UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Date: 

Subject: 

June 25, 2013 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

lpconazole: Occupational and Residential Exposure/Risk Assessment for 

Proposed Seed Treatment Uses on Legume Vegetables. 

PC Code: 125618 DP Barcode: D410928 

Decision No.: 469403 Registration No.: 400-544 

Petition No.: 2F8076 Regulatory Action: Section 3 Registration 

Risk Assessment Type: ORE Case No.: 7041 

TXRNo.:NA CAS No.: 125225-28-7 

MRIDNo.: NA 40 CFR: 180.646 

REVIEWER: 

Expo SAC: 

THROUGH: 

TO: 

Introduction 

Margarita Collantes, Biologist -;/J!a-;pt-~ (2_ #~ Risk Assessment Branch II 

Health Effects Division (7509P) 

Cassi 

James 

Walls, 

Scott Miller, 

Biologist 

Environmental 

~ )_ L>~

En~i~eer {J ~ 

Christina 

Risk Assessment 

Swartz, 

Branch 

Chief 

II 

~~ 

Health Effects Division (7509P) 

Tony Kish, RM 22 

Dominic Schuler, Risk Manager Reviewer 

Registration Division (7505P) 

The Registration Division (RD) requested that the Health Effects Division (HED) conduct a risk 

assessment for proposed uses of ipconazole. Chemtura has proposed a new use of ipconazole for 

treatment of legume vegetable seeds. It is HED policy to use the best available data to assess 

exposure. Sources of generic data, used as surrogate data in the absence of chemical-specific 

data, include the Standard Operating Procedures (SOPs) for Seed Treatment (Policy 14), Amount 

of Seed Treated or Planted per Day (Policy 15) and Interim Guidance "Amount of Commercial 

Seed Treated Per Day" (Policy 15.1). 

Note: This memorandum was reviewed by the Exposure Science Advisory Committee 

(ExpoSAC) on April18, 2013. 

Page 1 of14 
Page 2 of 14

Table of Contents

1.0 Executive Summary ............................................................................................................. 3

2.0 Summary of Conclusions/Data Deficiencies ....................................................................... 3

3.0 Hazard Characterization ....................................................................................................... 5

4.0 Use Profile ........................................................................................................................... 7

5.0 Residential Exposure and Risk Estimates ............................................................................ 8

5.1 Spray Drift ........................................................................................................................ 8

5.2 Residential Bystander Post-Application Inhalation Exposure ......................................... 8

6.0 Occupational Exposure and Risk Estimates ........................................................................ 8

6.1 Occupational Handler Exposure/Risk Estimates.............................................................. 8

6.2 Occupational Post-application Exposure/Risk Estimates .............................................. 13

 Appendix A. Summary of Occupational Algorithms 
Page 3 of 14

1.0 Executive Summary 

The Registration Division (RD) requested that the Health Effects Division (HED) conduct an 

exposure and risk assessment for the active ingredient (ai), ipconazole. Chemtura AgroSolutions 

is requesting a new proposed use for ipconazole as a commercial and on-farm seed treatment for 

legume vegetable (dried and succulent) seeds. Although the product is proposed for on-farm use, 

the label specifies that seed should be treated using a water-based slurry with other registered 

seed treatment insecticides and fungicides through standard slurry or mist-type commercial seed 

treatment equipment and not for use in hopper, planter or slurry boxes at or immediately before 

planting. Ipconazole is currently registered for seed treatment uses on brassica leafy vegetable, 

canola, cucurbit vegetable group, leafy vegetable group, mustard, rape, root and tuber vegetable, 

sorghum, sunflower, cotton, peanut, soybean, dry shelled peas and beans (subgroup 6C), cereal 

grain (except rice), ornamental flowers, conifers, and grass seeds. With the current petition, the 

registrant is requesting seed treatment uses on all of Crop Group 6. 

The product, Rancona® 3.8 FS, is a systemic broad spectrum fungicide seed dressing 

specifically for protection against soilborne and seed borne disease of crop plants. Rancona® 

3.8 FS is formulated as a flowable concentrate containing 40.7% (ai or 3.77 lb ai per gallon. 

There are no registered or proposed residential uses associated with ipconazole and residential 

exposure is not expected from the commercial use of this product; therefore, only occupational 

exposure is assessed in this memorandum. 

