on the recent 

Agency’s Pollinator Guidance (USEPA 2014c) additional data is required to assess risks to bees.

a. Effects to Aquatic Organisms

Table 6.1. Summary of the Most Sensitive Endpoints from Aquatic Toxicity Studies for 

Propanil

Taxonomic 

Group

Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification

Freshwater fish1 Acute

Rainbow Trout

(Oncorhynchus

mykiss)

LC50 = 2300 μg ai/L

Sub-lethal effects: 

lethargy, loss of 

equilibrium, dark 

pigmentation

Moderately 

toxic

Acc. 246087 

Acceptable

11
Taxonomic 

Group

Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification

Acute

Fathead Minnow

(Pimephales 

promelas)

LC50 = 8600 μg ai/L

Sub-lethal effects: not 

reported

Moderately 

toxic

Acc. 126344 

Acceptable

Chronic (Early 

Life-Stage)

Fathead Minnow

(Pimephales 

promelas)

NOAEC = 19.0 μg ai/L

LOAEC = 34.0 μg ai/L

Based on hatch/post 

hatch survival

--

41776501

(original 

submission)

42259601

(additional 

data)

Acceptable

Chronic (LifeCycle)

Fathead Minnow

(Pimephales 

promelas)

NOAEC = 9.1 μg ai/L

LOAEC = 21.0 μg ai/L

Based on male length 

and 30 day 

weight/length

--

42475301

Acceptable

Freshwater 

invertebrates

Acute Water Flea 

(Daphnia magna) LC50 = 6700 μg ai/L Moderately 

toxic

Acc. 249347

Acceptable

Acute

44% Propanil 

formulation

Water Flea 

(Daphnia magna)

EC50 = 530 μg ai/L

Sub-lethal effects: 

Erratic movement, 

Quiescence, Loss of 

equilibrium.

Moderately 

toxic

41776801

Acceptable

Chronic Water Flea 

(Daphnia magna)

28-d NOAEC = 86 μg 

ai/L

LOAEC = 160 μg ai/L

Based on number of 

offspring and survival

--

41776601

42145600 

(resubmission 

with raw data 

for upgrade)

Acceptable

Estuarine/marine 

fish Acute

Sheepshead Minnow 

(Cyprinodon 

variegatus)

LC50 = 4600 μg ai/L

Sub-lethal effects: 

lethargy, loss of 

equilibrium

Moderately 

toxic

41776001

Acceptable

Estuarine/marine 

invertebrates Acute

Eastern Oyster 

(Crassostrea 

virginica)

EC50 = 4960 μg ai/L

Based on shell 

deposition

Moderately 

toxic

41777101

Acceptable

12
Taxonomic 

Group

Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification

Acute

Mysid Shrimp 

(Americamysis 

bahia)

LC50 = 400 μg ai/L

Sub-lethal effects: 

lethargy

Highly toxic

41776901

Acceptable

Aquatic plants 

and algae

Vascular Duckweed 

(Lemna gibba)

NOAEC = 20 μg ai/L

EC50 = 110 μg ai/L

Based on frond number 

--

41777201 

Acceptable 

Non-vascular

Freshwater Diatom

(Navicula 

pelliculosa)

NOAEC = 6.3 μg ai/L

EC50 = 16.0 μg ai/L

Based on cell density

--

41777501

Acceptable

Marine Diatom

(Skeletonema 

costatum)

NOAEC = 1.18 μg ai/L

EC50 = 1.5 μg ai/L

Based on number of 

cells

-- 41777401

Acceptable

Green algae

(Raphidocelis 

subcapitata)

NOAEC = 6.0 μg ai/L

EC50 = 29.0 μg ai/L

Based on cell density

--

41777301

Acceptable

Cyanobacteria

Cyanobacteria

(Anabaena flosaquae)

NOAEC = 25 μg ai/L

EC50 = 111 μg ai/L

Based on cell density

--

41776701

Acceptable

1 Freshwater fish are surrogates for aquatic-phase amphibians.

b. Effects to Terrestrial Organisms

Table 6.2. Summary of the Most Sensitive Endpoints from Terrestrial Toxicity Studies for Propanil

Taxonomic 

Group

Study Type Surrogate Species Toxicity Value

(all units in terms of ai)

Acute

Toxicity 

Classification

Source and 

Classification

Birds Acute oral 

Bobwhite quail

(Colinus 

virginianus)

LD50 = 201 mg ai/kg-bw

NOAEC = 62.5 mg ai/kgbw

Sublethal effects: Weight 

loss, reduced food 

consumption

Moderately 

toxic

41361001

Acceptable

13
Taxonomic 

Group

Study Type Surrogate Species Toxicity Value

(all units in terms of ai)

Acute

Toxicity 

Classification

Source and 

Classification

Acute dietary

Bobwhite quail

(Colinus 

virginianus)

LC50 = 2861 mg ai/kgdiet

NOAEC = 1000 mg 

ai/kg-diet

NOAEC is based on 

reduced body weight in 

all treatment groups tested

Slightly toxic

41361101

Acceptable

Acute dietary

Mallard duck

(Anas 

platyrhynchos)

LC50 = 5627 mg ai/kgdiet (based on nominal 

concentration)

NOAEC < 562 mg ai/kgdiet

NOAEC is based on 

reduced body weight in 

all treatment groups tested

Practically nontoxic

41360701

Acceptable

Chronic 

reproduction

Bobwhite quail

(Colinus 

virginianus)

NOAEC = 247 mg ai/kgdiet

LOAEC = 495 mg ai/kgdiet

Endpoints(s) affected: 

Visually determined –

adult mortality and gross 

necropsy. Statistically 

determined – adult female 

weight gain, adult food 

consumption, eggs laid, 

and egg shell thickness

--

48235101

Acceptable

Chronic 

reproduction

Mallard duck

(Anas 

platyrhynchos)

NOAEC = 46 mg ai/kgdiet

LOAEC = 116 mg ai/kgdiet

Based on adult male and 

female weight gain

--

48327201

Acceptable

Mammals Acute oral

Laboratory rat

(Rattus norvegicus)

LD50 = 1080 mg ai/kg-bw

No sublethal effects

Slightly toxic 41360801

Acceptable

14
Taxonomic 

Group

Study Type Surrogate Species Toxicity Value

(all units in terms of ai)

Acute

Toxicity 

Classification

Source and 

Classification

Chronic 

Reproduction

Laboratory rat

(Rattus norvegicus)

NOAEL = 150 mg ai/kgdiet

LOAEC = 600 mg ai/kgdiet

Based on delayed sexual 

maturation in F1 males 

and females, organ weight 

alterations in F2 

weanlings and decreased 

pup weight

-- 44604301

Acceptable

Terrestrial 

insects

Acute 

contact 

Honeybee

(Apis mellifera)

LD50 > 24.17 μg ai/bee

No effects reported

Practically nontoxic

00009181

Acceptable 

Terrestrial 

plants

Vegetative 

vigor

(60% 

propanil 

formulation)

Monocot

Onion (Allium 

cepa), oat (Avena 

sativa), rice (Oryza 

sativa), ryegrass 

(Lolium perenne) 

Dicot

Oilseed rape 

(Brassica napus), 

cabbage (Brassica 

oleracea), pea 

(Pisum sativum), 

carrot (Daucus 

carota), cucumber 

(Cucumis sativus), 

cotton (Gossypium 

hirsutum)

Monocot (onion)

EC25 = 0.13 lb ai/A

NOAEC = 0.03 lb ai/A

Based on reduction in 

fresh weight of onion.

Dicot (cabbage)

EC25 = 0.09 lb ai/A

NOAEC = 0.03 lb ai/A

Based on reduction in 

fresh weight of cabbage. 

Phytotoxic effects in all 

species with the exception 

of the control plants, 

ryegrass, and cotton. The 

observed injuries were not 

recorded.

--

47144702

Acceptable

15
Taxonomic 

Group

Study Type Surrogate Species Toxicity Value

(all units in terms of ai)

Acute

Toxicity 

Classification

Source and 

Classification

Seedling 

emergence

Monocot

Onion (Allium 

cepa), corn (Zea 

mays), ryegrass 

(Lolium perenne), 

oat (Avena sativa)

Dicot

Cucumber 

(Cucumis sativus), 

cabbage (Brassica 

oleracea), soybean 

(Glycine max), 

lettuce (Lactuca 

sativa), tomato 

(Lycopersicum 

esculentum), radish 

(Raphanus sativus)

Monocot (onion)

EC25 = 1.4 lb ai/A

NOAEC = 0.61 lb ai/A

Based on reduction in 

shoot length. 

Dicot (lettuce)

EC25 = 0.54 lb ai/A

NOAEC = 0.11 lb ai/A

Based on reduction in 

shoot length. 

Phytotoxic effects in all 

species included 

chlorosis, necrosis, leaf 

wilt, and leaf-tip burn 

--

43069901

Acceptable

c. Degradates

Propanil has one degradate (3,4-DCA) of concern. Available data indicate that 3,4-DCA is also a 

metabolite of two other chemicals, linuron and diuron, but it forms (<1%) to a much lesser 

extent. Based on conclusions from the RED and amended RED (USEPA 2003, USEPA 2006) 

that 3,4-DCA may pose a risk to non-target organisms, and with limited supplemental 

information, a DCI for Agency guideline studies was issued to address the toxicity of 3,4-DCA. 

In 2011, a waiver package (USEPA 2011 D339060+) was reviewed by EFED. The waiver review 

stated the information summary submitted from the waiver was sufficient to address effect 

endpoint requirements for aquatic invertebrates and fish (guideline studies 850.1010, 850.1035, 

850.1075, 850.1300, and 850.1350). Submitted information is still subject to review and the

lowest endpoints from studies which meet the EFED quality/validity criteria will be used to assess 

risk to aquatic organisms from 3,4-DCA exposure. Subsequently, open literature studies for 

invertebrate (acute and chronic) exposure to 3,4-DCA have been reviewed by the Agency and 

deemed suitable for quantitative use in risk assessment. These studies suggest 3,4-DCA is more 

toxic to freshwater invertebrates than the parent propanil. The ECOTOX reference numbers and 

endpoints are listed in Table 6.3. The submitted information did not address concerns for 3,4-

DCA exposure relative to requested guideline studies 850.2200, 850.4100 and 850.4150. The 

endpoints in the information package relative to these guideline studies were merely suggestive 

(850.4100 and 850.4150) of potential plant growth toxicity or did not use a comparable species 

(850.2200 used passeriformes to compare to upland game/waterfowl). It is likely 3,4-DCA could 

form on surfaces of plants based on aquatic metabolism studies, potentially putting both nontarget plants and organisms which use those plants at risk. Consequently, additional data are 

necessary for 3,4-DCA to properly evaluate the toxicity of 3,4-DCA to non-target organisms.

