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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES,

AND TOXIC SUBSTANCES

MEMORANDUM

Date: 7-AUG-2009

SUBJECT: Triticonazole. Human Health Risk Assessment for Proposed Seed Treatment 

Use on Cereal Grains (Crop Group 15) Including Barley, Field Corn, Oats, 

Popcorn, Rye, Sorghum Grain, Sweet Corn, Triticale, and Wheat (Excluding 

Rice); and Forage, Fodder, and Straw of Cereal Grains (Crop Group 16), 

Excluding Rice.

PC Code: 125620 DP Barcode: 358614

Decision No.: 399232 Registration No.: 7969-EIT

Petition No.: 8F7420 Regulatory Action: Section 3 Registration

Risk Assessment Type: Single Chemical/Aggregate Case No.: NA

TXR No.: NA CAS No.: 131983-72-7

MRID No.: NA 40 CFR: 180.583

FROM: Nancy J. Tsaur, Risk Assessor

Amelia Acierto, Chemist

Myron Ottley, Toxicologist

Risk Assessment Branch 3 (RAB3)

Health Effects Division (7509P)

THROUGH: Paula Deschamp, Branch Chief 

Risk Assessment Branch 3 (RAB3)

Health Effects Division (7509P)

TO:

Tony Kish/Bryant Crowe, Risk Management Team 22

and

Cynthia Giles-Parker, Branch Chief

Fungicide Branch (FB)

Registration Division (7505P)
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Table of Contents

INTRODUCTION .......................................................................................................................................................4

1.0 EXECUTIVE SUMMARY...........................................................................................................................6

2.0 SUMMARY OF PROPOSED USES............................................................................................................9

3.0 HAZARD CHARACTERIZATION/ASSESSMENT ..............................................................................10

3.1 Database Summary.................................................................................................................................11

3.1.1 Sufficiency of studies/data.................................................................................................................11

3.1.2 Mode of action, metabolism, toxicokinetic data ..............................................................................11

3.1.3 Toxicological Effects..........................................................................................................................11

3.2 FQPA Considerations.............................................................................................................................12

3.2.1 Adequacy of the Toxicity Database ..................................................................................................12

3.2.2 Evidence of Neurotoxicity .................................................................................................................13

3.2.3 Developmental Toxicity Studies........................................................................................................13

3.2.4 Reproductive Toxicity Study ............................................................................................................13

3.2.5 Additional Information from the Literature ...................................................................................13

3.2.6 FQPA Safety Factor for Infants and Children................................................................................13

3.3 Hazard Identification and Toxicity Endpoint Selection......................................................................14

3.3.1 Level of Concern for Margin of Exposure/Population Adjusted Dose..........................................14

3.3.2 Recommendation for Aggregate Exposure Risk Assessments.......................................................14

3.3.3 Summary of Toxicological Doses and Endpoints for Triticonazole for Use in Human Risk 

Assessments ......................................................................................................................................................15

3.4 ENDOCRINE DISRUPTION................................................................................................................17

4.0 PUBLIC HEALTH AND PESTICIDE EPIDEMIOLOGY DATA ........................................................18

5.0 DIETARY EXPOSURE/RISK CHARACTERIZATION .......................................................................18

5.1 Drinking Water Residue Profile............................................................................................................18

5.2 Metabolism in Primary Crops...............................................................................................................19

5.3 Metabolism in Livestock ........................................................................................................................19

5.4 Analytical Methodology .........................................................................................................................20

5.5 Food Residue Profile ..............................................................................................................................21

5.6 International Residue Limits.................................................................................................................22

5.7 Dietary Exposure and Risk....................................................................................................................23

6.0 RESIDENTIAL (NON-OCCUPATIONAL) EXPOSURE/RISK CHARACTERIZATION................25

7.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION.....................................25

7.1 Acute Aggregate Risk.............................................................................................................................26

7.2 Short-Term and Intermediate-Term Aggregate Risk .........................................................................26
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7.3 Long-Term Chronic Aggregate Risk ....................................................................................................27

7.5 Cancer Aggregate Risk ..........................................................................................................................27

8.0 CUMULATIVE RISK CHARACTERIZATION/ASSESSMENT .........................................................27

9.0 OCCUPATIONAL EXPOSURE/RISK PATHWAY...............................................................................28

9.1 Short-/Intermediate -Term Handler Risk ............................................................................................28

9.2 Short-/Intermediate-Term Postapplication Risk .................................................................................31

10.0 DATA NEEDS AND LABEL RECOMMENDATIONS..........................................................................31

10.1 Toxicology ...............................................................................................................................................31

10.2 Residue Chemistry..................................................................................................................................32

10.3 Occupational and Residential Exposure...............................................................................................32

Appendix A: TOXICOLOGY ASSESSMENT ......................................................................................................33

A.1 Toxicology Data Requirements .............................................................................................................33

A.2 Acute Toxicity .........................................................................................................................................34

A.3 Toxicity Profile........................................................................................................................................34

Appendix B: INTERNATIONAL RESIDUE LIMIT STATUS ...........................................................................37

Appendix C: METABOLISM ASSESSMENT ......................................................................................................38
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INTRODUCTION

The Health Effects Division (HED) has conducted a human health risk assessment for the 

fungicidal active ingredient (ai), triticonazole, for the purpose of a registration eligibility decision 

to establish tolerances for the seed treatment uses (cereal grains, except rice) requested by the 

petitioner, BASF Corporation (BASF). Triticonazole is currently formulated for use as a seed 

treatment on barley and wheat seeds (for which there are associated tolerances on barley and 

wheat commodities), as well as on turfgrass.

BASF has submitted a petition (PP#8F7420) to register the end use product (EP) Triticonazole 

HL Fungicide Seed Treatment, a 43.5% ai (4.17 lbs ai/gallon) liquid flowable formulation of 

triticonazole (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1 H -1,2,4-triazol-1-

ylmethyl)cyclopentanol, for use in/on cereal grains (crop group 15, excluding rice) and forage, 

fodder, and straw of cereal grains (crop group 16, excluding rice) and proposed the following 

tolerances:

Commodity Proposed Tolerance (ppm)

Grain, cereal, group 15 (except rice) 0.05

Grain, cereal, forage, fodder, and straw, group 16 (except rice) 0.10

HED recommends that a revised Section F be submitted to reflect the tolerance 

recommendation of 0.01 ppm for grain, cereal, group 15 (except rice); to reflect the 

tolerance recommendation of 0.25 ppm for grain, cereal, forage, fodder, and straw, group 

16 (except rice); and to reflect the correct commodity definitions as listed in the tolerance 

summary below:

Tolerance Summary for Triticonazole

Commodity Established/Proposed 

Tolerance (ppm)

Recommended 

Tolerance (ppm)

Comments; Correct Commodity 

Definition

Established tolerances under 180.583(a)

Barley, grain 0.05 Remove Barley grain will be covered with the 

establishment of the cereal grain, 

group 15 (except rice) tolerance.

Barley, hay 0.05 Remove Increase in the tolerance based on 

residues resulting from new uses. 

Barley hay and straw and wheat 

forage will be covered with the 

establishment of the cereal grain 

group 16 (except rice) tolerance.

Barley, straw 0.05 Remove

Wheat, forage 0.05 Remove

Wheat grain 0.05 Remove Wheat grain will be covered with the 

establishment of the cereal grain, 

group 15 (except rice) tolerance

Wheat, hay 0.05 Remove Increase in the tolerance based on 
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Tolerance Summary for Triticonazole

Commodity Established/Proposed 

Tolerance (ppm)

Recommended 

Tolerance (ppm)

Comments; Correct Commodity 

Definition

Wheat, straw 0.05 Remove residues resulting from new uses. 

Wheat hay and straw and will be 

covered with the establishment of the 

cereal grain group 16 (except rice) 

tolerance.

Tolerances to be established under 180.583(a)

Grain, cereal, group 15 

(except rice)

0.05 0.01 NA

Grain, cereal, forage, 

fodder, and straw, group 

16 (except rice)

0.10 0.25

NA

The most recent prior human health risk assessment was conducted in conjunction with a request 

for use of triticonazole on turfgrass (S. Winfield, DP#316612, 12/20/2006). The following 

information from the 12/20/2006 risk assessment can be applied directly to this action:

 Sections 2.2-2.3: Structure and Nomenclature, Physical and Chemical Properties,

 Section 3.0: Hazard Characterization/Assessment, and

 Sections 5.1.1-5.1.8: Pesticide Metabolism and Environmental Degradation.

This document contains only those aspects of the risk assessment which are affected by the 

proposed Section 3 request for use of triticonazole for seed treatments of the cereal grain crop 

groups (15 and 16), excluding rice.

This document provides a summary of the findings from the data evaluation and subsequent 

assessment of human health risk resulting from these requests. The hazard assessment and 

characterization were conducted by Myron Ottley (RAB3), the residue chemistry data review 

and dietary exposure assessment were completed by Amelia Acierto (RAB3), and the 

occupational residential exposure data review and human health risk assessment were performed 

by Nancy J. Tsaur (RAB3); additionally, the drinking water assessment was conducted by Cheryl 

Sutton of the Office of Pesticide Program’s (OPP’s) Environmental Fate and Effects Division 

(EFED).
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1.0 EXECUTIVE SUMMARY

Triticonazole is a triazole fungicide that is proposed for use as a seed treatment on cereal grains, 

except rice, for the control of various seed-borne plant diseases. As a triazole fungicide, the 

contribution of triazole derivatives [1,2,4-triazole, triazolylalanine, and triazolylacetic acid] from 

the use of triticonazole on cereal grains must be considered in the aggregate exposure for a 

triazole human health risk assessment. The requested seed treatment uses of triticonazole do not 

result in increases in dietary exposure estimates for free triazole or conjugated triazoles and thus, 

no updated risk assessments are needed for the triazole derivatives. 

