1

MEMORANDUM December 6, 2012

Subject: Registration Review – Preliminary Problem Formulation for Ecological Risk and 

Environmental Fate, Endangered Species, and Drinking Water Assessments for 

Iprodione (PC Code 109801; DP Barcode D402502)

To: James Parker, Risk Manager Reviewer

Laura Parsons, Team Leader

Neil Anderson, Risk Manager

Risk Management and Implementation Branch 1

Pesticide Re-evaluation Division

From: Chuck Peck, Environmental Engineer

Scott Glaberman, Ph.D., Biologist 

Environmental Risk Branch IV

Environmental Fate and Effects Division

Reviewed By: Jim Carleton, Ph.D., Senior Scientist

Thomas Steeger, Ph.D., Senior Science Advisor

Environmental Risk Branch IV

Environmental Fate and Effects Division

Through: Marietta Echeverria, Branch Chief

Environmental Risk Branch IV

Environmental Fate and Effects Division

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

formulation (attached) for the ecological risk, environmental fate, endangered species, and 

drinking water assessments to be conducted as part of the Registration Review of the fungicide 

iprodione (PC Code 109801). The problem formulation draws on studies submitted by the 

technical registrant in response to data requirements, studies available in the open literature, and 

other supporting documents (e.g., guidance documents, white papers). This document is intended 

to provide an overview of what is currently known about the environmental fate and ecological 

effects associated with total toxic residues of iprodione and its degradates, and outlines 

uncertainties regarding attributes of the parent compound and its transformation products. It 

describes the preliminary ecological risk hypothesis and the processes that will be used during 

the completion of drinking water and ecological risk assessments in support of Registration 

Review. This document also recommends studies that should be included in a data call-in (DCI) 

to address uncertainties surrounding the environmental fate and potential ecological effects of 

iprodione.

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460
Page 2 of 55

Problem Formulation for the

Environmental Fate and Ecological Risk, Endangered 

Species, and Drinking Water Assessments in Support 

of the Registration Review of Iprodione

3-(3,5-dichlorophenyl)-N-(1-methylethyl)-2,4-dioxo-1-imidazolidinecarboxa-mide

CAS No. 36734-19-7

PC Code: 109801

Prepared by:

Chuck Peck, Environmental Engineer

Scott Glaberman, Ph.D., Biologist

U. S. Environmental Protection Agency

Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch IV

1200 Pennsylvania Ave., NW

Mail Code 7507P

Washington, DC 20460

Reviewed by:

Jim Carleton, Ph.D., Senior Scientist

Thomas Steeger, Ph.D., Senior Science Advisor

Marietta Echeverria, Branch Chief

December 6, 2012
Page 3 of 55

Table of Contents

1. Introduction ............................................................................................................................ 4

2. Conclusions from Previous Risk Assessments....................................................................... 5

2.1. Ecological Risk Assessments....................................................................................... 5

2.2. Drinking Water Exposure Assessments....................................................................... 6

2.3. Clean Water Act Programs .......................................................................................... 6

3. Environmental Fate and Transport......................................................................................... 6

3.1. Parent ........................................................................................................................... 6

3.2. Transformation Products of Concern........................................................................... 8

4. Receptors................................................................................................................................ 9

4.1. Effects to Aquatic Organisms.................................................................................... 10

4.2. Effects to Terrestrial Organisms................................................................................ 13

4.3. Ecological Incidents................................................................................................... 15

5. Exposure Pathways of Concern and Risk Hypothesis.......................................................... 16

6. Analysis Plan........................................................................................................................ 17

6.1. Stressors of Concern .................................................................................................. 17

6.1.1. Ecological Risk Assessment ................................................................................... 17

6.1.2. Drinking Water Assessment ................................................................................... 18

6.2. Measures of Exposure................................................................................................ 18

6.3. Measures of Effect ..................................................................................................... 18

6.4. Endangered Species Assessments.............................................................................. 18

6.5. Endocrine Disruptor Screening Program................................................................... 19

7. Preliminary Identification of Data Gaps .............................................................................. 19

7.1. Environmental Fate Data ........................................................................................... 19

7.2. Effects Data................................................................................................................ 22

8. References............................................................................................................................ 30

Appendix A. Chemical Identity Table and Proposed Degradation Pathway ........................... 32

Appendix B. BEAD USE and Usage Reports.......................................................................... 35

Appendix C. OPPIN Bibliography........................................................................................... 38

Appendix D. SIP/STIR Model Results..................................................................................... 51

Appendix E. IDS Aggregate Incident Report for Iprodione .................................................... 53

Appendix F. Data Call-In Justification Tables for Non-guideline / Special Studies ............... 54
Page 4 of 55

1. Introduction

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

association with the updated toxicity, exposure, and usage information to determine if sufficient 

data are available and if further updates are needed to support Registration Review. Recent risk 

assessments include a 2012 assessment for the use of iprodione on fruiting vegetables and 

cucurbits (DP Barcode: D359480+, dated 2/2012). In addition, EFED considered the latest 

Agency science policies and risk assessment methodologies. The structure, chemical name, and 

other identifiers of iprodione and its major transformation products can be found in the chemical 

identity table attached to this document (Appendix A).

Iprodione (CAS No. 36734-19-7) is a dicarboximide contact and/or locally systemic fungicide, 

intended to inhibit germination of fungal spores and the growth of mycelia. In 2011, the 

Residues of Concern Knowledge Subcommittee (ROCKS) included three major degradates (e.g., 

≥ 10%) of iprodione as residues of concern, based on structures similar to the parent: 3-(1-

methylethyl)-N-(3,5-dichlorophenyl)-2,4-dioxo-1-imidazolidine-carboxamide (RP30228); 

[(dichloro-3,5-phenyl)-1-isopropylcarbamoyl-3]-2-acetic acid (RP35606); and 3-(3,5-

dichlorophenyl)-2,4-dioxo-1-imidazolidine-carboxamide (RP32490) (D393960, October 5, 

2011). Structurally, iprodione is related to dichloroanilines (DCA), with one of its degradates 

being 3,5-DCA, which is also considered a residue of concern. 

Iprodione is currently registered for use on a variety of field, fruit, and vegetable crops; and on 

turf (sod farms, golf courses, and ornamental turf uses). The chemical can be applied by

chemigation, aircraft, and foliar ground spray. Prior assessments have estimated exposure for 

maximum annual application rates ranging from 0.27 (cotton) to 24 (turf) lbs a.i./A (D359480+, 

2/2012). The chemical profile produced by the Biological and Economic Assessment Division 

(BEAD), located in the docket, lists the use patterns of maximum exposures for the current uses 

of iprodione. A brief summary of this chemical profile is provided in Appendix B.

For risk assessment purposes EFED will employ application scenarios that are expected to result 

in maximum exposure for each given use. Absence of information on the labels regarding

maximum single application rates, application intervals, allowable annual maximum rates, or 

application methods will result in conservative assumptions as illustrated in the following 

examples:

 If a maximum single application rate is specified with a re-application interval of 7 days

without specifying a maximum annual rate, an assumption of 26 applications with 7-day

intervals will be used;

 If a label does not preclude aerial applications, aerial pesticide applications will be 

assumed;

 If a label does not specify an application interval, an application interval of 3 days will be 

assumed.
Page 5 of 55

2. Conclusions from Previous Risk Assessments

2.1. Ecological Risk Assessments

The Agency has conducted ecological risk assessments on iprodione that serve as a basis for this 

problem formulation, including the 1998 Reregistration Eligibility Decision (RED) (USEPA, 

1998), the 2009 California Red-legged Frog (CRLF; Rana draytonii) endangered species 

assessment (USEPA 2009), and new use assessments in 2007. The potential risks identified in 

these assessments are briefly summarized in Table 1 and Table 2 below.

Iprodione has been characterized as moderately mobile, relatively nonvolatile, and most likely to 

degrade via alkaline hydrolysis (USEPA 2009).

The 1998 RED for iprodione indicated acute and chronic risks to Federally-listed threatened and 

endangered species (hereafter referred to as “listed”) and non-listed terrestrial birds and 

mammals at the higher application rates (e.g., greater than 4 lbs ai/A/year), particularly for 

granular products. Risk levels for listed and non-listed freshwater and estuarine/marine 

invertebrates exceeded levels of concern (LOCs) for acute risk for almost all uses, while chronic 

risks were only a concern at the highest application rates on turf for freshwater organisms, and 

on all uses for estuarine/marine organisms. Freshwater and estuarine/marine vertebrate acute 

and chronic risk quotient (RQ) values exceeded LOCs only at the highest application rates used 

on turf. Nonvascular aquatic plants had LOC exceedences at the highest application rates used 

on turf and rice.

Iprodione is a member of the imide group of the dicarboximide class of fungicides, as are the 

active ingredients vinclozolin and procymidone. In the 2000 RED for vinclozolin (USEPA 

2000), the Agency concluded that, while current data were limited, certain evidence was 

available that these compounds may modulate androgens by a common mechanism of toxicity. 

Because of the complexity of the androgen system, a careful evaluation was needed before a 

formal decision could be made. At that time, the Agency did not believe it had sufficient reliable 

information concerning common mechanism issues to determine whether or not vinclozolin 

shares a common mechanism of toxicity with iprodione and/or procymidone. For the purposes of 

that risk assessment, the Agency assumed that vinclozolin did not share a common mechanism of 

toxicity with other imide fungicides.

Previous ecological risk assessments (DP Barcode D315437, DP Barcode D313332, USEPA 

2007a and DP Barcode D339724, USEPA 2007b) identified acute risks to listed terrestrial birds 

and mammals, aquatic vertebrates and invertebrates, and aquatic plants. Chronic risks were 

identified for non-listed terrestrial birds and mammals. Risks were also identified for listed 

aquatic plants. At the time terrestrial plant data were unavailable, so acute and chronic risks to 

terrestrial plants could not be precluded.

The most recent ecological risk assessment was an endangered species assessment conducted for 

the California Red-legged Frog (USEPA 2009). Acute and chronic RQs for the aquatic-phase 

CRLF exceeded the LOCs for all iprodione uses. Acute and chronic risk LOCs were also 

exceeded for the majority of the iprodione uses for the terrestrial-phase CRLF.
Page 6 of 55

Previous ecological assessments only focused on risks from iprodione and did not include

degradates RP30228, RP35606, and RP32490. Had exposure values accounted for these 

residues, RQ values would have been higher and the number of uses/taxa for which acute and/or 

chronic risk LOCs would have been exceeded likely increased.

Table 1. Potential risk concerns identified in previous assessments for iprodione

Birds Mammals Terrestrial

Invertebrates

Aquatic 

Vertebrates

Aquatic 

Invertebrates

Terrestrial

Plants

Aquatic 

Plants

Non-listed C C -- -- -- No data --

Listed A, C A, C -- A, C A, C No data A

A- Acute risk, C – Chronic risk, -- - no risk

Table 2. Potential environmental concerns identified in previous assessments for iprodione

Bioaccumulation Groundwater Contamination Persistence Degrades of Concern

√ √ Water, Sediment 3,5-DCA (RP32596), RP30228, 

RP35606, and RP32490

2.2. Drinking Water Exposure Assessments

A drinking water exposure assessment for the proposed new uses of iprodione on fruiting 

vegetables and cucurbits was conducted in 2012 (USEPA, 2012). Exposure estimates of 

iprodione total toxic residues from currently labeled uses that produce maximum exposure (turf) 

were 92 μg/L (1-in-10-year peak), 31 μg/L (1-in-10-year annual mean), and 18.0 μg/L (30-year 

mean) for surface water and 0.29 μg/L for ground water. Exposure estimates of 3,5-DCA from 

currently labeled uses that produce maximum exposure (turf) were 115 μg/L (1-in-10-year peak), 

42 μg/L (1-in-10-year annual mean), and 27.0 μg/L (30-year mean) for surface water and 0.81 

μg/L for ground water. The 2012 drinking water assessment included a comprehensive 

evaluation of all registered uses and characterized available monitoring data, especially for turf 

uses, as well as modeling results. Observed differences in the modeling and monitoring turf 

concentrations appeared to be driven by the difference in maximum allowable use specified on 

the labels and the amount that was used during the monitoring study. 

2.3. Clean Water Act Programs

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

section 303(d) of the Clean Water Act. No Total Maximum Daily Loads (TMDL) or section 

304(a) ambient water quality criteria have been developed for iprodione. Aquatic life 

benchmarks have been established for iprodione 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. 

3. Environmental Fate and Transport

3.1. Parent

Iprodione is moderately mobile (FAO soil mobility classification) in soils, with an organic 

carbon partition coefficient (Koc) around 500 mL/g. It is not volatile and, as such, is not subject 
Page 7 of 55

to long-range aerial transport. Iprodione is expected to be most persistent in acidic environments

(pH 5), with hydrolysis half-lives around 130 days in aquatic systems; however, in neutral (pH 7)

aquatic systems, the hydrolytic half-life is only 4.7 days, and in alkaline systems (pH 9)

iprodione hydrolyzes rapidly (half-life 27 minutes). As a result, iprodione degradation is 

expected to occur primarily via hydrolysis in the water in natural aquatic environments. It

should be noted that the half-life in the aerobic aquatic metabolism study is longer (t1⁄2 = 9 days at 

pH 8.5), indicating that the addition of sediment impedes the degradation of iprodione. As only 

one aerobic aquatic metabolism study has been submitted, additional data could potentially

clarify this uncertainty. In an aquatic photolysis study, iprodione degraded slowly with a halflife of 67 days in a pH 5 buffered solution, with no major degradates (≥10% of the applied) 

observed. The iprodione log octanol/water partition coefficient (log Kow) of 3.1 indicates limited 

potential for bioaccumulation. According to the submitted study (MRID 430910-01), iprodione 

does not bioaccumulate appreciably in bluegill sunfish (Lepomis macrochirus), with maximum 

bioaccumulation factors of only 116X for nonedible tissues, 51X for edible tissues, and 72X for 

whole fish. Depuration was rapid (t1⁄2 < 1 day). 