16
To further evaluate the toxicity of 3,4-DCA to aquatic organisms, ECOSAR (ECOSAR predictive 

software is available publically though the Epi SuiteTM program) estimates for propanil and 3,4-

DCA are presented in Table 6.3, below. A full ECOSAR output is provided in Appendix 4. 

ECOSAR uses quantitative structure activity relationships (QSAR) to predict effects on 

organisms from acute and chronic exposure to propanil and the degradate 3,4-DCA. To verify the 

reliability of the ECOSAR predictions, the results are compared to known toxicity endpoints. The

results suggest that the degradate is more toxic than the parent to aquatic freshwater invertebrates. 

The toxicity for fish is predicted to be about the same, while ECOSAR predicts a much less toxic 

effect on green algae.

Table 6.3. ECOSAR Estimates for Propanil and 3,4-DCA Compared to Known Toxicity Endpoints

Assessment 

Endpoint

Toxicity Studies on 

Propanil

ECOSAR Estimate 

Propanil

Effects Studies

3,4-DCA

ECOSAR Estimate 

3,4-DCA

Acute Freshwater 

Fish

LC50 = 2,300 ppb (Acc. 

246087) LC50 = 15,303 ppb N/A LC50 = 12,886 ppb

Chronic Freshwater 

Fish

NOAEC = 9.1 ppb (MRID 

42475301) NOAEC = 44 ppb N/A NOAEC = 67 pp

Acute Freshwater 

Invertebrate

EC50 = 6700 ppb (Acc. 

249347) EC50 = 11,234 ppb EC50 = 34.9* ppbECOTOX E55961 EC50 = 1,149 ppb

Chronic Freshwater 

Invertebrate

NOAEC = 86 ppb (MRID 

41776601) NOAEC = 1,126 ppb NOAEC = 10* ppbECOTOX E102280 NOAEC = 15 ppb 

Non-vascular plant 

toxicity EC50 = 30 ppb EC50 = 582 ppb N/A EC50 = 31,464 ppb

*Open literature data indicate 3,4-DCA is more toxic than the parent propanil

Bold values indicate a more toxic degradate prediction.

d. Ecological Incidents

The ecological incident information system (EIIS) is an Office of Pesticide Programs database 

that houses ecological incidents that have been reported to the Agency. When available, EIIS 

includes the date and location of an incident, type and magnitude of effects observed in various 

species, use(s) of pesticides known or suspected of contributing to the incident, and results of any 

chemical residue analysis or other analyses conducted during incident investigation. EIIS 

incidents are categorized according to the certainty that the incident resulted from pesticide 

exposure. The Avian Incident Monitoring System (AIMS) is a database administered by the 

American Bird Conservancy that contains publicly available data on reported avian incidents 

involving pesticides. Incidents listed in this database may also be in the EIIS. 

Searches of the Ecological Incident Information System (EIIS v. 2.1.1), Avian Incident 

Monitoring System (AIMS), and the aggregate Incident Data System were performed on 1/13/15. 

Three incidents laid out in detail in the 2009 CRLF assessment were a direct result of propanil use 

on rice. Two resulted in plant damage to rice crop from use and one incident resulted in lack of 

leaf growth on trees as a result of drift. Since the CRLF assessment in 2009, one ecological 

incident (I022862-001) was reported in the EIIS database for propanil. The incident reported 5 

17
horse mortalities and is classified as uncertain and unlikely, and did not report an exposure route

which suggests that the incident may not be linked to propanil. Although incident reporting is 

required under FIFRA Section 6(a)(2), the absence of additional reports in EIIS does not indicate 

that the chemical has no effects on wildlife; rather, it is possible that incidents have gone 

unreported.

7. Exposure Pathways of Concern

The environmental fate properties and use patterns of propanil indicate that direct spray, spray 

drift, leaching to ground water, and runoff represent potential transport mechanisms to aquatic 

and terrestrial organisms. Drinking water and inhalation exposure pathways were screened using 

SIP (Screening Imbibition Program) and STIR (Screening Tool for Inhalation Risk) screening 

methods. Drinking water and inhalation exposure were found to be exposure pathways of low 

concern (no LOC exceedances are expected) for mammals. However, drinking water and

inhalation pathways could both be an issue for birds (Appendix 3). SIP and STIR are described 

in detail at: http://www.epa.gov/oppefed1/models/terrestrial/index.htm.

8. Analysis Plan

a. Stressors of Concern

i. Ecological Risk Assessment

The stressors of ecological concern for terrestrial/aquatic plants and animals are propanil and its 

degradate 3,4-DCA. Toxicity data from both guideline and open literature studies (reviewed by 

the agency as acceptable for quantitative use in risk assessment) suggest 3,4-DCA is more toxic to 

aquatic invertebrates on both an acute and chronic exposure basis. Consequently, risks to aquatic 

invertebrates will be modeled and assessed using the toxic equivalency (TEQ) approach for the 

parent and degradate. ECOSAR estimates, and information contained in the waiver submission 

package (USEPA 2011) suggest equal or lesser toxicity for fish and aquatic plants, the toxicity of 

the parent and degradate will be considered together when estimating aquatic exposure 

concentrations in a total toxic residues (TTR) approach. Data from the submitted waiver package 

will be further reviewed and determined if quantitative use or qualitative characterization is 

acceptable to determine the toxicity of 3,4-DCA in the absence of guideline toxicity endpoints.

In addition to propanil only products, there are eight registered multiple active ingredient 

formulations (listed in Section 3) that contain propanil as part of the formulation. Although the 

Agency does not routinely include an evaluation of mixtures of active ingredients (either those

mixtures of multiple active ingredients in product formulations or those in the applicator’s tank) 

in its risk assessments, there are seven of these registrations (5905-495, 71085-09, 71085-16, 

71085-23, 71085-25, 71085-26 and 71085-29) which have definitive LD50 values and associated 

confidence intervals from mammalian studies. From the analysis of the multiple active ingredient 

products containing propanil, the toxicity of these compounds was not significantly different than the 

18
single active ingredient products of propanil alone. Thus, the toxicity for all of these registrations 

can be attributed to propanil. 

ii. Drinking Water 

New drinking water assessment that will be conducted as part of the registration review will 

include the parent propanil and major degradate 3,4-dichloroaniline (3,4-DCA) based on the

Agency’s Metabolism Assessment Review Committee recommendation (MARC’s meeting dates 

of January 16, 1996 and August 7, 2001) that 3,4-DCA is assumed to be of equal toxicity to the 

parent (USEPA 2006 RED). The assessment will be performed based on EFED’s current 

guidance using the latest surface water and groundwater models such as the surface water 

concentration calculator (SWCC) and PRZM-GW. Descriptions of all executable versions of 

current models for drinking water exposure can be obtained from URL 

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

b. Measures of Exposure

EFED will use the latest standard available models to evaluate potential exposures to aquatic and 

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

parent propanil and degradate 3,4-DCA will be assessed for both terrestrial exposures and aquatic 

exposures including drinking water exposure. The toxic equivalency (TEQ) approach for the 

parent and degradate will be used for aquatic invertebrate exposures while the toxicity of the 

parent and degradate will be considered together for fish and aquatic plants when estimating 

aquatic exposure concentrations in a total toxic residues (TTR) approach.

i. Available Monitoring Data

The Agency is aware of monitoring conducted by federal and state agencies such as the U.S. 

Geological Survey (USGS) National Water Quality Assessment (NAWQA) Data Warehouse and 

California Environmental Data Exchange Network (CEDEN). This exposure data will be

considered in the assessment to the extent that data on propanil and/or its degradate 3,4-DCA are 

available.

The previous RED (USEPA 2006) documented that 62 agricultural streams sampled as part of 

NAWQA/USGS studies (1992-1996), propanil was detected in 2.56% of the 1560 water samples 

analyzed with a maximum concentration of 2.05 ppb. 3,4-DCA, a common degradate for 

propanil, diuron, and linuron, was detected with extremely high frequency in surface water 

(96.2% of 346 samples collected in MS, MO, TN, AR, and North LA) but did not exceed 26 

ppb. Limited monitoring data were found from NAWQA/USGS for propanil in groundwater. 

Propanil was detected at 0.06 and 0.07 ppb in only two wells out of a total of 124 in Missouri. 

19
c. Measures of Effect 

Toxicity data presented in Section 6 of this problem formulation will be used to calculate risk 

quotients. Any additional information submitted by the registrant or found in the open literature 

prior to conducting the risk assessment will also be considered. The open literature studies are

identified using EPA’s ECOTOXicology database (ECOTOX), 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 and 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 EPA’s responsibility under the Endangered Species Act (ESA), the Agency will 

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

pesticides in accordance with the Joint Interim Approaches developed to implement the 

recommendations of the April 2013 National Academy of Sciences (NAS) report, (National 

Research Council, 2013). The NAS report outlines recommendations on specific scientific and 

technical issues related to the development of pesticide risk assessments that EPA and the 

Services must conduct in connection with their obligations under the ESA and FIFRA. EPA will 

address concerns specific to propanil in connection with the development of its final registration 

review decision for propanil. 

In November 2013, EPA, the US Fish and Wildlife Service, National Marine Fisheries (the 

Services), and USDA released a white paper containing a summary of their joint Interim 

Approaches for assessing risks to endangered and threatened (listed) species from 

pesticides. These Interim Approaches were developed jointly by the agencies in response to the 

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

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

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

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

Recommendations of the National Academy of Sciences April 2013 Report.

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

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

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

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

species or designated critical habitat, to be conducted during registration review. While the 

agencies continue to develop a common method for ESA analysis, the planned risk assessment for 

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

particular registration review case. This assessment will allow EPA to focus its future evaluations 

on the types of species where the potential for effects exists once the scientific methods being 

developed by the agencies have been fully vetted. Once the agencies have fully developed and 

implemented the scientific methods necessary to complete risk assessments for endangered and 

20
threatened (listed) species and their designated critical habitats, these methods will be applied to 

subsequent analyses of propanil as part of completing this registration review.

