UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, DC 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

DATE: 14 August 2013 

SUBJECT: lpconazole. Acute and Chronic Aggregate Dietary (Food and Drinking Water) 

Exposure and Risk Assessments for the Section 3 Registration Action; Food Use 

on Legume Vegetables, Group 6 (Revised). 

PC Code: 125618 DP Barcode: 0413901 

Decision Number: 469403 Registration Number: 400-544 

Petition: 2F8076 Regulatory Action: Section 3 

Risk Assessment Type: Dietary Case Number: 7041 

TXR Number: NA CAS Number: 125225-28-7 

MRID Numbers: NA 40CFR: §180.646 

FROM: 

Risk 

William 

Assessment 

T. Drew, 

Branch 

ChemistII ~ (RAB2) 

Health Effects Division (HE~), 7~ 

THRU: William Cutchin, Chemist ·'/v~ · ~H ?----

Ideliz Negron-Encarnacion, PhD, Chemist /~ 

Dietary Exposure Science Advisory Council (DESAC) 

TO: Michael A. Doherty, PhD, Senior Chemist 

RAB2/HED, 7509P 

and 

Tony Kish and Dominic Schuler, RM Team 22 

Fungicide Branch (FB) 

Registration Division (RD), 7505P 

NOTE: These revised dietary exposure assessments were conducted to incorporate updated 

estimated drinking water concentrations (EDWCs) resulting from the use on ginseng. The 

revised EDWCs replaced those inadvertently used in the previous assessment (D411 023; W.T. 

Drew; 14 May 2013), which were based on a non-registered use pattern (potatoes). 

Page l of 14 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901 

Executive Summary 

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments 

were conducted using the Dietary Exposure Evaluation Model software with the Food 

Commodity Intake Database, Version 3.16 (DEEM-FCID). This software uses 2003-2008 food 

consumption data from the US Department of Agriculture's (USDA's) National Health and 

Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The analyses 

were conducted in support of a human-health risk assessment for the proposed Section 3 use of 

ipconazole on legume vegetables, group 6. Per DESAC SOP 2012.1, this memorandum was 

reviewed by two peer reviewers of the DESAC. 

Acute dietary exposure assessment: The acute assessment was conducted only for females 13-49 

years old. The assumptions utilized for the acute analysis include tolerance-level residues, 100 

percent crop treated (%CT) for all commodities, and default processing factors (from DEEM 

Version 7.8) for corn syrup (1.5X) and peanut butter (1.89X). For the acute assessment, the 

highest daily groundwater value of0.00101 ppm was used for all drinking water inputs. The 

acute analysis was conservative and unrefined. 

The results ofthe DEEM-FCID acute analysis showed that exposure of females 13-49 to 

ipconazole was <1% of the acute population adjusted dose (aPAD). The result is reported at the 

95th percentile of exposure, and does not exceed HED's level of concern (LOC). 

Chronic dietary exposure assessment: The assumptions utilized for the chronic analysis include 

tolerance-level residues, 100 %CT for all commodities, and default processing factors from 

DEEM version 7.8 for corn syrup (1.5X) and peanut butter (1.89X). For the chronic assessment, 

the post-breakthrough average groundwater value of 0.000822 ppm was used for all drinking 

water inputs. The chronic analysis was conservative and unrefined. 

The results of the DEEM-FCID chronic analysis showed that exposures of all population 

subgroups to ipconazole were <1% of the chronic population adjusted dose ( cP AD). The results 

do not exceed HED's LOC. 

Cancer dietary exposure assessment: Because there is "no evidence of carcinogenicity" for 

ipconazole, an assessment was not conducted. Cancer risk from dietary exposure is not of 

concern. 

I. Introduction 

Dietary risk assessment incorporates both exposure to, and toxicity of, a given pesticide. For 

acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable 

dose (the dose that HED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population-adjusted dose (PAD). The PAD is equivalent to the 

Page 2 of 14 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901

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point of departure (POD), such as the NOAEL or LOAEL, divided by the required uncertainty 

and/or safety factors. 

