### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D

. C. 20460

OFFICE OF CHEM I CAL SAFETY AND POL LUTIO N PR EVE NTION



### Date: 

### Apr il 28

, 20 15 PC Code: 

### 028201 MEMORANDUM DP Barcode: 

### D424442

SUBJECT :



### FROM:

THROUGH: Registration Revie w: Preliminary Problem Formulation for E nvironm enta l Fate, Ecological Ri?k, Endangered Species, and Drinking Water Exposure Assessments for Propanil

Ryan Mroz, Biologist He Z hong

, Ph.D

., Biologist Env ironmental Risk Branch l E nvironm enta l Fate and Effects Division (7507P)**~**

# ;.--J.0\_c~~ Sujatha Sa nkul a, Ph.D

., Branch Chief /

-- \**<~** 

### Environmental Risk Branch I Environmental Fat e and Effects Divi sion (7507P)

TO: 

### Joel Wolf

, Chemic a l Review Manager Dana Fri e dman

, Acting Team Leader Kevin Coste ll o, Branch Chief Risk Management a nd Impl ementat i on Branch II Pesticide Re-Evalu a tion Di vis ion (7508P)

# Contents
1. Executive Summary

................................ ................................ ................................ ............. 3 2. Introduction

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

................................ ................................ ................................ ............ 4 4. Con clusions 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. Stress ors 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. Eco logical 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 S ummary

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 pr oblem 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 ove rview of the environmental fate, ecological effects , and potential r isks 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 conduct ing 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 lo wer 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 a cute o ral t oxicity with a passerine species (TGAI)

• Special study (OECD 213)

- Acute oral toxicity to adult honey bees (TGAI)

• Special study

- Chronic oral toxici ty 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

- fie ld 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 we re identified for the degradate 3,4

- DCA (see Section 11 for details):

• 850.2200

– Avian s ubacute d ietary t oxicity

- b obwhite q uail

• 850.4100

– Seedling e mergence (Tier 1 )

• 

### 850.4150

– Vegetative v igor (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

P ropanil is a selective post

- emergence, contact (require s 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 herb icide 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 a dverse 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 gro wing actively under favorable soil moist ure and weather conditions (USE P A 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 s everal days after the herbicide application (Herbicide Handbook, 2014).



### T he 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 (US EPA 2014 b )

.



# 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 p ost

- emergen t phase (March through May) and requires an average temperature of 70 o 

### F to be effective ( USEPA 2003 ).

Propanil currently has 41 active Section 3 registrations. Six registrations are technical products and 3 5 are end

- use products formulated as emulsifiable concentrate liquid, water dispersible granule (dry flowable), soluble concentrate liquid, and flowable concentr ate 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



### 471085

- 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 o f information :

• Seasonal, rather than yearly

, application information is provided , and a minimum re

treatment interval is missing for most of the uses. The number of applications and the maximum application rate should be reported on an annu al 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 tho se 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 p ropanil that serve as a basis for this problem formulation , including a Reregistration Eligibility Decision (RED) ( USEPA 200 1 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 20 09 for propanil use on rice . The registration s 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 p otential direct risk concerns from th e rice use :

• acute risk to birds (including endangered species);

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

• risk to no n

- target aquatic nonvascular plants; and

• risk to non

- target terrestrial plants.

Bas ed on the RED the following EFED relevant mitigation s were implemented:

• A 7

- day water holding (discharge) interval for the Mississippi Delta (Arkansas, Mississippi, Missou ri and Northern Louisiana) and California was established to address concerns for both endangered and no n

- 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)

850.101 0 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

850.13 00 Early

- Life Stage in Freshwater and Estuarine/Marine Fish 3,4

- DCA Waived

- 12/9/2011 339060, 339061, 339063, 339065, 339069

850.135 0 Life Cycle in Freshwater and Estuarine/Marine Invertebrates 3,4

- DCA Waived

- 12/9/2011 339060, 339061, 339063, 339065, 339069

850.22 00 Avian Subacute Dietary Toxicity (bobwhite quail) 3,4

- DCA Waiver denied

- 12/9/2011 339060, 339061, 339063, 339065, 339069

850.23 00 Avian Reproduction (bobwhite quail) Propanil Data received

- Acceptable study 382979

850.23 00 Avian Reproduction (bobwhite quail) 3,4

- DCA Waived

- 12/9/ 20 11 339060, 339061, 339063, 339065, 339069



### 6850.23 00 Avian Reproduction (mallard duck) Propanil Data received

- Acceptable study 405966, 387605

850.23 00 Avian Reproduction (mallard duck) 3,4

- DCA Waived

- 12/9/ 20 11 339060, 339061, 339063, 339065, 339069

850.41 00 Seedling Emergence (Tier 1) 3,4

- DCA Waiver denied

- 12/9/ 20 11 339060, 339061, 339063, 339065, 339069

850.415 0 Vegetative Vigor (Tier 1) 3,4

- DCA Waiver denied

- 12/9/ 20 11 339060, 339061, 339063, 339065, 339069

850.415 0 Vegetative Vigor (Tier 2) Propanil Data received

- Acceptable study 343057



## b. Drinking Water Exposure Assessment s The most recent drinking water assessment for propanil and its major degradate 3,4