Use Profile

Triticonazole is currently registered and formulated for use as a seed treatment for barley and 

wheat, and for use in fungicidal products to control certain diseases of residential and 

commercial turfgrass, golf courses, and sod farms. The proposed formulated end use product 

evaluated in this assessment is labeled under the trade name Triticonazole HL Fungicide Seed 

Treatment (liquid flowable containing 43.5% ai or 4.17 lbs ai/gallon). The proposed use rates for 

seed treatment range from 0.155 to 1.55 fl oz/100 lbs seed (0.005 – 0.05 lbs ai/100 lbs seed). 

The formulation is to be applied once in a commercial seed treatment facility.

Toxicity/Hazard Assessment

Triticonazole has low acute toxicity, is not a skin, eye, or respiratory irritant, or a dermal 

sensitizer. Dermal absorption was reported to be less than 2%. Non-acute toxicity studies show 

that the liver (rat, mouse, dog) and adrenals (rat, dog, rabbit) are target organs across species. 

Adverse body weight changes (rat, dog, rabbit, mouse) and clinical signs (rat, dog, mouse) also 

were observed in multiple species. In the developmental and reproductive toxicity studies, 

adverse effects on the offspring occurred only at dose levels which were toxic in the adults, and 

the offspring were not qualitatively more susceptible compared with adults. In the rat subchronic 

study, decreased thymus weights were reported at a dose level (2309.3 mg/kg/day) two times 

higher than the limit dose (1000 mg/kg/day). Triticonazole was negative for mutagenicity, and 

the cancer classification is “Not Likely to Be Carcinogenic to Humans” based on a lack of 

evidence of carcinogenicity in the two guideline studies conducted on rats and mice. The nature 

and severity of toxicity from triticonazole exposure are adequately characterized, and the no 

observed adverse effect levels (NOAELs) and lowest observed adverse effect levels (LOAELs)

established for the studies in the database are judged by HED to be adequately protective for risk 

assessment purposes.

Food Quality Protection Act (FQPA) Considerations

There is a complete toxicity database for triticonazole, with the exception of a required 

immunotoxicity study, and exposure is estimated based on data that reasonably account for 

potential exposures. There is no evidence of increased susceptibility following in utero and/or 

postnatal exposure in the developmental toxicity studies in rats or rabbits, and in the 2-generation 

rat reproduction study. There are no residual uncertainties concerning pre- and post-natal toxicity

and no neurotoxicity concerns. The acute and chronic dietary food and drinking water exposure 

assessments utilize screening-level and modeled residue values which will not underestimate 

exposures/risks. Based on these data and conclusions, the FQPA Safety Factor can be reduced to 
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1X.

Dietary Exposure/Risk (food + water)

Acute and chronic dietary exposure and risk assessments were conducted using the Dietary

Exposure Evaluation Model (DEEM-FCIDTM, Version 2.03) which uses food consumption data 

from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals 

(CSFII) from 1994-1996 and 1998. The proposed new uses do affect and add food commodities 

to the dietary assessment but they do not trigger new modeled estimated drinking water 

concentrations (EDWCs) of the 1-in-10 year annual peak concentration of 75.5 ppb (for acute) 

and the 1-in-10 annual mean concentration of 32.8 ppb (for chronic), which are reflected in this 

assessment. Both the acute and chronic dietary assessments assumed that tolerance level 

residues of triticonazole were found in all commodities and that all commodities consumed were 

100% crop treated (100% CT). The dietary exposures for food and drinking water are well 

below the level of concern (LOC) for all populations for acute and chronic risk. Combined acute 

dietary exposure from food and drinking water is <1% of the acute population adjusted dose 

(aPAD) for the most highly exposed population subgroup, females 13-49 years old. For the 

general U.S. population and for all infants <1 year old, the exposure is also <1% of the aPAD. 

The chronic dietary exposure is estimated to be <1% of the chronic adjusted population dose 

(cPAD) for the general U.S. population and 1.4% of the cPAD for all infants (<1 year old), the 

population subgroup with the highest estimated chronic dietary exposure to triticonazole. The 

assessment is conservative and actual exposure is likely to be much lower.

Residential Exposure/Risk

Based on the proposed label restrictions, non-occupational (residential) handler exposure is not 

expected. However, exposure is possible during postapplication activities on treated turf 

(existing use) and such risks have been previously assessed (S. Winfield, DP#316612, 

12/20/2006). This document only presents the assessment of the proposed new agricultural uses 

of triticonazole. No residential uses are being requested at this time; therefore, no residential risk 

assessment has been conducted. 

Aggregate Risk

Acute and chronic aggregate assessments consider dietary (food + drinking water) exposure only

and are therefore, addressed in the dietary risk assessments (dietary risk estimates were not of 

concern). However, short- and intermediate-term aggregate assessments consider residential 

postapplication incidental oral exposure for children in addition to background dietary exposure. 

All aggregate risk assessments indicated risks were not of concern as the margins of exposure 

(MOEs) ranged from 740 to 1100 and are greater than the LOC of 100.

Occupational Exposure/Risk

Occupational handler exposure is expected for individuals involved in commercial seed 

treatment (primary handlers) and planting treated seeds (secondary handlers). The results of the 

occupational handler exposure and risk assessment indicate that inhalation risks do not exceed 

HED’s LOC (i.e., MOEs, ranging from 2,200 to 3,200,000, are greater than the LOC of 100) at 

the baseline level of risk mitigation (i.e., no respirator) for any of the cereal seed treatment 

scenarios. 
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There is the potential for postapplication exposures following the planting of triticonazoletreated seeds. 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 postapplication 

assessment is required for exposure to treated seeds that have already been planted.

The triticonazole ai has been classified in Toxicity Category III for acute dermal toxicity and 

Toxicity Category IV for primary eye irritation and primary skin irritation. The Worker 

Protection Standard (WPS) requires a 12-hour restricted entry interval (REI) for active 

ingredients classified as Toxicity Category III or IV for these routes of exposure.

Environmental Justice Considerations

Potential areas of environmental justice concerns, to the extent possible, were considered in the 

human-health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions 

to Address Environmental Justice in Minority Populations and Low-Income Populations," 

(http://www.eh.doe.gov/nepa/tools/guidance/Volume1/2-6-EO_12898envjustice.pdf). OPP 

typically considers the highest potential exposures from the legal use of a pesticide when 

conducting human health risk assessments including, but not limited to, people who obtain 

drinking water from sources near agricultural areas, the variability of diets within the U.S., and 

people who may be exposed when harvesting crops. Should these highest exposures indicate 

potential risks of concern, OPP further refines the risk assessments to ensure that the risk 

estimates are based on the best available information.

Review of Human Research

This risk assessment relies in part on data from studies (PHED and Seed Treatment Standard 

Operating Procedures, or SOPs) in which adult human subjects were intentionally exposed to a 

pesticide or other chemical. These studies have been determined to require a review of their 

ethical conduct, have received that review, and have been determined ethical.

Label Recommendations 

- The labeling should state: Seed that has been treated with this product that is then packaged 

or bagged for future use must contain the following labeling on the outside of the seed 

package or bag:

"Treated Seed - Do Not Use for Food, Feed, or Oil Purposes.

When opening this bag or loading/pouring the treated seed, wear longsleeved shirt, long pants, shoes, socks, and chemical resistant gloves.

After the seeds have been planted, do not enter or allow worker entry into 

treated areas during the restricted-entry interval (REI) of 12 hours. 

Exception: Once the seeds are planted in soil or other planting media, the 

Worker Protection Standard allows workers to enter the treated area 

without restriction if there will be no worker contact with the treated seeds 

in the soil or planting media."
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- For directions for use: The label for Triticonazole HL Fungicide must be amended to include 

the following rotational crop restrictions: a 120-day plantback interval for leafy vegetables, a 

365-day plantback interval for root and tuber vegetables, and a prohibition of the planting of 

all other crops not listed on the label.

Tolerance Recommendations

- For tolerances for the cereal grain crop group 15, except rice: A revised Section F must be 

submitted to reflect the tolerance recommendation of 0.01 ppm for grain, cereal, group 15 

(except rice); to reflect the tolerance recommendation of 0.25 ppm for grain, cereal, forage, 

fodder, and straw, group 16 (except rice); and to reflect the correct commodity definitions.

Conditions of Registration

- HED recommends conversion of conditional registration to unconditional registration 

for the cereal grains (except rice) upon adequate resolution of data pertaining to 

storage stability, field accumulation in rotational crops, and immunotoxicity.

Deficiencies

- 860.1380 Storage Stability: To support the reported results for 1,2,4-triazole and the triazole 

conjugates, the final report of the ongoing storage stability study with free triazole and 

triazole conjugates in plant commodities must be submitted.

- 860.1900 Field Accumulation in Rotational Crops: Data from limited field accumulation 

studies on rotational crops are required.

- Biliary Excretion Study.