10. Endocrine Disruptor Screening Program

Propanil was not included in the first group of 67 chemicals nor the second group of 109 

chemicals that will or have been issued an order to conduct Tier 1 EDSP testing. For additional 

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

11. Preliminary Identification of Data Gaps 

a. Environmental Fate

Table 11.1 identifies environmental fate studies for each guideline requirement, and study 

classifications, as well as the data gaps with the justifications to support the risk assessment. In 

the absence of the necessary fate data, a conservative assumption will be made to assume that the 

compound (propanil or 3,4-DCA) is stable for the modeling inputs. The following major 

environmental fate data gaps are identified in this risk assessment: 

1) 835.4100 - An aerobic soil metabolism study for parent propanil (TGAI) and 3,4-DCA; 

2) 835.4300 - An aerobic aquatic metabolism study for degradate 3,4-DCA; 

3) 835.4400 - An anaerobic aquatic metabolism study for degradate 3,4-DCA; 

4) 850.6100 - ECM/ILVs (water) for both propanil (TGAI) and 3,4-DCA 

Table 11.1. Submitted Environmental Fate Data for Propanil and 3,4 DCA

OCSPP 

Guideline

Data 

Requirement

Source

MRID

Classification Are data needed to 

conduct risk 

assessment?

Justification and 

Assumptions EPA Will 

Make in the Absence of Data

835.2120 Hydrolysis 41066601

00111395

Acceptable

Supplemental

No ---

47165601 Acceptable

(3,4 DCA)

No ---

835.2240 Aqueous 

Photolysis

41070701

47165603

Acceptable

Supplemental No ---

835.2410 Soil Photolysis 42820401 Supplemental No ---

835.4100 Aerobic Soil 

Metabolism

(Only one soil 

submitted.)

41538701 Supplemental Yes

Data for four soils are required 

for propanil and 3,4 DCA

(TGAI) under 40 CFR Part 

158; three more soil types are 

requested.

835.4200 Anaerobic Soil 

Metabolism N/A1 N/A No ---

21
OCSPP 

Guideline

Data 

Requirement

Source

MRID

Classification Are data needed to 

conduct risk 

assessment?

Justification and 

Assumptions EPA Will 

Make in the Absence of Data

835.4300 Aerobic Aquatic 

Metabolism 41848701 Supplemental No ---

835.4300 Aerobic Aquatic 

Metabolism for 

3,4-DCA NA NA Yes

Data are requested for 

degradate 3,4-DCA (TGAI), 

which was formed at 72% at 

30 days (MRID41848701)

835.4400 Anaerobic 

Aquatic 

Metabolism

41872601 Supplemental No

---

835.4400 Anaerobic 

Aquatic 

Metabolism for 

3,4-DCA

NA NA Yes

Data are requested for 

degradate 3,4-DCA (TGAI), 

which peaked at 78% at 14 

days (MRID41872601)

835.1230

835.1240

Adsorption/ 

Desorption and 

Leaching

42780401 Supplemental No ---

47165602 Supplemental 

(3,4 DCA) No ---

835.6100 Aquatic Field 

Dissipation

42200401

42200501

Acceptable

Acceptable No ---

850.6100 ECM/ILVs

(water) --- --- Yes Data are requested for both propanil and 3,4-DCA (TGAI)

850.1730 Fish 

bioconcentration NA NA No

Data were waived on 

4/26/1989 due to low Kow 

value. 

1 N/A – Not available

b. Ecological Effects

Table 11.2 and Table 11.3 identify ecological effects studies that offer data for each guideline 

requirement, as well as study classifications and whether or not further data are needed to support 

a risk assessment. Justification for additional non-guideline data requested is presented is 

subsequent tables. ECOSAR modeling predicts, and open literature confirms the degradate, 3,4-

DCA, can be more toxic to some taxa. Consequently, some studies are requested to evaluate the 

actual toxicity of this chemical. Additional honeybee data (Tier II/III semi-field/filed studies) 

may be required pending results of the requested Tier I data (acute/chronic studies with adults and 

larvae) based on the toxicity results.

22
Table 11.2. Aquatic Ecological Effects Data and Remaining Data Gaps for Propanil and 

3,4-DCA

OCSPP

Guideline

Data 

Requirement

Submitted Studies 

(MRID)

Study 

Classifications

Are data 

needed to 

conduct 

risk 

assessment?

Justification and 

Assumptions EPA will 

Make in Absence of 

Data

850.1010 Freshwater 

invertebrate 

acute toxicity

41776801 (TEP) 

Acc. 249347 (TGAI)

(water flea)

Acceptable No --

Freshwater 

invertebrate 

acute toxicity

for 3,4-DCA

Waiver USEPA 2011, 

D339060+)

-- No additional studies 

are requested at this 

time. The information 

supplied in the waiver 

summary in response 

to the previous DCI

(GDCI-028201-17893

will be used to address 

the 3,4-DCA effects 

endpoint for 850.1010.

EFED will consider 

the lowest tested 

endpoint in studies 

identified within the 

submitted information 

package that meet 

minimal 

quality/validity 

criteria as indicated in 

EFED open literature 

review policy 

guidance. However, a 

study may be 

requested at a later 

time if no toxicity 

endpoint is deemed 

acceptable for use in 

risk assessment.

850.1025

850.1035

Saltwater 

invertebrate 

acute toxicity 

41777101

(mollusk)

Acceptable No --

41776901

(mysid)

Acceptable

23
OCSPP

Guideline

Data 

Requirement

Submitted Studies 

(MRID)

Study 

Classifications

Are data 

needed to 

conduct 

risk 

assessment?

Justification and 

Assumptions EPA will 

Make in Absence of 

Data

Saltwater 

invertebrate 

acute toxicity

for 3,4-DCA

Waiver USEPA 2011, 

D339060+)

-- No additional studies 

are requested at this 

time. The information 

supplied in the waiver 

summary in response 

to the previous DCI

(GDCI-028201-17893)

will be used to address 

the 3,4-DCA effects 

endpoint for 850.1035.

EFED will consider 

the lowest tested 

endpoint in studies 

identified within the 

submitted information 

package that meet 

minimal 

quality/validity 

criteria as indicated in 

EFED open literature 

review policy 

guidance. However, a 

study may be 

requested at a later 

time if no toxicity 

endpoint is deemed 

acceptable for use in 

risk assessment.

850.1075 Freshwater fish 

acute toxicity 

Acc. 246087 

(rainbow trout TGAI)

41360201 (rainbow 

trout TEP)

Acc. 249347

(bluegill sunfish TGAI)

41359801

(bluegill sunfish TEP)

Acc. 126344 

(fathead minnow 

TGAI)*

Acceptable No *This study would be 

used to calculate the 

acute to chronic ratio 

for estuarine/marine fish

24
OCSPP

Guideline

Data 

Requirement

Submitted Studies 

(MRID)

Study 

Classifications

Are data 

needed to 

conduct 

risk 

assessment?

Justification and 

Assumptions EPA will 

Make in Absence of 

Data

Freshwater fish 

acute toxicity

for 3,4-DCA

Waiver USEPA 2011, 

D339060+)

-- No additional studies

are requested at this 

time. The information 

supplied in the waiver 

summary in response 

to the previous DCI

(GDCI-028201-17893)

will be used to address 

the 3,4-DCA effects 

endpoint for 850.1075.

EFED will consider 

the lowest tested 

endpoint in studies 

identified within the 

submitted information 

package that meet 

minimal 

quality/validity 

criteria as indicated in 

EFED open literature 

review policy 

guidance. However, a 

study may be 

requested at a later 

time if no toxicity 

endpoint is deemed 

acceptable for use in 

risk assessment.

850.1075 Saltwater fish 

acute toxicity 

41776001

(sheepshead minnow)

Acceptable No

850.1300 Freshwater 

invertebrate 

life cycle 

42145600

(water flea)

Acceptable No

25
OCSPP

Guideline

Data 

Requirement

Submitted Studies 

(MRID)

Study 

Classifications

Are data 

needed to 

conduct 

risk 

assessment?

Justification and 

Assumptions EPA will 

Make in Absence of 

Data

Freshwater 

invertebrate 

life cycle for 

3,4-DCA

Waiver USEPA 2011, 

D339060+)

-- No additional studies 

are requested at this 

time. The information 

supplied in the waiver 

summary in response 

to the previous DCI

(GDCI-028201-17893)

will be used to address 

the 3,4-DCA effects 

endpoint for 850.1300.

EFED will consider 

the lowest tested 

endpoint in studies 

identified within the 

submitted information 

package that meet 

minimal 

quality/validity 

criteria as indicated in 

EFED open literature 

review policy 

guidance. However, a 

study may be 

requested at a later 

time if no toxicity 

endpoint is deemed 

acceptable for use in 

risk assessment.

26
OCSPP

Guideline

Data 

Requirement

Submitted Studies 

(MRID)

Study 

Classifications

Are data 

needed to 

conduct 

risk 

assessment?

Justification and 

Assumptions EPA will 

Make in Absence of 

Data

850.1350 Saltwater 

invertebrates 

life cycle 

(None) N/A No No chronic data exist 

for estuarine/marine 

invertebrates. An acute 

to chronic ratio can be 

calculated using the

studies listed above in 

addition to Acc. 249347 

(TGAI) to estimate a 

conservative toxicity 

endpoint for 

estuarine/marine 

invertebrates.

Saltwater 

invertebrates 

life cycle for 

3,4-DCA

Waiver USEPA 2011, 

D339060+)

-- No additional studies 

are requested at this 

time. The information 

supplied in the waiver 

summary in response 

to the previous DCI

(GDCI-028201-17893)

will be used to address 

the 3,4-DCA effects 

endpoint for 850.1350.

EFED will consider 

the lowest tested 

endpoint in studies 

identified within the 

submitted information 

package that meet 

minimal 

quality/validity 

criteria as indicated in 

EFED open literature 

review policy 

guidance. However, a 

study may be 

requested at a later 

time if no toxicity 

endpoint is deemed 

acceptable for use in 

risk assessment.

850.1400 Freshwater fish 

early-life stage

41776501 and 

42259601

(fathead minnow)

Acceptable No

27
OCSPP

Guideline

Data 

Requirement

Submitted Studies 

(MRID)

Study 

Classifications

Are data 

needed to 

conduct 

risk 

assessment?