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

exceeds 100% of the PAD. References that discuss the acute and chronic risk assessments in 

more detail are available on the EPA/pesticides web site, Available Information on Assessing 

Exposure from Pesticides, A User’s Guide of 21 June 2000. The web link is

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf, or see SOP 99.6 (20

August 1999). 

The most recent dietary risk assessment for ipconazole was conducted by William T. Drew 

(D411023; W.T. Drew; 14 May 2013). 

II. Residue Information

Tolerances are established for residues of ipconazole under 40CFR §180.646[a]. A Section 3 

registration is being requested for an end-use product (EP) containing ipconazole as the active 

ingredient (ai). This EP, Rancona 3.8FS (EPA Registration #400-544), is a flowable suspension 

(FS) formulation of ipconazole containing approximately 41% of the ai by weight, equivalent to 

3.77 pounds of ai per gallon (lb ai/gal). The proposed use is on all legume vegetables, group 6, 

(expanded from uses on soybeans and dried shelled peas and beans, subgroup 6C, except 

soybean). This product is for use in commercial seed treatment equipment only; on-farm 

treatments are prohibited (it is not for use in hopper-box, planter-box, slurry-box or other seed 

treatment applications at, or immediately before, planting). 

Ipconazole is currently registered for seed treatment use on the Brassica leafy vegetable group, 

canola, the cucurbit vegetable group, the leafy vegetable (except Brassica) group, mustard, rape, 

the root and tuber vegetable group, sorghum, and sunflower; based on the use pattern and residue 

levels, these are considered non-food uses. The currently registered uses on cotton, peanuts, 

soybeans, dry shelled peas and beans (subgroup 6C) except soybean, and cereal grains (group 

15) except rice are considered food uses, and have been included in this assessment. 

The residues of concern for ipconazole are the parent compound, along with the common triazole 

metabolites 1,2,4-triazole, triazolylalanine, triazolylacetic acid, and triazolylpyruvic acid. The 

dietary analyses herein address only the parent compound. The metabolites have been assessed 

in a separate dietary exposure analysis (D411385; T. Morton; 1 May 2013). The levels of 

ipconazole used for food inputs in the acute and chronic assessments are tolerance-level residues 

(0.01 ppm for all commodities) that were derived from crop field trials. The trials used 

ipconazole as a seed treatment at either a 1X or a 5X rate. Even at the exaggerated 5X rate, 

residues of ipconazole were below the LOQ of 0.01 ppm in all commodities. Both the acute and 

chronic assessments assume 100%CT and, despite the lack of residues at the 5X rate, include 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901

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default processing factors (from DEEM Version 7.8) for corn syrup (1.5X) and peanut butter 

(1.89X).

These dietary assessments are characterized as screening-level, unrefined and highly 

conservative. 

III. Percent Crop Treated Information

Both the acute and chronic assessments assumed 100%CT, for the existing uses and the proposed 

new (unregistered) uses. 

IV. Drinking Water Data

A drinking water assessment (DWA) for the current ipconazole action was provided by the 

Environmental Fate and Effects Division (EFED) in the memorandum Revised Estimated 

Drinking Water Concentrations (EDWCs) of lpconazole from its Proposed New Use by 

Expansion of Uses from Crop Subgroup 6C to the Entire Crop Group 6 for Use in Human 

Health Risk Assessment. (D406894; M.A. Ruhman; 15 July 2013). The EDWCs used in the 

dietary assessments result from the registered use on ginseng; the requested use on legume 

vegetables would not result in higher concentrations. The EDWCs were obtained via PRZMGW (Pesticide Root Zone Model for GroundWater) modeling. A description of this water model 

can be found at http://www.epa.gov/oppefed1/models/water/. 

For the acute assessment, the highest daily groundwater value of 0.00101 ppm was used for the

drinking water inputs. The chronic assessment used the post-breakthrough average groundwater 

value of 0.000822 ppm. Water residues were incorporated into DEEM-FCID under the “water, 

direct, all sources” and “water, indirect, all sources” food categories. 