- Immunotoxicity Study.

2.0 SUMMARY OF PROPOSED USES

A summary of the proposed use directions is presented in Table 2.0. Information pertaining to 

the proposed use pattern was obtained from a 2008 specimen label submitted for Triticonazole 

HL Fungicide Seed Treatment (4.17 lb/gal FS). The EP is proposed for the control of various 

seed-borne diseases in cereal crops, excluding rice. 

Table 2.0 shows that Triticonazole HL Fungicide Seed Treatment is proposed for seed treatment 

on cereal grains (except rice) at a maximum rate of 0.05 lb ai/100 lb seed. The EP, Charter® 

Fungicide Treatment (EPA Reg. No. 7969-386; accepted 6/27/2007), is currently registered on 

barley and wheat for preplant seed treatment at a maximum rate of 0.005 lb ai/100 lb seed.

Table 2.0. Summary of Proposed Seed Treatment Use of Triticonazole.

Application 

Type

Formulation

[EPA Reg. No.]

Seed Treatment 

Application Rate

fl ozs/100 lbs seed

(lbs ai/100 lbs seed)

Maximum 

Seeding Rate 1

(lb seed planted/A)

Maximum Equivalent 

Field Application Rate 2

(lb ai/A)

Barley

Seed 

Treatment

4.17 lb/gal FS

[7969-EIT]

0.155-1.55

(0.005-0.050) 96 0.048
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Field Corn and Popcorn (includes seed production)

Seed 

Treatment

4.17 lb/gal FS

[7969-EIT]

0.155-1.55

(0.005-0.050) 15 0.008

Sweet Corn

Seed 

Treatment

4.17 lb/gal FS

[7969-EIT]

0.31

(0.010)

15 0.002

Oats

Seed 

Treatment

4.17 lb/gal FS

[7969-EIT]

0.155-1.55

(0.005-0.050) 128 0.064

Rye

Seed 

Treatment

4.17 lb/gal FS

[7969-EIT]

0.155-1.55

(0.005-0.050) 112 0.056

Sorghum

Seed 

Treatment

4.17 lb/gal FS

[7969-EIT]

0.31-0.62

(0.010-0.020)

10 0.002

Wheat and Triticale

Seed 

Treatment

4.17 lb/gal FS

[7969-EIT]

0.155-1.55

(0.005-0.050) 150 0.075

General Use Directions and Limitations: To be applied as a water-based mixture using standard or mist-type 

seed treatment application equipment. A colorant must be added to identify the treated seed. The proposed label 

does not include water amounts needed to provide the mixture or slurry rate for optimum coverage, but 

recommends consulting a seed-treatment specialist. The product may be tank-mixed with other water-based seed 

treatments. Use of treated seed for food, feed, or oil processing is prohibited. Planting of any crop not listed on 

the label within 30 days after planting treated seed is not allowed. 

1

From Science Advisory Council for Exposure, Standard Operating Procedure, SOP#15, 3/2/04.

2 Calculated by the study reviewer using the maximum seed treatment rate and maximum seeding rate.

3.0 HAZARD CHARACTERIZATION/ASSESSMENT

References:

- Triticonazole – Report of the Hazard Identification Assessment Review Committee. A. Assaad, TXR#014698, 

10/11/2001.

- Triticonazole – Report of the FQPA Safety Factor Committee. C. Christensen, TXR#0050801, 06/13/2002.

- Triticonazole: Report of the Cancer Assessment Review Committee. J. Kidwell, TXR#0054249, 06/15/2006.

- Response to Bayer CropScience Request to Waive the Requirement of a 28-day Inhalation Toxicity Study for 

Triticonazole. A. Assaad, TXR#0054207, 04/12/2006.

- Triticonazole (PC Code 125620) Developmental Neurotoxicity Study Waiver Request. S. Dapson, 

TXR#0053424, 11/13/2006.

- Triticonazole: HED Human Health Risk Assessment for Proposed Use on Turf. PC Code: 125620, Reg Nos. 

264-ANR, 432-REAI. S. Winfield, DP#s316612 and 313844, 12/20/2006.

With the exception of a new data requirement for immunotoxicity, the hazard characterization, 

toxicological effects, mode of action, dose response considerations, and absorption, distribution, 
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metabolism, excretion (ADME) determinations have not changed since completion of the 

previous risk assessment (S. Winfield, DP#316612, 12/20/2006). A biliary excretion study in the 

rat has been submitted (MRID#47158901) and is currently under review. The results of this 

study are not expected to change the hazard assessment or endpoints selected for risk assessment. 

Refer to the listed references for further extensive details. Refer to Appendix A for the toxicity

profile of triticonazole. Since no new toxicity data are associated with this action, the hazard 

characterization and endpoint selection for triticonazole summarized below are supported by the 

data evaluations and conclusions from the previous risk assessment which apply directly to this 

section.

3.1 Database Summary

3.1.1 Sufficiency of studies/data

With the exception of an immunotoxicity study, the toxicology database for triticonazole is 

complete. There are acceptable studies available for endpoint selection that include: 1) 

subchronic oral toxicity studies in rats; 2) chronic oral toxicity studies in rats and dogs, and 

carcinogenicity studies in rats and mice; 3) developmental studies in rats and rabbits and a 

reproduction study in rats; 4) acute and subchronic neurotoxicity studies in rats; and 5) 

subchronic dermal toxicity and dermal penetration studies in rats. There is also a complete 

mutagenicity battery, and a set of metabolism studies in rats. A waiver for a developmental 

neurotoxicity (DNT) study has been granted.

3.1.2 Mode of action, metabolism, toxicokinetic data

Triticonazole is in the class of fungicides known as azoles which commonly inhibit the synthesis 

of ergosterol (specifically C-14 demethylation). The data show that at higher dose levels the 

absorption mechanism can become saturated. The extent of absorption following oral dosing 

was not determined. It was not widely distributed in rat tissue. Excretion was rapid, >90% 

within 48 hours following a single dose. It was excreted mostly from the GI tract in bile and 

feces, and also from the kidney. The major metabolites identified were diastereo isomers (acid 

metabolites) and hydroxylated derivatives.

3.1.3 Toxicological Effects

Toxicity Summary

Triticonazole has low acute toxicity, is not a skin, eye, or respiratory irritant, and does not cause 

dermal sensitization in guinea pigs. Dermal absorption was reported to be less than 2%. 

Repeated dosing studies show that the liver (rat, mouse, dog) and adrenals (rat, dog, rabbit) are 

target organs across species. Adverse body weight changes (rat, dog, rabbit, mouse) and 

neurotoxic signs (rat, dog, mouse) also were observed in multiple species. 

The data does not demonstrate susceptibility in the offspring. In the developmental and 

reproductive toxicity studies, adverse effects on the offspring (supernumery ribs and cranial 
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variations) occurred only at dose levels where maternal and parental toxicities were seen. In 

addition, toxicity in the offspring was more severe compared with adults (in rabbits, an increase 

in mortality was observed in both dams and offspring at the same dose).

Triticonazole was negative for mutagenicity, and the cancer classification is “Not Likely to Be 

Carcinogenic to Humans” based on a lack of evidence of carcinogenicity in rats and mice up to 

the limit dose at 24 and 18 months, respectively.

Immunotoxicity

In the oral subchronic rat study (MRID 44802102) triticonazole was offered in feed for 13 weeks 

to 10 CD rats/sex at dose levels of 0, 25, 250, 12,500 or 25,000 ppm (males: 0, 2.0, 19.8, 1117.0, 

or 2309.3 mg/kg body weight/day; females: 0, 2.2, 22.3, 1183.5, or 2368.8 mg/kg/day). In 

addition to adverse effects on body weight and food consumption, primary target organ effects 

involved the thymus (decreased weight), adrenals (decreased weight, and increased lesions), liver 

(hypertrophy), blood (decreases in hematocrit, hemoglobin, and red blood cells) and skin (hair 

loss).

The decrease in thymus weights was reported at the high dose level (2309.3 mg/kg/day). The 

NOAEL for thymus weight changes was 1117 mg/kg/day. The NOAEL for the study was 2 

mg/kg/day (males) and the LOAEL was 19.8 mg/kg/day, based on adverse effects on the 

adrenals (a statistically significant increase in the incidence of adrenocortical fatty vacuolation).

No other adverse effects indicative or suggestive or indicative of immunotoxicity were observed 

in any other studies in the available database. A clear NOAEL for thymus effects has been 

established, and the points of departure for risk assessment are protective of the adverse thymus 

weight change. Additionally, triticonazole does not belong to a class of chemicals that would be 

expected to be immunotoxic. It is not likely that conducting a special 870.7800 immunotoxicity

study will result in a NOAEL less than 17 mg/kg/day which is presently used as the cRfD POD. 

Therefore, there an additional uncertainty factor (UFDB) does not need to be applied at this time.

3.2 FQPA Considerations

3.2.1 Adequacy of the Toxicity Database

The toxicity database for triticonazole is considered complete except for:

1. additional information on absorption. A biliary excretion study in the rat has been 

submitted (MRID 47158901) and is currently in review. The results of this study will 

provide the needed information on the extent of absorption of triticonazole in the rat, but 

are not expected to change the hazard assessment, endpoints selected for risk assessment, 

or Uncertainty Factors for FQPA.