Justification and 

Assumptions EPA will 

Make in Absence of 

Data

850.1400 Saltwater fish 

early-life stage 

(None) N/A No No chronic data are 

available for 

estuarine/marine fish. 

An acute to chronic 

ratio can be calculated 

using the available 

studies to estimate a 

conservative toxicity 

endpoint for

estuarine/marine 

invertebrates.

850.1500 Fish life cycle 42475301

(fathead minnow)

Acceptable No --

850.4400 Aquatic vascular 

plant toxicity 

test using Lemna 

spp.

41777201 Acceptable No --

850.4500 Non-vascular 

plant toxicity

41777301 (green algae)

41777401 (marine 

diatom)

41777501 (freshwater 

diatom)

Acceptable No

850.4550 Non-vascular 

plant toxicity 

41776701

(cyanobacteria)

Acceptable No

28
Table 11.3. Terrestrial Ecological Effects Data and Remaining Data Gaps for Propanil and 

3,4-DCA

OCSPP 

Guideline Data Requirement

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed for 

risk 

assessment?

Justification and 

Assumptions EPA 

will Make in 

Absence of Data 

850.2100 Avian oral toxicity 41361001

(bobwhite)

Acceptable Yes In previous 

assessments, levels of 

concern have been 

exceeded for birds on 

an acute basis.

Because passerine 

species have higher 

metabolic rates due 

to their smaller sizes 

than either 

waterfowl or upland 

game bird species 

and because they 

may utilize different 

metabolic pathways, 

they may be more or 

less sensitive to

propanil. An acute 

oral study with a 

passerine species is 

requested. If data are 

not submitted, than 

risk to passerines 

from acute exposure

will be assumed.

850.2200 Avian dietary 

toxicity 

41361101

(bobwhite)

Acceptable No --

41360701

(mallard)

Acceptable

29
OCSPP 

Guideline Data Requirement

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed for 

risk 

assessment?

Justification and 

Assumptions EPA 

will Make in 

Absence of Data 

Avian dietary 

toxicity for 3,4-DCA

(None) N/A Yes The previous DCI 

(GDCI-028201-

17893) requested 

data for this study, 

and the submitted 

waiver information

was not sufficient to 

waive that request. 

Data are requested 

for the bobwhite 

quail (which is more 

sensitive to propanil 

than the mallard 

duck) with 3,4-DCA 

to establish dietary 

toxicity of the 

degradate. In the 

absence of data 

conservative 

assumptions may be 

made about the 

toxicity of 3,4-DCA 

to birds on a dietary 

basis.

850.2300 Avian reproduction 48235101

(bobwhite)

Acceptable No --

48327201

(mallard)

Acceptable

30
OCSPP 

Guideline Data Requirement

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed for 

risk 

assessment?

Justification and 

Assumptions EPA 

will Make in 

Absence of Data 

Avian reproduction 

for 3,4-DCA

Waiver USEPA 

2011, 

D339060+)

-- No No additional studies 

are requested at this 

time. The 

information supplied 

in the waiver 

summary in 

response to the 

previous DCI

(GDCI-028201-

17893) will be used.

EFED will proceed 

using the submitted 

available 

reproduction data 

for birds using the

propanil parent 

compound. EFED 

will use the no effect 

concentrations 

established for 

propanil and convert 

it to a corresponding 

3,4-DCA using the 

results of the avian 

metabolism data cited 

in the waiver request. 

The uncertainty with 

this approach may 

result in a 

conservative 

representation of the 

reproduction 

toxicity of the 

metabolite as the 

observed effects

in the parent 

compound study will 

be attributed in 

entirety to the 

potential proportion 

of administered 

material that is 

observable as 3,4-

DCA.

NonguidelineAvian inhalation (None) N/A No --

850.3020 Honeybee adult acute 

contact toxicity

00009181 Acceptable No --

31
OCSPP 

Guideline Data Requirement

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed for 

risk 

assessment?

Justification and 

Assumptions EPA 

will Make in 

Absence of Data 

Nonguideline 

(OECD 213)

Honeybee adult acute 

oral toxicity

(None) N/A Yes An acute oral 

toxicity study with 

the adult honey bee 

is needed per the 

Agency’s pollinator 

guidance (USEPA 

2014c).

NonguidelineHoneybee adult 

chronic toxicity 

(including acute 

endpoints)

(None) N/A Yes A chronic oral 

toxicity study with 

the adult honeybee is 

needed per the 

Agency’s pollinator 

guidance (USEPA 

2014c).

NonguidelineHoneybee larval 

chronic toxicity 

(including acute 

endpoints)

(None) N/A Yes A larval toxicity 

study is needed per 

the Agency’s 

pollinator guidance 

(USEPA 2014c). 

The 21-day larval 

toxicity study 

currently under 

development by

OECD provides both 

acute and chronic 

oral toxicity data on 

developing bee 

brood and or the 

registrant can 

submit separate 

acute (single dose) 

and chronic (repeat 

dose) toxicity tests.

850.3030 Honeybee toxicity of 

residues on foliage

(None) NA No The acute contact 48-

hr LD50 was above 

>24 μg ai/bee. This 

study is only triggered 

if contact toxicity is 

less than 11 μg ai/bee.

32
OCSPP 

Guideline Data Requirement

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed for 

risk 

assessment?

Justification and 

Assumptions EPA 

will Make in 

Absence of Data 

NonguidelineResidues in pollen 

and nectar

(None) N/A Yes Additional studies 

may be necessary if 

risk concerns are 

identified for bees at 

the Tier I level per 

the Agency’s 

pollinator guidance 

(USEPA 2014c). 

Pollen/nectar 

residue data may be 

required to refine 

the risk assessment 

to bees. A protocol 

should be submitted 

in advance of 

conducting the study.

NonGuideline

(OECD 75)

Semi-Field Testing 

for Honeybees

None NA Yes Additional semi-field

studies to identify 

more identify more 

targeted risk 

mitigation options

may be necessary if 

risk concerns are 

identified for bees at 

the Tier I level per 

the Agency’s 

pollinator guidance 

(USEPA 2014c).

Typically semi-field 

studies are usually 

conducted under 

conditions that 

represent the worstcase exposure 

scenario of proposed 

uses to the entire 

colony. 

33
OCSPP 

Guideline Data Requirement

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed for 

risk 

assessment?

Justification and 

Assumptions EPA 

will Make in 

Absence of Data 

850.3040 Field testing for 

pollinators

(None) N/A Yes Full field studies 

may be necessary to 

identify more 

targeted risk 

mitigation options if 

risk concerns are 

identified for bees at 

the Tier II level per 

the Agency’s 

pollinator guidance 

(USEPA 2014c). A 

protocol should be 

submitted in advance 

of conducting the 

study.

850.4100 Seedling Emergence 

and Seedling Growth

43069901 Acceptable No --

Seedling Emergence 

and Seedling Growth 

(Tier 1) for 3,4-DCA

(None) N/A Yes The previous DCI

(GDCI-028201-

17893) requested 

data for this study, 

and the submitted 

waiver was not 

sufficient to waive 

that request. Data 

are requested for 

3,4-DCA because it

has the potential to 

leave the rice paddy,

is longer-lived than 

the parent and the 

mode of action of the 

parent is herbicidal.

850.4150 Vegetative Vigor 43069901 Acceptable No --

34
OCSPP 

Guideline Data Requirement

Submitted 

Studies 

(MRID)

Study 

Classifications

Are data 

needed for 

risk 

assessment?

Justification and 

Assumptions EPA 

will Make in 

Absence of Data 

Vegetative Vigor 

(Tier 1) for 3,4-DCA

(None) N/A Yes The previous DCI

(GDCI-028201-

17893) requested 

data for this study, 

and the submitted 

waiver was not 

sufficient to waive 

that request. Data 

are requested for 

3,4-DCA because it

has the potential to 

form on plants, is 

longer-lived than the 

parent and the mode 

of action of the 

parent is herbicidal.

Additional justification for non-guideline data requests:

Study Title: Honey Bee Adult Acute Oral Toxicity Test;

Guideline Number: Special Study – OECD 213;

Test Substance: Propanil – TGAI

Rationale for Requiring the Data

No data are available with which to assess the toxicity of propanil to honey bees on an acute oral

exposure basis. Based on the registered use patterns, terrestrial invertebrates have the potential to be

exposed by contacting and consuming propanil residues. Therefore, the acute oral toxicity test is

needed for EFED’s current screening-level process for assessing potential effects to terrestrial

invertebrates.

The Agency finalized its framework to assess risk to pollinators (USEPA, 2014). EPA now requires

these studies for all use sites where potential exposure to pollinators may occur. Registrants may

request a waiver of the studies if use practices significantly restrict exposure of the pesticide to bees.

The Agency does not have a guideline for the acute oral honey bee study; however, the OECD 213

guideline may be useful in protocol development.

Practical Utility of the Data

How will the data be used and how could the data impact the Agency’s future decision-making?

Data will be used to assess hazard and characterize risk to non-target listed and non-listed terrestrial

invertebrate species. See Guidance for Assessing Pesticide Risks to Bees (USEPA, 2014) 

foradditional details.

If future endangered species risk assessments are performed without these data, the Agency would

have to assume that propanil "may affect" endangered terrestrial insects directly (and

endangered species from other taxa indirectly), and use of propanil might need to be restricted in areas 

where endangered species could be exposed. The lack of these data will limit the flexibility

the Agency and registrants have in coming into compliance with the Endangered Species Act and

could result in use restrictions for propanil which are unnecessarily severe. In addition, the

35
lack of these data may result in an uncertain assumed risk and potential mitigation of propanil

formulations under FIFRA

[1] Draft guidance for the 21-day larval toxicity study is available 

at: http://www.oecd.org/env/ehs/testing/Draft_GD_honeybees_rep_exp_for_2nd_CR_25_November_2013.pdf

[2] OECD Guideline 237 is available at: http://www.oecdilibrary.org/docserver/download/9713171e.pdf?expires=1407449911&id=id&accname=guest&checksum=E67BEDEB01DB12D

815E858CB45A989FB

Study Title: Honey Bee Adult Chronic Oral Toxicity Study;

Guideline Number: Special Study – Non-guideline;

Test Substance: Propanil – TGAI

Rationale for Requiring the Data

No data have been submitted on the chronic toxicity of propanil to adult honey bees. A study is 

needed to determine the chronic toxicity of the compound to adult honey bees, including mortality and 

sub-lethal effects. This study is part of EFED’s current screening-level process for determining 

potential effects to terrestrial invertebrates. Therefore, a non-guideline honeybee larval toxicity study 

is recommended. Although EPA has not developed a guideline for this study and OECD has yet to 

finalize test guidance for chronic studies, efforts are currently underway to develop standardized 

guidelines for assessing effects from chronic (10-day) exposures to adult bees in the laboratory. The 

registrant should submit a proposed protocol for review and approval by EFED prior to initiation of 

the study.