V. DEEM-FCID Program and Consumption Information

Ipconazole acute and chronic dietary exposure assessments were conducted using DEEM-FCID 

(Version 3.16), which incorporates 2003-2008 consumption data from USDA’s 

NHANES/WWEIA. The data are based on the reported consumption of more than 20,000 

individuals over two non-consecutive survey days. Foods “as consumed” (such as apple pie) are 

linked to EPA-defined food commodities (such as apples, peeled fruit – cooked, fresh or N/S,

baked; or wheat flour – cooked, fresh or N/S, baked) using publicly available recipe translation 

files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption 

data are averaged for the entire US population, and within population subgroups. However, for 

acute exposure assessment, consumption data are retained as individual consumption events. 

Based on analysis of the 2003-2008 WWEIA consumption data, which took into account dietary 
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patterns and survey respondents, HED concluded that it is most appropriate to report risk for the 

following population subgroups: The general US population, all infants (<1 year old), children 

1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99

years old. 

For a chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (such as orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

The resulting residue intake estimate for each food/food form is summed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed both in mg/kg body weight/day and as a 

percent of the cPAD. This procedure is performed for each population subgroup. 

For an acute exposure assessment, individual one-day food consumption data are used on an 

individual-by-individual basis. The reported consumption amounts of each food item can be 

multiplied by a residue point estimate, and summed to obtain a total daily pesticide exposure for 

a deterministic exposure assessment, or “matched” in multiple random pairings with residue 

values, and then summed in a probabilistic assessment. The resulting distribution of exposures is 

expressed as a percentage of the aPAD on both a user (only those who reported eating relevant 

commodities/food forms) and a per-capita (those who reported eating the relevant commodities 

as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk 

are reported for analyses performed at all levels of refinement. However, for deterministic 

assessments, any significant differences in user versus per capita exposures and risks are 

specifically identified and noted in the risk assessment. 

VI. Toxicological Information

The toxicological endpoints and points of departure for human health dietary risk assessment are 

summarized in Table 1, below. After reviewing the toxicology database, HED recommended

that the FQPA safety factor be reduced to 1X because: 

1. The toxicity database is largely complete, with no data gaps for the assessment 

of the effects of ipconazole following in utero and/or postnatal exposure. 

2. An immunotoxicity study is required for ipconazole, and is considered a data 

gap; however the existing database shows no evidence of immunotoxicity. 

3. There is no evidence of neurotoxicity in the available database. An acute 

neurotoxicity study is not available, but was waived by the Hazard and 

Science Policy Council (HASPOC), based on the lack of evidence of 

neurotoxicity in the database, and a developmental neurotoxicity study is 

not required. The subchronic neurotoxicity study requirement is 

considered to be satisfied by the neurotoxicity assessments performed in 

both the rat subchronic and chronic toxicity/carcinogenicity studies. 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901

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4. There is no indication of quantitative or qualitative susceptibility of rats or 

rabbits to in utero and/or postnatal exposure to ipconazole. 

5. The dietary exposure assessments are based on models using input parameters 

which are designed to provide conservative, health protective, high-end 

estimates of dietary (food + drinking water) exposure and risk.

6. At this time, there are no registered residential uses for ipconazole. As a result, 

infants and children are not expected to be exposed through residential 

uses. 

TABLE 1 Summary of Toxicological Doses and Endpoints for Use in Ipconazole Dietary Human 

Health Risk Assessments. 

Exposure

Scenario

Point of 

Departure 

(POD)

Uncertainty/

FQPA Safety 

Factors

RfD, PAD, 

LOC for Risk 

Assessment

Study and Toxicological Effects

Acute dietary 

(general population, 

including infants and 

children)

NA* NA NA No appropriate endpoint is 

available.

Acute dietary

(females 13-49 and 

general population)

NOAEL = 10 

mg/kg 

bw/day

UFA = 10X

UFH = 10X

FQPA SF = 1X

Acute RfD = 0.1 

mg/kg bw/day

aPAD = 0.1 

mg/kg bw/day

Co-critical developmental toxicity 

studies in rats and rabbits. 