2. the current requirement for an immunotoxicity study.
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3.2.2 Evidence of Neurotoxicity

Neurotoxicity was observed as transient signs (tremors, hyperactivity or hypoactivity, 

convulsions, and ataxia) in the one-year dog study at 150 mg/kg/day. However, no neurological 

effects were seen in rats, mice, or rabbits at dose levels that caused death (rabbits) or at the limit 

dose (rats). Increases in motor activity were observed in a rat oral acute neurotoxicity study

above the limit dose (i.e., at 2000 mg/kg), but a LOAEL for neurological effects could not 

established in the rat oral subchronic neurotoxicity study (NOAEL = 695 mg/kg/day (M), 820 

mg/kg/day (F)). A DNT study waiver was submitted and granted (S. Dapson, TXR#0053424, 

11/13/2006). Thus, there are no concerns for neurotoxicity associated with exposure to 

triticonazole at this time.

3.2.3 Developmental Toxicity Studies

In the rat developmental study, extra ribs (unilateral and bilateral supernumerary ribs) were 

observed at the dose level where maternal toxicity (reduced body weight gain) was observed. 

The LOAEL was 1000 mg/kg/day and the NOAEL was 200 mg/kg/day. 

In the rabbit developmental study, a reduction in maternal body weight and food consumption 

and increased mortality was observed at the LOAEL of 50 mg/kg/day (NOAEL = 25 

mg/kg/day). No effects in the fetus were observed at the maternal LOAEL. At the 

developmental LOAEL of 75 mg/kg/day cranial variations, abortion and increased pre- and postimplantation losses were observed.

3.2.4 Reproductive Toxicity Study

The multigeneration reproduction study yielded all NOAELs (parental, reproductive, offspring)

occurring at 37.5 mg/kg/day and all LOAELS occurring at 250 mg/kg/day. The parental LOAEL 

is based on reduced body weights, mortality and microscopic lesions in adrenals. The 

reproductive LOAEL is based on decreased fertility. The offspring LOAEL is based on 

decreased pup survival and decreased pup body weights.

3.2.5 Additional Information from the Literature

A literature search did not reveal information that would impact the risk assessment. 

3.2.6 FQPA Safety Factor for Infants and Children

EPA has determined that reliable data show the safety of infants and children would be 

adequately protected if the FQPA SF were reduced to 1X. That decision is based on the 

following findings:

 There is a complete toxicity database for triticonazole, with the exception of a required 

immunotoxicity study, and exposure is estimated based on data that reasonably account 

for potential exposures.
14 of 39

 A clear NOAEL for thymus effects was established in the available database and the 

PODs for risk assessment are protective of these thymus effects. Therefore, there is no 

basis for concern for immunotoxicity or for retaining the 10X FQPA factor due to 

concerns for immunotoxicity at this time.

 There is no evidence of increased susceptibility following in utero and/or postnatal 

exposure in the developmental toxicity studies in rats or rabbits, and in the 2-generation 

rat reproduction study. 

 There are no residual uncertainties concerning pre- and post-natal toxicity and there are 

no neurotoxicity concerns.

 The acute and chronic dietary food and drinking water exposure assessments utilize 

screening-level and modeled residue values which will not underestimate exposures/risks. 

3.3 Hazard Identification and Toxicity Endpoint Selection

3.3.1 Level of Concern for Margin of Exposure/Population Adjusted Dose

Table 3.3.1. Summary of Levels of Concern for Risk Assessment.

Route Short-Term

(1 - 30 Days)

Intermediate-Term

(1 - 6 Months)

Long-Term

(> 6 Months)

Occupational (Worker) Exposure

Inhalation MOE < 100 MOE < 100 NA

Residential Exposure

Inhalation MOE < 100 MOE < 100 NA

Incidental Oral MOE < 100 MOE < 100 NA

Dietary (Food and Water) exposure > 100% aPAD

(acute, 1-day exposure)

NA exposure > 100% cPAD 

(chronic exposure)

The LOCs for the inhalation and incidental oral routes (MOEs) are based on the conventional 

interspecies extrapolation (10X) and intraspecies variation (10X) uncertainty factors. No 

additional uncertainty factors are necessary. The LOCs for the dietary route are expressed as a 

percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in 

no unreasonable adverse health effects). This dose is referred to as the population adjusted dose 

(PAD). For acute and non-cancer chronic exposures, HED is concerned when estimated dietary

risk exceeds 100% of the PAD.

3.3.2 Recommendation for Aggregate Exposure Risk Assessments

As per FQPA, 1996, when there are potential residential exposures to a pesticide, aggregate risk 

assessment must consider exposures from three major routes: oral, dermal and inhalation 

exposures. No systemic toxicity was observed in the rat dermal toxicity study and there are no 

developmental or neurotoxic concerns; therefore, no hazard was identified via the dermal route 

that would contribute to aggregate exposure/risk. However, the toxicity endpoints were selected 

for short- and intermediate-term incidental oral and inhalation routes of exposure may be 

aggregated due to the presence of a common toxicity endpoint (short-term: decreased body 
15 of 39

weight gain, reduced food consumption, and mortality; intermediate-term: decreased body 

weight gain and liver toxicity). Even though these exposures may be aggregated due to common 

toxicity endpoints, residential exposure via the inhalation route is not expected to occur due to 

label restrictions. Therefore, short- and intermediate-term incidental oral exposures were 

aggregated with background dietary (food and drinking water) exposure and compared to the 

short- and intermediate-term incidental oral quantitative hazard estimates. Expected sources of 

exposure for acute and chronic durations are dietary alone (i.e., food and drinking water 

exposures are aggregated).

3.3.3 Summary of Toxicological Doses and Endpoints for Triticonazole for Use in Human 

Risk Assessments

Tables 3.3.3.1 and 3.3.3.2 summarize the up-to-date toxicological doses and endpoints for 

triticonazole for use in dietary and occupational human health risk assessments, respectively.

Table 3.3.3.1. Summary of Toxicological Doses and Endpoints for Triticonazole for Use in 

Dietary and Non-Occupational Human Health Risk Assessments.

Exposure/

Scenario

Point of 

Departure

Uncertainty/FQPA 

Safety Factors

RfD, PAD, 

Level of 

Concern for 

Risk 

Assessment

Study and Toxicological Effects

Acute Dietary 

(General 

Population, 

including 

Infants and 

Children)

NOAEL=400 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= 1x

Acute RfD = 

4 mg/kg/day

aPAD =

4 mg/kg/day

Acute Neurotoxicity - Rat

LOAEL = 2000 mg/kg/day based on 

increased motor activity in both sexes.

Acute Dietary

(Females 13-

49 years of 

age)

NOAEL = 50 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= 1x

Acute RfD = 

0.5 mg/kg/day

aPAD =

0.5 mg/kg/day

Developmental - Rabbit

LOAEL = 75 mg/kg/day based on cranial 

variations, abortion, and increased pre- and 

post-implantation losses assumed to occur 

following a single dose (developmental 

toxicity).

Chronic 

Dietary (All 

Populations)

NOAEL= 

17.4 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= 1x

Chronic RfD 

= 0.17 

mg/kg/day

cPAD = 0.17 

mg/kg/day

Carcinogenicity - Mouse

LOAEL of ~ 200 mg/kg/day based on 

decreased body weight gain and liver 

toxicity.

[LOAEL=202/209.5 mkd for males/females]

Incidental Oral 

Short-Term (1-

30 days)

NOAEL= 25 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= 1x

Residential 

LOC for MOE 

= 100

Developmental - Rabbit

LOAEL = 50 mg/kg/day based on 

decreased body weight gain, reduced food 

consumption, and mortality (maternal 

toxicity).

Incidental Oral 

Intermediate

-Term (1-6 

months)

NOAEL= 

17.4 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= 1x

Residential 

LOC for MOE 

= 100

Carcinogenicity - Mouse

LOAEL of ~ 200 mg/kg/day based on 

decreased body weight gain and liver 

toxicity.
16 of 39

Table 3.3.3.1. Summary of Toxicological Doses and Endpoints for Triticonazole for Use in 

Dietary and Non-Occupational Human Health Risk Assessments.

Exposure/

Scenario

Point of 

Departure

Uncertainty/FQPA 

Safety Factors

RfD, PAD, 

Level of 

Concern for 

Risk 

Assessment

Study and Toxicological Effects

Dermal 

Short- (1-30 

days), 

Intermediate-

(1-6 months), 

and LongTerm (>6

months)

None

Dermal absorption is minimal (<2% of the total administered dose) regardless of 

dose, and rats treated by dermal occlusion for 6-7 hours/day for 23 days at doses 

up to 1000 mg/kg/day (Limit-Dose) did not exhibit any signs of systemic toxicity 

or dermal irritation, and no treatment-related histopathological effects were noted. 

Therefore, quantification of dermal risk was not conducted. 

Inhalation 

Short- Term

(1-30 days)

NOAEL= 25 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= 1x

Residential 

LOC for MOE 

= 100

Developmental - Rabbit

LOAEL = 50 mg/kg/day based on 

decreased body weight gain, reduced food 

consumption, and mortality (maternal 

toxicity).

Inhalation 

IntermediateTerm (1-6 

months) and 

Long-Term 

(>6 months)

NOAEL= 

17.4 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= 1x

Residential 

LOC for MOE 

= 100

Carcinogenicity - Mouse

LOAEL of ~ 200 mg/kg/day based on 

decreased body weight gain and liver 

toxicity.