The Agency finalized its framework to assess risk to pollinators (USEPA, 2014). EPA now requires 

this study for all use sites where potential exposure to pollinators may occur. Registrants may request 

a waiver of the study if use practices significantly restrict exposure of the pesticide to bees.

Practical Utility of the Data

How will the data be used and how could the data impact the Agency’s future decision-making?

The 10-day toxicity study with young adult bees provides no-observed adverse effect level (NOAEL) 

and lowest-observed adverse effect level (LOAEL) for assessing chronic effects. Data obtained from 

this study will be used in estimating chronic risk to individual adult bees. Risk estimates based on 

these data will be considered along with other lines of evidence to determine whether higher-tier 

studies are needed at the whole colony level.

These data are needed for the registration review risk assessment and for future endangered species 

assessments. The data would allow the Agency better characterize the potential for risk to insects 

(including beneficial pollinators) from the use of propanil. This data may help the Agency determine 

whether any mitigations are needed. If the registration review and any future endangered species risk 

assessments are performed without these data, the Agency would have to assume that propanil "may 

affect" insects, including bees and beneficial pollinators, directly (and endangered species from other 

taxa indirectly), and uses of propanil might need to be restricted in areas where pollinators could be 

exposed.

Study Title: Honey Bee Acute and Chronic Larvae Oral Toxicity Study;

Guideline Number: Special Study – Non-guideline;

Test Substance: Propanil – TGAI

Rationale for Requiring the Data

No data have been submitted on the toxicity of propanil to honey bee larvae. A larval toxicity study is 

needed to determine the toxicity of the compound to developing brood (i.e., larvae and pupae), 

including mortality and adult emergence. This study is part of EFED’s current screening level process 

for determining potential effects to terrestrial invertebrates. Although EPA has not developed a 

guideline for this study, the 21-day larval toxicity study currently under development by

36
OECD provides both acute and chronic oral toxicity data on developing bee brood and (when this 

guidance is finalized) may be used to satisfy the requirement for both acute and chronic oral toxicity 

to honey bee larvae. Registrants are at liberty though to submit a separate acute (single dose) larval 

toxicity study following OECD TG 237 as well as the 21-day repeat dose chronic toxicity study. For 

the chronic toxicity study though, since no guideline is available, it is recommended that the registrant 

should submit a proposed protocol for review and approval by EFED prior to initiation of the study.

The Agency finalized its framework to assess risk to pollinators (USEPA, 2014). EPA now requires 

these studies for all use sites where potential exposure to pollinators may occur. Registrants may 

request a waiver of the studies if use practices significantly restrict exposure of the pesticide to bees.

Practical Utility of the Data

How will the data be used and how could the data impact the Agency’s future decision making?

The 21-day larval toxicity study under development by OECD provides both acute and chronic

toxicity data on developing bee brood and will yield a median lethal dose (LD50) for assessing acute

toxicity during the early part of the study as well as a 21-day no-observed adverse effect level

(NOAEL) and lowest-observed adverse effect level (LOAEL) for assessing chronic effects. Effects on 

survival and development (adult bee emergence) from repeat exposures to the active ingredient will be 

used in estimating chronic risk to individual brood. Risk estimates based on these data will be 

considered along with other lines of evidence to determine whether higher-tier studies are needed at 

the whole colony level.

Data will be used to assess risk to non-target listed and non-listed terrestrial invertebrate species. This 

study would allow the Agency to refine the screening-level hazard assessment for beneficial terrestrial 

invertebrates. The effects data will be used to determine the potential for adverse effects on beneficial 

terrestrial invertebrates through direct effects on larval bees. See Guidance for Assessing

Pesticide Risks to Bees (USEPA, 2014) for additional details.

These data are needed for the registration review risk assessment and for future endangered species 

assessments. The data would allow the Agency better characterize the potential for risk to insects 

(including beneficial pollinators) from the use of propanil. This data may help the Agency determine 

whether any mitigations are needed. If the registration review and any future endangered species risk 

assessments are performed without these data, the Agency would have to assume that propanil "may 

affect" insects, including bees and beneficial pollinators, directly (and endangered species from other 

taxa indirectly), and uses of propanil might need to be restricted in areas where pollinators could be 

exposed.

Study Title: Semi-Field Toxicity Testing (tunnel/enclosure studies)

Guideline Number: Special Study – Non-guideline; OECD 75

Test Substance: Propanil – TEP

Rationale for Requiring the Data

Tier II studies are conditional on the outcome of the screening-level assessment where acute and/or 

chronic risk levels of concern have been exceeded for terrestrial invertebrates. Terrestrial 

invertebrates are likely to be impacted if exposed to pesticides in various use settings. Pesticide 

residues may be transferred to pollen and/or nectar of treated plants and subsequently brought back to 

the hive and may adversely affect developing brood (egg, larvae, and pupae) and adult bees. 

Screening-level (Tier I) studies of individual bees do not address possible effects and/or exposure to 

pesticide residues at the colony-level. Because of the potential for pollen and nectar to be 

contaminated with pesticide residues, and subsequently brought back to the hive, it is important to 

determine whether bee colonies may be negatively affected under relatively controlled exposure 

37
conditions of a semi-field study. In addition to providing effects data, these studies can provide data 

on exposure as pesticide residues in pollen/nectar of treated plants.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for 

invertebrates with the honeybee. The guidance describes the tiered testing process and can be found 

at: http://www2.epa.gov/pollinator-protection/pollinator-risk-assessment-guidance . Additional 

information on honeybee colony studies under semi-field conditions can be found in the OECD 

Guidance 75 

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono%28 . 

Practical Utility of the Data

How will the data be used? 

Tier II colony-level data will be used to assess potential risk to non-target organisms including listed 

and non-listed terrestrial social invertebrate species and to determine whether effects observed in the 

screening-level (Tier I) laboratory-based studies of individual bees are evident in colony-level studies 

under semi-field conditions. The Tier II semi-field test of whole colonies is a relatively controlled 

study, i.e., bees are confined to a specific area, that is designed to represent potential field-level 

exposure and account for hive dynamics, which are not achievable from other pollinator studies. This 

study will be used to determine whether adverse effects to insect pollinators at the whole colony level, 

may result for the use of pesticides and will help to refine risk estimates derived in the screening-level 

risk assessment for beneficial terrestrial invertebrates. Measured residues in pollen/nectar can also be 

used to refine risk estimates derived from model-based or default values in the screening-level 

assessment.

How could the data impact the Agency’s future decision-making?

The data will inform the determination required under FIFRA or the ESA as to whether continued 

registration of a pesticide is likely to result in unreasonable adverse effects to non-target species or is 

likely to adversely affect federally listed threatened or endangered species or their designated critical 

habitat. Without these data, EPA may need to presume risk which will limit the flexibility of pesticide 

products to comply with FIFRA and the ESA, and could result in significant use restrictions.

Study Title: Semi-Field Toxicity Testing (feeding studies)

Guideline Number: Special Study – Non-guideline; 

Test Substance: Propanil – TEP

Rationale for Requiring the Data

Pesticide residues may be transferred to pollen and/or nectar of treated plants and subsequently 

brought back to the hive, and may adversely affect developing brood (egg, larvae, and pupae) and 

adult bees. Tier II feeding studies are conditional on the outcome of the screening-level assessment 

where acute and/or chronic risk levels of concern have been exceeded for terrestrial invertebrates 

based on Tier I studies of individual bees. Feeding studies utilize free foraging bee colonies that are 

“dosed” with specific quantities of test material and represent a means of ensuring exposure to the 

test material through spiked pollen and/or sugar solutions fed to the colony while still allowing the 

bees to forage freely. Since bee colonies are not confined to enclosures, colonies can be exposed for 

longer duration periods without subjecting the bees to stress that typically results from Tier II tunnel 

studies. Available toxicity studies of individual bees (Tier 1) conducted to support screening-level 

assessments do not address possible effects and/or exposure to pesticide residues at the colony-level. 

Because of the potential for pollen and nectar to be contaminated with pesticide residues, and 

subsequently brought back to the hive, it is important to determine whether bee colonies may be 

negatively affected where bees are free foraging and have the option to collect/consume alternative 

38
forage items beyond the spiked food. Since multiple dose levels can be more readily tested, feeding 

studies can help to define dose-response relationships at the whole colony level.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for 

invertebrates with the honeybee. The guidance describes the tiered testing process and can be found at: 

http://www2.epa.gov/pollinator-protection/pollinator-risk-assessment-guidance . Additional 

information on honeybee colony feeding studies can be found in the EPPO Guidance 170 at: 

http://www.nationalbeeunit.com/index.cfm?pageId=187 .

Practical Utility of the Data

How will the data be used?

Tier II colony feeding data will be used to assess potential risk to non-target organisms including 

listed and non-listed terrestrial social invertebrate species. The colony feeding study is designed to 

represent potential field-level exposure and account for hive dynamics using longer duration 

exposure periods than are possible in Tier II tunnel studies. The study will be used to determine 

whether potential adverse effects to insect pollinators at the whole colony level when bees are able to 

forage naturally beyond the spiked food. Results from the feeding study will help to refine the 

screening-level risk assessment for beneficial terrestrial invertebrates that were based on Tier I 

studies on individual bees. Since feeding studies can help to define a dose-response relationship at 

the colony level, the studies can provide a means of determining exposure thresholds below which 

the likelihood of adverse effects on colonies may be low.

How could the data impact the Agency’s future decision-making?