- DCA was conducted to support the Re r egistration Eligibility Decision (RED) for the propanil uses in three rice growing region s (USEPA 20 01 ; D 275423 ). 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 C oncentrations (EDWC) (ppb) of Propanil and 3,4

- DCA in Surface W ater from Two Applications to Three D iffer ent Rice

- Growing S cenarios. 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 re ported 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 Act 1



### . 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; t 1/2 

### = 11 days), it appears to be microbially mediated. A erobic aquatic (MRID 41848701) and soil (MRID 41538701) metabolisms of the parent propanil are rapid (t 1/2 

### =2 days and t 1/2 

### =0.5 days, respectively). Anaerobic soil and aquatic metabolism (t 1/2 

### =2

- 3 days ) are also rapid (MRID 41872601)

. The aerobic and anaerobic
aqu atic metabolism of propanil a re the important routes of degradation for the rice use pattern. Propanil is considered moderately mobile in the environment (K d 

### = 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 che micals such as diuron and linuron. The m inor degradates (< 2%) includ e 3,4

- dichloroni trobenzene, and 3,3’,4,4’

- tetra chloroazobenzene. A separate batch equilibrium study ( MRID 47165602) reports that 3,4

- DCA is less mobile (K d 

### = 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 s ame plots with half

- lives of 9.5 and 11.6 days, respectively. These studies w ere 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 m 3 

### 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 semi

volatile compound, as indicated by the vapor pressure of 6.32 E

- 3 mmHg @ 25°C and Henry’s la w cons tant 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 hab itats does not appear to be a major route of transportation for parent propanil based on the short half

- lives of aerobic aquatic metabolism (t 1/2 

### = 2 days, MRID 41848701 ) and 

### soil metabolism ( t 1/2 

### = 0.5 d ays, MRID 41 538701 ) . 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, aquati c metabolism studies are recommended to clarify the transportation pathway.

P hysical/chemical property and fate data for p ropanil and 3,4

- DCA are presented in Table s 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 (25 o C) 152 mg/L EPI Suite (v4.11)
Vapor Pressure (25 o C) 9.08 X 10

- 7 mm Hg EPI Suite (v4.11)
Henry’s Law constant 4.5 x 10

- 9 atm m 3 mol

- 1 EPI Suite (v4.11) Hydrolysis Half

- life t 1/2 = stable MRID 41066601
MRID 00111395 Stable at 30 days (pH 5, 7, 9)



### 9Parameter Value(s) (units) Source Comment Aqueous Photolysis Half

life t 1/2 = 103 days (12

- h light / 12

- h dark)
t 1/2 = 61 days (Continuous Irradiation) MRID 41070701

MRID 47165603 Stable for 30 days

Soil Photolysis Half

- life t 1/2 = 11 days MRID 42820401 t 1/2 = 2 days in dark control

Aerobic Soil Metabolism Half

- life t 1/2 = 0.5 days MRID 41538701 Only sandy loam soil tested, Degradate 3,4

- DCA (44%), Bound material 65% at 360 days Anaerobic Aquatic Metabolism t 1/2 = 2

- 3 days MRID 41872601 3,4

- DCA formed 78% at 14 days
Aerobic Aquatic Metabolism t 1/2 = 2 days (parent only) MRID 41848701 3,4

- DCA reached 76% at 7 days and 72% at 30 days.

Organic Carbon Partition Coefficient (K OC ) mL/g 306; 239; 703; 800; and 389 MRID 42780401

Soil Partition Coefficient (K d ) mL/g 0.54; 2.3; 5.8; 8.0; and 11.7 MRID 42780401

Aquatic Field Dissipation t 1/2 = 1.5 days (soil)
t 1/2 = 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)



### 10Hydrolysis (5 day test at pH 4 ,7, and 9 and temperature 50oC) Stable MRID 47165601

Aerobic Soil Metabolism Half

- life t 1/2 = 30 days MRID 41538701

Organic Carbon Partition Coefficient (Koc) 1,182; 488; and 883 MRID 47165602

Soil Partition Coefficient (K d ) mL/g 35.2; 1.4; and 3.0 MRID 47165602

Aquatic Field Dissipation t 1/2 = 9.5 days (soil)
t 1/2 = 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 eco logical effects of propanil

. All endpoints are based on TGAI test substance unless otherwise indicated. I 

### n 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 fre shwater 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 ad ult s on a contact basis , but based on the recent Agency’s Pollinator Guidance (USEPA 2014c) additiona l data is required to assess ri s ks to bees.