Cancer (oral, 

dermal, 

inhalation)

Classification: “Not likely to be Carcinogenic to Humans” based on the absence of significant 

tumor increases in two adequate rodent carcinogenicity studies as per the CARC report dated June 

15, 2006, TXR No.: 005249.

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). FQPA SF = FQPA Safety Factor. PAD = 

population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level 

of concern.
17 of 39

Table 3.3.3.2. Summary of Toxicological Doses and Endpoints for Triticonazole for 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- (1-30 

days), 

Intermediate-

(1-6 months), 

and LongTerm (>6 

months)

None

Dermal absorption is minimal (<2% of the total administered dose) regardless of 

dose, and rats treated by dermal occlusion for 6-7 hours/day for 23 days at doses up 

to 1000 mg/kg/day (Limit-Dose) did not exhibit any signs of systemic toxicity or 

dermal irritation, and no treatment-related histopathological effects were noted. 

Therefore, quantification of dermal risk was not conducted.

Inhalation 

Short- Term

(1-30 days)

NOAEL= 

25 

mg/kg/day

UFA= 10x

UFH=10x

Occupational 

LOC for MOE = 

100

Developmental - Rabbit

LOAEL = 50 mg/kg/day based on 

decreased body weight gain, reduced food 

consumption, and mortality (maternal 

toxicity).

Inhalation 

IntermediateTerm (1-6 

months) and 

Long-Term

(>6 months)

NOAEL= 

17.4 

mg/kg/day

UFA= 10x

UFH=10x

Occupational 

LOC for MOE = 

100

Carcinogenicity - Mouse

LOAEL of ~ 200 mg/kg/day based on 

decreased body weight gain and liver 

toxicity.

Cancer (oral, 

dermal, 

inhalation)

Classification: “Not likely to be Carcinogenic to Humans” based on the absence of significant 

tumor increases in two adequate rodent carcinogenicity studies as per the CARC report dated June 

15, 2006, TXR No.: 005249.

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

concern.

3.4 ENDOCRINE DISRUPTION

EPA is required under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 

FQPA, to develop a screening program to determine whether certain substances (including all 

pesticide active and other ingredients) “may have an effect in humans that is similar to an effect 

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

may designate.” Following recommendations of its Endocrine Disruptor and Testing Advisory

Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of 

the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone 

system. EPA also adopted EDSTAC’s recommendation that the Program include evaluations of 

potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that 

effects in wildlife may help determine whether a substance may have an effect in humans, 

FFDCA authority to require the wildlife evaluations. As the science develops and resources 

allow, screening of additional hormone systems may be added to the Endocrine Disruptor 

Screening Program (EDSP).
18 of 39

When additional appropriate screening and/or testing protocols being considered under the 

Agency’s EDSP have been developed, triticonazole may be subjected to further screening and/or 

testing to better characterize effects related to endocrine disruption.

4.0 PUBLIC HEALTH AND PESTICIDE EPIDEMIOLOGY DATA

References:

- Review of Triticonazole Incident Reports. M. Hawkins, DP#325380, 9/19/2006.

There were no reports and/or cases related to triticonazole in the OPP Incident Data System 

(IDS), Poison Control Centers data, California Department of Pesticide Regulation data, the 

National Pesticide Information Center (NPIC) data, and the National Institute of Occupational 

Safety and Health’s Sentinel Event Notification System for Occupational Risks (NIOSH 

SENSOR). Furthermore, no scientific literature was found concerning human poisoning or other 

adverse effects from exposure to triticonazole.

5.0 DIETARY EXPOSURE/RISK CHARACTERIZATION

References:

- Triticonazole: HED Human Health Risk Assessment for Proposed Use on Turf. S. Winfield, DP#s316612 and 

313844, 12/20/2006.

- Triticonazole Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk 

Assessments for a Section 3 Registration Action for Seed Treatment of Cereals. A. Acierto, DP#366041, 

06/10/2009.

- MARC Decision Memo. N. Dodd and A. Assaad, TXR#0050233, 06/04/2001.

- Tier II Drinking Water Assessment for the Triticonazole Proposed Section 3 Registration for Use on Crop 

Group 15 (Cereal Grains, Except Rice) and Crop Group 16 (Forage Fodder and Hay of the Cereal Grains 

Group, Except Rice). C. Sutton, DP#313847, 10/11/2006.

The exposure pathways resulting from use of this chemical are dietary (food and drinking water), 

residential, and occupational. The residue chemistry data submitted in support of the proposed 

use and increased existing tolerances were summarized in the HED memorandum by A. Acierto 

(DP#360624, 06/12/2009). The acute and chronic dietary exposure assessment was completed in 

a HED memorandum by A. Acierto (DP#366041, 06/10/2009).

Pesticide metabolism (in primary crops, rotational crops, and livestock), associated analytical 

methodology), and environmental degradation (metabolic profiles of major metabolites and 

degradates) were previously assessed in a human health risk assessment (S. Winfield, 

DP#316612, 12/20/2006). See Appendix C for the chemical structure and metabolic profile.

5.1 Drinking Water Residue Profile

Triticonazole and its transformation products are very persistent and moderately mobile in 

terrestrial and aquatic environments. These fate properties suggest that it has a potential to move 
19 of 39

into surface water and shallow ground water while undergoing slow degradation.

The EDWCs used in the dietary risk assessment were provided by EFED and incorporated 

directly into the dietary assessment (C. Sutton, DP#358625, 03/24/2009). The EDWCs used in 

the dietary assessment were modeled using the surface water model PRZM-EXAMS. For the 

acute point estimate, the PRZM-EXAMS 1-in-10 yr annual maximum EDWC was used. For the 

chronic point estimate, the PRZM-EXAMS 1-in-10 year annual mean EDWC was used. PRZMEXAMS EDWCs were used because they were higher (and therefore more protective) than the 

groundwater model’s (SCI-GROW’s) EDWC. The modeled EDWCs are shown in Table 5.1.

Table 5.1. Summary of Estimated Surface Water and Groundwater Concentrations for Triticonazole.

Surface Water Conc., ppb a Ground Water Conc., ppb b

Acute (1-in-10-year annual concentration) 75.5 5.7

Chronic (non-cancer; 1-in-10-year avg. 

annual concentration)

32.8

Chronic (cancer; 30-year avg. annual 

concentration)

21.4

a

From the Tier II PRZM-EXAMS - Index Reservoir model. Based on the FL turf scenario, using the application rate on the 

CHIPCO brand TRITON label (resubmitted 9/22/06) of 1.15 lb ai/A, applied by ground equipment 3 times with 14-day interapplication intervals.

b

From the SCI-GROW model assuming a maximum seasonal use rate of 1.15 lb ai/A, a Koc of 533 mL/g, and a half-life 

considered stable.

5.2 Metabolism in Primary Crops

The nature of the residue in plant commodities is considered adequately understood only for the 

purpose of the proposed/registered seed treatment uses on cereal grain-type crops. Based on the 

barley and wheat metabolism studies, triticonazole is metabolized primarily via hydroxylation of 

the dimethylcyclopentane moiety to form a series of dihydroxy metabolites which subsequently 

cleave to form numerous minor polar metabolites. The residue of concern for cereal grain 

commodities, excluding rice commodities, for risk assessment and tolerance expression is parent 

only. Although hydroxylated metabolites were identified in the plant metabolism studies, they

were not included as residues of concern because exposure to metabolites is not significant 

relative to parent, and exposure is very low from the seed treatment uses. No triazole 

metabolites [1,2,4-triazole (T), triazolylalanine (TA), or triazolylacetic acid (TAA)] were 

detected in barley or wheat grain. 

5.3 Metabolism in Livestock

The nature of the residue in livestock commodities is considered adequately understood only for 

the purpose of the proposed/registered seed treatment uses on cereal grain-type crops, based on 

marginally adequate dairy cattle and laying hen studies with phenyl-labeled triticonazole only. 

HED has previously deemed that triticonazole is the residue of concern in ruminants and poultry

from seed treatment uses on barley and wheat. This determination may be extended to include 

seed treatment uses for all crop commodities in the cereal grains crop group. 
20 of 39

5.4 Analytical Methodology

The contribution of triazole derivatives [1,2,4-triazole, triazolylalanine, and triazolylacetic acid] 

from the use of triticonazole on barley and wheat to the aggregate exposure for human health risk 

assessment was previously considered (M. Doherty, DP#322215, 02/07/2006). The requested 

seed treatment uses of triticonazole do not result in increases in dietary exposure estimates for 

free triazole or conjugated triazoles. Therefore, the last dietary exposure analyses for the triazole 

metabolites have not changed.

Plant Commodity Methods

An adequate LC/MS and LC/MS/MS method (Method 148.02) is available for the enforcement 

of the proposed tolerances for triticonazole in cereal grain matrices. A similar method, 

LC/MS/MS method (Method 562/0), was used for data collection in the cereal grain field trial 

and processing studies. The method was adequate for data collection based on acceptable 

method verification and concurrent method recoveries. The validated LOQ was 0.01 ppm for 

triticonazole in/on all cereal grain crop matrices. Analytical standards for triticonazole are 

currently available in the EPA National Pesticide Standards Repository.