Based on the proposed use pattern, short- and intermediate-term durations of exposure are 

expected for occupational handlers. HED has new information to suggest that in commercial 

seed treatment facilities with high throughput for various seed types (e.g., corn or soybean), the 

durations of exposure for occupational handlers might exceed those typically considered in shortand intermediate-term assessments. However, HED decided not to conduct a long-term exposure 

assessment due to the conservative nature of the unit exposures which are based on open-pour 

systems rather than the closed and/or automated systems that would be used in larger facilities 

operating over longer durations. HED also notes that it would be unlikely for a single chemical 

to be used continuously, even in high throughput facilities, over long term durations. Using 

conservative assumptions, the short- and intermediate-term scenarios are considered protective 

of longer-term exposure and risk. 

Hazard Characterization

Ipconazole may cause local, portal-of-entry irritation following oral, dermal, or inhalation 

exposure. Systemic effects that were observed in laboratory animals following exposure to 

ipconazole include decreases in body weight, body weight gain, and food consumption; liver and 

kidney effects; and developmental effects (the latter being in the presence of maternal toxicity). 

Carcinogenicity studies showed no treatment-related increases in tumors in rats and mice after 

exposure to ipconazole. 

The 28-day dermal study in the rat was selected for assessing short-and intermediate-term dermal 

exposure and risk. The no observed adverse effect level (NOAEL) of 150 mg/kg/day and the 

lowest observed adverse effect level (LOAEL) of 1000 mg/kg/day were based on decreased body 
Page 4 of 14

weight, and body weight gains, food consumption, as well as increased incidences of dermal 

irritation. The 28-day inhalation rat study was selected for the short- and intermediate-term 

inhalation risk assessment. An inhalation POD was selected for adults based on epithelial 

hyperplasia in the hard palate in males, epithelium hyperplasia in the larynx mucosa of both 

sexes, and mixed inflammatory cells in the trachea of females. 

Since the short- and intermediate-term dermal and inhalation points of departure (PODs) were 

based on route-specific toxicity studies, no absorption factors were needed to estimate exposure. 

Furthermore, dermal and inhalation exposure estimates were not combined since the 

toxicological effects are different for these routes of exposure. 

Based on the available toxicity and exposure data, HED has recommended that the 10X Food 

Quality Protection Act (FQPA) Safety Factor (for the protection of infants and children) be 

reduced to 1X. Therefore, the level of concern (LOC) for dermal risk assessments is a margin of 

exposure (MOE) of 100, based on the combined interspecies (10X) and intraspecies (10X) 

uncertainty factors. The LOC for all inhalation occupational scenarios is equal to a MOE of 300, 

based on the combined uncertainty factors: 10X for lack of a NOAEL in the inhalation study, 

10X for intraspecies variability, and a 3X uncertainty factor for interspecies variability. 

Occupational Handler Exposure and Risk Estimates

The proposed label-required personal protective equipment (PPE) states that all handlers must 

wear long-sleeved shirt and long pants, chemical-resistant gloves, and socks and shoes. 

Commercial handler dermal and inhalation risk estimates are not of concern (Dermal LOC = 

MOE ≥ 100 and Inhalation LOC = MOE ≥ 300) for the proposed legume seed treatment use with 

label required PPE. The short-term handler MOEs for treating seed ranged from 2000 for 

inhalation exposure to 74,000 for dermal exposure, with the lowest MOE resulting from 

performing multiple activities with baseline clothing (long-sleeved shirt and long pants, socks 

and shoes) and gloves. The seed planter exposure estimates resulted in MOEs ranging from 

20,000 for inhalation to 140,000 for dermal using baseline clothing and gloves (note that gloves 

are only assumed to be used during loading of seed into the planter, and not during planting seed 

into the field using a tractor). 

HED assumes that the commercial seed treatment risk assessment is protective of on-farm seed 

treatment exposure and risk because the equipment is similar but the on-farm throughput is 

significantly less than the commercial throughput. Therefore, risk estimates for on-farm seed 

treatment have not been separately quantified. 

Occupational Post-Application Exposure and Risk Estimates

A quantitative post-application exposure assessment is not required for seed treatment, as the 

exposure is expected to be negligible, since there will be no residue on foliage from contact once 

plants are grown. 
Page 5 of 14

Restricted Entry Interval

No quantitative post-application assessment is required for exposure to treated seeds that have 

already been planted. Therefore, the labeling properly states the exception to the Agricultural 

Use Requirements restricted entry interval (REI) of 12 hours. 