LOAELrats = 30 mg/kg bw/day, 

based on increased visceral and 

skeletal variations. 

LOAELrabbits = 50 mg/kg bw/day, 

based on increased incidence of 

skeletal variations and 

malformations. 

Chronic dietary

(all populations)

NOAEL = 

1.5 

mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 1X

Chronic RfD = 

0.015 mg/kg/day

cPAD = 0.015 

mg/kg/day

Chronic toxicity study in dogs. 

LOAEL = 5 mg/kg bw/day, based 

on skin reddening (both sexes),

and decreased body weight gain in 

females. 

Cancer (oral, 

dermal, inhalation) 

No evidence of carcinogenicity. 

* NA = Not Applicable. Point of Departure (POD) = a data point or an estimated point that is derived from 

observed dose-response data, and used to mark the beginning of extrapolation to determine risk associated with 

lower environmentally relevant human exposures. NOAEL = no-observed-adverse-effect level. LOAEL = lowestobserved-adverse-effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). 

UFH = potential variation among members of the human population (intraspecies). FQPA SF = FQPA Safety 

Factor. aPAD = acute population adjusted dose. cPAD = chronic population adjusted dose. RfD = reference dose. 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901

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VII. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCID analyses estimate the dietary exposure of the US 

population and various population subgroups. The results reported in Table 2 (below) are for the 

general US Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 

13-19, females 13-49, adults 20-49, and adults 50+ years. 

Based on the highly-conservative nature of the acute assessment, evaluation of exposure and risk 

at the 95th percentile of exposure is appropriate. For females of child-bearing age (the only 

population subgroup of interest for acute analysis), the risk estimate (<1% aPAD) is well below 

HED’s LOC. 

For the chronic assessment, risk estimates are below HED’s LOC for all population subgroups, 

including infants and children. For children 1-2 years old, the subgroup with the highest 

exposure estimate, the risk estimate is <1% of the cPAD. 

TABLE 2 Summary of Dietary Exposure and Risk Estimates for Ipconazole.

Population Subgroup Acute Dietary (95th Percentile) Chronic Dietary

Dietary Exposure 

(mg/kg/day)

% aPAD Dietary Exposure

(mg/kg/day)

% cPAD

General U.S. Population NA* NA 0.000065 <1

All Infants (<1 year old) 0.000122 <1

Children 1-2 years old 0.000142 <1

Children 3-5 years old 0.000133 <1

Children 6-12 years old 0.000095 <1

Youth 13-19 years old 0.000063 <1

Adults 20-49 years old 0.000058 <1

Adults 50+ years old 0.000047 <1

Females 13-49 years old 0.000117 <1 0.000055 <1

* NA = Not Applicable. The population subgroup with the highest risk estimate is in bold typeface. 

VIII. Characterization of Inputs/Outputs

Both the acute and chronic dietary analyses are based on highly conservative, health-protective 

assumptions (tolerance-level residues, 100%CT, and default processing factors). They also 

incorporated model-derived, conservative estimates of ipconazole residues in drinking water. 

The resulting exposure and risk estimates should be considered screening-level estimates that 

likely overestimate any actual dietary exposures that may occur from the requested uses of 

ipconazole. Various refinements could be made to the assessments. However, as there are no 

risk estimates of concern, no refinements were incorporated. 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901

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IX. Conclusions

Acute and chronic dietary risk estimates associated with the requested uses of ipconazole are 

below HED’s LOC for all population subgroups, including those of infants and children. There 

are no dietary exposure considerations that would preclude registration of the requested uses, nor 

the establishment of tolerances.

X. List of Attachments

Attachment 1. Residue Inputs for the Acute Dietary Exposure Analysis of Ipconazole. 

Attachment 2. Summary of the Acute Dietary Exposure Analysis for Ipconazole. 

Attachment 3. Residue Inputs for the Chronic Dietary Exposure Analysis of Ipconazole. 