Livestock Commodity Methods

Livestock feeding studies, livestock tolerances, and livestock enforcement methods are not 

required for the purpose of this petition. Based on the recommended tolerances for triticonazole 

residues in livestock feedstuffs, the maximum reasonable dietary burdens (MRDB) for livestock 

were calculated at 0.089 ppm for beef cattle, 0.346 ppm for dairy cattle, 0.038 ppm for poultry, 

and 0.042 ppm for swine. The results of the reviewed cow and poultry metabolism studies along 

with the low levels of residues found in the cereal grain field trials indicate that there is no 

reasonable expectation that quantifiable residues of triticonazole will occur in livestock 

commodities [40 CFR §180.6(a)(3)]. HED will re-examine this determination if additional uses 

on livestock feedstuffs are proposed in the future.

Multiresidue Methods

The data requirements for testing with multiresidue methods have been fulfilled. Based on the 

results of the testing, the multiresidue methods are not appropriate for determining triticonazole 

residues.

Storage Stability Methods

Adequate data are available supporting the stability of triticonazole residues during frozen 

storage of samples collected from the cereal grain crop field trials and processing studies. 

Adequate storage stability data are also available for the triazole-related metabolites (T, TA, and 

TAA) to support the storage conditions and durations of wheat, corn, sorghum, and rice grain 

samples from the field studies, and wheat flour and polished rice from the processing study. The 

adequacy of the additional triazole storage stability data to support the storage durations of cereal 
21 of 39

grain forages, fodders and/or straws, corn kernel plus cob with husk removed (K+CWHR), and 

sorghum stalks from the cereal grain field trial studies will be determined when the final results 

of an ongoing triazole storage stability study are submitted to the Agency. According to current 

Agency policy, storage stability in the raw agricultural commodity (RAC) can be translated to 

the processed commodity.

5.5 Food Residue Profile

Primary Crops

The submitted magnitude of the residue data are adequate to support the requested seed treatment 

uses for cereal grain crops (except rice). There are adequate data for the representative crops of 

the cereal grain groups 15 and 16 to establish crop group tolerances. The number and locations 

of field trials were conducted according to the OPPTS 860.1500 guidelines. The seed treatment 

rate (0.05 lb ai/100 lbs seed) used in the field trials reflects the proposed use of Triticonazole HL 

Fungicide (EPA Reg. No. 7969-EIT) on barley, field corn and popcorn, oats, rye, wheat, and 

triticale. However, the rate reflects 5X and 2.5X the proposed seed treatment rate for sweet corn 

and sorghum, respectively. 

The registered uses of triticonazole as a seed treatment on cereal grains, excluding rice, are 

expected to result in limited residues in the food supply. The field trial data indicate very low 

and/or non-detectable residues on edible portions of cereal grains, excluding rice. Residues of 

triticonazole were below the LOQ of 0.01 ppm in treated wheat grain, corn grain, corn 

K+CWHR, and sorghum grain. Low but quantifiable residues of triticonazole were observed in 

rice grain. The available data support a tolerance level of 0.01 ppm for cereal grains, group 15 

(except rice). The value of 0.05 ppm proposed by the petitioner is excessive, when rice is 

excluded. Moreover, the 0.01 ppm level harmonizes with Canada. A revised Section F must be 

submitted to reflect the tolerance recommendation of 0.01 ppm for cereal grains, group 15 

(except rice). The individual tolerances established for barley grain and wheat grain at 0.05 

ppm in 40 CFR §180.583(a) should be deleted when the crop group tolerance is established.

Residues of triticonazole were also nonquantifiable in treated field and sweet corn forage and 

stover, and sorghum forage and stover. Quantifiable residues of triticonazole were observed in 

treated wheat forage, hay and straw, and rice straw. Appropriate tolerance levels were 

determined statistically according to Guidance for Setting Pesticide Tolerances Based on Field 

Trial Data SOP. The residue data for rice straw was excluded from the spreadsheet because the 

petitioner is not applying for use on rice. The tolerance spreadsheet calculated tolerances of 0.20 

ppm for wheat forage, 0.25 ppm for wheat hay, and 0.20 ppm for wheat straw. HED 

recommends a crop group tolerance of 0.25 ppm based on the highest calculated value for the 

representative crop (wheat hay). 

A revised Section F must be submitted to reflect the tolerance recommendation of 0.25 ppm for 

the forage, fodder, and straw of cereal grains, group 16 (except rice). The individual tolerances 

established for barley hay and straw, and wheat forage, hay and straw in 40 CFR §180.583(a) 

should be deleted when the crop group tolerance is established. 
22 of 39

Processed Food and Feed

The processing data for field corn, rice, sweet sorghum, and wheat are adequate. The results 

indicate that residues of triticonazole were nonquantifiable (<0.01 ppm) in the cereal grain RACs 

(corn, rice, wheat, and sorghum) grown from seeds treated at 250 g triticonazole/100 kg seed (5X 

the maximum proposed seed treatment rate). Analysis of rice processed matrices showed that 

residues of triticonazole may concentrate in hulls (2.8X) but not significantly in bran (1.1X); 

residues in polished rice were nonquantifiable. As the petitioner is not seeking to register use on 

rice at this time, no tolerances are required for rice processed matrices.

Rotational Crops

The confined rotational crop study is acceptable. The application rate used in the study reflects 

1.4X the equivalent per acre rate for cereal grain crops. The metabolism of triticonazole in 

rotated crops appears similar to those observed for primary crops, except that triazole-related 

metabolites were detected in the rotated crops. The data indicate that residues of triticonazole 

may be present at >0.01 ppm in 30-DAT rotated lettuce (0.017 ppm), radish tops (0.049 ppm) 

and wheat forage (0.041 ppm), straw (0.133 ppm) and chaff (0.139 ppm); 120-DAT rotated 

radish tops (0.016 ppm), and wheat forage (0.019 ppm), straw (0.150 ppm), and chaff (0.114 

ppm); and 365-DAT rotated wheat forage (0.025 ppm), straw (0.086 ppm) and chaff (0.133 

ppm). Wheat hay was not analyzed but forage and straw were analyzed, and residues of 

triticonazole were found in forage and straw.

The proposed label for the 4.17 lb/gal FS specifies that “planting of any crop not listed on the 

label within 30 days after planting treated seed is not allowed”. The results of the submitted 

confined rotational crop study do not support this restriction. The data from the confined 

rotational crop study indicate that triticonazole residues greater than 0.01 ppm were detected at 

the 30-day PBI. To support a 30-day plantback restriction on the label, limited field rotational 

crop data for leafy vegetables, root and tuber vegetables, foliage of root and tuber vegetables, 

and a cereal grain are required. Until the requested data are provided, the label must be modified 

to specify a 120-day (4-month) plantback restriction for leafy vegetables, a 365-day (12-month) 

plantback restriction for root and tuber vegetables, and to prohibit the planting of all other crops 

not listed on the label.

5.6 International Residue Limits

There are no established Codex or Mexican MRLs/tolerances on wheat or barley. In Canada, 

triticonazole is registered as a seed treatment for oats, barley, and wheat, and established with the 

following MRLs (expressed as parent only):

Eggs ............................................. 0.05 ppm

Meat and meat byproducts of cattle, goats, 

hogs, horses, poultry, and sheep ............

0.05 ppm

Barley .......................................... 0.01 ppm
23 of 39

Milk ............................................ 0.01 ppm

Oats ............................................. 0.01 ppm

Wheat .......................................... 0.01 ppm

The Canadian MRL levels at 0.01 ppm on barley, oats, and wheat harmonize with the 

recommended U.S. 0.01 ppm tolerance level. Additionally, no U.S. tolerances have been 

established on livestock commodities. No harmonization issues exist in connection with the 

proposed use on turf. See Appendix B for the International Residue Limit Status (IRLS).

5.7 Dietary Exposure and Risk

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

were conducted using DEEM-FCIDTM (Version 2.03), incorporating food consumption data from 

USDA’s CSFII from 1994-1996 and 1998. For both acute and chronic dietary exposure 

assessments, only the expansion of cereal grain crop group 15 was considered because cereal 

grain crop group 16 consists of livestock feed items which do not contribute to the human diet.

Acute Dietary Exposure/Risk

The acute analyses assumed that triticonazole residues are present in all registered and proposed 

food commodities at tolerance levels and that 100% of all commodities are treated. All 

processing factors were set to 1, based on the results of processing studies indicating that 

residues of triticonazole in processed commodities would not exceed the RAC tolerances. 

Drinking water residues were incorporated directly into the dietary assessment using the EDWCs 

for triticonazole in surface water, generated using the PRISM/EXAMS models. For the acute 

assessment, the 1-in-10 year annual peak concentration of 75.5 ppb was used. The water 

residues were incorporated in the DEEM-FCIDTM into the food categories “water, direct, all 

sources” and “water, indirect, all sources.”

The acute dietary (food and drinking water) exposure assessment for females 13-49 years was 

performed separately, since the acute toxicological endpoint of concern was different from that 

identified for the general U.S. population. The most highly exposed population subgroup is 

females 13-49 years old. Combined acute dietary exposure from food and drinking water is less 

than 1% of the aPAD for females 13-49 years old. For the general U.S. population and for all 

infants <1 year old, the exposure is also less than 1% of the aPAD. The results of the acute 

dietary exposure analyses are reported in Table 5.7, and all exposures are below the LOC.

With all included commodities from the expanded use of cereal grains (crop group 15), risk 

estimates have not increased. Thus, for all registered and proposed uses, the acute dietary risk 

estimates do not exceed HED’s LOC (i.e., <100% aPAD).