Human Studies Review

This risk assessment relies in part on data from studies in which adult human subjects were 

intentionally exposed to a pesticide or other chemical. These data, which include studies from 

SOPs for Seed Treatment, Policy 14, 15, and 15.1 are (1) subject to ethics review pursuant to 40 

CFR 26, (2) have received that review, and (3) are compliant with applicable ethics 

requirements. For certain studies, the ethics review may have included review by the Human 

Studies Review Board. Descriptions of data sources, as well as guidance on their use, can be 

found at http://www.epa.gov/pesticides/science/handler-exposure-data.html and 

http://www.epa.gov/pesticides/science/post-app-exposure-data.html.

2.0 Summary of Conclusions and Data Requirements 

There are no residential/occupational risk estimates of concern associated with the proposed new 

uses of ipconazole. There are no data gaps in the exposure database. 

2.1 Summary of Risk Estimates 

Occupational exposure scenarios assessed resulted in MOEs that do not exceed HED's level of 

concern (Dermal MOEs ≥ 100 and Inhalation MOE ≥ 300) for ipconazole dermal and inhalation 

exposures; no changes are needed for the label-required PPE. 

2.2 Label Recommendations from Occupational Assessment 

There are no label recommendations based on the occupational assessment. 

2.3 Label Recommendations from Residential Assessment 

There are no proposed or registered residential uses associated with ipconazole at this time. 

2.4 Data Deficiencies and Requirements 

There are no outstanding exposure data deficiencies or data requirements for the active 

ingredient, ipconazole. 

3.0 Hazard Characterization 

Acute Toxicity

Acute exposure to ipconazole resulted in low toxicity via the oral, dermal and inhalation routes 

of exposure and it was classified as Category III for these routes. Ipconazole is classified as 
Page 6 of 14

Category IV for dermal irritation, is a low to mild eye irritant and is not a dermal sensitizer. A 

summary of the acute toxicity profile is provided in Table 3.1 below. 

Table 3.1 Acute Toxicity Profile - Ipconazole

Guideline 

No.

Study Type MRID(s) Results Toxicity 

Category

870.1100 Acute oral [rat] 45552702 LD50 M = 1338 mg/kg 

LD50 F = 888 mg/kg 

III 

870.1200 Acute dermal [rabbit] 45552703 LD50 > 2000 mg/kg (both sexes) III 

870.1300 Acute inhalation [rat] 46110501 LD50 > 1.88 mg/L (both sexes) III 

870.2400 Acute eye irritation [rabbit] 45552705 Eye irritation present at 24 hours, 

cleared by day 7 

III 

870.2500 Primary dermal irritation [rabbit] 45552706 Primary irritation index = 0.8 IV 

870.2600 Skin sensitization [guinea pig] 45552707 Non-sensitizer NA 

Toxicological PODs Used for Risk Assessment

The 28-day dermal study in the rat was selected for short- and intermediate term dermal 

exposure and risk assessment. The NOAEL of 150 mg/kg/day and the LOAEL of 1000 

mg/kg/day were based on decreased body weight, and body weight gains, food consumption, as 

well as increased incidences of dermal irritation. 

The 28-day inhalation rat study was selected for the short- and intermediate-term inhalation risk 

assessment. An inhalation NOAEL was not identified; therefore, the selected POD was based on 

the lowest dose tested, 0.03 mg/L. The LOAEL was based on epithelial hyperplasia in the hard 

palate in males, epithelium squamous/squamoid hyperplasia in the larynx mucosa of both sexes, 

and mixed inflammatory cells in the trachea of females. For purposes of estimating inhalation 

risk resulting from occupational exposure, a human equivalent concentration (HEC) and human 

equivalent dose (HED) were derived in accordance with standard methodology that results in a 

reduction in the interspecies uncertainty factor (UF) from 10X to 3X. The HED determined for 

occupational inhalation risk assessment is 0.2832 mg/kg/day. 