Tier II colony-level data will be used to refine screening-level risk estimates derived using Tier I 

laboratory-based data on individual bees. The Tier II data will inform the determination required 

under FIFRA or the ESA as to whether continued registration of a pesticide is likely to result in 

unreasonable adverse effects to non-target species or is likely to adversely affect federally listed 

threatened or endangered species or their designated critical habitat. Without these data, EPA may 

need to presume risk which will limit the flexibility of pesticide products to comply with FIFRA and 

the ESA, and could result in significant use restrictions.

Study Title: Residues in Pollen and Nectar

Guideline Number: Special Study – Non-guideline; 

Test Substance: Propanil – TEP

Rationale for Requiring the Data

Terrestrial invertebrates are likely to be impacted if exposed to pesticide residues in various use 

settings. Pesticide residues may be transferred to pollen and/or nectar of treated plants and 

subsequently brought back to hive where all life stages may be exposed. For some pesticides, the 

quantification of pollinator-relevant residues in treated flowering plants is needed, since pollinators 

will be exposed to residues from either current or prior season applications (due to the potential for 

residues to accumulate in plants and trees). Residues in edible/transportable-to-hive parts of treated 

trees and plants, including (where appropriate), but not limited to, guttation water, sap/resins, whole 

plant tissue (e.g., leaves, stems), as well as blooming, pollen-shedding, and nectar producing parts 

(i.e., flowers and, if present, extra-floral nectaries) of plants may inform the potential for risk. 

Studies should be designed to provide residue data for crops and application methods of concern.

The Office of Pesticide Programs has made available a guidance regarding ecological testing for 

invertebrates with the honeybee. The guidance can be found at: http://www2.epa.gov/pollinatorprotection/pollinator-risk-assessment-guidance .

Practical Utility of the Data

39
How will the data be used?

Measured residue data will be used to refine conservative estimates of pesticide exposure and reduce 

uncertainties associated with the Tier I exposure assessment by providing direct measurements of 

pesticide concentrations resulting from actual use settings. Measured residues may provide a more 

realistic understanding of exposure through contact or ingestion with which to calculate risk quotients 

for individual bees as well as to characterize exposure to the colony. If measured residue data are not 

available, risk estimates for terrestrial insects will be based on model-generated or default values 

used to support the screening-level assessment.

How could the data impact the Agency’s future decision-making?

The data will inform the determination required under FIFRA or the ESA as to whether continued 

registration of a pesticide is likely to result in unreasonable adverse effects to non-target species or is 

likely to adversely affect federally listed threatened or endangered species or their designated critical 

habitat. Without these data, EPA will have to rely on conservative estimates of exposure which will 

limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in use 

restrictions. 

12. References 

Hess, D., Warren, F. 2002. The Herbicide Handbook of the Weed Science Society of America 8th

Edition. 159-161.

National Research Council. 2013. Assessing Risks to Endangered and Threatened Species from 

Pesticides. Washington, DC: The National Academies Press.

http://www.nap.edu/catalog/18344/assessing-risks-to-endangered-and-threatened-species-frompesticides

USEPA. 2001. Review of Environmental Fate and Ecological Effects for the Re-Registration 

Eligibility Decision (RED) for Propanil. Environmental Fate and Effects Division, 

Office of Pesticide Programs, United States Environmental Protection Agency. DP 

Barcode: D275423

USEPA. 2003 Reregistration Eligibility Decision (RED) for Propanil (September 2003), Office 

of Pesticide Programs, United States Environmental Protection Agency. Docket: EPAHQ-2003-0348-0002

USEPA. 2006. Amendment to Reregistration Eligibility Decision (RED) for Propanil (March 

2006). Office of Pesticide Programs, United States Environmental Protection Agency. 

Docket: EPA-HQ-OPP-2003-0348-0024

USEPA. 2009. Propanil Use to Federally Threatened California Red-legged Frog (Rana aurora 

draytonii). Environmental Fate and Effects Division, Office of Pesticide Programs, 

United States Environmental Protection Agency.

USEPA. 2011. EFED Review of Propanil Degradate 3,4-Dichloroaniline Ecological Effects 

Data Waiver Request Information Package. Environmental Fate and Effects Division, 

40
Office of Pesticide Programs, United States Environmental Protection Agency. DP 

Barcodes 339060, 339061, 339063, 339065, and 339069

USEPA. 2014a. BEAD Chemical Profile (BCP) for Registration Review: Propanil (028201). 

Biological and Economic Analysis Division, Office of Pesticide Programs, United States 

Environmental Protection Agency.

USEPA. 2014b. Propanil Screening Level Usage Analysis. Biological and Economic Analysis 

Division, Office of Pesticide Programs, United States Environmental Protection Agency.

USEPA. 2014c. Guidance for Assessing Pesticide Risks to Bees. U.S. Environmental Protection

Agency, Office of Pesticide Programs; Health Canada Pest Management Regulatory

Agency; and California Department of Pesticide Regulation. Jun. 23, 2014. Available at

http://www2.epa.gov/pollinator-protection/pollinator-risk-assessment-guidance.

Fate Bibliography 

MRID Citation Reference

00111395 Jones, B.; Adler, I. (1970) Hydrolysis of Propanil in Water as a Function of pH: 

Report No. 34-2. (Unpublished study received Oct 1, 1975 under 707-75; 

submitted by Rohm & Haas Co., Phila- delphia, PA; CDL:195113-A) 

41066601 Spare, W. (1989) Hydrolysis of ?Carbon 14|-Propanil at pH 5: Final Rept.: 

Study No. 2509. Unpublished study prepared by Agrisearch Inc. 81 p. 

41070701 Kesterson, A.; Lawrence, B.; Marsh, J.; et al. (1989) Aqueous Photolysis of 

?Carbon 14|Propanil in Natural Sunlight: PTRL Project No. 276: Report No. 

1186. Unpublished study prepared by Pharmacology & Toxicology Research 

Laboratory. 94 p. 

47165603 Burgener, A. (2000) Aqueous Photolysis of (carbon-14)-Propanil Under 

Laboratory Conditions, Determination of the Quantum Yield and Calculation of 

Environmental Lifetime. Project Number: 769072. Unpublished study prepared 

by RCC Umweltchemie Ag. 57 p.

42820401 Reynolds, J. (1993) Soil Photolysis of (carbon 14)-Propanil: Lab Project 

Number: 92121: RPT00117: 34P-92-54. Unpublished study prepared by 

XenoBiotic Labs, Inc. 105 p. 

41538701 Arthur, M.; Marsh, S.; Marsh, B. (1990) Aerobic Soil Metabolism of (Carbon 

14)-Propanil in Gardenia Soil: Rohm and Haas Technical Report No. 34-90-

05: Battelle Project No. N-4839-0001. Unpublished study prepared by Battelle 

Memorial Institute, Environmental Sciences Dept. 40 p. 

41872601 Spare, W. (1991) Anaerobic Aquatic Metabolism of Propanil: Lab Pro- ject 

Number: 2511. Unpublished study prepared by Agrisearch Inc. 154 p. 

41848701 Spare, W. (1991) Aerobic Aquatic Metabolism of Propanil: Lab Pro- ject 

Number: 2510. Unpublished study prepared by Agrisearch Inc. 127 p. 

41
42780401 Fathulla, R. (1990) The Adsorption and Desorption of (carbon 14)-Propanil on 

Typical Agricultural Soils: Final Report: Lab Project Number: HLA 6322-100. 

Unpublished study prepared by Hazleton Labs America, Inc. 79 p. 

42200401 Young, D.; Palmer, D.; Johnson, G.; et al. (1992) Aquatic Field Dissipation and 

Irrigation Water Residues of Propanil Following Application of Propanil 4 EC to 

an Arkansas Rice Paddy: Lab Project Number: 90-0019. Unpublished study 

prepared by Wildlife International Ltd. 666 p. 

42200501 Young, D.; Palmer, D.; Johnson, G.; et al. (1992) Aquatic Field Dissipation and 

Irrigation Water Residues of Propanil Following Application of Propanil 4 EC to 

a Louisiana Rice Paddy: Lab Project Number: 90-0019. Unpublished study 

prepared by Wildlife International Ltd., and EN-CAS Analytical Labs. 682 p. 

Ecological Effects Bibliography 

MRID Citation Reference

41361001

Grimes, J; Jaber, M. (1989) Propanil: An Acute Oral Toxicity Study 

with the Bobwhite: Lab Project Number: 271/104. Unpublished study 

prepared by Wildlife International, Ltd. 20 p. 

41360701

Grimes, J.; Jaber, M. (1989) Propanil: A Dietary LC50 Study with the 

Mallard: Lab Project Number: 271-102. Unpublished study prepared 

by Wildlife International, Ltd. 38 p. 

41361101

Grimes, J.; Jaber, M. (1989) Propanil: A Dietary LC50 Study with the 

Bobwhite: Lab Project Number: 271/101. Unpublished study prepared 

by Wildlife International, Ltd. 38 p. 

48235101

Stafford, J. (2009) Reproductive Toxicity Test with Propanil in the Diet 

of Northern Bobwhite (Colinus virginiaus). Project Number: 

12177/4101. Unpublished study prepared by Springborn Smithers 

Laboratories and En-Cas Analytical Laboratories. 264 p.

48327201

Stafford, J. (2005) Propanil: Reproductive Toxicity Test with the 

Mallard Duck (Anas platyrhynchos). Project Number: 12177/4100. 

Unpublished study prepared by Springborn Smithers Laboratories and 

En-Cas Analytical Laboratories. 166 p.

41359801

Ritchie, P.; McAllister, W. (1989) Acute 96-Hour Flow-through Toxicity 

of Propanol-4 Formulation to Bluegill (Lepomis macro- chirus): Lab 

Project Number: 37768. Unpublished study prepared by Analytical 

Bio-Chemistry Laboratories, Inc. 218 p. 

41360201

Ritchie, P.; McAllister, W. (1989) Acute 96-Hour Flow-through Toxicity 

of Propanil-4 Formulation to Rainbow Trout (Oncorhynchus mykiss): 

Lab Project Number: 37769. Unpublished study prepared by Analytical 

Bio-Chemistry Laboratories, Inc. 199 p. 

41613602

Bowman, J. (1986) Acute Toxicity of Ordram: Propanil 3:3E to Bluegill Sunfish (Lepomis macrochirus): Lab Project Number: 35224; 

12556. Unpublished study prepared by Analytical Bio-Chemistry 

Laboratories, Inc. 61 p. 