Submitted iprodione soil degradation studies show high levels of unextracted and unidentified 

residues, leading to uncertainty in characterization of the chemical’s degradation. In an aerobic 

soil degradation study (MRID 430910-02), 75-87% of the residues at Day 276 were unextracted 

and uncharacterized. Unextracted residues exceeded 10% of applied between Days 14 and 30 of 

the study. Thus the extent to which these residues constitute parent iprodione or degradates of 

concern remains unknown. However, based on 3,5-DCA’s affinity to bind to soil in aged 

systems or be transformed to other unextracted residues that are not available for off-site 

transport (see discussion under Section 3.2 Transformation Products of Concern) and that 3,5-

DCA is considered the terminal degradate in iprodione metabolism studies, EFED will assume 

that the unextracted and uncharacterized residues in the iprodione aerobic soil metabolism soil 

study (MRID 430910-02) are 3,5-DCA. EFED will conservatively estimate a 75% molar 

conversion of iprodione to 3,5-DCA. In terrestrial and aquatic field dissipation studies, 

iprodione dissipated with half-life (DT50) values ranging from 3 to 7 days, at pH values (6.2-8) 

which suggest that hydrolytic degradation may have been a contributing factor in the observed 

dissipation. However, due to the presence of substantial unextracted/unidentified residues in the 

aerobic soil metabolism study, the extent to which these DT50 values represent degradation, as 

opposed to (for example) temporary sequestration of iprodione (and/or its degradates of concern) 

is not known. 

Table 3 summarizes the general fate properties of iprodione and the three residues of concern 

RP30228, RP35606, and RP32490. Table 4 summarizes properties of 3,5-DCA as ascertained 

using a combination of registrant-submitted studies and the Estimation Program Interface 

(EPI)Suite1of tools.

 

1 The EPI (Estimation Programs Interface) SuiteTM is a Windows®

-based suite of physical/chemical property and environmental 

fate estimation programs developed by the EPA’s Office of Pollution Prevention Toxics and Syracuse Research Corporation 

(SRC). EPI SuiteTM uses a single input to run the following estimation programs: KOWWINTM, AOPWINTM, HENRYWINTM, 

MPBPWINTM, BIOWINTM, BioHCwin, KOCWINTM, WSKOWWINTM, WATERNTTM, BCFBAFTM, HYDROWINTM, 

KOAWIN and AEROWINTM, and the fate models WVOLWINTM, STPWINTM and LEV3EPITM. ECOSARTM, which estimates 

ecotoxicity, is also included in EPI SuiteTM.
Page 8 of 55

Table 3. Chemical properties and environmental fate parameters of iprodione

Property Value Source/MRID Comments

Molecular formula C13H13Cl2N3O3 Formula reported for iprodione

Molecular weight (g/mole) 330.2 Value reported for iprodione

Vapor pressure (Torr, 20oC) 1.0x10-7412305-03 Value reported for iprodione

Henry’s Law Constant 

(atm m3/mol) 3.3x10-9 calculated =(vp/760)/(MW/sol); vp in Torr; sol in mg/L; MW in g/mol

Octanol/Water Coefficient

(Log Kow, 22°C) 3.1 477788-02 Value reported for iprodione

Solubility in water (mg/L, 20oC) 13 477788-02

Hydrolysis half- life (days)

pH Parent TTR1

418854-01

Study conducted for 30 days 

(pH 5), 125 hours (pH 7), and 

121 minutes (pH 9).

5

7

9

131

4.7

0.02

772

266

56

Aqueous photolysis half- life 

(days) 64 (parent and TTR) 418619-01

Aerobic soil half-life (days)

Parent TTR

430910-022

High amounts of unextracted 

material (75-87%). These 

residues are assumed to be 3,5-

DCA.

16 19.2

Aerobic aquatic half-life (days) Parent TTR 419276-01/

425038-01 pH = 8.5 9 60.7

Anaerobic aquatic half-life (days) Parent TTR 417558-01 pH = 7.4 11 92

Organic carbon partitioning 

coefficient (Koc) (mL/goc)

223(sandy loam)

432 (loamy sand)

507 (loam)

543 (clay)

433492-02 Values reported for iprodione

Bioconcentration factor 72 (whole fish) 430910-01

Terrestrial field dissipation DT50

(days)

Parent TTR

418774-01 CA - silt loam

NC - loamy sand CA 7 28

NC <3 <3

Aquatic field dissipation DT50

Water

 3.7 days (TX)

 2.9 days (MS)

Sediment

 3.4 months (TX)

 4.1 months (MS)

437183-01 Values reported for iprodione

1. TTR = Total Toxic Residue. Includes iprodione, RP30228, RP35606, and RP32490.

2. A second aerobic soil metabolism study (MRID 445905-01) was conducted in 1993. However the study was classified as supplemental because 

nonextractable [14C] residues and volatiles were not measured, so a material balance could not be determined.

3.2. Transformation Products of Concern

A summary of major degradates observed in laboratory and field studies, their structures, and 

degradation pathways, as proposed by the registrant, is provided in Appendix A. Appendix A

also lists the degradates by study type, and the maximum percent of applied at which each of the 

degradates was detected. The human Health Effects Division (HED) has identified degradates 

3,5-DCA (RP32596), RP30228, RP35606, and RP32490 as residues of concern (D393960, 

October 5, 2011). By including the precursor degradates RP30228, RP35606, and RP32490 in 

the risk assessment with parent iprodione (iprodione TTR) and conducting a separate assessment 

for 3,5-DCA, the ROCKS felt the overall approach would be sufficiently conservative and 
Page 9 of 55

protective of the assessed risks, including those for cancer. As such, this assessment will also 

separately consider exposures to iprodione TTR and to 3,5-DCA. 

An aerobic soil metabolism study (MRID 452392-01) conducted by applying 3,5-DCA to two 

different soils showed little evidence that 3,5-DCA appreciably degraded over a 9-month period 

at 25oC. Apparent dissipation was caused by a high level of unextracted residues. Unextracted 

residues accounted for 66% and 81% of the applied in the two systems. The only residues that 

were distinguishable from the applied 3,5-DCA amounted to only 4 to 5% of the applied 14C. In

order to address the issue of unextracted residues, a second study was submitted in 2010 which 

used more aggressive analytical methods to extract 3,5-DCA from the soil (MRID 482192-01). 

Based on nonlinear regression analysis, estimated half-lives ranged from 40 to 107 days in silt 

loam and sand soils. Unextractable residues were still high, and averaged 54.4-67.8% of the 

applied at 119 days posttreatment; however, based on an EPA review of the analytical method, in 

which sufficiently exhaustive methods were employed to extract 3,5-DCA, it was determined 

that the 3,5-DCA residues were bound to the soil and assumed unavailable for off-site transport.

Table 4. Summary of fate properties of the iprodione degradate 3,5-DCA

Property Value Source/MRID Comments

Molecular formula C6H5Cl2N

Molecular wt 162 Product chemistry data

Solubility (mg/L) 784 EPI Suite

Vapor pressure 

(Torr, 25oC) 8.5x10-3 EPI Suite

Henry’s Law Constant

(atm m3/mol) 10-6 EPI Suite

Aerobic soil half-life

(days)

50.2 (sandy loam) 430910-02 High levels of 

unextracted residues (see 

text). Half-lives do not 

include unextracted 

residues based on 

extensive extraction 

techniques.

7.9 (silt loam)

17.6 (sandy loam) 452392-01

49 (silt loam)

107 (sand) 482192-01 (8.3 mg/kg applied)

40 (silt loam)

59 (sand)

482192-01 (1.47 mg/kg applied)

Organic carbon 

partitioning coefficient 

(Koc) (mL/goc)

380 (silt loam)

593 (sandy loam)

626 (loamy sand)

788 (pond sediment, sand)

932 (clay)

451141-01

4. Receptors

The most sensitive endpoint for each group of organisms will be used in the risk assessment. 

Assessment endpoints include direct toxic effects on the survival, reproduction, and growth of 

terrestrial and aquatic life, as well as indirect effects, such as reduction in prey base and/or 

modification of habitat. A summary of the available aquatic and terrestrial toxicity data for 

iprodione and its degradates is provided in Sections 4.1 and 4.2, respectively. In addition, a 

summary of ecological incidents associated with iprodione is provided in Section 4.3. Further 

discussion of potential degradate toxicity is provided in the description of the stressors of 

concern for iprodione (Section 6.1).
Page 10 of 55

Acute toxicity to fish and aquatic invertebrates is categorized using the system shown in Table 5

(USEPA 2004). Acute toxicity to terrestrial fauna (birds and mammals) is categorized using the 

system shown in Table 6. Acute toxicity categories for plants have not been defined.

Table 5. Categories of acute toxicity for aquatic animals

LC50 (mg/L) Toxicity Category

< 0.1 Very highly toxic

> 0.1 - 1 Highly toxic

> 1 - 10 Moderately toxic

> 10 - 100 Slightly toxic

> 100 Practically nontoxic

Table 6. Categories of acute toxicity for terrestrial animals

LD50 (mg/kg) LC50 (ppm) Toxicity Category

<10 <50 Very highly toxic

10-50 50-500 Highly toxic

51-500 501 - 1000 Moderately toxic

501-2000 1001 - 5000 Slightly toxic

>2000 >5000 Practically nontoxic

4.1. Effects to Aquatic Organisms
Page 11 of 55

Table 7 contains a summary of available iprodione toxicity data for aquatic organisms.

Iprodione is highly toxic to freshwater invertebrates and moderately toxic to estuarine/marine 

invertebrates on an acute exposure basis. No acceptable acute toxicity data are available for 

freshwater or estuarine/marine fish; since fish serve as surrogates for aquatic-phase amphibians, 

there is uncertainty regarding the potential effects of iprodione to amphibians as well. Chronic 

exposure to iprodione affected survival, growth, and reproduction in freshwater invertebrates and 

offspring survival in freshwater fish.

Several toxicity studies with aquatic organisms that were submitted to the Agency in the past 

have recently been re-evaluated and deemed unacceptable due to exposure concentration and/or 

solubility problems with the test substance (see Table 12 for a list of reclassified studies and the 

rationale for reclassification).

Acceptable aquatic plant toxicity data for iprodione are available for green algae, marine 

diatoms, and duckweed (Lemna gibba), but not for freshwater diatoms and cyanobacteria. Green 

algae and duckweed were not adversely affected by iprodione during limit tests, while a 

definitive endpoint was derived for marine diatoms.
Page 12 of 55

Table 7. Aquatic Toxicity Profile for Iprodione

Group Species

(Common Name)

Study Type:

Measured Effect

Endpoint

(Test 

Duration)

Toxicity Value

mg ai/L

(Acute Toxicity 

Category)

MRID 

(Study 

Classification)

Freshwater 

Fish1

Pimephales 

promelas

(Fathead Minnow)

Chronic early lifestage

(Reduced larval 

survival 

NOAEC

(34 days) 0.26*

405508-01

(Supplemental)

Freshwater 

Invertebrates Daphnia magna Acute (Immobilization)

EC50

(48 hours)

0.24*

(Highly Toxic)

416420-01

(Supplemental)

Estuarine/

Marine 

Invertebrates

Crassostrea 

virginica

(Eastern oyster)

Acute

(Shell deposition)

EC50

(96 hours)

2.3*

(Moderately 

Toxic)

404892-02

(Supplemental)

Americamysis bahia

(Mysid shrimp) Chronic/life-cycle

NOAEC

(28 days) 0.0035* 408322-01

NOAEC

(28 days) <0.015† 405508-02(Supplemental)

Vascular 

Aquatic Plants

Lemna gibba

(duckweed)

(Frond number, 

growth rate, 

biomass)

EC50

(7 days) >12.64†

457413-01

(Supplemental) NOAEC 12.64

Non-Vascular 

Aquatic Plants

Pseudokirchneriella 

subcapitata

(green algae)

(Cell density)

EC50 >0.13†

416041-07

(Supplemental)‡ NOAEC 0.13

Skeletonema 

costatum

(marine diatom)

(Cell density)

EC50

(120 hours) 0.226*

416041-09

NOAEC (Acceptable)

(120 hours) 0.0145*

EC50 Effect concentration for 50% of the organisms tested; NOAEC no observed adverse effect concentration

* Bold values represent most sensitive endpoint and will be used for RQ calculations unless more sensitive data become available.

† Non-definitive study endpoint; cannot be used to calculate RQs for risk estimation.

‡ Freshwater fish may be surrogates for aquatic-phase amphibians.

§

Study only tested up to 0.13 mg ai/L (0.17 lbs ai/A)

Four degradates of iprodione are considered residues of concern for risk assessment: RP30228,

RP35606, RP32490, and 3,5-DCA. No registrant-sponsored toxicity studies have been 

submitted for these degradates. According to the most recent risk assessment of iprodione, 

several open-literature toxicity studies are available for 3,5-DCA which indicate that this 

degradate is less toxic to aquatic organisms than iprodione (USEPA, 2009). However, these 

open-literature studies have not been thoroughly reviewed by EPA. A comprehensive literature 

review of all relevant toxicity studies for 3,5-DCA and other degradates of concern using the 

ECOTOXicology (ECOTOX) database2 will be carried out during the upcoming Registration 

Review ecological risk assessment of iprodione. Additionally, EPA will consider data for other 

dichloroanalines and parachloroanalines (e.g., 3,4-DCA, p-chloroaniline) as surrogates in the 

absence of data for 3,5-DCA.

 

2

The ECOTOXicology database (ECOTOX) is a source for locating single chemical toxicity data for aquatic life, terrestrial 

plants and wildlife. ECOTOX was created and is maintained by the U.S.EPA. http://cfpub.epa.gov/ecotox/
Page 13 of 55

4.2. Effects to Terrestrial Organisms

Table 8 contains a summary of available iprodione toxicity data for terrestrial organisms.

Iprodione is classified as practically non-toxic to birds on a subacute dietary exposure basis and 

practically non-toxic to slightly toxic to birds and mammals on an acute oral exposure basis. 

Since birds serve as surrogates for reptiles and terrestrial-phase amphibians, and without data to 

the contrary, toxicity estimates for birds will apply to these other taxa as well. No suitable acute 

toxicity data are available for young adult honeybees (Apis mellifera), which are used as a 

surrogate for terrestrial invertebrates; however, it should be noted that a recent incident with 

honeybees, which reported large losses in bee colonies (approximately 50% of bees), has been

attributed to application of iprodione (see Section 4.3 for further description of iprodione-related 

incidents).

Chronic exposure to iprodione in birds resulted in a NOAEC of 300 mg/kg-diet in the Northern 

bobwhite quail, with a LOAEC of 1000 mg/kg-diet based on reduced number of eggs laid, 

decreased hatchling body weight and decreased number of hatchlings per number of eggs set.

The most sensitive chronic effects in mammals were during a 2-year feeding carcinogenicity

study in rats which reported a NOAEC of 150 ppm (6.1 in males and 8.4 mg/kg/day in females) 

and a LOAEC of 300 ppm (12.4 in males and 16.5 mg/kg/day in females) based on reduced 

spermatozoa in the epididymis and reduced secretion of the seminal vesicles of males. The 

effects of iprodione on sperm and semen production are considered effects that could potentially

reduce male fertility and impact reproductive success in mammals. 