Attachment 4. Summary of the Chronic Dietary Exposure Analysis for Ipconazole. 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901

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Attachment 1. Residue Inputs for the Acute Dietary Exposure Analysis of Ipconazole.

Filename: C:\Documents and Settings\wdrew\My Documents\IpconazoleDEEM072313AcuteInput.R08

Chemical: Ipconazole

RfD(Chronic): .015 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .1 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day

Date created/last modified: 07-23-2013/08:30:25 Program ver. 3.16, 03-08-d

Comment: RfDs are PADs. aPAD is for Females 13-49 only.

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

1500027000 15 Barley, bran 0.010000 1.000 1.000 

1500026000 15 Barley, flour 0.010000 1.000 1.000 

1500026001 15 Barley, flour-babyfood 0.010000 1.000 1.000 

1500025000 15 Barley, pearled barley 0.010000 1.000 1.000 

1500025001 15 Barley, pearled barley-babyfood 0.010000 1.000 1.000 

0603035000 6C Bean, great northern, seed 0.010000 1.000 1.000 

0603030000 6C Bean, black, seed 0.010000 1.000 1.000 

0603032000 6C Bean, broad, seed 0.010000 1.000 1.000 

0602031000 6B Bean, broad, succulent 0.010000 1.000 1.000 

0603034000 6C Bean, cowpea, seed 0.010000 1.000 1.000 

0602033000 6B Bean, cowpea, succulent 0.010000 1.000 1.000 

0603036000 6C Bean, kidney, seed 0.010000 1.000 1.000 

0603038000 6C Bean, lima, seed 0.010000 1.000 1.000 

0602037000 6B Bean, lima, succulent 0.010000 1.000 1.000 

0603039000 6C Bean, mung, seed 0.010000 1.000 1.000 

0603040000 6C Bean, navy, seed 0.010000 1.000 1.000 

0603041000 6C Bean, pink, seed 0.010000 1.000 1.000 

0603042000 6C Bean, pinto, seed 0.010000 1.000 1.000 

0601043000 6A Bean, snap, succulent 0.010000 1.000 1.000 

0601043001 6A Bean, snap, succulent-babyfood 0.010000 1.000 1.000 

1500065000 15 Buckwheat 0.010000 1.000 1.000 

1500066000 15 Buckwheat, flour 0.010000 1.000 1.000 

0603099000 6C Chickpea, flour 0.010000 1.000 1.000 

0603098000 6C Chickpea, seed 0.010000 1.000 1.000 

0603098001 6C Chickpea, seed-babyfood 0.010000 1.000 1.000 

1500122000 15 Corn, field, bran 0.010000 1.000 1.000 

1500120000 15 Corn, field, flour 0.010000 1.000 1.000 

1500120001 15 Corn, field, flour-babyfood 0.010000 1.000 1.000 

1500121000 15 Corn, field, meal 0.010000 1.000 1.000 

1500121001 15 Corn, field, meal-babyfood 0.010000 1.000 1.000 

1500125000 15 Corn, field, oil 0.010000 1.000 1.000 

1500125001 15 Corn, field, oil-babyfood 0.010000 1.000 1.000 

1500123000 15 Corn, field, starch 0.010000 1.000 1.000 

1500123001 15 Corn, field, starch-babyfood 0.010000 1.000 1.000 

1500124000 15 Corn, field, syrup 0.010000 1.500 1.000 

1500124001 15 Corn, field, syrup-babyfood 0.010000 1.500 1.000 

1500126000 15 Corn, pop 0.010000 1.000 1.000 

2003128000 20C Cottonseed, oil 0.010000 1.000 1.000 

2003128001 20C Cottonseed, oil-babyfood 0.010000 1.000 1.000 

0603182000 6C Guar, seed 0.010000 1.000 1.000 

0603182001 6C Guar, seed-babyfood 0.010000 1.000 1.000 

0603203000 6C Lentil, seed 0.010000 1.000 1.000 

1500226000 15 Millet, grain 0.010000 1.000 1.000 

1500231000 15 Oat, bran 0.010000 1.000 1.000 

1500232000 15 Oat, flour 0.010000 1.000 1.000 

1500232001 15 Oat, flour-babyfood 0.010000 1.000 1.000 