41613604

Bowman, J. (1986) Acute Toxicity of Ordram: Propanil 3:3E to Rainbow Trout (Salmo gairdneri): Lab Project Number: 35225; 12555. 

Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 59 p. 

42
41613606

Burgess, D. (1986) Acute Toxicity Ordram: Propanil 3:3E to Daphnia 

magna: Lab Project Number: 35226; T-12554. Unpublished study 

prepared by Analytical Bio-Chemistry Laboratories, Inc. 48 p. 

Acc 95187 USFWS Circular 167 Rainbow trout study 48 hour test- supplemental

41776801

Burgess, D. (1990) Acute Flow-through Toxicity of Propanil-4-Isopho 

rone Formulation to Daphnia magna: Final Report: Lab Project No: 

37770. Unpublished study prepared by Analytical Bio-Chemistry 

Labs., Inc. 236 p. 

41776001

Sousa, J. (1990) Propanil-Acute Toxicity to Sheepshead Minnow 

(Cyprinodon veriegatus (sic)) under Flow-through Conditions: Final 

Report: Lab Project Number: 12177/0789/6102/505: 90-02-3227. 

Unpublished study prepared by Springborn Laboratories, Inc. 52 p. 

41776901

Sousa, J. (1990) Propanil-Acute Toxicity to Mysid Shrimp (Mysidopsis bahia) Under Flow-through Conditions: Final Report: Lab Pro- ject 

Number: 90-4-3275: 12177.0789.6101-515. Unpublished study 

prepared by Springborn Laboratories, Inc. 50 p. 

41777101

Dionne, E. (1990) Propanil-Acute Toxicity to Eastern Oyster 

(Crassotrea virginica) Under Flow-through Conditions: Final Report: 

Project Number: 89-10-3184. Unpublished study prepared by 

Springborn Laboratories, Inc. 52 p. 

41776501

Sousa, J. (1991) Propanil Technical-Toxicity Test with Fathead 

Minnow (Pimephales promelas) Embryos and Larvae: Final Report: 

Lab Project Number: 90-6-3357: 12177.1189.6106.120. Unpublished 

study prepared by Springborn Labs., Inc. 63 p. 

41776601

McNamara, P. (1991) Propanil Technical-Chronic Toxicity to Daphnids 

(Daphnia magna) Under Flow-through Conditions: Final Report: Lab 

Project Number: 90-6-3361: 12177.1189.6105.105. Unpublished study 

prepared by Springborn Labs., Inc. 69 p. 

42145601

McNamara, P. (1991) Propanil Technical: Chronic Toxicity to 

Daphnids (Daphnia magna) Under Flow-Through Conditions: Lab 

Project Number: 90-6-3361: 12177.1189.6105.130. Unpublished study 

prepared by Springborn Labs, Inc. 367 p. 

42259601

Propanil Task Force (1991) Propanil Technical--Toxicity Test with 

Fathead Minnow (Pimephales promelas) Embryos and Larvae: Lab 

Project Number: 90-6-3357. Unpublished study prepared by 

Springborn Laboratories, Inc. 392 p. 

42475301

Dionne, E. (1992) Propanil Technical: The Chronic Toxicity to the 

Fathead Minnow (Pimephales promelas during a Full Life-Cycle 

Exposure: Final Report: Lab Project Number: 12177.0191.6109.122: 

92-1-4085. Unpublished study prepared by Springborn Labs, Inc. 398 

p. 

43069901

Christensen, K. (1993) Propanil Technical--Determination of Effects on 

Seed Germination, Seedling Emergence and Vegetative Vigor of Ten 

Plant Species: Final Report: Lab Project ID: 92-11- 4510; 

86.0592.6154.610; 92RC-0056. Unpublished study prepared by 

Springborn Labs., Inc. 235 p. 

43069901

Christensen, K. (1993) Propanil Technical--Determination of Effects on 

Seed Germination, Seedling Emergence and Vegetative Vigor of Ten 

Plant Species: Final Report: Lab Project ID: 92-11- 4510; 

86.0592.6154.610; 92RC-0056. Unpublished study prepared by 

Springborn Labs., Inc. 235 p. 

43
47144702

Eley, R. (2004) Evaluation of the Phytotoxicity of Propanil (60% WG), 

Based on OECD Guideline 208 B, Vegetative Vigour Test Terrestrial 

Non Target Plants - Southern Europe, 2004. Project Number: 

ACE/04/087. Unpublished study prepared by AgroChemex Ltd. 105 p.

41776701

Giddings, J. (1990) Propanil-Toxicity to the Freshwater Blue-green 

Alga Anabaena flos-aquae: Final Report: Lab Project Number: 90-3-

3273: 12177-0789-6104-420. Unpublished study prepared by 

Springborn Labs., Inc. 47 p. 

41777201

Giddings, J. (1990) Propanil-Toxicity to Duckweed (Lemna gibba G3): 

Final Report: Lab Project No: 90-4-3294: 12177-0789-6104-410. 

Unpublished study prepared by Springborn Laboratories, Inc. 44 p. 

41777301

Giddings, J. (1990) Propanil-Toxicity to the Freshwater Green Alga 

Selenastrum Capricornutum: Final Report: Lab Project Number: 90-3-

3253: 12177-0789-6104-430. Unpublished study prepared by 

Springborn Laboratories, Inc. 48 p. 

41777401

Giddings, J. (1990) Propanil-Toxicity to the Marine Diatom Skeletonema Costatum: Final Report: Lab Project Number: 90-3-3255: 

12177-0789-6104-450. Unpublished study prepared by Springborn 

Laboratories, Inc. 47 p. 

41777501

Giddings, J. (1990) Propanil-Toxicity to the Freshwater Diatom 

Navicula Pelliculosa: Final Report: Lab Project No: 90-3-3254: 12177-

0789-6104-440. Unpublished study prepared by Springborn 

Laboratories, Inc. 48 p. 

9181

Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of 

Pesticides on Apiculture: Project No. 1499. (Unpublished study 

received Jul 29, 1976 under 352-342; prepared by Univ. of California--Riverside, Dept. of Entomology, submitted by E.I. du Pont de 

Nemours & Co., Wilmington, Del.; CDL:224800-C)

44
Appendix 1. Propanil Uses and Application Rates 

Use

Maximum 

Single 

Application 

Rate (lb ai/A)

Maximum 

Number of 

Applications*

(minimum 

application 

interval)

Maximum 

Yearly 

Application 

Rate in lb of 

ai**

Formulation Description***

Rice 6.0 2 (NS) 8

Emulsifiable Concentrate, 

Flowable Concentrate, Soluble 

Concentrate/Liquid, Soluble 

Concentrate/Solid, Water 

Dispersible Granules (Dry 

Flowable)

* Assumed based on maximum single application rate.

** Labels list maximum application rater per season. One season per year is assumed.

*** Application method for each formulation is aerial or ground broadcast. 

NS – Minimum application interval is not specified. The label allows for a max single application of 6 lb ai/A 

not to exceed 8 lb ai/A per season. EFED may assume 2 applications of 6 lb ai/A and 2 lb ai/A respectively for

modeling purposes unless otherwise stated on label. Some other labels list the use pattern as 2 applications at 4 

lb ai/A 

45
Appendix 2. Previous Actions and Uses of Propanil

Crop Application Rate (lb ai/A) Number of 

Applications 

(Application 

Interval in 

Days)

Action/DP 

Barcode/Date

Risk Conclusions

Single Seasonal/ 

Annual

Rice Paddies 8 8 1* California Redlegged Frog 

10/15/2009

Likely to adversely affect the 

aquatic and terrestrial phase 

California red-legged frog 

based on survival, growth 

and/or reproduction. 

Expected risks: acute and 

chronic to freshwater fish and 

invertebrates, acute risk to 

bird, acute and chronic risk to 

mammals, and risk to 

Nontarget aquatic vascular and 

non-vascular plants. 

Based on calculated EECs 

from refined modeling, the 

LOC for risk to vascular 

aquatic plants was not exceed. 

However, the LOC is 

exceeded for non-vascular 

aquatic plants.

Rice Paddies 4 8 2* Refined Tier I 

Rice Model

D290202

9/24/2003

Rice Crops

Small Grains 

(≤1% of total 

use)

Turf (no 

evidence of use)

8 8 1 Re-Registration 

Eligibility 

Decision (RED)

D275423

10/4/2001

Dry Seeded Rice 

(Propanil/Machet

e tank mix)

n/a n/a n/a Emergency 

Exemption

Arkansas

1983

n/a= not available

*7-day water holding time minimum for rice paddy.

46
Appendix 3. Screening Level Models to Evaluate Potential Importance 

of Drinking Water and Inhalation Exposure Pathways

SIP (Screening Imbibition Program, v1.0) was used to calculate an upper bound estimate 

of propanil exposure via drinking water using solubility (152 mg/L), the most sensitive 

acute and chronic avian toxicity endpoints (bobwhite quail, LD50 = 201 mg ai/kg-bw; 

bobwhite quail and mallard duck NOAEC = 247 and 46 mg ai/kg-diet respectively) and 

the most sensitive acute and chronic mammalian toxicity endpoints (rat LD50 = 1080 mg 

ai/kg-bw and NOAEL = 150 mg ai/kg-bw). The model indicated that there are no acute 

or chronic concerns to mammals through the drinking water exposure pathway; however 

potential concerns exist for birds exposed through drinking water (Tables A3.1 and 

A3.2). 

Table A3.1. SIP Mammalian Results for Propanil

Parameter Acute Chronic

Upper bound exposure (mg/kg-bw) 26.1440 26.1440

Adjusted toxicity value (mg/kg-bw) 830.6934 115.3741

Ratio of exposure to toxicity 0.0315 0.2266

Conclusion*

Drinking water exposure 

alone is NOT a potential 

concern for mammals

Drinking water exposure 

alone is NOT a potential 

concern for mammals

STIR (Screening Tool for Inhalation Risk, v1.0) was used to calculate an upper bound 

estimate of propanil exposure via inhalation using molecular weight (218.1 g/mole), 

vapor pressure (9.08 x 10-7 mmHg), high end application rates (aerial/ground: 6 lb ai/A), 

most sensitive acute avian toxicity endpoint (bobwhite quail, LD50 = 201 mg ai/kg-bw), 

and most sensitive acute oral and inhalation mammalian toxicity endpoints (rat, LD50 = 

1808 mg ai/kg-bw and 4-hr LC50 > 2.06 mg ai/L, respectively (MRID 46862604). The 

results indicated that droplet inhalation alone is potentially a pathway of concern for 

birds. 