No acceptable terrestrial plant toxicity data were identified for iprodione.

Table 8. Terrestrial toxicity profile for iprodione

Group Species Study Type (Effect)

Endpoint

(Test 

Duration)

Toxicity Value

(Acute Toxicity 

Category)

MRID

(Study 

Classification)

Birds‡

Anas 

platyrhynchos 

(mallard duck)

Acute oral (Survival)

LD50

(Not 

Reported)

>10,437 mg a.i./kgbw†

(Practically nontoxic)

Acc. No. 

00232703

(Supplemental)

Sub-acute dietary 

(Survival)

LC50

(8 days)

>5,620 mg a.i./kgdiet†

(Practically nontoxic)

416041-03

(Acceptable)

Reproductive toxicity 

test (Reduction in 14-day

old survivors)

NOAEC 300 mg ai/kg-diet Acc. No.00086840

(Acceptable)

Colinus 

virginianus

(Northern 

Bobwhite 

Quail)

Acute oral (Survival)

LD50

(6 days)

930 mg a.i./kg-bw*

(Slightly toxic)

Acc. No. 

00232703

(Supplemental)

LD50

(14 days)

>2,000 mg a.i./kgbw†

(Practically nontoxic)

416041-01

(Acceptable)
Page 14 of 55

Group Species Study Type (Effect)

Endpoint

(Test 

Duration)

Toxicity Value

(Acute Toxicity 

Category)

MRID

(Study 

Classification)

Sub-acute dietary 

(Survival)

LC50

(8 days)

>5,620 mg a.i./kgdiet†

(Practically nontoxic)

416041-02

(Acceptable)

Reproductive toxicity

(Eggs laid, hatchling 

body weight, percentage 

of hatchlings of eggs set)

NOAEC 300 mg ai/kg-diet*

Acc. No.

00099126

(Acceptable)

Mammals

Rattus 

norvegicus

(laboratory rat)

Acute oral (Survival)

LD50

1,160 mg ai/kg-bw*

(Slightly toxic)

Acc. No. 

00236497

LD50

3,050 mg ai/kg-bw

(Practically nontoxic)

Acc. No. 

00232701

LD50

4,468 mg ai/kg-bw

(Practically nontoxic)

423063-01

Rat 2-year feeding/

carcinogenicity study

(Testicular hyperplasia, 

reduced spermatozoa in 

epididymis)

NOAEC 150 mg ai/kg-diet* 426378-01

Rat 2-generation 

reproductive toxicity test

(Decreased parental body 

weight, body weight 

gain, and food 

consumption in both 

sexes)

NOAEC 300 mg ai/kg-diet 418716-01

Terrestrial 

Invertebrates No Toxicity Data Available

Terrestrial 

Plants No Toxicity Data Available

LC50 lethal concentration for 50% of the animals tested; LD50 lethal dose for 50% of the animals tested; NOAEC no observed adverse effect 

concentration (mg/kg-diet); NOAEC no observed adverse effect concentration (mg/kg-diet)

* Bold values represent the most sensitive endpoint and will be used for RQ calculations unless more sensitive data become available.

† Non-definitive study endpoint; cannot be used to calculate RQs for risk estimation.

‡ Birds represent surrogates for terrestrial-phase amphibians and reptiles.

No iprodione degradate (e.g., RP30228, RP35606, RP32490, and 3,5-DCA) toxicity data are 

available for terrestrial organisms; however, based on the structural similarity between RP30228,

RP35606, RP32490 to iprodione, and in the absence of data to the contrary, the degradates are 

presumed to exhibit similar toxicity to that of the parent compound . 

As noted in the RED (USEPA 1998), the degradate 3,5-DCA is not a registered pesticide; 

therefore, there are no FIFRA (Federal Insecticide, Fungicide and Rodenticide Act) toxicology

data for this compound. In the past, EPA has used p-chloroaniline (PCA) to assess the 
Page 15 of 55

carcinogenic risk for other structurally related chloroanilines. The EPA policy specifies that 

chloroaniline metabolites should be considered to be toxicologically equivalent to PCA unless 

there is sufficient evidence that the metabolite is not carcinogenic. Therefore, given the 

structural similarity of 3,5-DCA and PCA, the degradate is considered to be of concern. For the 

purposes of risk assessment, if suitable toxicity data are not available for 3,5-DCA, either 

through registrant-submitted studies or studies located in the ECOTOX database, risks from 3,5-

DCA may be evaluated by considering toxicity data from PCA and 3,4-DCA, both of which have 

similar molecular structures to 3,5-DCA. EFED is also recommending, at a minimum, that a 

chronic reproduction study with Daphnia be carried out with 3,5-DCA to provide some 

information on the toxicity of this degradate to aquatic organisms. The results of this study

would provide information on the relative toxicity of 3,5-DCA as compared to iprodione, which 

would help determine whether 3,5-DCA is of toxicological concern for risk assessment. Results 

from this study would also serve as a basis for comparing the toxicity of 3,5-DCA to PCA and 

3,4-DCA, which would indicate whether these chemicals are suitable toxicity surrogates for 

estimating risks from 3,5-DCA.

4.3. Ecological Incidents

A review of the Ecological Incident Information System (EIIS) for incidents involving iprodione 

was completed on August 9, 2012. A total of 19 incidents were identified in the EIIS of which 

fourteen are from iprodione use on blueberries and took place during March/April, 2003 

(I014027-001 to I014027-014). Except for one incident in Mississippi, the remainder of the 

incidents involving blueberries and occurred in Georgia. The damage to blueberries was due to 

direct treatment with iprodione, but the nature of the damage was not specified in the incident 

report. The level of certainty that iprodione was the cause of these incidents is listed as “highly 

probable.” All incidents involved registered uses of the substance. 

An incident involving ornamental plants in Washington County, Oregon (IO13636-027), resulted 

in unspecified damage to 6 acres of tulips following direct application of iprodione on February

4, 2002.

Application of iprodione to an unspecified agricultural area in California (IO20302-002) resulted 

in the death of honeybee brood following application of Rovral to blooming almond trees. The 

incident report included an unpublished manuscript by Mussen et al. (2008) describing the 

adverse effects of the formulated iprodione product Rovral®on honeybee brood development. 

The certainty of the bee kill incident being related to iprodione is classified as “probable”.

Another bee kill incident was recently reported and took place on March 13, 2012 (I023830-

001). Rovral®fungicide was reportedly applied to a cherry orchard by airblast sprayer during the 

evening when bees being used for pollination services were in the vicinity. Of the 80 colonies 

reported to be in the orchard, roughly 20% exhibited a reduction in forage force (reduced 

numbers of adult bees), and adult bee populations in these colonies were estimated at roughly

50%. Although spraying occurred in the evening hours, bees were likely bearding on the outside 

of the colonies and were directly sprayed with Rovral®. This was a registered use of iprodione.
Page 16 of 55

Application of iprodione to golf course turf (B000177-001) in Arlington, Virginia, in 1992 

resulted in the death of a single bluebird (Sialia spp.). The legality of the use is not reported and 

the certainty of it being related to iprodione is classified as “unlikely.” This incident is also 

captured in the Avian Incident Monitoring System (AIMS; American Bird Conservancy 2009)3

in which it is reported that the insecticide chlorpyrifos (CAS No. 2921-88-2) and the fungicide 

metalaxyl (57837-19-1) were also in use at the time. Given that chlorpyrifos is considerably 

more toxic to birds than iprodione on an acute oral and subacute dietary exposure basis, the 

likelihood that the death of the bluebird resulted from iprodione is considered low.

Only a single aquatic incident is reported in EIIS associated with the registered use of iprodione 

on golf course turf (I000910-001) in St. John the Baptist Parish, Louisiana, on June 7, 1992. The 

incident involved the death of an unspecified number of golden shiners (Notemigonus 

crysoleucas), catfish (Ictaluridae), needlefish (Strongylura exilis), minnows (Cyprinidae), perch 

(Percidae) and sunfish (Centrarchidae) due to runoff. The certainty of the incident being related 

to the application of iprodione to the golf course is classified as “possible”.

A search of OPP’s aggregate incident report database on July 24, 2012 revealed a total of 9 

minor plant incidents between 2003 and 2006 that were attributed to iprodione (Appendix E). 

Since little detail is provided about the individual incidents in the aggregate database, it is 

unclear whether there is overlap with the plant incident entries in the EIIS database.

5. Exposure Pathways of Concern and Risk Hypothesis

The environmental fate properties of iprodione and its transformation products indicate that 

direct application, spray drift, and runoff represent potential transport mechanisms of iprodione 

TTR and 3,5-DCA exposure to aquatic and terrestrial organisms and plants. Drinking water and 

inhalation exposure pathways were screened using the SIP (Screening Imbibition Program) and 

STIR (Screening Tool for Inhalation Risk) screening methods, respectively, and were found to 

be exposure pathways of low concern (no LOC exceedances are expected) (Appendix D). SIP 

and STIR are described in detail at: http://www.epa.gov/oppefed1/models/terrestrial/index.htm.

Based on previous ecological risk assessments, iprodione has the potential to result in acute risk 

to listed terrestrial birds and mammals, listed aquatic vertebrates and invertebrates, and aquatic 

plants, as well as result in chronic risk to listed and non-listed terrestrial birds and mammals and 

listed aquatic vertebrates and invertebrates. However, as the prior assessments did not include 

the new degradates as iprodione residues of concern, the following risk hypothesis will be used 

for this risk assessment: 

Based on environmental fate parameters and potential transport pathways, iprodione total toxic 

residues and 3,5-DCA have the potential to reduce survival, reproduction, and/or growth in nontarget terrestrial animals, aquatic vertebrates and invertebrates, and aquatic plants when used 

in accordance with the current labels. These non-target organisms include Federally listed 

threatened and endangered species as well as non-listed species.

 

3 Available at: http://www.abcbirds.org/abcprograms/policy/toxins/aims/aims/index.cfm
Page 17 of 55

6. Analysis Plan

6.1. Stressors of Concern

6.1.1. Ecological Risk Assessment

The stressors of ecological concern for terrestrial organisms are iprodione and its major

degradates RP30228, RP35606, RP32490, and 3,5-DCA (RP32596), the last of which will be 

assessed separately during risk assessment. Because of their structural similarity to iprodione

and in the absence of data to the contrary, RP30228, RP35606, and RP32490 are expected to 

have toxicity similar to that of iprodione, and will therefore be included with iprodione as part of 

total toxic residues (TTR). A TTR approach for the above three degradates is the default option 

for risk assessment if suitable toxicity information on these degradates is not available. However, 

if suitable degradate toxicity data are submitted or located through the ECOTOX database, there 

is the potential to derive exposure and risk values for these degradates independently, or 

eliminate the degradates from the TTR. Conversely, since the general structural properties of 3,5-

DCA are different from iprodione, the mode of action in ecological receptors is also likely to be 

different. Therefore, 3,5-DCA will be evaluated separately during risk assessment using a 

separate set of exposure and toxicity values. A list and discussion of recommended toxicity data 

for iprodione degradates is provided in Section 7.2 and Table 13.

In an effort to generate at least some relative toxicity information for iprodione and its 

degradates for purposes of problem formulation, toxicity estimates were obtained using the 

Assessment Tools for the Evaluation of Risk (ASTER) (Table 9). The ASTER database4

integrates aquatic and terrestrial toxicity information and quantitative structure activity 

relationships (QSARs) to assess the environmental toxicity of discrete chemicals. ASTER is 

designed to provide high quality data for discrete chemicals, when available in the ECOTOX 

database, and mechanistically-based QSAR estimates when data are lacking. Based on a 

comparison of QSAR-predicted toxicity values for parent and degradates, RP30228 and 

RP35606 are potentially more toxic than the parent based on QSAR estimates, while degradate 

RP32490 appears to be substantially less toxic than the parent. The degradate 3,5-DCA is also 

potentially more toxic than iprodione, but will be assessed separately. It should be noted that the 

mode of action basis from QSAR predictions in ASTER was nonpolar narcosis for iprodione and 

its structurally similar degradates, and polar narcosis for 3,5-DCA. Since these modes of action 

are highly non-specific, they are of limited utility for predicting toxicity.

Table 9. ASTER Ecotoxicity Profile for Iprodione and Degradates.

Compound

Estimated 4-day LC50 Median Concentration (μg/L)

Pimephales 

promelas

(fathead minnow)

Ictalurus 

punctatus

(channel catfish)

Daphnia 

magna

(waterflea)

Oncorhynchus 

mykiss

(rainbow trout)

Lepomis 

macrochirus

(bluegill sunfish)

Iprodione 23,310 10,062 13,251 9,473 18,645

3,5-

Dichloraniline

(RP32596)

14,198 6,127 7,983 5,820 11,307

RP30228 16,019 6,918 9,282 6,413 12,910

RP32490 505,614 217,558 243,983 233,664 379,257

 

4 More information at: http://www.epa.gov/med/Prods_Pubs/aster.htm
Page 18 of 55

Compound

Estimated 4-day LC50 Median Concentration (μg/L)

Pimephales 

promelas

(fathead minnow)

Ictalurus 

punctatus

(channel catfish)

Daphnia 

magna

(waterflea)

Oncorhynchus 

mykiss

(rainbow trout)

Lepomis 

macrochirus

(bluegill sunfish)

RP35606 5,349 2,312 3,287 2,045 4,411

Note: all toxicity estimates in this table are based on QSAR, as ASTER did not identify any empirical toxicity data 

for degradates through the ECOTOX database.

6.1.2. Drinking Water Assessment

In 2012 a drinking water assessment (USEPA 2012, D359480+) was conducted which modeled 

separately the estimated drinking water concentrations (EDWCs) for iprodione residues of 

concern (iprodione and the three degradates RP30228, RP35606, and RP 32490) and 3,5-DCA in 

surface water and groundwater. The 3,5-DCA was assessed separately because the mechanism of 

action for 3,5-DCA is different from that of iprodione. Pending receipt and review of additional 

environmental fate and toxicity data for iprodione and its degradates, or changes in labeled use 

rates, the drinking water assessment will be reevaluated. However, if no new, relevant data 

regarding the environmental fate, toxicity, or use of iprodione or its degradates are submitted, the 

EDWCs from the 2012 drinking water assessment will be used in this risk assessment.

6.2. Measures of Exposure

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

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

Iprodione residues of concern (iprodione and the three degradates RP30228, RP35606, and RP 

32490) and 3,5-DCA will be modeled separately in aquatic environments.

6.3. Measures of Effect

Selected toxicity data presented in Section 4 of this problem formulation will be used to calculate 

RQ values. Any additional information submitted by the registrant or found in the open 

literature prior to conduct of the risk assessment will also be considered. The open literature 

studies are identified using EPA’s ECOTOX5database, 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.