Chronic Dietary Exposure/Risk

The chronic analyses assumed that triticonazole residues are present in all registered and 

proposed food commodities at tolerance levels and that 100% of all commodities are treated. All 
24 of 39

processing factors were set to 1, based on the results of processing studies indicating that 

residues of triticonazole in processed commodities would not exceed the raw agricultural 

commodity RAC tolerances. Drinking water residues were incorporated directly into the dietary

assessment using the EDWCs for triticonazole in surface water, generated using the 

PRISM/EXAMS models. For the chronic assessment, the 1-in-10 annual mean concentration of 

32.8 ppb was used. The water residues were incorporated in the DEEM-FCID into the food 

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

With the increased dietary exposure from the expanded use of cereal grains (crop group 15), the 

chronic dietary risk estimates have not increased. Currently, for all included commodities for all 

registered and proposed uses, the chronic dietary risk estimates do not exceed HED’s LOC

(i.e., <100% cPAD). For the general U.S. population the exposure from food and drinking water 

utilized is still less than 1% of the cPAD. The most highly exposed population subgroup at 1.4% 

of the cPAD was all infants (<1 year old) and all other population subgroups are at less than 1% 

of the cPAD. The results of the chronic dietary exposure analyses are also reported in Table 5.7, 

and again, all exposures are below the LOC.

Table 5.7. Result of Acute and Chronic Dietary Exposure and Risk Estimates for Triticonazole.

Population Subgroup

Acute Dietary

(95th Percentile) Chronic Dietary

Dietary Exposure 

(mg/kg/day) % aPAD* Dietary Exposure(mg/kg/day) % cPAD*

General U.S. Population 0.004192 <1.0 0.000865 <1.0

All Infants (< 1 year old) 0.015052 <1.0 (0.38) 0.002431 1.4

Children 1-2 years old 0.006674 <1.0 0.001422 <1.0

Children 3-5 years old 0.006171 <1.0 0.001376 <1.0

Children 6-12 years old 0.004301 <1.0 0.000959 <1.0

Youth 13-19 years old 0.003414 <1.0 0.000694 <1.0

Adults 20-49 years old 0.003806 <1.0 0.000787 <1.0

Adults 50+ years old 0.003426 <1.0 0.000781 <1.0

Females 13-49 years old* 0.003813 <1.0 (0.76) 0.000777 <1.0

* The acute endpoint for females 13-49 years old is different than the acute endpoint for all other subpopulations, 

which is why females 13-49 have a lower dietary exposure estimate than all infants, but a higher risk estimate.

Note: The bolded values indicate the population with the highest risk estimate for each type of risk assessment

All dietary (food with modeled EDWCs) risk estimates were below the LOC. The assessments 

can be considered highly conservative as they assume all the subject crops are treated and bear 

residues at the tolerance level (compounded by the conservative tolerance). Actual dietary

exposure is likely to be much lower.
25 of 39

Cancer Dietary Risk

There is no evidence that triticonazole is carcinogenic to humans; therefore, a dietary cancer 

assessment is not required.

6.0 RESIDENTIAL (NON-OCCUPATIONAL) EXPOSURE/RISK 

CHARACTERIZATION

There is potential for exposure to homeowners in residential settings during the application of 

existing registered products containing triticonazole, and from entering areas previously treated 

with triticonazole, such as lawns where children might play, or golf courses and home gardens 

that could lead to exposures for adults. As a result, risk assessments were previously completed 

for both residential handler and postapplication scenarios (S. Winfield, DP#316612, 12/20/2006). 

The proposed uses of triticonazole on cereal grain crop groups (15 and 16) do not add any 

additional residential exposures or risks. Spray drift is not expected to pose a risk to residents as 

seed treatment does not result in spray applications. Residential postapplication has also been 

previously assessed and is not of concern with the currently proposed action. For aggregate 

calculations, Table 6.0 presents the exposure and risk estimates calculated in the previous memo 

for children’s incidental oral postapplication scenarios (S. Winfield, DP#316612, 12/20/2006).

Table 6.0. Children’s Total Exposure and Risk Estimates from Residential Lawns.

Children’s Scenarios

TTR/GR/SR0

(ug/cm2or g) 1

PDR0-norm

(mg/kg/day) 2

ShortTerm

MOE 3

Int-Term

MOE 3

Total MOE 4

ShortTerm

IntermediateTerm

(1) Hand-to-Mouth 0.64 0.017 1,500 1,000

1,200 800 (2) Mouthing Grass 2.6 0.0043 5,800 4,100

(3) Soil Ingestion 8.6 0.000058 430,000 300,000

1 TTR=turf transferable residue on day “0”; GR=grass residue on day “0”; SR0=soil residue on day “0”.

2

PDR0norm=potential dose rate on day “0”.

3 MOE = NOAEL/PDR; where Short- and Intermediate-term NOAELs = 25 mg/kg/day and 17.4 mg/kg/day, respectively.

4 Total MOE = S-T or I-T NOAEL/total incidental oral exposure (hand-to-mouth + mouthing grass + soil ingestion = 0.021358 

mg/kg/day)

7.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION

In accordance with the FQPA, HED must consider and aggregate (add) pesticide exposures and 

risks from three major sources: food, drinking water, and residential exposures. In an aggregate 

assessment, exposures from relevant sources are added together and compared to quantitative 

estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can be aggregated. When 

aggregating exposures and risks from various sources, HED considers both the route and 

duration of exposure.

The aggregate assessments in this document use a deterministic approach, in that point estimates 

of exposure from each source are added together; and each of the point estimates used are

deterministic (dietary exposure estimates use point estimates for food and drinking water 

residues [tolerance level and modeled values, respectively] and the residential SOP scenarios 
26 of 39

also employ point estimates [central to high-end values considered protective]). Exposures are 

assumed to occur over the same time frame, and no use frequency data are considered. In sum, 

these aggregate risk assessments are screening-level assessments.

7.1 Acute Aggregate Risk

Refer to Section 5.7, which discusses dietary exposure (food and drinking water). The dietary

route alone is relevant for acute exposure and risk assessment.

7.2 Short-Term and Intermediate-Term Aggregate Risk

Short-term aggregate exposures are compared to the oral NOAEL of 25 mg/kg/day (based on 

decreased body weight gain and food consumption at the LOAEL of 50 mg/kg/day in the rabbit 

developmental study) to estimate the risk from short-term exposure. Intermediate-term 

exposures are compared to the NOAEL of 17.4 mg/kg/day (based on decreased body weight and 

liver toxicity at the LOAEL of ~ 200 mg/kg/day in the mouse carcinogenicity study) to estimate 

the risk from intermediate-term exposure. The LOC for non-occupational aggregate risk is 

expressed as an MOE = 100.

Over the short-term (1 to 30 days), both dietary and residential postapplication incidental oral 

exposure may co-occur (exposures and risks are shown in Table 7.2.1). The short-term 

aggregate MOEs do not exceed the LOC and, therefore, are not of concern.

Table 7.2.1. Short-Term Aggregate Risk Calculations (Incidental oral exposure with background dietary exposure).

Population NOAEL

mg/kg/day LOC1

Max 

Allowable

Exposure2

mg/kg/day

Average

Food & 

Water

Exposure

mg/kg/day

Residential 

Exposure3

mg/kg/day

Aggregate 

Exposure (dietary 

and residential)

mg/kg/day

Aggregate 

MOE

(food and

residential)4

Children 1-2 25 100 0.25 0.0014 0.021 0.022 1100

All Infants 

(< 1 year old)5

25 100 0.25 0.0024 0.021 0.023 1100

1 The LOC is based on standard inter- and intra- species uncertainty factors (10x and 10x, for a total of 100).

2 Maximum Allowable Exposure (mg/kg/day) = NOAEL/LOC

3 Residential Exposure = Incidental Oral exposure (postapplication inhalation exposure is not expected, and there is no hazard via 

the dermal route). See S. Winfield, DP#316612, 12/20/2006 for source of residential exposure values.

4 Aggregate MOE = [NOAEL / (Avg Food & Water Exposure + Residential Exposure)]

5 Highest exposed child subpopulation. Although the incidental oral exposure estimates are calculated with the activities of 

children 1-3 in mind (toddlers), the dietary exposure for the highest exposed child subpopulation is also aggregated with the 

incidental oral exposure estimate for comparison and characterization purposes.

Although less likely over the intermediate-term (1 to 6 months), both dietary and residential 

postapplication incidental oral exposure may co-occur (exposures and risks are shown in Table 

7.2.2). The intermediate-term aggregate MOEs do not exceed the LOC and, therefore, are not of 

concern.
27 of 39

Table 7.2.2. Intermediate-Term Aggregate Risk Calculations (Incidental oral exposure with background dietary exposure)

Population NOAEL

mg/kg/day LOC1

Max 

Allowable

Exposure2

mg/kg/day

Average

Food & 

Water

Exposure

mg/kg/day

Residential 

Exposure3

mg/kg/day

Aggregate 

Exposure 

(dietary and 

residential)

mg/kg/day

Aggregate 

MOE

(food and

residential)4

Children 1-2 17.4 100 0.174 0.0014 0.021 0.022 780

All Infants 

(< 1 year old)5

17.4 100 0.174 0.0024 0.021 0.023 740

1The LOC is based on standard inter- and intra- species uncertainty factors (10x and 10x, for a total of 100)

2 Maximum Allowable Exposure (mg/kg/day) = NOAEL/LOC

3 Residential Exposure = Incidental Oral exposure (postapplication inhalation exposure is not expected, and there is no hazard via 

the dermal route). See S. Winfield, DP#316612, 12/20/2006 for source of residential exposure values.