## a. Effects to A quatic O rganisms

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 fish 1 Acute Rainbow Trout ( Oncorhynchus mykiss ) LC 50 = 2300 μg ai/L

Sub

- lethal effects: lethargy, loss of equilibrium, dark pigmentation Moderately toxic Acc. 246087

Acceptable



### 11Taxonomic Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

Acute Fathead Minnow ( Pimephales promelas ) LC 50 = 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 (Life

Cycle) Fathead Minnow ( Pimephales promelas ) NOAEC = 9.1 μg ai/L LOAEC = 21.0 μg ai/L

Based on male length and 30 day weight/len g th -- 42475301

Acceptable

Freshwater invertebrates Acute Water Flea ( Daphnia magna ) L C 50 = 6700 μg ai/L Moderately toxic Acc. 24 9347

Acceptable

Acute

44% Propanil formulation Water Flea ( Daphnia magna ) EC 50 = 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 ) LC 50 = 4600 μg ai/L

Sub

- lethal effects: lethargy, loss of equilibrium Moderately toxic 41776001

Acceptable

Estuarine/marine invertebrates Acute Eastern Oyster ( Crassostrea virginica ) EC 50 = 4960 μg ai/L

Based on shell deposition Moderately toxic 41777101

Acceptable



### 12Taxonomic Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

Acute Mysid Shrimp ( Americamysis bahia ) LC 50 = 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 EC 50 = 110 μg ai/L

Based on frond number -- 41777201

Acceptable

Non

- vascular Freshwater Diatom ( Navicula pelliculosa ) NOAEC = 6.3 μg ai/L EC 50 = 16.0 μg ai/L

Based on cell density -- 41777501

Acceptable

Marine Diatom ( Skeletonema

costatum ) NOAEC = 1.18 μg ai/L EC 50 = 1.5 μg ai/L

Based on number of cells -- 41777401 Acceptable

Green algae ( Raphidocelis subcapitata ) NOAEC = 6.0 μg ai/L EC 50 = 29.0 μg ai/L

Based on cell density -- 41777301

Acceptable

Cyanobacteria Cyanobacteria ( Anabaena flos

aquae ) NOAEC = 25 μg ai/L EC 50 = 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 ) LD 50 = 201 mg ai/kg

- bw NOAEC = 62.5 mg ai/kg

bw

Sublethal effects: Weight loss, reduced food consumption Moderately toxic 41361001

Acceptable



### 13Taxonomic 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 ) LC 50 = 2861 mg ai/kg

diet 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) LC 50 = 5 6 2 7 mg ai/kg

diet (based on nominal concentration) NOAEC < 562 mg ai/kg

diet

NOAEC is based on reduced body weight in all treatment groups tested Practically non

toxic 41360701

Acceptable

Chronic reproduction Bobwhite quail

( Colinus virginianus ) NOAEC = 247 mg ai/kg

diet LOAEC = 495 mg ai/kg

diet

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/kg

diet LOAEC = 116 mg ai/kg

diet

Based on adult male and female weight gain -- 48327201

Acceptable

Mammals Acute oral Laboratory rat

( Rattus norvegicus ) LD 50 = 1080 mg ai /kg

- bw

No sublethal effects Slightly toxic 41360801 Acceptable



### 14Taxonomic 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 /kg

diet

LOAEC = 600 mg ai/kg

diet

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 ) LD 50 > 24.17 μg ai /bee

No effects reported Practically non

toxic 00009181

Acceptable

Terrestrial plants Vegetative vigor

(60% propanil formulation) Monocot Onion ( Allium
cep a), oat ( Avena sativa ), rice ( Oryza

sat i va ), 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) EC 25 = 0.13 lb ai/A NOAEC = 0.03 lb ai/A

Bas ed on reduction in fresh weight of onion

.
Dicot (cabbage) EC 25 = 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



### 15Taxonomic Group Study Type Surrogate Species Toxicity Value (all units in terms of ai) Acute Toxicity Classification Source and Classification

Seedling
emergence Monocot Onion ( Allium
cep a), corn ( Zea
mays ), ryegrass ( Lolium perenne ), oat ( Avena sativa )

Dicot C ucumber ( Cucumis sativus ), cabbage ( Brassica oleracea ), soybean ( Glycine max ), lettuce ( Lactuca sativa ), tomato ( Lycopersicum esculentum ), radish (Raphanus sativus) Monocot ( onion ) EC 25 = 1

. 4 lb ai/A NOAEC = 0. 61 lb ai/A

Based on reduction in shoot length.