6.4. Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the

Agency will evaluate risks to listed species from registered uses of pesticides in Registration 

Review. These assessments will be conducted in accordance with standard EPA procedures and 

good scientific judgment. The process for evaluating potential risks to listed species is further 

 

5

http://cfpub.epa.gov/ecotox/
Page 19 of 55

described in the Overview Document at 

http://www.epa.gov/oppfead1/endanger/litstatus/riskasses.htm.

6.5. Endocrine Disruptor Screening Program

As required by FIFRA and the Federal Food Drug and Cosmetic Act (FFDCA), EPA reviews 

numerous studies to assess potential adverse outcomes from exposure to chemicals. 

Collectively, these studies include acute, subchronic and chronic toxicity, including assessments 

of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. 

These studies include endpoints which may be susceptible to endocrine influence, including 

effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual 

maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For 

ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, 

developmental and reproductive effects in different taxonomic groups. As part of its 

reregistration decision, EPA reviewed these data and selected the most sensitive endpoints for 

relevant risk assessment scenarios from the existing hazard database. However, as required by 

FFDCA section 408(p), iprodione is subject to the endocrine screening part of the Endocrine 

Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 

2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, 

which contains 58 pesticide active ingredients and 9 inert ingredients. Iprodione was included 

on that list and an order has been issued to conduct the Tier 1 testing. Once all required Tier 1 

and Tier 2 data have been received and reviewed, the endpoints and safety factors used for risk 

assessment purposes will be examined and a new risk assessment performed if necessary. For 

further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website: http://www.epa.gov/endo/.

7. Preliminary Identification of Data Gaps 

7.1. Environmental Fate Data

Table 10 identifies environmental fate studies by MRID that provide data on iprodione for each 

guideline requirement, as well as study classifications and whether or not further data are needed 
Page 20 of 55

in order to support risk assessment. Studies identified as needed in Table 10 should be 

conducted using the parent; however, the formation and decline of the degradates, particularly 

RP30228, RP35606, RP32490 and 3,5-DCA, should also be monitored to determine if degradatespecific half-life values can be estimated. It should be noted that separate environmental fate 

studies have not been submitted for the iprodione degradates RP30228, RP35606, and RP32490. 

As EFED will be evaluating risk to these degradates using a TTR approach, a batch equilibrium 

study (OCSPP (formerly OPPTS) Guideline 835. 12306) should be conducted for each of the 

three degradates to determine if they are more mobile than the parent. If toxicity data are 

provided indicating that one or all of the degradates are less toxic than the parent, they may be 

removed from the risk analysis. 

Table 11 provides the same data for the iprodione degradate 3,5-DCA. Because this 

transformation product has a different mechanism of action than that of iprodione, the following 

kinds of fate studies stipulated under 40 CFR 158 data requirements would help clarify the 

overall risk picture for 3,5- DCA: OCSPP Guidelines 835.21207(hydrolysis), 835.22408

(aqueous photolysis), 835.24109(soil photolysis), 835.430010 (aerobic aquatic metabolism), and 

835.440011 (anaerobic aquatic metabolism). In the absence of such data EFED will consider this

degradate stable to these transformation pathways.

Table 10. Submitted environmental fate data for iprodione

OCSPP 

Guideline

Data 

Requirement

Submitted 

Studies (Acc. 

No. or MRID)

Study 

Classifications

Are data 

needed to 

conduct risk 

assessment?

Justification and Assumptions EPA 

will Make in Absence of Data

835.2120 Hydrolysis

418854-01 Acceptable No

00059481 Acceptable

00068287 Unacceptable

835.2240 Aqueous 

photolysis

418619-01/

422013-01 Acceptable No

835.2410 Soil photolysis

419121-01 Unacceptable

No

428971-01 Acceptable

835.4100 Aerobic soil 

metabolism 430910-02 Acceptable Yes

Data are required for four soils. MRID 

43091002 was acceptable for one soil, 

 

6 USEPA. 2008a. Fate, Transport and Transformation Test Guidelines OPPTS 835.1230 Absorption/Desorption (Batch 

Equilibrium). EPA 712-C-08-009. October 2008. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-

0006 

7 USEPA 2008b. Fate, Transport and Transformation Test Guidelines OPPTS 835.2120 Hydrolysis. EPA 712-C-08-012. October 

2008. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0009 

8 USEPA 2008c. Fate, Transport and Transformation Test Guidelines OPPTS 835.2240 Photodegradation in Water. EPA 712-C08-013. October 2008. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0012

9 USEPA 2008d. Fate, Transport and Transformation Test Guidelines OPPTS 835.2410. Photodegradation on Soil. EPA 712-C08-015. October 2008. http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0015

10USEPA 2008f. Fate, Transport and Transformation Test Guidelines OPPTS 835.4300. Aerobic Aquatic Metabolism. OPPTS 

835.4400 Anaerobic Aquatic Metabolism EPA 712-C-08-018 and 712-C-08-019. October 2008. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0039

11 Ibid USEPA 2008f.
Page 21 of 55

OCSPP 

Guideline

Data 

Requirement

Submitted 

Studies (Acc. 

No. or MRID)

Study 

Classifications

Are data 

needed to 

conduct risk 

assessment?

Justification and Assumptions EPA 

will Make in Absence of Data

445905-01 Supplemental

so a study with three additional soils is 

required. MRID 44590501 cannot be 

used for half-life estimates as material 

balance could not be determined. In lieu 

of data, EFED will assume a TTR halflife value of 58 days (3x singlevalue).

835.4200 Anaerobic soil 

metabolism -- -- No

No data submitted. Data not necessary 

for modeling purposes. Will use 

information from anaerobic aquatic 

metabolism for characterization 

purposes.

835.4300 Aerobic aquatic 

metabolism

00162219 Unacceptable

Yes

Data are required for two 

water/sediments systems. Currently 

only have one system, so an additional 

study is required. In lieu of additional 

data, EFED will assume a TTR half-life 

value of 183 days (3 x 61 days).

419276-01/

425038-01 Acceptable

416002-01 Unacceptable

446050-01 Unacceptable

835.4400

Anaerobic 

aquatic 

metabolism

00162220 Unacceptable

Yes

Data are required for two 

water/sediments systems. Currently 

only have one system, so an additional 

study is required. In lieu of additional 

data, EFED will assume a TTR half-life 

value of 276 days (3 x 92 days).

417558-01/

428541-01 Acceptable

835.1230 Adsorption/ 

desorption 

00059479 Acceptable

Yes

Batch equilibrium studies are required 

for the three degradates RP30228, 

RP35606, and RP32490.

00068286 Acceptable

418788-01 Unacceptable

433492-02 Acceptable

835.1240 Leaching

418896-01 Unacceptable

No

433492-01 Acceptable

835.6100

Terrestrial field 

dissipation

00059484 Acceptable

No

Study conducted with 8 applications at 1 

lb ai/A. Other uses have higher single 

application rates.

00068290 Acceptable

418774-01 Acceptable

Analytical 

method in soil 437183-02 Acceptable

835.6200

Aquatic field 

dissipation

00162218 Unacceptable

No 437183-01 Acceptable

Analytical 

method in water 452392-03 Acceptable

165-4 

(850.1730)

Fish 

bioconcentration

00162221 Supplemental

00162222 Supplemental No

430910-01 Acceptable
Page 22 of 55

Table 11. Submitted environmental fate data for the iprodione transformation product 3,5-

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

835.2120 Hydrolysis -- -- Yes

No data submitted. In lieu of data, 

EFED will assume 3,5-DCA is stable to 

hydrolysis.

835.2240 Aqueous 

photolysis -- -- Yes

No data submitted. In lieu of data, 

EFED will assume 3,5-DCA is stable to 

aqueous photolysis.

835.2410 Soil photolysis -- -- Yes

No data submitted. In lieu of data, 

EFED will assume 3,5-DCA is stable to 

soil photolysis.

835.4100 Aerobic soil 

metabolism

430910-02 Acceptable

452392-01 Acceptable No

482192-01 Acceptable

835.4300 Aerobic aquatic 

metabolism -- -- Yes

No data submitted. In lieu of data, 

EFED will assume a half-life of 129 

days (2 x the 90% upper confidence 

limit around the mean value for the 

aerobic soil half-life).

835.4400

Anaerobic 

aquatic 

metabolism

-- -- Yes

No data submitted. In lieu of data, 

EFED will assume 3,5-DCA is stable to 

anaerobic aquatic metabolism.

835.1230 Adsorption/ 

desorption 451141-01 Acceptable No

7.2. Effects Data

Table 12 identifies all available ecological effects studies for iprodione by MRID or Accession 

Number (Acc. No.), as well as a description of whether further data are needed to support risk 

assessment.

In addition, the following rationale is being used to justify asking for particular non-guideline 

studies. 

 Honeybee Larval Toxicity Study w/ TGAI – Non-guideline [1 Study] 

Incident data (IO20302-002; Mussen et al. 2008) suggest that iprodione may adversely affect 

honeybee brood (larval and pupal bees) development. In addition, iprodione has been reported to 

occur in bee colony wax samples, where it could potentially affect development of young

(vanEnglesdorp et al., 2009). Therefore, a non-guideline honeybee larval toxicity study is 

recommended. Honeybee brood studies are not currently a data requirement in the U.S., 

however, a non-guideline honeybee larval toxicity study is recommended as a special study (see 

Appendix F for DCI justification table). Since this is a non-guideline study, EFED recommends 

that the proposed study protocol be submitted for review and approval prior to study initiation.

The following references may be useful in the design of a larval toxicity test: (1) Aupinel P, 
Page 23 of 55

Fortini D, Michaud B, Marolleau F, Tasei JN, Odoux JF. 2007. Toxicity of dimethoate and 

fenoxycarb to honey bee brood (Apis mellifera), using a new in vitro standardized feeding 

method. Pest Management Science 63:1090-1094; (2) Oomen PA, De Ruijter A, Van Der Steen 

J. 1992Method for honeybee brood feeding tests with insect growth-regulating insecticides. 

EPPO Bulletin 22:613-616.

 Honeybee Acute Oral Toxicity Study w/ TGAI – OECD TG213 [1 Study] 

Iprodione is applied to several pollinated crops, including almonds, which had the highest annual 

usage of iprodione from 2003-2010 (Apppendix B). Therefore, exposure to foraging worker 

bees is possible. EFED is also recommending toxicity data for honeybees on an acute oral

exposure basis to account for potential differences in sensitivity when exposed via contact versus 

oral routes.

Table 12. Submitted terrestrial and aquatic animal ecological effects data for iprodione

(parent)

Guideline Description—

Test Substance MRID Study Classification

Are data 

Needed for 

Risk 

Assessment?

Justification and Assumptions 

EPA will Make in Absence of 

Data

Avian and Mammalian Testing

850.2100

Avian acute oral

toxicity, 

waterfowl—

TGAI

Acc. No. 

00232703 Supplemental No Number of study animals per test level not reported

Avian acute oral

toxicity, upland 

game bird 

species—TGAI

Acc. No. 

00232703 Supplemental No

Study recently reclassified from 

acceptable to supplemental due to 

lack of reported information about 

sublethal effects and test conditions

416041-01 Acceptable No

Avian acute oral

toxicity, passerine 

species—TGAI

None N/A Yes

Part of 40 CFR Part 158 data 

requirements as of December 2007 

to address passerine sensitivity. 

In addition, a passerine study could 

help resolve uncertainty 

surrounding toxicity of iprodione to 

birds, since two acute oral toxicity 

studies in bobwhite quail yielded 

conflicting results. Study Acc. No. 

00232703 resulted in LD50 of 930 

mg ai/kg-bw, while study MRID 

416041-01 resulted in LD50 of 

>2,000 mg ai/kg-bw.
Page 24 of 55

Guideline Description—

Test Substance MRID Study Classification

Are data 

Needed for 

Risk 

Assessment?

Justification and Assumptions 

EPA will Make in Absence of 

Data

850.2200

Avian dietary 

toxicity, 

waterfowl 

species—TGAI

416041-03 Acceptable No

Non-definitive endpoint of 5,620 

mg a.i./kg-diet is <10 times the 

dietary EEC for all food items 

except fruits, pods, and seeds at 

current maximum application rate 

(turf) of 24 lbs ai/A

Avian dietary 

toxicity, upland 

game bird—

TGAI

416041-02 Acceptable No

Non-definitive endpoint of 5,620 

mg a.i./kg-diet is <10 times the 

dietary EEC for all food items 

except fruits, pods, and seeds at 

current maximum application rate 

(turf) of 24 lbs ai/A

850.2300

Avian 

reproduction, 

waterfowl 

species—TGAI

Acc. No.

00086840 Acceptable No

850.2300

Avian 

reproduction, 

upland game bird 

species—TGAI

Acc. No.

00099126 Acceptable No

850.2400 Wild mammal 

toxicity—TGAI None N/A No

Not triggered based on ecotoxicity 

data, predicted EECs, fate 

properties, and use pattern criteria.

850.2500

Simulated or 

actual field 

testing—TEP

None N/A No

Not triggered based on ecotoxicity 

data, predicted EECs, fate 

properties, and use pattern criteria.

Aquatic Animal Testing

850.1010

Freshwater 

invertebrate, 

acute toxicity—

TGAI

416420-01 Supplemental No Study recently reclassified from 

unacceptable to supplemental

Freshwater 

invertebrate, 

acute toxicity—

TEP

None N/A Yes

Study required when product(s) are 

applied directly to water, as in the 

case of the iprodione rice use. A 

study should be performed on one

representative end use product used 

on rice (e.g., EPA Reg. No. 264-

689, 66222-144, 264-482, 264-524, 

264-532)

850.1025

Estuarine/Marine 

Mollusk acute 

toxicity—TGAI

404892-02 Supplemental No
Page 25 of 55

Guideline Description—

Test Substance MRID Study Classification

Are data 

Needed for 

Risk 

Assessment?

Justification and Assumptions 

EPA will Make in Absence of 

Data

850.1035

Estuarine/Marine 

crustacean acute 

toxicity—TGAI

404892-04 Unacceptable Yes

Precipitate observed during test and 

filtration was not reported. 

Estuarine/marine invertebrate acute 

toxicity data is a standard data 

requirement in Part of 40 CFR Part 

158. In addition, a new study is also 

recommended because iprodione can 

be applied directly to water for use 

on rice.

850.1075

Freshwater fish, 

acute toxicity—

TGAI

Acc. No.