1500233000 15 Oat, groats/rolled oats 0.010000 1.000 1.000 

1500233001 15 Oat, groats/rolled oats-babyfood 0.010000 1.000 1.000 

0603256000 6C Pea, dry 0.010000 1.000 1.000 

0603256001 6C Pea, dry-babyfood 0.010000 1.000 1.000 

0601257000 6A Pea, edible podded, succulent 0.010000 1.000 1.000 

0603258000 6C Pea, pigeon, seed 0.010000 1.000 1.000 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901

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0602259000 6B Pea, pigeon, succulent 0.010000 1.000 1.000 

0602255000 6B Pea, succulent 0.010000 1.000 1.000 

0602255001 6B Pea, succulent-babyfood 0.010000 1.000 1.000 

9500263000 O Peanut 0.010000 1.000 1.000 

9500264000 O Peanut, butter 0.010000 1.890 1.000 

9500265000 O Peanut, oil 0.010000 1.000 1.000 

1500329000 15 Rye, flour 0.010000 1.000 1.000 

1500328000 15 Rye, grain 0.010000 1.000 1.000 

0603348000 6C Soybean, flour 0.010000 1.000 1.000 

0603348001 6C Soybean, flour-babyfood 0.010000 1.000 1.000 

0600350000 6 Soybean, oil 0.010000 1.000 1.000 

0600350001 6 Soybean, oil-babyfood 0.010000 1.000 1.000 

0600347000 6 Soybean, seed 0.010000 1.000 1.000 

0600349000 6 Soybean, soy milk 0.010000 1.000 1.000 

0600349001 6 Soybean, soy milk-babyfood or in 0.010000 1.000 1.000 

0601349500 6AB Soybean, vegetable 0.010000 1.000 1.000 

1500381000 15 Triticale, flour 0.010000 1.000 1.000 

1500381001 15 Triticale, flour-babyfood 0.010000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.001010 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.001010 1.000 1.000 

1500404000 15 Wheat, bran 0.010000 1.000 1.000 

1500402000 15 Wheat, flour 0.010000 1.000 1.000 

1500402001 15 Wheat, flour-babyfood 0.010000 1.000 1.000 

1500403000 15 Wheat, germ 0.010000 1.000 1.000 

1500401000 15 Wheat, grain 0.010000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 0.010000 1.000 1.000 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901

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Attachment 2. Summary of the Acute Dietary Exposure Analysis for Ipconazole. 

US EPA Ver. 3.16, 03-08-d

DEEM-FCID ACUTE Analysis for IPCONAZOLE NHANES 2003-2008 2-Day

Residue file: IpconazoleDEEM072313AcuteInput.R08 Adjustment factor #2 NOT used.

Analysis Date: 07-23-2013/10:25:32 Residue file dated: 07-23-2013/08:30:25

RAC/FF intake summed over 24 hours

Run Comment: "RfDs are PADs. aPAD is for Females 13-49 only."

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

Summary calculations--per capita:

 95th Percentile 99th Percentile 99.9th Percentile

Exposure % aRfD Exposure % aRfD Exposure % aRfD 

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

Female 13-49:

 0.000117 0.12 0.000158 0.16 0.000227 0.23 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901

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Attachment 3. Residue Inputs for the Chronic Dietary Exposure Analysis of Ipconazole. 

Filename: C:\Documents and Settings\wdrew\My Documents\IpconazoleDEEM072313ChronicInput.R08

Chemical: Ipconazole

RfD(Chronic): .015 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): .1 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day

Date created/last modified: 07-23-2013/08:32:54 Program ver. 3.16, 03-08-d

Comment: RfDs are PADs. aPAD is for Females 13-49 only.