Dicot ( lettuce ) EC 25 = 0.5 4 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 n on

- 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 informatio n 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 r eviewed by the Agency and deemed suitable for quant it ative use in risk assessment. These studies suggest 3,4

- DCA is more toxic to freshwater invertebrates than the parent propanil. The ECOTOX reference numbe rs and endpoints are listed in T able 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 putti ng both non

target 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 T able 6.3

, below. A full ECOSAR output is provided in Appendix 4. ECOSAR uses quantitativ e 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 th at 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 C ompared to K nown T oxicity E ndpoints

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 * pp b ECOTOX E55961 EC50 = 1,149 ppb

Chronic Freshwater Invertebrate NOAEC = 86 ppb (MRID 41776601) NOAEC = 1,126 ppb NOAEC = 10 * ppb ECOTOX E 102280 NOAEC = 15 ppb

Non

- vascular plant toxicity EC 50 = 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 pesti cides. Incidents listed in this database may also be in the EIIS.

Searches of the Ecological Incident Information System (EIIS v. 2.1.1), Avian In cident Monitoring System (AIMS) , and the a ggregate 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

, o ne 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

w hich suggests that the i ncident 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 terrestria l 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 sub mission 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 p roducts , t here are eight registered multiple active ingredient formulations (listed in Section 3) that contain propanil as part of the formulation. Although t he 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 s even of these registrations (5905

- 495, 71085

- 09, 71085

- 16, 71085

- 23, 71085

- 25, 71085

- 26 and 71085

- 29) which have definit ive LD 50 

### 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, 

### t he toxicity for all of these registratio ns can be attributed to propanil.

ii. Drinking Water

New d rinking water assessment that will be conducted as part of the registration review will include the parent propanil an d 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 eq ual toxicity to the parent ( USEPA 2006 RED ). T he 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. T he toxic equivalency (TEQ) approach for the parent an d 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. Av ailable 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 200 6 ) documented that 62 agricultural streams sampled as pa rt 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. P ropanil 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 conduct ing 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 de veloped 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 a nd 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 develop ment 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 ass essing 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

- Le vel 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 s pecific 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 t he 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 th e 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 wil l 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 Identi fication 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 a bsence 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) 835.4 100

- 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 1 1.1 . 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/A 1 N/A No ---



### 21OCSPP 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 d egradate 3,4

- DCA (TGAI), which w as 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/ILV s (water) --- --- Yes Data are requested for both
p ropanil 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 1 1.3 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 pre sented 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 1 1.2

. 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 l ater 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



### 23OCSPP 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 request ed 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



### 24OCSPP 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 ide ntified 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 us e 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



### 25OCSPP 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 l ater time if no toxicity endpoint is deemed acceptable for use in risk assessment.



### 26OCSPP 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 850.13 5 0. 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 l ater 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



### 27OCSPP 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 ( c yanobacteria) 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

or al study with a passerine species is
requ ested

. 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



### 29OCSPP 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

s ensitive 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



### 30OCSPP 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 conve rt 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 effec ts in the parent compound study will be attributed in entirety to the potential proportion of administered material that is observable as 3,4

- DCA.

Non

guideline Avian inhalation (None) N/A No

--

850.3020 Honeybee adult acute contact toxicity 00009181 Acceptable No

--



### 31OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for risk assessment? Justification and Assumptions EPA will Make in Absence of Data

Non

guideline (OECD 213) Honeybee adult acute oral toxicity ( N one) N/A Yes An acute oral toxicity study with the adult honey bee is needed per the Agency’s pollinator guidance (USEPA 2014c)

. Non

guideline Honeybee adult chronic toxicity (including acute endpoints) ( N one) N/A Yes A chronic oral toxicity study with the adult honeybee is needed per the Agency’s pollinator guidance (USEPA 2014c)

. Non

guideline Honeybee larval chronic toxicity (including acute endpoints) ( N one) N/A Yes A larval toxicity study is needed per the Agency’s pollinator guidance (USEPA 2014c)

. T he 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 t oxicity of

r esidues on f oliage ( None ) NA No The acute contact 48

- hr LD 50 was above >24 μg ai/bee. This study is only triggered if contact toxicity is less than 11 μg ai/bee.