Table A3.2. SIP Avian Results for Propanil

Parameter Acute Chronic

Upper bound exposure (mg/kg-bw) 123.1200 123.1200

Adjusted toxicity value (mg/kg-bw) 144.8063 2.2822

Ratio of exposure to acute toxicity 0.8502 53.9485

Conclusion*

Exposure through drinking 

water alone is 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.

47
Table A3.3. STIR Avian (0.020 kg) Results for Propanil

Maximum Vapor Concentration in Air at 

Saturation (mg/m3)

1.07E-02

Maximum 1-hour Vapor Inhalation Dose (mg/kg) 1.34E-03

Adjusted Inhalation LD50 1.28E+00

Ratio of Vapor Dose to Adjusted Inhalation LD50 1.05E-03 Exposure not Likely Significant

Maximum Post-treatment Spray Inhalation Dose 

(mg/kg)

5.76E-01

Ratio of Droplet Inhalation Dose to Adjusted 

Inhalation LD50

4.51E-01 Proceed to Refinements

Table A3.4. STIR Mammalian (0.15 kg) Results for Propanil

Maximum Vapor Concentration in Air at 

Saturation (mg/m3)

1.07E-02

Maximum 1-hour Vapor Inhalation Dose (mg/kg) 1.68E-03

Adjusted Inhalation LD50 1.23E+02

Ratio of Vapor Dose to Adjusted Inhalation LD50 1.37E-05 Exposure not Likely Significant

Maximum Post-treatment Spray Inhalation Dose 

(mg/kg)

7.25E-01

Ratio of Droplet Inhalation Dose to Adjusted 

Inhalation LD50

5.91E-03 Exposure not Likely Significant

Appendix 4. ECOSAR Output for Propanil and 3,4-DCA

ECOSAR Version 1.11 Results Page

SMILES : CCC(=O)Nc1cc(CL)c(CL)cc1

CHEM : Propanil

CAS Num: 

ChemID1: 

MOL FOR: C9 H9 CL2 N1 O1 

MOL WT : 218.08

Log Kow: 2.880 (EPISuite Kowwin v1.68 Estimate)

Log Kow: (User Entered)

Log Kow: 3.07 (PhysProp DB exp value - for comparison only)

Melt Pt: (User Entered for Wat Sol estimate)

Melt Pt: 92.00 (deg C, PhysProp DB exp value for Wat Sol est)

Wat Sol: 60.71 (mg/L, EPISuite WSKowwin v1.43 Estimate)

Wat Sol: (User Entered)

Wat Sol: 152 (mg/L, PhysProp DB exp value)

48
--------------------------------------

Values used to Generate ECOSAR Profile

--------------------------------------

Log Kow: 2.880 (EPISuite Kowwin v1.68 Estimate)

Wat Sol: 152 (mg/L, PhysProp DB exp value)

------------------------------------------------

Available Measured Data from ECOSAR Training Set

------------------------------------------------

 Measured

CAS No Organism Duration End Pt mg/L (ppm) Ecosar Class Reference

=========== ========== ========== ====== ========== =========================== 

=========================

000709-98-8 Fish ChV 0.00048 Amides DUL

000709-98-8 Fish ChV 0.00049 Amides OPP Pesticide Ecotoxicity DB

000709-98-8 Fish ChV 0.01 Amides OPP Pesticide Ecotoxicity DB

000709-98-8 Fish ChV 0.02 Amides OPP Pesticide Ecotoxicity DB

000709-98-8 Green Algae 96-hr EC50 0.03 Amides OPP Pesticide Ecotoxicity DB

000709-98-8 Daphnid ChV 0.11 Amides OPP Pesticide Ecotoxicity DB 

(2028003)

000709-98-8 Mysid 96-hr LC50 0.4 Amides OPP Pesticide Ecotoxicity DB

000709-98-8 Fish 96-hr LC50 2.3 Amides OPP Pesticide Ecotoxicity DB

000709-98-8 Fish (SW) 96-hr LC50 4.6 Amides OPP Pesticide Ecotoxicity DB

000709-98-8 Fish 96-hr LC50 5.4 Amides OPP Pesticide Ecotoxicity DB

000709-98-8 Daphnid 48-hr LC50 6.7 Amides OPP Pesticide Ecotoxicity DB

000709-98-8 Fish 96-hr LC50 8.6 Amides DUL

--------------------------------------

ECOSAR v1.1 Class-specific Estimations

--------------------------------------

Amides 

 Predicted

ECOSAR Class Organism Duration End Pt mg/L (ppm)

=========================== ================== ======== ====== ==========

Amides : Fish 96-hr LC50 15.303

Amides : Daphnid 48-hr LC50 11.234

Amides : Green Algae 96-hr EC50 0.582

Amides : Fish ChV 0.044

Amides : Daphnid ChV 1.126

Amides : Green Algae ChV 0.792

Amides : Fish (SW) 96-hr LC50 13.638

Amides : Mysid (SW) 96-hr LC50 1.138

=========================== ================== ======== ====== ==========

Neutral Organic SAR : Fish 96-hr LC50 29.045

49
(Baseline Toxicity) : Daphnid 48-hr LC50 17.888

 : Green Algae 96-hr EC50 18.643

 : Fish ChV 3.125

 : Daphnid ChV 2.187

 : Green Algae ChV 5.850

Note: * = asterisk designates: Chemical may not be soluble enough to measure this predicted 

effect. If the effect level exceeds the water solubility by 10X, typically no effects at saturation 

(NES) are reported.

------------------------------

Class Specific LogKow Cut-Offs

------------------------------

If the log Kow of the chemical is greater than the endpoint specific cut-offs presented below, 

then no effects at saturation are expected for those endpoints.

Amides :

-------

Maximum LogKow: >8.5 (LC50)

Maximum LogKow: >8.0 (EC50,ChV)

Baseline Toxicity SAR Limitations:

---------------------------------

Maximum LogKow: 5.0 (Fish 96-hr LC50; Daphnid LC50)

Maximum LogKow: 6.4 (Green Algae EC50)

Maximum LogKow: 8.0 (ChV)

------------------------------------------------------------------------------

ECOSAR Version 1.11 Results Page

SMILES : Nc1cc(CL)c(CL)cc1

CHEM : 3,4-DCA

CAS Num: 

ChemID1: 

MOL FOR: C6 H5 CL2 N1 

MOL WT : 162.02

Log Kow: 2.365 (EPISuite Kowwin v1.68 Estimate)

Log Kow: (User Entered)

Log Kow: 2.69 (PhysProp DB exp value - for comparison only)

Melt Pt: (User Entered for Wat Sol estimate)

Melt Pt: 72.00 (deg C, PhysProp DB exp value for Wat Sol est)

Wat Sol: 239.3 (mg/L, EPISuite WSKowwin v1.43 Estimate)

Wat Sol: (User Entered)

Wat Sol: 92 (mg/L, PhysProp DB exp value)

--------------------------------------

Values used to Generate ECOSAR Profile

50
--------------------------------------

Log Kow: 2.365 (EPISuite Kowwin v1.68 Estimate)

Wat Sol: 92 (mg/L, PhysProp DB exp value)

------------------------------------------------

Available Measured Data from ECOSAR Training Set

------------------------------------------------

 Measured

CAS No Organism Duration End Pt mg/L (ppm) Ecosar Class Reference

=========== ========== ========== ====== ========== =========================== 

=========================

000095-76-1 Fish ChV 0.0014 Anilines (Unhindered) TSCA 8d, DCN 878214956

000095-76-1 Fish ChV 0.006 Anilines (Unhindered) Call, 1987 (VN sheet)

000095-76-1 Daphnid ChV 0.01 Anilines (Unhindered) 8e-4734

000095-76-1 Fish ChV 0.01 Anilines (Unhindered) DUL

000095-76-1 Fish ChV 0.02 Anilines (Unhindered) Call, 1987 (VN sheet)

000095-76-1 Fish 96-hr LC50 7 Anilines (Unhindered) DUL

000095-76-1 Fish 96-hr LC50 7.7 Anilines (Unhindered) DUL

000095-76-1 Fish 96-hr LC50 8 Anilines (Unhindered) DUL

--------------------------------------

ECOSAR v1.1 Class-specific Estimations

--------------------------------------

Anilines (Unhindered)

 Predicted

ECOSAR Class Organism Duration End Pt mg/L (ppm)

=========================== ================== ======== ====== ==========

Anilines (Unhindered) : Fish 96-hr LC50 12.866

Anilines (Unhindered) : Daphnid 48-hr LC50 1.149

Anilines (Unhindered) : Green Algae 96-hr EC50 1.509

Anilines (Unhindered) : Fish ChV 0.067

Anilines (Unhindered) : Daphnid ChV 0.015

Anilines (Unhindered) : Green Algae ChV 2.850

=========================== ================== ======== ====== ==========

Neutral Organic SAR : Fish 96-hr LC50 62.569

(Baseline Toxicity) : Daphnid 48-hr LC50 36.745

 : Green Algae 96-hr EC50 31.464

 : Fish ChV 6.364

 : Daphnid ChV 3.936

 : Green Algae ChV 8.882

Note: * = asterisk designates: Chemical may not be soluble enough to measure this predicted 

effect. If the effect level exceeds the water solubility by 10X, typically no effects at saturation 

(NES) are reported.

51
------------------------------

Class Specific LogKow Cut-Offs

------------------------------

If the log Kow of the chemical is greater than the endpoint specific cut-offs presented below, 

then no effects at saturation are expected for those endpoints.

Anilines (Unhindered):

---------------------

Maximum LogKow: 6.0 (Fish 96-hr LC50)

Maximum LogKow: >3 (Daphnid 48-h LC50)

Maximum LogKow: >4 (Green Algae 96-hr EC50 and ChV)

Maximum LogKow: >4.3 (Fish ChV)

Maximum LogKow: >2.4 (Daphnid ChV)

Baseline Toxicity SAR Limitations:

---------------------------------

Maximum LogKow: 5.0 (Fish 96-hr LC50; Daphnid LC50)

Maximum LogKow: 6.4 (Green Algae EC50)

Maximum LogKow: 8.0 (ChV)

------------------------------------------------------------------------------

52