HED has recommended that the 10X FQPA Safety Factor (for the protection of infants and 

children) be reduced to 1X. Therefore, the level of concern (LOC) for dermal risk assessments 

is a margin of exposure (MOE) of 100, based on the combined interspecies (10X) and 

intraspecies (10X) uncertainty factors. The LOC for all inhalation occupational scenarios is 

equal to a MOE of 300, based on the following uncertainty factors: 10X for lack of a NOAEL, 

10X for intraspecies variability, and 3X for interspecies variability. A summary of the 

toxicological endpoints and doses for ipconazole is provided in Table 3.2 below. 
Page 7 of 14

Table 3.2. Summary of Toxicological Doses and Endpoints for Ipconazole Use in Occupational Human 

Health Risk Assessments 

Exposure 

Scenario 

Point of 

Departure 

Uncertainty 

Factors 

Level of Concern 

for Risk 

Assessment 

Study and Toxicological Effects 

Dermal 

Short-Term 

(1 - 30 days) 

 and 

Intermediateterm 

(1 - 6 months) 

NOAEL = 150 

mg/kg/day 

UFA=10X 

UFH =10X LOC for MOE =100

28-day Dermal Toxicity Study in Rats

LOAEL = 1000 mg/kg /day, based on 

decreased body weight, body weight 

gain, and food consumption, as well 

as, increased incidences of dermal 

irritation 

Inhalation 

Short-Term 

(1 - 30 days) 

and 

Intermediateterm 

(1 – 6 months) 

LOAEL = 0.03 

mg/L 

HEC = 

0.00531 mg/L 

HED = 0.2832 

mg/kg/day 

UFA = 3X 

UFH = 10X 

UFL = 10X 

LOC for MOE =300 

28-Day Inhalation Toxicity Study in 

Rats

LOAEL = 0.03 mg/L, based on 

epithelial hyperplasia in the hard 

palate in males, epithelium 

squamous/squamoid hyperplasia in the 

larynx mucosa of both sexes, and 

mixed inflammatory cells in the 

trachea of females 

Cancer (oral, 

dermal, 

inhalation) 

No Evidence of Carcinogenicity. Classified as “Not Likely to be Carcinogenic to Humans.” 

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 = lowest observed adverse effect level. UF 

= uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). UFL= use of a LOAEL to extrapolate a NOAEL. 

MOE = margin of exposure. LOC = level of concern. 

Absorption

Since the short- and intermediate-term dermal and inhalation points of departure (PODs) were 

based on route-specific toxicity studies, no absorption factors were needed to estimate exposure. 

 

Body Weight

The standard body weight for the general population (80 kg) was used for all exposure scenarios 

covered in this risk assessment since the endpoints selected were not based on developmental 

and/or fetal effects. 

4.0 Use Profile 

Chemtura AgroSolutions is requesting a new proposed use for ipconazole as a commercial and 

on-farm seed treatment for legume vegetable (dried and succulent) seeds. The proposed product 

label specifies that seed should be treated using a water-based slurry with other registered seed 

treatment insecticides and fungicides through standard slurry or mist-type commercial seed 

treatment equipment and not for use in hopper, planter or slurry boxes at or immediately before 

planting. Rancona® 3.8 FS is formulated as a flowable concentrate containing 40.7% ai or 3.77 

lb ai per gallon. The PPE statement on the proposed label requires applicators and other handlers 
Page 8 of 14

to wear the following: long-sleeved shirt and long pants, socks, shoes, and chemical-resistant 

gloves. The proposed use directions are summarized in Table 4.1. 

 1 Rate = Maximum application rates specified on proposed labels. 

*Maximum Application Rate (lb ai/lb seed) = (.085fl oz/cwt x 3.77 lb ai/gal x 1 gal/128 fl. oz)/100 cwt 

5.0 Residential Exposure and Risk Estimates 

There are currently no registered or proposed residential uses of ipconazole. 

5.1 Spray Drift and Residential Bystander Post-Application Inhalation Exposure 

A quantitative post-application exposure assessment is not required since there is no application 

of pesticide to the fields (seeds are previously treated in seed treatment facilities). Therefore, 

exposure is expected to be negligible. 

6.0 Occupational Exposure and Risk Estimates 

6.1 Occupational Handler Exposure/Risk Estimates 

HED uses the term handlers to describe those individuals who are involved in the pesticide 

application process. HED believes that there are distinct job functions or tasks related to 

applications, and exposures can vary depending on the specifics of each task. Job requirements 

(amount of chemical used in each application), the kinds of equipment used, the target being 

treated, and the level of protection used by a handler can cause exposure levels to differ in a 

manner specific to each application event. 