### 32OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for risk assessment? Justification and Assumptions EPA will Make in Absence of Data

Non

guideline Residues 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.

Non

Guideline (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 worst

case exposure scenario of proposed uses to the entire colony.



### 33OCSPP 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 I I level per the Agency’s pollinator guidance (USEPA 2014c). A protocol should be submitted in advance of conducting the study.

850.4100 Seedling Emerg ence 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

--



### 34OCSPP 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 request s :

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 fram ework 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 p esticide 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 n eed 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.oecd

ilibrary.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 pote ntial 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 curr ently 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 restr ict 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 (N OAEL) 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 lin es 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 propan il . 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" insec ts, 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 l arval 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. Altho ugh 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 satis fy 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 asses s 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 be es. 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 t o 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 ass essment 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 benefi cial 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 a ffected 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 b e 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 studi es 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 fiel d

- 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 scre ening

- 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 t he 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

assessme nts 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 determi ne 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 defin e 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 natur ally 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 o f 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 ri sk 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: Pr opanil

– 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 app lications (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/pollinator

protection/pollinator

- risk

- assessment

- guidance

. Practical Utility of the Data



### 39

### How will the data be used? Measured residue d ata 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 fo r 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 8 th 

### 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

- from

pesticides

USEPA. 2001. Review of Environmental Fate and Ecological Ef fects 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 Decis ion (RED) for Propanil (September 2003) , Office of Pesticide Programs, United States Environmental Protection Agency. Docket: EPA

HQ

- 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 Pestici de 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. 2014 b . Propanil S creening L evel U sage A nalysis. Biological and Economic Analysis Division, Office of Pesticide Programs, United States Environmental Protection Agency.

USEPA. 2014 c . 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 Natu ral 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 Metaboli sm 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.



### 4142780401 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.; John son, 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.

422 00501 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 Wildlif e 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 Bobw hite: 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. U npublished 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 Rit chie, 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 Bow man, J. (1986) Acute Toxicity of Ordram: Propanil 3:3E to Blue

gill Sunfish (Lepomis macrochirus): Lab Project Number: 35224; 12556. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 61 p.

41613604 Bowman, J. (1986) Acute Toxicit y of Ordram: Propanil 3:3E to Rain

bow Trout (Salmo gairdneri): Lab Project Number: 35225; 12555. Unpublished study prepared by Analytical Bio

- Chemistry Labora

tories, Inc. 59 p.


### 4241613606 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

- s upplemental

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 (Mysidop

sis 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.

41 777101 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) Prop anil 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 Forc e (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. 3 98 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 stud y 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 Spr ingborn Labs., Inc. 235 p.



### 4347144702 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 Skele

tonema 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 Fres hwater 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 Apic ulture: Project No. 1499. (Unpublished study received Jul 29, 1976 under 352

- 342; prepared by Univ. of Cali

fornia

-- 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 ass ume 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 U ses 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 Red

legged 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

m ammals, 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, LD 50 

### = 201 mg ai/kg

- b w; 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 LD 50 

### = 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 A 3 .1 and A 3 .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 ( S creening T ool for I nhalation R isk, 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 appl ication rates (aerial/ground: 6 lb ai/A), most sensitive acute a vian toxicity endpoint (bobwhite qua i l, LD 50 

### = 201 mg ai/kg

- bw), and most sensitive acute oral and inhalation mammalian toxicity endpoints (rat, LD 50 

### = 1808 mg ai/kg

- bw and 4

- hr LC 50 

### > 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.



### 47Table A 3 .3. STIR Avian (0.020 kg) Results for Propanil
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 

### 1.07E

- 02

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 

### 1.34E

- 03 Adjusted Inhalation LD 50 

### 1.28E+00 Ratio of Vapor Dose to Adjusted Inhalation LD 50 

### 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 LD 50 

### 4.51E

- 01 Proceed to Refinements

Table A 3 .4. STIR Mammalian (0.15 kg) Results for Propanil
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 

### 1.07E

- 02

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 

### 1.68E

- 03 Adjusted Inhalation LD 50 

### 1.23E+02 Ratio of Vapor Dose to Adjusted Inhalation LD 50 

### 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 LD 50 

### 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

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

========================= 0007 09

- 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 Ec otoxicity 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 Log Kow 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) Maximu m 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 Estimat e) 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 Esti mate) Wat Sol: 92 (mg/L, PhysProp DB exp value)

------------------------------------------------ Available Measured Data from ECOSAR Training Set

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

Measur ed 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 (Un hindered) 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

- speci fic 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.

An ilines (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 Toxici ty 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