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Commodity Name (ppm) #1 #2 

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

1500027000 15 Barley, bran 0.010000 1.000 1.000 

1500026000 15 Barley, flour 0.010000 1.000 1.000 

1500026001 15 Barley, flour-babyfood 0.010000 1.000 1.000 

1500025000 15 Barley, pearled barley 0.010000 1.000 1.000 

1500025001 15 Barley, pearled barley-babyfood 0.010000 1.000 1.000 

0603035000 6C Bean, great northern, seed 0.010000 1.000 1.000 

0603030000 6C Bean, black, seed 0.010000 1.000 1.000 

0603032000 6C Bean, broad, seed 0.010000 1.000 1.000 

0602031000 6B Bean, broad, succulent 0.010000 1.000 1.000 

0603034000 6C Bean, cowpea, seed 0.010000 1.000 1.000 

0602033000 6B Bean, cowpea, succulent 0.010000 1.000 1.000 

0603036000 6C Bean, kidney, seed 0.010000 1.000 1.000 

0603038000 6C Bean, lima, seed 0.010000 1.000 1.000 

0602037000 6B Bean, lima, succulent 0.010000 1.000 1.000 

0603039000 6C Bean, mung, seed 0.010000 1.000 1.000 

0603040000 6C Bean, navy, seed 0.010000 1.000 1.000 

0603041000 6C Bean, pink, seed 0.010000 1.000 1.000 

0603042000 6C Bean, pinto, seed 0.010000 1.000 1.000 

0601043000 6A Bean, snap, succulent 0.010000 1.000 1.000 

0601043001 6A Bean, snap, succulent-babyfood 0.010000 1.000 1.000 

1500065000 15 Buckwheat 0.010000 1.000 1.000 

1500066000 15 Buckwheat, flour 0.010000 1.000 1.000 

0603099000 6C Chickpea, flour 0.010000 1.000 1.000 

0603098000 6C Chickpea, seed 0.010000 1.000 1.000 

0603098001 6C Chickpea, seed-babyfood 0.010000 1.000 1.000 

1500122000 15 Corn, field, bran 0.010000 1.000 1.000 

1500120000 15 Corn, field, flour 0.010000 1.000 1.000 

1500120001 15 Corn, field, flour-babyfood 0.010000 1.000 1.000 

1500121000 15 Corn, field, meal 0.010000 1.000 1.000 

1500121001 15 Corn, field, meal-babyfood 0.010000 1.000 1.000 

1500125000 15 Corn, field, oil 0.010000 1.000 1.000 

1500125001 15 Corn, field, oil-babyfood 0.010000 1.000 1.000 

1500123000 15 Corn, field, starch 0.010000 1.000 1.000 

1500123001 15 Corn, field, starch-babyfood 0.010000 1.000 1.000 

1500124000 15 Corn, field, syrup 0.010000 1.500 1.000 

1500124001 15 Corn, field, syrup-babyfood 0.010000 1.500 1.000 

1500126000 15 Corn, pop 0.010000 1.000 1.000 

2003128000 20C Cottonseed, oil 0.010000 1.000 1.000 

2003128001 20C Cottonseed, oil-babyfood 0.010000 1.000 1.000 

0603182000 6C Guar, seed 0.010000 1.000 1.000 

0603182001 6C Guar, seed-babyfood 0.010000 1.000 1.000 

0603203000 6C Lentil, seed 0.010000 1.000 1.000 

1500226000 15 Millet, grain 0.010000 1.000 1.000 

1500231000 15 Oat, bran 0.010000 1.000 1.000 

1500232000 15 Oat, flour 0.010000 1.000 1.000 

1500232001 15 Oat, flour-babyfood 0.010000 1.000 1.000 

1500233000 15 Oat, groats/rolled oats 0.010000 1.000 1.000 

1500233001 15 Oat, groats/rolled oats-babyfood 0.010000 1.000 1.000 

0603256000 6C Pea, dry 0.010000 1.000 1.000 

0603256001 6C Pea, dry-babyfood 0.010000 1.000 1.000 

0601257000 6A Pea, edible podded, succulent 0.010000 1.000 1.000 

0603258000 6C Pea, pigeon, seed 0.010000 1.000 1.000 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901