00162224 Unacceptable No

Study recently reclassified from 

supplemental to unacceptable; 

precipitate was observed during test 

and filtration was not reported

Freshwater fish, 

acute toxicity, 

warm water 

species—TGAI

416041-04 Unacceptable Yes

Precipitate observed at all test 

concentrations and filtration was not 

reported

Freshwater fish, 

acute toxicity, 

cold water 

species—TGAI

416041-05 Unacceptable Yes

Test substance concentrations not 

consistent between sampling time 

points

Freshwater fish, 

acute toxicity, 

warm water 

species—TEP 

(Rovral 50 WP)

404892-03 Unacceptable No

Study recently reclassified from 

supplemental to unacceptable; 

precipitate was observed at all test 

concentrations and filtration was not 

reported

Estuarine/Marine 

fish acute 

toxicity—TGAI

404892-05 Unacceptable Yes

Study recently reclassified from 

supplemental to unacceptable; 

precipitate observed during test and 

filtration was not reported

850.1300

Freshwater 

invertebrate,

reproduction 

test—TGAI

404892-01 Unacceptable Yes

The test concentrations varied 

substantially throughout the test 

period (i.e., the highest measured 

concentration in three treatments 

was more than twice the lowest in 

the same concentration).

850.1350

Estuarine/marine 

invertebrate,

reproduction

test—TGAI

408322-01/

405508-02 Supplemental Yes

Reproductive effects occurred at all 

test levels, indicating need for 

additional testing. Test is triggered 

according to 40 CFR §158.630 

15(ii): test is required if acute LC50

or EC50 <1 mg/l.

850.1400

Freshwater fish, 

early life stage 

test—TGAI

405508-01 Supplemental No

Study recently reclassified from 

acceptable to supplemental due to 

lack of information provided in 

study report
Page 26 of 55

Guideline Description—

Test Substance MRID Study Classification

Are data 

Needed for 

Risk 

Assessment?

Justification and Assumptions 

EPA will Make in Absence of 

Data

Saltwater fish, 

early life stage 

test—TGAI

None N/A Yes

Need for this test cannot be 

determined until an acceptable acute 

toxicity study (850.1075) with an 

estuarine/marine fish species is 

submitted. If a saltwater fish ELS 

study is not submitted, an acute-tochronic ratio using freshwater fish 

acute and chronic data and saltwater 

fish acute data will be used to derive 

a saltwater fish chronic endpoint 

during risk assessment.

850.1500

Freshwater fish 

life cycle test None N/A Yes

Aquatic EECs are > 0.1 of the 

estuarine/marine invertebrate life 

cycle test NOAEC of 0.0035 mg 

a.i./L; EECs are > 0.1 of the 

NOAECs from the freshwater fish 

ELS study (NOAEC=0.26 mg a.i./L) 

and the daphnid life cycle study 

(NOAEC=0.26 mg a.i./L) for 

ornamental uses of iprodione. An 

additional rationale for 

recommending this study includes 

the potential anti-androgenic effects 

of iprodione as well as the potential 

exposure to aquatic organisms 

through direct application of 

iprodione to water during use on 

rice.

Estuarine/marine 

fish life cycle test None N/A No

850.1950

Simulated or 

actual field 

testing for aquatic 

organisms

None N/A No

Higher tier testing to address risk 

uncertainties have not been 

identified at this time

Sediment Testing

850.1735

Whole sediment 

10-d freshwater 

invertebrate—

TGAI

None N/A No

Data requirement not triggered since 

Kd <50 and Koc <1,000. Although 

log Kow of 3.1 is slightly greater 

than trigger value (KOW >3), the 

short hydrolysis half lives (5-9 

days) indicate that the compound is 

not expected to persist in aquatic 

environments.
Page 27 of 55

Guideline Description—

Test Substance MRID Study Classification

Are data 

Needed for 

Risk 

Assessment?

Justification and Assumptions 

EPA will Make in Absence of 

Data

850.1740

Whole sediment 

10-d 

estuarine/marine 

invertebrate—

TGAI

None N/A No

Data requirement not triggered since 

Kd <50 and Koc <1,000. Although 

log Kow of 3.1 is slightly greater 

than trigger value (Kow >3), the short 

hydrolysis half lives (5-9 days) 

indicate that the compound is not 

expected to persist in aquatic 

environments.

Agencywide 

guideline

Whole sediment 

chronic 

freshwater and/or 

marine 

invertebrate—

TGAI

None N/A No

Data requirement not triggered since 

Kd <50 and Koc <1,000. Although 

log Kow of 3.1 is slightly greater 

than trigger value (Kow >3), the short 

hydrolysis half lives (5-9 days) 

indicate that the compound is not 

expected to persist in aquatic 

environments.

Insect Pollinator Testing

850.3020

Honeybee acute 

contact toxicity—

TGAI

442620-01 Supplemental No

An acute contact toxicity study is 

available for honeybees that 

originated in the open-literature 

(MRID 44262001); this study 

provides insufficient information on 

methods and results to make it 

useful for risk assessment; however, 

an acute oral study is being

requested in lieu of an additional 

acute contact study.

OECD 213

Honeybee acute 

oral toxicity 

study—TGAI 

None N/A Yes

Study guideline can be found at:

http://www.oecdilibrary.org/docserver/download/full

text/9721301e.pdf?expires=134512

6780&id=id&accname=freeContent

&checksum=3D3E8D93D5EB11D6

F751673FFFC8725F

850.3030

Honeybee 

toxicity of 

residues on 

foliage—TEP

None N/A No Data requirement not triggered

NonguidelineLarval Toxicity 

Test—TGAI None N/A Yes

Recommended based on incident 

data from larval bees as well as 

detection of iprodione in bee hives 

where larvae may be exposed.

It is recommended that a protocol be 

submitted before conducting this 

test.
Page 28 of 55

Guideline Description—

Test Substance MRID Study Classification

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 No

Field testing to address risk 

uncertainties have not been 

identified at this time

Terrestrial Plant Testing

850.4100

Tier I 

and/or II

Seedling 

emergence (10 

species)—TEP

None N/A Yes

Submitted study should test up to 

highest currently registered 

application rate of iprodione.

850.4150

Tier I 

and/or II

Vegetative vigor 

(10 species)—

TEP

None N/A Yes

Submitted study should test up to 

highest currently registered 

application rate of iprodione.

Aquatic Plant Testing

850.4400

Tier I 

and/or II

Tier II Aquatic 

plant growth, 

vascular plant —

TGAI

457413-01 Supplemental No

Test evaluates up to 12.64 mg a.i./L 

(i.e., 16.8 lbs a.i./A). However, 

maximum iprodione application rate 

is 24 lbs a.i./A, and aquatic EECs 

range from 0.014 to 51 mg a.i./L for 

various registered uses of iprodione. 

However, solubility limit of 

iprodione is 13 mg/L.

850.4500*

Tier I 

and/or II

Tier II Aquatic 

Plant, freshwater 

green alga 

species—TGAI 

416041-07 Acceptable Yes

Test evaluates up to 0.13 mg a.i./L 

(i.e., 0.17 lbs a.i./A). However, 

maximum iprodione application rate 

is 24 lbs a.i./A for turf use. In 

addition, aquatic EECs range from 

0.014 to 51 mg a.i./L for various 

registered uses of iprodione. 

Therefore additional testing at higher 

concentrations is needed.

850.4500*

Tier I 

and/or II

Tier II Aquatic 

Plant, freshwater 

diatom—TGAI 

416041-11 Unacceptable Yes

Study deemed unacceptable due to 

cell adhesion to flasks during test.

Note: new study should test up to 

highest application rate and/or 

aquatic EECs as defined in this 

problem formulation or previous risk 

assessments.

850.4500*

Tier I 

and/or II

Tier I Aquatic 

Plant, marine 

diatom — TGAI

416041-09 Acceptable No

<50% reduction in growth observed 

a limit dose. Also, the maximum 

peak EEC is more than 10 times 

lower than the limit concentration 

tested. Tier II testing is not 

recommended.
Page 29 of 55

Guideline Description—

Test Substance MRID Study Classification

Are data 

Needed for 

Risk 

Assessment?

Justification and Assumptions 

EPA will Make in Absence of 

Data

850.4550

†

Tier I 

and/or Tier 

II

Tier II Aquatic 

Plant, 

cyanobacterium 

— TGAI 

416041-10 Unacceptable Yes

Study deemed unacceptable due to 

erratic cell counts during test.

Note: new study should test up to 

highest application rate and/or 

aquatic EECs as defined in this 

problem formulation or previous risk 

assessments.

TGAI = Technical Grade Active Ingredient

TEP = technical end product

* Algal toxicity tests are now under guideline OCSPP 850.4500 (formerly 850.5400)

† Cyanobacterium tests are now under guideline 850.4550 (formerly 850.5400)

For the major degradates RP30228, RP35606, and RP32490, no toxicity data are available for 

any animal or plant taxa. Therefore, there are insufficient data to evaluate these degradates in the 

Registration Review risk assessment for iprodione. In the absence of any new toxicity data for

these degradates, a TTR approach will be used in which total residue data for iprodione, 

RP30228, RP35606, and RP32490 will be compared to available toxicity data for the parent 

compound. A TTR approach is appropriate for these three degradates since they have very

similar molecular structures as the parent and would likely result in similar levels of toxicity.

No ecological effects data have been submitted for 3,5-DCA (RP32596), which is another 

degradate of concern for iprodione. Since 3,5-DCA likely has a different mode of action in 

ecological receptors as compared to iprodione, including this degradate in the TTR approach is 

not appropriate. Therefore, during the risk assessment, if suitable toxicity data are not available 

for 3,5-DCA, either through registrant-submitted studies or studies located in the ECOTOX 

database, risks from 3,5-DCA may be evaluated by considering toxicity data from PCA and 3,4-

DCA, both of which have similar molecular structures to 3,5-DCA. EFED is recommending, at a 

minimum, that a chronic reproduction study with Daphnia be carried out with 3,5-DCA to 

provide some information on the toxicity of this degradate to aquatic organisms. The results of 

this study would provide information on the relative toxicity of 3,5-DCA to iprodione, which 

would help determine whether 3,5-DCA is of toxicological concern for risk assessment. Results 

from this study would also serve as a basis for comparing the toxicity of 3,5-DCA to PCA and

3,4-DCA, which would indicate whether these chemicals are suitable toxicity surrogates for 

estimating risks from 3,5-DCA (see Appendix F for DCI justification table).
Page 30 of 55

Table 13. Ecological effects data for iprodione transformation products

Guideline Description MRID Study 

Classification

Are data 

Needed for 

Risk 

Assessment?

Comments

850.1300

Freshwater invertebrate,

reproduction test—

RP32596 (3,5-DCA)

None N/A Yes

In the absence of this or 

other submitted data, risks 

to aquatic organisms will 

based on ECOTOX openliterature studies or toxicity 

endpoints for 4-

chloroaniline and 3,4-

dichloroaniline, which have 

similar structures to 3,5-

DCA

8. References

Mussen EC, Lopez JE, Peng CYS. Effects of Selected Fungicides on Growth and Development 

of Larval Honey Bees, Apis mellifera L. (Hymenoptera: Apidae). Environmental Entymology

33(5):1151-1154. 

United States Environmental Protection Agency (USEPA). 1998. Registration Eligibility

Decision (RED) Iprodione. USEPA, Prevention, Pesticides, and Toxic Substances. EPA-738-R98-019. November 1998

USEPA. 2000. Registration Eligibility Decision (RED) Vinclozalin. USEPA, Prevention, 

Pesticides, and Toxic Substances. EPA-738-R-00-023. October 2000

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide 

Programs, U.S. Environmental Protection Agency. January 23, 2004

USEPA. 2007a. Memorandum: Review of Iprodione (PC Code 109801) Revised Application 

Rates and New IR-4 Use. Environmental Fate and Effects Division. March 31, 2007. DP 

Barcodes: D315437 and D313332

USEPA. 2007b. Memorandum: Section 18 Emergency Exemption Request for Use of Iprodione 

(PC Code 109801) on Almonds in California. Environmental Fate and Effects Division. May 10, 

2007. DP Barcodes: D339724

USEPA. 2009. Risks of Iprodione Use to Federally Threatened California Red-legged Frog

(Rana aurora draytonii). Pesticide Effects Determination. Environmental Fate and Effects 

Division. October 16, 2009

USEPA. 2011. Memorandum: Iprodione; Report of the Residues of Concern Knowledgebase 

Subcommittee (ROCKS). Health Effects Division. October 5, 2011. DP Barcode: D393960.
Page 31 of 55

USEPA. 2012. Memorandum: Refined iprodione drinking water assessment for label 

amendments and proposed new uses on fruiting vegetables and cucurbits. Environmental Fate 

and Effects Division. February 28, 2012. DP Barcodes: D359480 and D357471

VanEngelsdorp DJ, Evans D, Saegerman S, Mullin C, Haubruge E, Nguyen BK, Frazier M, 

Frazier J, Cox-Foster D, Chen Y, Underwood R, Tarpy DR, Pettis JS. 2009. Colony Collapse 

Disorder: A Descriptive Study. PLoS ONE 4(8): e6481.doi: 10.1371/journal.pone.0006481.
Page 32 of 55

9. Appendix A. Chemical Identity Table and Proposed Degradation Pathway

Name

Chemical Name

SMILES

CAS Number

Structure Study Type MRID Max % AR or 

Concentration (day)

Final % AR or 

Concentration 

(Time interval)

Iprodione

3-(3,5-dichlorophenyl)-

N-(1-methylethyl)-2,4-

dioxo-1-

imidazolidinecarboxamide

SMILES: 

c1c(Cl)cc(Cl)cc1N2C(=

O)CN(C(=O)NC(C)C)C

2(=O)

CAS No. 36734-19-7

Hydrolysis 418854-01

-- 82% (pH 5, Day 30)

-- 41% (pH 7, 125 hrs)

-- 5.6% (pH 9, 2 hrs)

Aqueous photolysis 418619-014-- 68% (Day 33)

Aerobic soil 430910-02 -- 0.75% (Day 276)

Aerobic soil 445905-011-- 6.85% (Day 100)

Aerobic aquatic 425038-013-- 7.8% (Day 30)

Anaerobic aquatic 417558-01 -- 3.4% (Day 365)

Terrestrial field 418774-01 -- <0.01 ppm (Day 538)

Aquatic field (H2O)

Aquatic field (soil) 437183-01 ----

0.008 ppm (Day 44)

0.007 ppm (Day 44)

RP32596

3,5-dichloroaniline

(3,5-DCA)

SMILES: 

Nc(cc(cc1CL)CL)c1

CAS No. 626-43-7

Aerobic soil 430910-02 9% (Day 30) ND7(Day 276)