Based on the anticipated use patterns and current labeling, types of equipment and techniques 

that can potentially be used, occupational handler exposure is expected from the proposed uses. 

Typically, for large-scale commercial seed treatments, workers perform only specific individual 

tasks; however, it is assumed that workers also may perform multiple activities throughout the 

day. As a result a “multiple activities” scenario (i.e. where one worker performs all seed 

treatment tasks such as loading/applying, bagging, cleaning, calibration, repair, forklift driver, 

etc.) was addressed. The quantitative exposure/risk assessment developed for occupational 

handlers is based on the following scenarios: 

 Mixing, loading, applying liquid formulations for commercially and on-farm treated 

seeds; 

 Multiple activities; and 

Table 4.1. Summary of Directions for Use of Ipconazole For Seed Treatment 

Crop/ Use Site Product/ Formulation 

(EPA Reg. No.) 

Treatment Type Maximum Application Rate1 

(lb ai/ lb seed)* 

Legume Vegetables (Crop 

Group 6) 

Rancona® 3.8 FS

(400-544) 

Commercial and 

On-Farm 

0.000025 

(0.085fl oz/cwt seed) 
Page 9 of 14

 Planting treated seed. 

Occupational Handler Exposure Data, and Assumptions

A series of assumptions and exposure factors served as the basis for completing the occupational 

handler (seed treatment and planting) risk assessments. Each assumption and factor is detailed 

below on an individual basis. 

Application Rate 

The maximum application rate listed on the proposed label provided by the Registration Division 

was used for all exposure assessments. The maximum rate is 0.000025 lbs ai/lb seed for legume 

vegetable seeds.

Unit Exposures: 

It is the policy of HED to use the best available data to assess handler exposure. Sources of 

generic handler data, used as surrogate data in the absence of chemical-specific data, include 

HED Exposure SAC Policy 14: SOPs for Seed Treatment. Some of these data are proprietary 

(e.g., Agricultural Handler Exposure Task Force (AHETF) data), and subject to the data 

protection provisions of FIFRA. The standard values recommended for use in predicting handler 

exposure that are used in this assessment, known as “unit exposures”, are outlined in the SOP 14. 

The registrant has not submitted a chemical-specific exposure study in support of this action. 

 Amount Handled: 

The AHETF is currently conducting surveys for use in seed treatment exposure assessment, 

providing daily seed treatment throughput data along with information on seed treating 

equipment and worker activities. The HED Interim Guidance (SOP 15.1) “Amount of 

Commercial Seed Treated Per Day” provides updated additional information regarding these 

throughput data which will ultimately be incorporated into a final revised Seed Treatment SOP 

15. Since the AHETF surveys only include information for the five major field crops (canola, 

corn, rice, soybean and wheat), throughput values for non-surveyed crops are assigned based on 

a combination of “best professional judgement;” similarity of seed size to that of the surveyed 

crops; and general knowledge of each crop and its production. The amount of seed treated per 

day at a commercial facility is summarized below for each crop: 

 281,250 lbs of legume vegetables (succulent or dried) for short-term exposure (no survey 

data available; based on daily soybean throughput values) 

Amount of Seed Planted Per Day: 

The amount of seed planted per day is based on information provided in the HED Reviewer’s 

Aid to Calculating Occupational Exposures from Activities Related to Agricultural Seed 

Treatment (November 29, 2012) and the BEAD Acres Planted per Day and Seeding Rates of 

Crops Grown in the United States, Appendix B, Table B-1: 

 13,280 lbs of legume vegetable (surrogate – soybeans) seeds planted per acre 

 [(250,000 seed/A × 1 lb seed/ 1,500 seeds) × 80 A (legumes) = 13,280] 
Page 10 of 14

Note: Although soybeans served as a surrogate for legumes and are considered a high 

acreage crop which therefore assumes that 200 acres will be planted, legumes are considered 

a typical acreage crop. Therefore 80 acres were used to refine the amount of legume seeds 

planted per day in place of 200 acres.

Exposure Duration: 

Treatment of the proposed seeds is expected to result in short- and intermediate-term exposure. 