Page 13 of 14

0602259000 6B Pea, pigeon, succulent 0.010000 1.000 1.000 

0602255000 6B Pea, succulent 0.010000 1.000 1.000 

0602255001 6B Pea, succulent-babyfood 0.010000 1.000 1.000 

9500263000 O Peanut 0.010000 1.000 1.000 

9500264000 O Peanut, butter 0.010000 1.890 1.000 

9500265000 O Peanut, oil 0.010000 1.000 1.000 

1500329000 15 Rye, flour 0.010000 1.000 1.000 

1500328000 15 Rye, grain 0.010000 1.000 1.000 

0603348000 6C Soybean, flour 0.010000 1.000 1.000 

0603348001 6C Soybean, flour-babyfood 0.010000 1.000 1.000 

0600350000 6 Soybean, oil 0.010000 1.000 1.000 

0600350001 6 Soybean, oil-babyfood 0.010000 1.000 1.000 

0600347000 6 Soybean, seed 0.010000 1.000 1.000 

0600349000 6 Soybean, soy milk 0.010000 1.000 1.000 

0600349001 6 Soybean, soy milk-babyfood or in 0.010000 1.000 1.000 

0601349500 6AB Soybean, vegetable 0.010000 1.000 1.000 

1500381000 15 Triticale, flour 0.010000 1.000 1.000 

1500381001 15 Triticale, flour-babyfood 0.010000 1.000 1.000 

8601000000 86A Water, direct, all sources 0.000822 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.000822 1.000 1.000 

1500404000 15 Wheat, bran 0.010000 1.000 1.000 

1500402000 15 Wheat, flour 0.010000 1.000 1.000 

1500402001 15 Wheat, flour-babyfood 0.010000 1.000 1.000 

1500403000 15 Wheat, germ 0.010000 1.000 1.000 

1500401000 15 Wheat, grain 0.010000 1.000 1.000 

1500401001 15 Wheat, grain-babyfood 0.010000 1.000 1.000 
Ipconazole Dietary Exposure and Risk Assessment DP Barcode D413901

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Attachment 4. Summary of the Chronic Dietary Exposure Analysis for Ipconazole. 

US EPA Ver. 3.16, 03-08-d

DEEM-FCID Chronic analysis for IPCONAZOLE NHANES 2003-2008 2-day

Residue file name: C:\Documents and Settings\wdrew\My 

Documents\IpconazoleDEEM072313ChronicInput.R08

 Adjustment factor #2 NOT used.

Analysis Date 07-23-2013/10:21:38 Residue file dated: 07-23-2013/08:32:54

Reference dose (RfD, Chronic) = .015 mg/kg bw/day

COMMENT 1: RfDs are PADs. aPAD is for Females 13-49 only.

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

Total US Population 0.000065 0.4%

Hispanic 0.000069 0.5%

Non-Hisp-White 0.000065 0.4%

Non-Hisp-Black 0.000062 0.4%

Non-Hisp-Other 0.000067 0.4%

Nursing Infants 0.000055 0.4%

Non-Nursing Infants 0.000153 1.0%

Female 13+ PREG 0.000057 0.4%

Children 1-6 0.000135 0.9%

Children 7-12 0.000090 0.6%

Male 13-19 0.000068 0.5%

Female 13-19/NP 0.000058 0.4%

Male 20+ 0.000056 0.4%

Female 20+/NP 0.000051 0.3%

Seniors 55+ 0.000046 0.3%

All Infants 0.000122 0.8%

Female 13-50 0.000055 0.4%

Children 1-2 0.000142 0.9%

Children 3-5 0.000133 0.9%

Children 6-12 0.000095 0.6%

Youth 13-19 0.000063 0.4%

Adults 20-49 0.000058 0.4%

Adults 50-99 0.000047 0.3%

Female 13-49 0.000055 0.4%

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