Aerobic soil 445905-0113.9% (Day 50) ND7(Day 100)

Aerobic aquatic 425038-01 11.7% (Day 30) 11.7% (Day 30)

Anaerobic aquatic 417558-01 3.6% (Day 275) 2.4% (Day 365)

Aquatic field (H2O)

Aquatic field (soil) 437183-01 <0.005 ppm (Day 44)<0.005 ppm (Day 44)

<0.005 ppm (Day 44)

<0.005 ppm (Day 44)

RP30228

3-(1-methylethyl)-N-

(3,5-dichlorophenyl)-

2,4-dioxo-1-

imidazolidinecarboxamide

SMILES: 

c1c(CL)cc(CL)cc1NC(=

O)N2CC(=O)N(C(C)(C)

)C2(=O)

CAS No. NA

Hydrolysis 418854-01 46% (pH 7, 125 hrs) 46% (pH 7, 125 hrs)

93% (pH 9, 2 hr) 93% (pH 9, 2 hr)

Aqueous photolysis 418619-0142.7% (Day 17) 2% (Day 33)

Aerobic soil 430910-02 6.9% (Day 14) 2% (Day 276)

Aerobic soil 445905-011

29% (Day 30) 15% (Day 100)

Aerobic aquatic 425038-01 65% (Day 14) 56% (Day 30)

Anaerobic aquatic 417558-01 70% (Day 14) 21% (Day 365)

Terrestrial field 418774-01 0.47 ppm (Day 28) 0.15 ppm (Day 538)

Aquatic field (H2O)

Aquatic field (soil) 437183-01 0.057 ppm (Day 2)0.13 ppm (1 mon)

0.016 ppm (Day 44)

0.012 ppm (Day 44)
Page 33 of 55

Name

Chemical Name

SMILES

CAS Number

Structure Study Type MRID Max % AR or 

Concentration (day)

Final % AR or 

Concentration 

(Time interval)

RP324901

3-(3,5-dichlorophenyl)-

2,4-dioxo-1-

imidazolidinecarboxamide

SMILES: 

c1c(CL)cc(CL)cc1N2C(

=O)CN(C(=O)N)C2(=O)

CAS No. NA

Aerobic soil 430910-02 0.28% (Day 1) ND7(Day 276)

Aerobic aquatic 425038-01 15% (Day 1) 4% (Day 30)

Anaerobic aquatic 417558-01 8.4% (Day 30) 0.8% (Day 365)

Terrestrial field 418774-01 0.09 ppm (Day 7) <0.01 ppm (Day 538)

Aquatic field (H2O)

Aquatic field (soil) 437183-01 0.006 ppm (Day 2)<0.005 ppm (Day 44)

<0.005 ppm (Day 44)

<0.005 ppm (Day 44)

RP356061,2

[(dichloro-3,5-phenyl)-1-

isopropylcarbamoyl-3]-

2-acetic acid

SMILES: 

c1c(CL)cc(CL)cc1NC(=

O)N(CC(=O)(O))C(=O)

NC(C)(C)

CAS No. NA

Hydrolysis 418854-01

12% (pH 5, Day 30) 12% (pH 5, Day 30)

10% (pH 7, 40 hrs) 5.5% (pH 7, 125 hrs)

2% (pH 9, 107 hrs) 2% (pH 9, 107 hrs)

Aerobic soil 430910-02 1.2% (Day 7) ND7(Day 276)

Aerobic soil 445905-0111.7% (Day 7) ND (Day 100)

Aerobic aquatic 419276-01 8.9% (Day 30) 8.9% (Day 30)

Bold indicates major degradate.

1. Analyzed for in aqueous photolysis study (MRID 418619-01), but not found.

2. Analyzed for in aerobic aquatic metabolism study (MRID 425038-01), but not found.
Page 34 of 55

Proposed Degradation Pathway (Aerobic Soil Metabolism Study, MRID 430910-02)
Page 35 of 55

10. Appendix B. BEAD USE and Usage Reports

Iprodione (109801)

Screening Level Usage Analysis (SLUA)

Date: January 31, 2012 

What is a Screening Level Usage Analysis (SLUA)?

 Available estimates of pesticide usage data for a particular active ingredient that is 

used on agricultural crops in the United States.

 Pesticide usage data obtained from various sources. The data are then merged, 

averaged, and rounded so that the presented information is not proprietary, business 

confidential, or trade secret. 

What does it contain?

 Pesticide usage data for a single active ingredient only.

 Agricultural use sites (crops) that the pesticide is reported to be used on.

 Available pesticide usage information from U.S. states that produce 80% or more of a 

crop, in most cases, or less than 80%, in rare cases, depending on the scope of the 

survey and available resources.

 Annual percent of crop treated (average & maximum) for each agricultural crop.

 Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the 

states surveyed, not for the entire United States).

What assumptions can I make about the reported data?

 Average pounds of active ingredient applied - Values are calculated by merging 

pesticide usage data sources together; averaging across all observations, then 

rounding. Note: If the estimated value is less than 500, then that value is labeled 

<500. Estimated values between 500 & <1,000,000 are rounded to 1 significant 

digit. Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)

 Average percent of crop treated - Values are calculated by merging data sources 

together; averaging by year, averaging across all years, & rounding to the nearest 

multiple of 5. Note: If the estimated value is less than 2.5, then the value is labeled 

<2.5. If the estimated value is less than 1, then the value is labeled <1.

 Maximum percent of crop treated - Value is the single maximum value reported 

across all data sources, across all years, & rounded up to the nearest multiple of 5. 

Note: If the estimated value is less than 2.5, then the value is labeled <2.5.

What are the data sources used?

 USDA-NASS (United States Department of Agriculture’s National Agricultural 

Statistics Service) – pesticide usage data from 2003 to 2010.

 Private pesticide market research – pesticide usage data from 2003 to 2010.

 California Department of Pesticide Regulation (DPR) Pesticide Use Reporting

(PUR) data for 2003 to 2009.

What are the limitations to the data?

 Additional registered uses may exist but are not included because the available 

surveys do not report usage (e.g., small acreage crops).

 Lack of reported usage data for the pesticide on a crop does not imply zero usage.
Page 36 of 55

 Usage data on a particular site may be noted in data sources, but not quantified. In 

these instances, the site would not be reported in the SLUA.

 Non-agricultural use sites (e.g., turf, post-harvest, mosquito control, etc.) are not 

reported in the SLUA. A separate request must be made to receive these estimates.

 Some sites show some use, even though they are not on the label. This usage could 

be due to various factors, including, but not limited to Section 18 requests, existing

stocks of the chemical, data collection errors, and experimental use permits (EUPs). 

Screening Level Estimates of Agricultural Uses of Iprodione (109801)

Sorted Alphabetically

Reported Years: 2003-2010

Crop

Pounds of

Active

Ingredient

Average 

Percent

of Crop

Treated

Maximum

Percent of Crop Treated

1 Almonds 200,000 45 55

2 Apricots 6,000 45 75

3 Beans, Green 20,000 5 15

4 Blueberries 1,000 5 10

5 Broccoli <500 <1 <2.5

6 Cabbage 1,000 <2.5 <2.5

7 Caneberries 2,000 5 20

8 Carrots 20,000 25 40

9 Cauliflower <500 <1 <2.5

10 Cherries 20,000 15 25

11 Cotton 6,000 <1 <2.5

12 Dry Beans/Peas 2,000 <1 <2.5

13 Garlic 7,000 10 25

14 Grapes 5,000 <1 <2.5

15 Lettuce 70,000 20 35

16 Nectarines 8,000 30 35

17 Onions 40,000 20 30

18 Peaches 20,000 15 25

19 Peppers 1,000 <1 <2.5

20 Plums/Prunes 7,000 10 25

21 Pluots * <500 60 70

22 Potatoes 20,000 <2.5 10

23 Rice 1,000 <1 <2.5

24 Spinach 2,000 <2.5 <2.5

25 Strawberries 2,000 5 10

26 Tobacco+ 20,000 <2.5 <2.5

All numbers rounded.

<500 Less than 500 pounds of active ingredient
Page 37 of 55

<2.5 Less than 2.5 percent of crop treated

<1 Less than 1 percent of crop treated

* Based on CA DPR data only (valid because 95% or more of U.S. acres grown are in California)

+ Crops not known to be listed on active end use product registrations or as Section 18 emergency

exemptions when this report was run

SLUA data sources include: 

USDA-NASS (United States Department of Agriculture's National Agricultural Statistics Service) 

Private Pesticide Market Research

California DPR (Department of Pesticide Regulation)

These results reflect amalgamated data developed by the Agency and are releasable to the public.

Adobe Acrobat 

Document

BEAD Use Report for Iprodione
Page 38 of 55

11. Appendix C. OPPIN Bibliography

(a) Environmental Fate Studies

Guideline: 63-0 Reports of Multiple Physical/chemical Characteristics

MRID: 41230503

Weiler, D.; Russell, D.; Oden, K. (1988) Vapor Pressure Determination of Iprodione: Report No. 

40426. Unpublished study prepared by Rhone-Poulenc Ag Co. 22 p.

MRID: 47778802

Miller, R. (2009) Product Properties: Color, Physical State, Odor, Stability to Normal and 

Elevated Temperatures, Oxidation/Reduction: Chemical Incompatibility, pH, UV/Visible 

Absorption, Melting Point/Melting Range, Density, Partition Coefficient (n-Octanol/Water), 

Water Solubility, and Vapor Pressure (Iprodione Technical). Project Number: 

CHB/EX/609/011/P/1. Unpublished study prepared by PhibroWood, LLC. 37 p.

Guideline: 161-1 Hydrolysis

MRID: 00059481

Laurent, M.; Buys, M.; Charassol, Y.; et al. (1976) 26 019 R.P.: Degradation in Water: 

R.P./R.D./C.N.G.-An--Report no. 3036. (Translation; unpublished study received May 24, 1977 

under 359-EX-55; prepared by Societe des Usines Chimiques Rhone- Poulenc, submitted by

Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:230241-F) 

MRID: 00068287

Laurent, M.; Buys, M.; Aublet, ?; et al. (1976) 26019 R.P.: Solubility and Stability in Water: 

S.U.C.R.P.-- D.S.An. Nord. No. 2585. (Translation; unpublished study received Jan 24, 1977 

under 359-EX-55; prepared by Societe des Usines Chimiques Rhone-Poulenc, France, submitted 

by Rhone- Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:227614-E) 

MRID: 41885401

Das, Y. (1990) Hydrolysis of ?Phenyl(U)-?carbon 14||Iprodione in Aqueous Solutions Buffered 

at pH 5, 7 and 9: Lab Project Number: 89100. Unpublished study prepared by Innovative 

Scientific Services, Inc. 96 p.

Guideline: 161-2 Photodegradation-water

MRID: 41861901

Adrian, P.; Robles, J. (1991) Carbon 14-Iprodione: Aqueous Photolysis: Lab Project Number: 

90/22: AG/CBLD/AN/9115524. Unpublished study prepared by Rhone-Poulenc Secteur Agro. 

97 p. 

MRID: 42201301
Page 39 of 55

Adrian, P.; Robles, J. (1992) Carbon 14-Iprodione Aqueous Photolysis Addendum to MRID No. 

41861901: Lab Project Number: 90-22. Unpublished study prepared by Rhone-Poulenc Secteur 

Agro. 13 p.

Guideline: 161-3 Photodegradation-soil

MRID: 41912101

Ayliffe, J.; Outram, J.; Reeves, G. (1991) Iprodione-?carbon 14|: Soil Photolysis Study: Lab 

Project Number: P91/048. Unpublished study prepared by Rhone-Poulenc Agric., Ltd. 86 p. 

MRID: 42897101

John, A.; French, N.; Lowden, P. (1993) Fungicides: (Carbon 14) Iprodione: Soil Photolysis: Lab 

Project Number: P93/073. Unpublished study prepared by Rhone-Poulenc Agriculture Ltd. 128 

p.

Guideline: 162-1 Aerobic soil metabolism

MRID: 43091002

Waring, A. (1993) (carbon 14)--Iprodione: Aerobic Soil Metabolism: Final Report: Lab Project 

Number: 68/132: 68/132-1015. Unpublished study prepared by Hazleton Europe. 105 p. 

MRID: 44590501

Waring, A. (1993) (carbon 14)-Iprodione: Soil Degradation: Final Report: Lab Project Number: 

68/139-1015. Unpublished study prepared by Hazleton UK. 73 p. 

MRID: 45239201

Quarmy, D. (2000) Iprodione Metabolite: (carbon-14)-3,5-Dichloroaniline Aerobic Soil 

Metabolism: Lab Project Number: 99R16743. Unpublished study prepared by Springborn 

Laboratories, Inc. 282 p. 

Guideline: 162-3 Anaerobic aquatic metabolism

MRID: 00162220

Thomas, R.; Cunningham, W. (1983) Anaerobic Aquatic Metabolism of [Carbon 14]-RP-26019: 

Final Report: Project No. 3/2202. Unpublished study prepared by Borriston Laboratories, Inc. 

35 p. 

MRID: 41600201

Spare, W. (1989) Aerobic Aquatic Metabolism of Iprodione: Final Report: Project Number: 

1509. Unpublished study prepared by Agrisearch Inc. 4 p. 

MRID: 41755801

Spare, W. (1990) Anaerobic Aquatic Metabolism of Iprodione: Lab Project Number: 1510. 

Unpublished study prepared by Agrisearch Inc. 114 p. 

MRID: 42854101
Page 40 of 55

Spare, W. (1993) Anaerobic Aquatic Metabolism of Iprodione: Supplemental: Lab Project 

Number: 1510. Unpublished study prepared by Agrisearch Inc. 55 p.

Guideline: 162-4 Aerobic aquatic metabolism

MRID: 00162219

Thomas, R.; Fletcher, C. (1983) Aquatic Metabolism of [Carbon 14]- RP-26019: Project No. 3-

2201. Unpublished study prepared by Borriston Laboratories, Inc. 41 p. 

MRID: 41927601

Spare, W. (1991) Aerobic Aquatic Metabolism of Iprodione: Lab Project Number: 1514. 

Unpublished study prepared by Agrisearch Inc. 147 p. 

MRID: 42503801

Spare, W. (1992) Aerobic Aquatic Metabolism of Iprodione: Supplemental Report ?MRID 

#41927601|: Lab Project Number: 1514. Unpublished study prepared by Agrisearch Inc. 117 p. 

MRID: 44605001

Purser, D. (1992) (Carbon 14)-Iprodione: Degradation and Retention in Water/Sediment 

Systems: Amended Final Report: Lab Project Number: 68/113: 7397: P6876D. Unpublished 

study prepared by Hazleton UK. 160 p. 