However, since the same dermal and inhalation endpoints were selected for their respective 

short- and intermediate-term exposure durations, short-term exposure and risk estimates are 

considered to be protective of intermediate-term exposure and a separate quantitative risk 

assessment for intermediate-term durations was not provided. The AHETF survey reports that 

39% of soybean is treated downstream for a duration of 49 days (50th percentile; range 4 to 150 

days), while soybean commercial facilities operate 210 days per year (50th percentile; range 1 to 

270 days). While these durations would be considered to potentially exceed the typical 

intermediate-term duration used in HED’s occupational assessments, HED had no information to 

indicate that the same chemical is used consecutively for a long-term duration. Therefore, 

chronic occupational handler exposure for seed treatment was not assessed. Furthermore, the 

dermal and inhalation unit exposure values specified in Policy 14 are based on open-pour 

systems, whereas the majority of the seed treatment facilities with large throughputs are 

equipped with fully or partially automated closed mixing and loading systems. Therefore, HED 

concluded that a chronic exposure assessment for ipconazole seed treatment would result in 

overly conservative estimates of exposure. 

Combining Exposures/Risk Estimates:

Dermal and inhalation exposure estimates were not combined since the toxicological effects 

were different for these routes of exposure. 

 

Summary of Occupational Handler Non-Cancer Exposure and Risk Estimates

Commercial handler dermal and inhalation risk estimates are not of concern (Dermal LOC = 

MOE ≥ 100 and Inhalation LOC = MOE ≥ 300) for the proposed legume seed treatment use with 

label required PPE. The short-term handler MOEs for treating seed ranged from 2000 for 

inhalation exposure to 74,000 for dermal exposure, with the lowest MOE resulting from 

performing multiple activities with baseline clothing (long-sleeved shirt and long pants, socks 

and shoes) and gloves. The seed planter exposure estimates resulted in MOEs ranging from 

20,000 for inhalation to 140,000 for dermal using baseline clothing and gloves (note that gloves 

are only assumed to be used during loading of seed into the planter, and not during planting seed 

into the field using a tractor). A summary of dermal and inhalation risk estimates for 

occupational handlers (treaters and planters) can be found in Tables 6.1 and 6.2. 

On- Farm Exposure and Risk

HED assumes that the commercial seed treatment risk assessment is protective of on-farm seed 

treatment because the equipment is similar but the on-farm throughput is significantly less. 
Page 11 of 14

Table 6.1. Occupational Seed-Treatment Handlers Exposure and Risk Estimates for Ipconazole 

Use Site PPE 

Dermal 

Unit 

Exposure a 

(mg/lb ai) 

Inhalation 

Unit 

Exposurea

(mg/lb ai) 

Application 

Rate b 

(lb ai/ lb seed) 

Amount 

Treatedc

(lb seed/ 

day) 

Dermal 

Dose d 

(mg/kg/day) 

Daily 

Inhalation 

Dosee 

(mg/kg/day)

Dermal 

MOEf Inhalation MOEg 

Loader/Applicator

Legume 

Vegetables 

(surrogate – 

soybeans) 

Single 

Layer, 

Gloves 

0.023 0.00034 0.000025 281,250 0.0020 0.00003 74,000 9,400 

Multiple Activities

Legume 

Vegetables 

(surrogate – 

soybeans) 

Single 

Layer, 

Gloves 

0.042 0.0016 0.000025 281,250 0.0037 0.00014 41,000 2,000 

a Unit Exposures are based on Policy 14: Standard Operating Procedures for Seed Treatment. b Application Rate is based on Proposed Label for V-10208 3.2 FS (EPA Reg No. 59639-185. c. Amount of Seed Treated is based on information provided in the HED Interim Guidance SOP 15.1: Amount of Commercial Seed Treated Per Day (d. Dermal Dose (mg/kg/day) = (unit exposure (mg/lb ai) × application rate (lb ai/lb seed) × daily amounts treated ÷ body weight (80 kg). 

e. Inhalation Dose (mg/kg/day) = (unit exposure (mg/lb ai) × application rate (lb ai/lb seed) × daily amounts treated ÷ body weight (80 kg). 

f Short- term Dermal MOE = NOAEL (150 mg/kg/day) ÷ dermal dose (mg/kg/day). g. Short-term Inhalation MOE = HED (0.28 mg/kg/day) ÷ inhalation dose (mg/kg/day). 
Page 12 of 14

Table 6.2: Seed Planter Exposure and Risk Estimates for Ipconazole Use Site Mitigation 

Level 

Dermal Unit Exposurea(mg/lb ai) 