Guideline: 163-1 Leaching/adsorption/desorption

MRID: 00059479

Gouot, J.M.; Lacroix, L.; Sauli, M.; et al. (1976) A Study to Investigate the Leaching of 26 019 

R.P. in Soil, Using ^14IC- Labelled 26 019 R.P.: R.P./R.D./C.N.G.-An no. 18845. (Translation; 

unpublished study received May 24, 1977 under 359-EX- 55; prepared by Societe des Usines 

Chimiques Rhone-Poulenc, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, 

N.J.; CDL:230241-D) 

MRID: 00068286

Gouot, J.M.; Lacroix, L; Sauli, M.; et al. (1976) A Study To Investigate the Leaching of 26 019 

R.P. in Soil, Using (14C)-Labelled 26 019 R.P. (Translation; unpublished study received Jan 24, 

1977 under 359-EX-55; prepared by Rhone-Poulenc, France, submitted by Rhone-Poulenc 

Chemical Co., Monmouth Junction, N.J.; CDL: 227614-D) 

MRID: 41878801

Outram, J.; Reeves, G.; Smith (1991) Iprodione-?Carbon 14|: Adsorption/Desorption on Four 

Soils: Lab Project Number: P91-049. Un- published study prepared by Rhone-Poulenc Ag. Ltd. 

87 p. 

MRID: 41889601

Doble, M.; Outram, J.; Reeves, G. (1991) Iprodione-[carbon 14]: Aged Leaching Study with 

Four Soils: Lab Project No: P91/050. Unpublished study prepared by Rhone-Poulenc Agric., Ltd. 

78 p. 
Page 41 of 55

MRID: 43349201

Newby, S.; Ayliffe, J.; Jones, M. (1994) Iprodione: Aged Leaching Study in Four Soils: Lab 

Project Number: P 94/013. Unpublished study prepared by Rhone-Poulenc Agriculture Ltd. 107 

p. 

MRID: 43349202

Burr, C.; Newby, S. (1994) Iprodione: Adsorption/Desorption to and from Four Soils and an 

Aquatic Sediment: Lab Project Number: P94/014. Unpublished study prepared by RhonePoulenc Agriculture Ltd. 81 p.

MRID: 45114101

Feung, C. (1999) Iprodione Metabolite: (carbon-14)-3,5-Dichloroaniline Soil 

Adsorption/Desorption Study: Lab Project Number: 99R16744. Unpublished study prepared by

Rhone Poulenc Ag Company. 165 p. 

Guideline: 164-1 Terrestrial field dissipation

MRID: 00059484

Rhodia, Incorporated (1976) RP 26019 and Metabolites: Residue Study in/on Turf Soil: Report 

No. 76/069/NB/AG. (Unpublished study received May 24, 1977 under 359-EX-55; submitted by

Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:230241-I) 

MRID: 00068290

Rhodia, Incorporated (1976) RP 26019 and Metabolites: Residue Study in/on Turf Soil, 1976 

Program: Lab. Ref. No. 76/069/NB/AG. (Unpublished study received Jan 24, 1977 under 359-

EX-55; sub- mitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:227614-I) 

MRID: 00162218

Gemma, A.; Heinzelmann, G.; Wargo, J. (1986) Iprodione Aquatic Field Dissipation and Field 

Irrigated Crop Study. Unpublished study prepared by Rhone-Poulenc Inc. 300 p. 

MRID: 41877401

Norris, F. (1991) A Terrestrial Field Soil Dissipation Study with Iprodione: Lab Project Number: 

40644: EC/P-89-0013. Unpublished study prepared by Rhone-Poulenc Ag Co.; A & L Eastern 

Agricultural Labs, Inc.; Morse Labs., Inc. 275 p.

MRID: 43718302

Citation: Hudson, J. (1995) Validation of Method of Analysis for Iprodione (RP26019) and its 

Metabolites (RP32490, RP32596, RP36221, and RP30228) in Soil: Final Report: Lab Project 

Number: EC-94-258: EC-95-298: EC-95-296. Unpublished study prepared by Rhone-Poulenc 

Ag Co. 180 p. 
Page 42 of 55

Guideline: 164-2 Aquatic field dissipation

MRID: 43718301

Chancey, E. (1995) An Aquatic Field Dissipation Study with Iprodione: Lab Project Number: 

44729: EC-92-187: FAD-IPR-RI-MS-92. Unpublished study prepared by Rhone-Poulenc Ag 

Co.; Agvise, Inc.; and South Texas Ag Research Inc. 374 p. 

MRID: 45239203

Citation: Carringer, S. (1999) Iprodione: Validation of Method of Analysis of Iprodione and its 

Metabolites RP 30228 and RP 32596 in Ground Water: Final Study Report: Lab Project Number: 

EC-98-432: 45593. Unpublished study prepared by Rhone-Poulenc Ag Company and Agvise 

Laboratories. 123 p. {OPPTS 850.7100} 

MRID: 45239204

Citation: Sweeney, R. (1999) Independent Laboratory Validation of Method of Analysis for 

Iprodione and its Metabolites RP 30228 and RP 32596 in Ground Water According to Ecological 

Effects Test Guidelines OPPTS 850.7100: Lab Project Number: 45380: 99R17181: ACFS45380. Unpublished study prepared by ABC Laboratories, Inc. 72 p. {OPPTS 850.7100} 

Guideline: 165-4 Bioaccumulation in fish

MRID: 00162221

McAllister, W.; Bunch, B.; Burnett, J. (1986) Bioconcentration and Depuration of [Carbon 14]-

Iprodione by Crayfish (Procambarus simulans, Faxon) under Static Uptake Conditions with a 

Treated Soil Substrate: Final Bioconcentration Report No. 33438. Unpublished study prepared 

by Analytical Bio-Chemistry Laboratories, Inc. 297 p. 

MRID: 00162222

Gemma, A.; Heinzelmann, G.; Wargo, J. (1986) Identification of Iprodione Residues in Crayfish. 

Unpublished study prepared by Rhone-Poulenc Inc. 23 p. 

MRID: 43091001

Pottinger, T. (1994) Final Report: A Fish Bioaccumulation and Depuration Study on Iprodione: 

Lab Project Number: FH-OECD-34FT/BR: 68/134-1011R. Unpublished study prepared by

Windermere Laboratory, Institute of Freshwater Ecology. 172 p.

(b) Ecological Effects Studies

Guideline: 71-1 Avian Single Dose Oral Toxicity

MRID: 48589

McGinnis, C.H., Jr.; Johnson, C.A. (1973) The Determination of the Acute Oral LDI50^ in 

Bobwhite Quail for 26019 RP: Research Report No. CHM 73:93. (Unpublished study received 

Jan 24, 1977 under 359-EX-55; submitted by Rhone-Poulenc Chemical Co., Monmouth 

Junction, N.J.; CDL:227615-K) 
Page 43 of 55

MRID: 48590

McGinnis, C.H., Jr.; Johnson, C.A. (1974) The Determination of the Acute Oral LDI50^ in 

Mallard Ducks for 26019 RP: Research Report No. CHM 74:49. (Unpublished study received 

Jan 24, 1977 under 359-EX-55; submitted by Rhone-Poulenc Chemical Co., Monmouth

Junction, N.J.; CDL:227615-L) 

MRID: 41604101

Culotta, J.; Hoxter, K.; Smith, G. et al. (1990) Iprodione: An Acute Oral Toxicity Study with the 

Northern Bobwhite: Lab Project Number: 171-120. Unpublished study prepared by Wildlife 

International Ltd. 43 p. 

Guideline: 71-2 Avian Dietary Toxicity

MRID: 48591

McGinnis, C.H., Jr.; Johnson, C.A. (1974) The Effects of Dietary 26019 R.P. and Technical 

Dieldrin on Young Mallard Ducks--an 8 Day Subacute Toxicity Test: Research Report No. CHM 

74:64. (Unpublished study received Jan 24, 1977 under 359-EX-55; sub- mitted by RhonePoulenc Chemical Co., Monmouth Junction, N.J.; CDL:227615-M) 

MRID: 48592

McGinnis, C.H., Jr.; Johnson, C.A. (1974) The Effects of Dietary 26019 RP and Technical 

Dieldrin on Young Bobwhite Quail--a 12 Day Subacute Toxicity Test: Report No. CMH 74:14. 

(Unpublished study received Jan 24, 1977 under 359-EX-55; submitted by Rhone-Poulenc 

Chemical Co., Monmouth Junction, N.J.; CDL: 227615-N) 

MRID: 68740

McGinnis, C.H., Jr.; Johnson, C.A. (1974) The Effects of Dietary 26019 RP and Technical 

Dieldrin on Young Bobwhite Quail--A 12 Day Subacute Toxicity Test: Report No. CHM 74.14. 

(Unpublished study received Jan 13, 1978 under 359-684; submitted by Rhone-Poulenc 

Chemical Co., Monmouth Junction, N.J.; CDL: 232703-J) 

MRID: 68741

McGinnis, C.H., Jr.; Johnson, C.A. (1974) The Effect of Dietary 26 019 RP on Body Weight, 

Feed Consumption, Reproduction and the Production of 26 019 RP Residues in Body Tissues 

and Eggs of Bobwhite Quail: Research Report No. CHM 74:105. (Unpublished study received 

Jan 13, 1978 under 359-684; submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, 

N.J.; CDL: 232703-K) 

MRID: 86839

Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Subacute Feeding--Reproduction 

Screening Bioassay--Bobwhite Quail: Iprodione Technical: Project No. 171-101. (Unpublished 

study received Oct 26, 1981 under 46153-1; prepared by Wildlife International, Ltd., submitted 

by Precision Compounding, Inc., Newark, N.J.; CDL:246150-A) 
Page 44 of 55

MRID: 41604102

Driscoll, C.; Foster, J.; Hoxter, K. et al. (1990) Iprodione Technical: A Dietary LC50 Study with 

the Northern Bobwhite: Lab Project Number: 171-118. Unpublished study prepared by Wildlife 

International Ltd. 73 p. 

MRID: 41604103

Driscoll, C.; Foster, J.; Hoxter, K. et al. (1990) Iprodione Technical: A Dietary LC50 Study with 

the Mallard: Lab Project Num- ber: 171-119. Unpublished study prepared by Wildlife 

International Ltd. 73 p. 

Guideline: 71-4 Avian Reproduction

MRID: 68741

McGinnis, C.H., Jr.; Johnson, C.A. (1974) The Effect of Dietary 26 019 RP on Body Weight, 

Feed Consumption, Reproduction and the Production of 26 019 RP Residues in Body Tissues 

and Eggs of Bobwhite Quail: Research Report No. CHM 74:105. (Unpublished study received 

Jan 13, 1978 under 359-684; submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, 

N.J.; CDL: 232703-K) 

MRID: 86840

Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report One-generation Reproduction 

Study--Mallard Duck: Iprodione Technical: Project No. 171-103. (Unpublished study received 

Oct 26, 1981 under 46153-1; prepared by Wildlife International, Ltd., and Rhone-Poulenc, Inc., 

submitted by Precision Compounding, Inc., Newark, N.J.; CDL:246150-C) 

MRID: 99126

Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report: One-generation Reproduction 

Study--Bobwhite Quail: Iprodione Technical: Project No. 171-102. (Unpublished study received 

Oct 26, 1981 under 46153-1; prepared by Wildlife International, Ltd. and Rhone-Poulenc, Inc., 

submitted by Precision Compound- ing, Inc., Newark, N.J.; CDL:246150-B) 

MRID: 92083002

Gregg, B. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 00099126. 

Iprodione - One-generation Reproduction Study - Bobwhite Quail: Project 171-102. Prepared by 

WILDLIFE INTERNATIONAL LTD. 36 p. 

MRID: 92083003

Gregg, B. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 00086840. 

Iprodione - One-generation Reproduction Study - Mallard Duck: Project 171-103. Prepared by 

WILDLIFE INTERNATIONAL. 37 p. 

Guideline: 72-1 Acute Toxicity to Freshwater Fish

MRID: 70148

Calmbacher, C.W.; Vilkas, A.G. (1978) The Acute Toxicity of RP26019 Technical (Assay

95.06%, Lot #77103-01) to the Bluegill Sunfish (~Lepomis macrochirus~Rafinesque): UCES 
Page 45 of 55

Proj. No. 11506-48-02. (Unpublished study received Sep 1, 1978 under 359-684; prepared by 

Union Carbide Corp., submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; 

CDL:234810-A) 

MRID: 70149

Calmbacher, C.W.; Vilkas, A.G. (1978) The Acute Toxicity of RP26019 Technical (Assay

95.06%, Lot #77103-01) to the Rainbow Trout (~Salmo gairdneri~Richardson): UCES Proj. No. 

11506-48-03. (Unpublished study received Sep 1, 1978 under 359-684; prepared by Union 

Carbide Corp., submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; 

CDL:234810-B) 

MRID: 162223

McAllister, W.; Bunch, B. (1986) Dynamic Acute Toxicity of Iprodione Technical to Juvenile 

Crayfish (Procambarus simulans, Faxon): Flow-through Acute Toxicity Report #33434. 

Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 148 p. 

MRID: 162224

Swigert, J.; Franklin, B.; Seidel, A.; et al. (1986) Acute Flow- through Toxicity of Iprodione 

Technical to Channel Catfish (Ictalurus punctatus): Report #34385. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 109 p. 

MRID: 40489203

Surprenant, D. (1987) Acute Toxicity of Rovral 50 WP to Bluegill (Lepomis macrochirus) under 

Flow-through Conditions: SLS Report #87-12-2578: SLS Study #10566.1087.6111.105. 

Unpublished study prepared by Springborn Life Sciences, Inc. 47 p. 

MRID: 41604104

Sousa, J. (1990) Iprodione Technical: Acute Toxicity to Bluegill sunfish (Lepomis macrochirus) 

under Flow-Through Conditions: Lab Project Number: 90-5-3329: 10566.1089.6140.105. 

Unpublished study prepared by Springborn Laboratories, Inc. 55 p. 

MRID: 41604105

Sousa, J. (1990) Iprodione Technical: Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) 

under Flow-through Conditions: Lab Project Number: 90-5-3331: 10566.1089.6139.108. 

Unpublished study prepared by Springborn Laboratories, Inc. 54 p. 

MRID: 92083004

Mihaich, E. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 40489203. Acute 

Toxicity of ROVRAL 50 WP to Bluegill (Lepomis macrochirus) under Flow-through 

Conditions: Project 87-12-2578. Prepared by Springborn Life Sciences Inc. 16 p. 

MRID: 92083069

Mihaich, E. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 00162224. 

Iprodione - Acute Flow-through Toxicity: Channel Catfish (Ictalurus punctatus): Project 34385. 

Prepared by ANALYTICAL BIO-CHEMISTRY LABORATORIES. 16 p. 
Page 46 of 55

MRID: 92083070

Mihaich, E. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 00162223. 

Iprodione - Acute Flow-through Toxicity: Juvenile Crayfish (Procambarus simulans, Faxon): 

Project 33434. Prepared by ANALYTICAL BIO-CHEMISTRY LABORATORIES. 16 p. 

Guideline: 72-2 Acute Toxicity to Freshwater Invertebrates

MRID: 68738

Ambrosi, D.; Desmoras, J.; LaCroix, L. (1977) Fungicides: Toxicity of R.P. 26 019 to Daphnia 

(~Daphnia pulex~): R.P./R.D./ C.N.G. No. 19 168. (Unpublished study received Jan 13, 1978 

under 359-684; prepared by Rhone-Poulenc, France, submitted by Rhone-Poulenc Chemical Co., 

Monmouth Junction, N.J.; CDL: 232703-F) 

MRID: 68739

Roberts, S.; Parke, G.S.E. (1977) Report: 48-hour Static LC50 of RP 26019 Technical 

in~Daphnia magna~: Laboratory No. 7E-8445. (Unpublished study received Jan 13, 1978 under 

359-684; pre- pared by Cannon Laboratories, Inc., submitted by Rhone-Poulenc, Chemical Co., 

Monmouth Junction, N.J.; CDL:232703-G) 

MRID: 79633

Vilkas, A.G. (1977) The Acute Toxicity of RP 26019 Technical to the Water Flea~Daphnia 

magna~Straus: UCES Proj. # 11506-48-01. (Unpublished study received Jan 13, 1978 under 

359-684; pre- pared by Union Carbide Corp., submitted by Rhone-Poulenc Chemical Co., 

Monmouth Junction, N.J.; CDL:232703-H) 

MRID: 40489206

Surprenant, D. (1988) Acute Toxicity of Rovral 50 WP to Daphnids (Daphnia magna) under 

Flow-through Conditions: Report #87-12- 2597: SLS Study #10566.1087.6112.115. 

Unpublished study pre- pared by Springborn Life Sciences, Inc. 47 p. 

MRID: 41642001

McNamara, P. (1990) Iprodione Technical--Acute Toxicity to Daphnids (Daphnia magna) during 

a 48-Hour Flow-through Exposure: Final Report: Lab Project Number: 90-7-3380: 

10566.1086.6138.115. Unpublished study prepared by Springborn Laboratories, Inc. 6 p. 

MRID: 92083005

Mihaich, E. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 40489206. Acute 

Toxicity of ROVRAL 50 WP to (Daphnia magna) under Flow- through Conditions: Project 87-

12-2597. Prepared by SPRINGBORN LIFE SCIENCES, INC. 17 p. 
Page 47 of 55

Guideline: 72-3 Acute Toxicity to Estuarine/Marine Organisms

MRID: 40489202

Surprenant, D. (1987) Acute Toxicity of Iprodione Technical to Eastern Oysters (Crassostrea 

virginica) under Flow-through Conditions: SLS Report #87-12-2584: SLS Study

#10566.1087.6115.504. Unpublished study prepared by Springborn Life Sciences, Inc. 45 p. 

MRID: 40489204

Surprenant, D. (1987) Acute Toxicity of Iprodione Technical to Mysid Shrimp (Mysidopsis 

bahia) under Flow-through Conditions: SLS Report #87-12-2580: SLS Study

#10566.1087.6113.515. Unpublished study prepared by Springborn Life Sciences, Inc. 45 p. 

MRID: 40489205

Surprenant, D. (1988) Acute Toxicity of Iprodione Technical to Sheepshead Minnow 

(Cyprinodon variegatus) under Flow-through Conditions: SLS Report #87-11-2583: SLS Study

#10566.1087.6114. 505. Unpublished study prepared by Springborn Life Sciences, Inc. 44 p. 

MRID: 42169301

Surprenant, D. (1991) Response to EPA FIFRA 88 Phase 4 Data Call-in on Iprodione (...)--Acute 

Toxicity to Mysid Shrimp: Lab Project Number: EMM1/2/92. Unpublished study prepared by

Springborn Labs., Inc. 6 p. 

MRID: 92083006

Mihaich, E. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 40489205. Acute 

Toxicity of Iprodione Technical to Sheepshead Minnow (Cyprinodon variegatus) under Flowthrough Conditions: Project 87-12-2583. Prepared by SPRINGBORN LIFE SCIENCES, INC.

17 p. 

MRID: 92083007

Mihaich, E. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 40489202. Acute 

Toxicity of IPRODIONE Technical to Eastern Oysters (Crassostrea virginica) under Flowthrough Conditions: Project 87-12-2584. Prepared by SPRINGBORN LIFE SCIENCES, INC. 

19 p. 

MRID: 92083008

Mihaich, E. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 40489204. Acute 

Toxicity of Iprodione Technical to Mysid Shrimp (Mysidopsis bahia) under Flow-through 

Conditions: Project 87-12-2580. Prepared by SPRINGBORN LIFE SCIENCES, INC. 17 p. 

Guideline: 72-4 Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study

MRID: 48593

Rausina, G.; McCollum, K.; Goode, J.W.; et al. (1974) Report to Rhodia, Inc., Chipman 

Division: Four-Day Static Fish Toxicity Studies with RP26019 Technical in Rainbow Trout, 

Bluegills, and Channel Catfish: IBT No. 621-05132. (Unpublished study received Jan 24, 1977 
Page 48 of 55

under 359-EX-55; submitted by Rhone- Poulenc Chemical Co., Monmouth Junction, N.J.; 

CDL:227615-O) 

MRID: 40489201

Surprenant, D. (1988) The Chronic Toxicity of Iprodione Technical to Daphnia magna under 

Flow-through Conditions: Report #87-12- 2573: Study #10566-1087-6116-130. Unpublished 

study prepared by Springborn Life Sciences, Inc. 59 p. 

MRID: 40550801

Surprenant, D. (1988) The Toxicity of Iprodione Technical to Fathead Minnow (Pimephales 

promelas) Embryos and Larvae: Rept. No. 88-2-2639. Unpublished study prepared by

Springborn Life Sciences, Inc. 59 p. 

MRID: 40550802

Surprenant, D. (1988) Chronic Toxicity of Iprodione Technical to Mysid Shrimp (Mysidopsis 

bahia): Report #88-3-2640. Unpublished study prepared by Springborn Life Sciences, Inc. 64 p. 

MRID: 40832201

Surprenant, D. (1988) Chronic Toxicity of Iprodione Technical to Mysid Shrimp (Mysidopsis 

bahia): Supplement Study: Report #88-6- 2761: Study #10566.0388.6117.530. Unpublished 

study prepared by Springborn Life Sciences, Inc. 65 p. 

MRID: 92083009

Gregg, B. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 40550801. 

Iprodione - Toxicity to Fathead Minnow (Pimephales promelas) Embryos and Larvae - Project 

88-2-2639. Prepared by SPRINGBORN LIFE SCIENCES, INC. 20 p. 

MRID: 92083010

Mihaich, E. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 40489201. The 

Chronic Toxicity of IPRODIONE Technical to Daphnia magna under Flow-through Conditions: 

Project 87-12-2573. Prepared by SPRINGBORN LIFE SCIENCES, INC. 22 p. 

MRID: 92083011

Mihaich, E. (1990) Rhone-Poulenc Ag Company Phase 3 Summary of MRID 40832201. The 

Chronic Toxicity of IPRODIONE Technical to Mysid Shrimp (Mysidopsis bahia): Project 88-6-

2761. Prepared by SPRINGBORN LIFE SCIENCE, INC. 23 p. 

Guideline: 81-1 Acute oral toxicity in rats

MRID: 42306301

Cummins, H. (1989) Iprodione: Acute Oral Toxicity Study in the Rat: Lab Project Number: 

RHA/255: 89/RHA255/0391. Unpublished study prepared by Life Science Research Ltd. 46 p. 
Page 49 of 55

Guideline: 81-3 Acute inhalation toxicity in rats

MRID: 42946101

Nachreiner, D. (1993) Iprodione: Acute Dust Inhalation Toxicity Study in Rats: Lab Project 

Number: 93N1216. Unpublished study prepared by Bushy Run Research Center, Union 

Carbide. 58 p. 

Guideline: 83-4 2-generation repro.-rat

MRID: 41871601

Henwood, S. (1991) Two-generation Reproduction Study with Iprodione Technical in Rats: 

Final Report: Lab Project Id.: HLA 6224-154. Prepared by Hazleton Laboratories America, Inc. 

1669 p. 

Guideline: 122-2 Aquatic plant growth

MRID: 41604108

Giddings, J. (1990) Iprodione Technical: Toxicity to the Duckweed Lemna gibba G3: Lab 

Project Number: 90-06-3351: 10566.1089.614. 410. Unpublished study prepared by Springborn 

Laboraotries, Inc. 40 p. 

Guideline: 123-2 Aquatic plant growth

MRID: 41604107

Giddings, J. (1990) Iprodione Technical: Toxicity to the Freshwater Green Alga Selenastrum 

Capricornutum: Final Report: Lab Project Number: 90-06-3346: 10566-1089-6141-430. 

Unpublished study pre- pared by Springborn Laboratories, Inc. 50 p. 

MRID: 41604109

Giddings, J. (1990) Iprodione Technical: Toxicity to the Marine Diatom Skeletonema Costatum: 

Lab Project Number: 90-06-3347: 10566.1089.6141.450. Unpublished study prepared by

Springborn Laboratories, Inc. 50 p. 

MRID: 41604110

Giddings, J. (1990) Iprodione Technical: Toxicity to the Freshwater Bluegreen Alga Anabaena 

Flos-Aquae: Lab Project Number: 90-05- 3338: 10566-1089-6141-420. Unpublished study

prepared by Springborn Laboratories, Inc. 47 p. 

MRID: 41604111

Giddings, J. (1990) Iprodione Technical: Toxicity to the Freshwater Diatom Navicula 

Pelliculosa: Final Report: Lab Project Number: 90-6-3340: 10566-1089-6141-440. Unpublished 

study prepared by Springborn Laboratories, Inc. 49 p. 

MRID: 43575601

Suprenant, D. (1995) Supplement Data for: Iprodione Technical: Toxicity to the Freshwater 

Diatom Navicula pelliculosa. Addendum to MRID No. 41604111: Lab Project Number: 
Page 50 of 55

90/6/3340: 10566/1089/6141/440. Unpublished study prepared by Springborn Laboratories Inc. 

12 p. 

MRID: 45741301

Sowig, P. (2002) Duckweed (Lemna gibba G3) Growth Inhibition Test Iprodione; Substance, 

Technical: Lab Project Number: CE02/033: C022577. Unpublished study prepared by Aventis 

CropScience GmbH. 47 p.
Page 51 of 55

12. Appendix D. SIP/STIR Model Results

(a) SIP Model Output
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(b) STIR Model Output
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13. Appendix E. IDS Aggregate Incident Report for Iprodione
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14. Appendix F. Data Call-In Justification Tables for Non-guideline/Degradate Studies and 

Study Title: Honeybee Larval Toxicity Study

Guideline Number: Non-guideline

Test Substance: Iprodione—TGAI

Rationale for Requiring the Data

Incident data suggest that iprodione may adversely affect honeybee (Apis mellifera) brood (larval 

and pupal) development. In an unpublished manuscript submitted as an incident report, increased 

mortality as well as abnormal morphological development occurred in female (worker) bee pupae. 

Although iprodione is practically non-toxic to adult worker bees on an acute contact exposure 

basis, a larval toxicity study is needed to determine the toxicity of the compound to developing 

brood. In addition, iprodione has been reported to occur in bee colony wax (comb) samples, where 

it could potentially affect development of young. Submitted studies of iprodione do not provide 

information on the potential toxicity to developing honeybee brood. Therefore, a non-guideline 

honeybee larval toxicity study is recommended. The registrant should submit a proposed protocol 

for review and approval by EFED prior to initiation of the study.

Practical Utility of the Data

How will the data be used?

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

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

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

on beneficial terrestrial invertebrates through direct effects on larval bees. 

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

EPA is required by section 7(a)(2) of the Endangered Species Act (ESA) to ensure that any action 

it authorizes or takes “...is not likely to jeopardize the continued existence of any endangered or 

threatened species or result in the destruction or adverse modification of critical habitat” and “to 

use the best scientific data available” in carrying out this obligation. The data EPA intends to call 

in are necessary to inform the determination required by ESA as to whether continued registration 

of a pesticide is or is not likely to jeopardize the species or its designated critical habitat. The lack 

of these data will limit the flexibility that the Agency has in coming into compliance with ESA 

and could result in use restrictions that are unnecessarily severe. In addition, the lack of these data 

may result in an uncertain assumed risk and potential mitigation of iprodione formulations under 

FIFRA.
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Study Title: Daphnid Reproduction Study

Guideline Number: 850.1300

Test Substance: 3,5-Dichloroaniline

Rationale for Requiring the Data

3,5-DCA (RP32596) is considered a degradate of concern of iprodione. Since 3,5-DCA likely has 

a different mode of action in ecological receptors as compared to iprodione, it will be assessed 

separately during risk assessment. No ecological effects data have been submitted for 3,5-DCA. 

EFED is recommending that a chronic reproduction study with Daphnia be carried out with 3,5-

DCA to provide some information on the toxicity of this degradate to aquatic organisms. The 

results of this study would provide information on the relative toxicity of 3,5-DCA to iprodione, 

which would help determine whether 3,5-DCA is of toxicological concern for risk assessment. 

Results from this study would also serve as a basis for comparing the toxicity of 3,5-DCA to pchloroaniline and 3,4-DCA, which would indicate whether these chemicals are suitable toxicity

surrogates for estimating risks from 3,5-DCA. The justification for requesting a chronic rather 

than an acute toxicity study to represent 3,5-DCA is because the slow rate of degradation of 3,5-

DCA in soil metabolism studies indicates that it is of chronic concern.

Practical Utility of the Data

How will the data be used?

Data will be used to compare toxicity of 3,5-DCA to the parent compound (iprodione) and 

potentially to calculate separate risk quotients for 3,5-DCA during risk assessment. 

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

This data will provide information on relative toxicity between a degradate (3,5-DCA) and its 

parent compound (iprodione). Since this data may be used to evaluate this degradate separately 

from the parent during risk assessment, such data may generally help inform how risk assessors 

evaluate degradates as residues of concern in risk assessment.