Inhalation Unit Exposurea(mg/lb ai) 

Application Rateb (lb ai lb seed) 

Amount Plantedc(lbs seed) 

Dermal Dosed(mg/kg/day) 

Dermal MOEe Inhalation Dosef

(mg/kg/day) 

InhMO

Legume 

Vegetables 

(surrogate – 

soybeans) 

Single 

Layer, 

Gloves 

0.25 0.0034 0.000025 13,280 0.0010 140,000 0.000014 2

a Unit Exposures are based on Policy 14: Standard Operating Procedures for Seed Treatment. Note the dermal unit exposure is based on expo

treated seed into hopper while using gloves and does not represent exposure for driver operating tractor (no gloves required). 

b Application Rate is based on Proposed Label for V-10208 3.2 FS (EPA Reg No. 59639-185). c. Amount planted is based on information provided in the HED Reviewer’s Aid to Calculating Occupational Exposures from Activities Relate

Treatment (November 29, 2012) and the BEAD Acres Planted per Day and Seeding Rates of Crops Grown in the United States, Appendix B

d. Dermal Dose (mg/kg/day) = (unit exposure (mg/lb ai) × application rate (lb ai/lb seed) × daily amounts treated / body weight (80 kg). e. Inhalation Dose (mg/kg/day) = (unit exposure (mg/lb ai) × application rate (lb ai/lb seed) × daily amounts treated / body weight (80 kg). 

f Short- term Dermal MOE = NOAEL (150 mg/kg/day) / dermal dose (mg/kg/day). g. Short-term Inhalation MOE = HED (0.28 mg/kg/day) /inhalation dose (mg/kg/day). 
Page 13 of 14

6.2 Occupational Post-application Exposure/Risk Estimates 

HED uses the term post-application to describe exposures that occur when individuals are 

present in an environment that has been previously treated with a pesticide (also referred to as reentry exposure). The potential for dermal and inhalation post-application exposures following 

the planting of ipconazole-treated seeds is unlikely because sustained levels of contact with 

treated seed after it has been placed in the soil or other planting media would not be expected 

because no routine cultural practice required for the production of agricultural commodities 

involves such an activity as defined in the no/low contact criteria in the Worker Protection 

Standard (WPS). Therefore, no quantitative post-application assessment is required for exposure 

to treated seeds that have already been planted. The labeling properly states the exception to the 

Agricultural Use Requirements restricted entry interval (REI) of 12 hours. 
Page 14 of 14

Appendix A. Summary of Occupational Non-cancer and cancer Algorithms 

Occupational Handler Non-Cancer Exposure and Risk Estimate Equations

Potential daily exposures for occupational handlers were calculated using the following 

formulas: 

Daily Exposure (mg ai /day) = UE (mgai / lb of seed) * AR (lb ai /100 lbs of seed) * AT (Amount of seed treated 

/day) * 1E-3 mg/μg 

Where : 

Daily Exposure = Amount (mg ai/day) that is available for dermal or inhalation absorption, 

UE = Unit Exposure (μg ai / lb ai), 

AR = maximum application rate according to proposed label (lb ai /100lbs of seed), and 

AT = daily amount treated (lbs/day). 

 

The daily doses were calculated using the following formula: 

Average Daily Dose (mg ai/kg/day) = [Daily Exposure (mg ai/day) * Absorption (%)]

 Body Weight (kg) 

Where: 

Average Daily Dose = Absorbed dose received from exposure to a pesticide in a given scenario (mg 

 pesticide active ingredient/kg body weight/day), 

Daily Exposure = Amount (mg ai/day) that is available for dermal or inhalation absorption, 

Absorption Factor = A measure of the amount of chemical that crosses a biological boundary such as 

 the skin and lungs (%), and 

Body Weight = Body weight determined to represent the population of interest in a risk 

 assessment (kg). 

MOE = POD (typically a NOAEL in mg/kg/day) 

 ADD (mg/kg/day) 

Where: 

MOE = Margin of Exposure: value used by HED to represent risk or risk estimates (unitless), 

POD = Point of Departure, 

NOAEL = No Observed Adverse Effect Level (mg/kg/day): Dose level in a toxicity study, where no 

observed adverse effects occurred in the study, and 

ADD = Average Daily Dose (mg/kg/day): the absorbed dose received from exposure to a 

pesticide in a given scenario.