4 Aggregate MOE = [NOAEL / (Avg Food & Water Exposure + Residential Exposure)]

5 Highest exposed child subpopulation. Although the incidental oral exposure estimates are calculated with the activities of 

children 1-3 in mind (toddlers), the dietary exposure for the highest exposed child subpopulation is also aggregated with the 

incidental oral exposure estimate for comparison and characterization purposes.

7.3 Long-Term Chronic Aggregate Risk

Refer to Section 5.7, which discusses dietary exposure (food and drinking water). The dietary

route alone is relevant for long-term/chronic exposure and risk assessment.

7.5 Cancer Aggregate Risk

Triticonazole is classified as “not likely to be carcinogenic to humans” based on the absence of 

significant tumor increases in two adequate rodent carcinogenicity studies (J. Kidwell, 

TXR#0054249, 06/15/2006). Thus, no aggregate cancer risk needs to be assessed.

8.0 CUMULATIVE RISK CHARACTERIZATION/ASSESSMENT

Triticonazole is a member of the triazole-containing class of pesticides. Although conazoles act 

similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a 

relationship between their pesticidal activity and their mechanism of toxicity in mammals. 

Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to 

establish that the chemicals operate by the same, or essentially the same, sequence of major 

biochemical events. In conazoles, however, a variable pattern of toxicological responses is 

found. Some are hepatotoxic and hepatocarcinogenic in mice; some induce thyroid tumors in 

rats; and some induce developmental, reproductive, and neurological effects in rodents. 

Furthermore, the conazoles produce a diverse range of biochemical events including altered 

cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood 

whether these biochemical events are directly connected to their toxicological outcomes. Thus, 

there is currently no evidence to indicate that conazoles share common mechanisms of toxicity

and EPA is not following a cumulative risk approach based on a common mechanism of toxicity

for the conazoles. For information regarding EPA’s procedures for cumulating effects from 

substances found to have a common mechanism of toxicity, see EPA’s website at 

http://www.epa.gov/pesticides/cumulative.
28 of 39

Triticonazole and other triazole-containing pesticides can form the common metabolite 1,2,4-

triazole and two triazole conjugates (triazolylalanine and triazolylacetic acid). To support 

existing tolerances and to establish new tolerances for triazole-derivative pesticides, including 

triticonazole, U.S. EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, 

triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of 

any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level 

evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum 

combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high 

end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the 

additional 10X FQPA safety factor for the protection of infants and children. The assessment 

includes evaluations of risks for various subgroups, including those comprised of infants and 

children. The Agency’s complete risk assessment is found in the propiconazole reregistration 

docket at http://www.regulations.gov, Docket Identification (ID) Number EPA-HQ-OPP-2005-

0497.

9.0 OCCUPATIONAL EXPOSURE/RISK PATHWAY

Based upon the proposed use on seeds, occupational handler exposure is expected for individuals 

involved in commercial seed treatment and on-farm planting. Postapplication exposure to 

agricultural workers is possible if they perform tasks that involve the soil subsurface following 

planting of treated seeds. 

9.1 Short-/Intermediate -Term Handler Risk

Occupational handlers may experience short- and intermediate-term exposure to triticonazole

while performing seed treatment activities in commercial settings. In addition, occupational 

secondary handlers may experience short- and intermediate-term exposure while planting 

triticonazole -treated seeds. No chemical-specific handler exposure data were submitted in 

support of this use pattern. For assessing commercial seed treatment and seed planting activities, 

unit exposure data were taken from HED ExpoSAC Policy 14: SOPs for Seed Treatment. The 

amount of ai handled depends on the application rate (lb ai/100 lb seed) and the pounds of seed 

treated in a day (or the pounds of seed that can be planted in a day), all of which vary depending 

upon the seed type. Values for the amount of seed treated and planted per day were obtained 

from HED SOP#15. The results are presented in Table 9.1.

For all cereal seeds, potential occupational exposure scenarios from the use of triticonazole as a 

commercial seed treatment include: mixing, loading, applying liquid formulations; bagging 

treated seed; sewing bags; multiple activities; and planting treated seed (secondary handler).

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

individual tasks listed above; however, it is assumed that workers may also 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, sewing, bagging, cleaning, 

calibrating, repairing, forklift driving, etc.) will be addressed. Planting treated seed consists of 
29 of 39

the farmer purchasing bags of treated seed, placing the seed in the hopper, and applying seed to 

fields. This is considered a secondary handler exposure scenario.

HED is currently in the process of revising ExpoSAC SOP#15 (Amount of Seed Treated or 

Planted per Day, 03/02/2004) in efforts to update the daily amount of seed treated in commercial 

seed treatment facilities. With the increasing demand for hybridized treated seeds, there have 

been modifications not only in the seed treatment equipment, but in the market shares of new and 

currently registered pesticide products. HED understands that due to high cost to produce hybrid 

seeds, direct seeding is done in a precise manner which requires lower volumes of seed per acre. 

However, this does not provide a direct correlation to the amount of seed which is treated in the 

commercial seed treatment facilities. The amount of seed treated per day at a commercial 

facility is summarized below for each crop. 

 Barley – 718,000 lbs,

 Field Corn and Popcorn – 550,000 lbs,

 Oats– 718,000 lbs,

 Rye – 718,000 lbs,

 Sorghum Grain – 718,000 lbs, 

 Sweet Corn – 194,000 lbs,

 Triticale – 718,000 lbs, and

 Wheat – 718,000 lbs.

Based on SOP#15, the amount of seed planted per day is summarized below for each crop.

 Barley – 19,000 lbs (96 lb seed/A * 200 A/day),

 Field Corn and Popcorn – 3,000 lbs (15 lb seed/A * 200 A/day),

 Oats – 26,000 lbs (128 lb seed/A * 200 A/day),

 Rye – 22,000 lbs (112 lb seed/A * 200 A/day),

 Sorghum Grain – 800 lbs (10 lb seed/A * 200 A/day) ,

 Sweet Corn – 3,000 lbs (15 lb seed/A * 200 A/day),

 Triticale – 20,000 lbs (100 lb seed/A * 200 A/day), and

 Wheat – 30,000 lbs (150 lb seed/A * 200 A/day).

A summary of the inhalation risks for each exposure scenario is presented below in Table 9.1 for 

short-term and intermediate-term inhalation exposures. 

The results of the short- and intermediate-term occupational handler exposure and risk 

assessment indicate that inhalation risks do not exceed HED’s LOC (i.e., MOEs range from 

2,200 to 3,200,000 which are greater than the LOC of 100) at baseline level of risk mitigation 

(i.e., no respirator) for any of the cereal seed treatment scenarios.
30 of 39

Table 9.1. Short- and Intermediate-Term Triticonazole Handler Inhalation Exposures and Risks.

Crop Exposure Scenario

lbs seed 

treated or 

planted/ 

daya

Application 

Rateb

(lb ai/lb 

seed)

Baseline 

Inhal. Unit 

Exposurec,d

(μg/lb ai)

Baseline 

Inhalation 

Dosee

(mg/kg/day)

Baseline Inhalation MOEf

(Target MOE = 100)

Short-Term IntermediateTerm

Barley

Loader/Applicator 718,000 0.00049 0.34 1.7E-03 15,000 10,000

Sewer 718,000 0.00049 0.23 1.2E-03 22,000 15,000

Bagger 718,000 0.00049 0.16 8.0E-04 31,000 22,000

Multiple Activities 718,000 0.00049 1.6 8.0E-03 3,100 2,200

Planter (Secondary 

Handler) 19,000 0.00049 3.4 4.5E-04 55,000 38,000

Corn 

(field & 

popcorn)

Loader/Applicator 550,000 0.00049 0.34 1.3E-03 19,000 13,000

Sewer 550,000 0.00049 0.23 8.9E-04 28,000 20,000

Bagger 550,000 0.00049 0.16 6.2E-04 41,000 28,000

Multiple Activities 550,000 0.00049 1.6 6.2E-03 4,100 2,800

Planter 

(Secondary Handler) 3,000 0.00049 3.4 7.1E-05 350,000 240,000

Corn 

(sweet)

Loader/Applicator 194,000 0.0001 0.34 9.4E-05 270,000 180,000

Sewer 194,000 0.0001 0.23 6.4E-05 390,000 270,000

Bagger 194,000 0.0001 0.16 4.4E-05 560,000 390,000

Multiple Activities 194,000 0.0001 1.6 4.4E-04 56,000 39,000

Planter 

(Secondary Handler) 3,000 0.0001 3.4 1.5E-05 1,700,000 1,200,000

Oats

Loader/Applicator 718,000 0.00049 0.34 1.7E-03 15,000 10,000

Sewer 718,000 0.00049 0.23 1.2E-03 22,000 15,000

Bagger 718,000 0.00049 0.16 8.0E-04 31,000 22,000

Multiple Activities 718,000 0.00049 1.6 8.0E-03 3,100 2,200

Planter 

(Secondary Handler) 26,000 0.00049 3.4 6.2E-04 40,000 28,000

Rye

Loader/Applicator 718,000 0.00049 0.34 1.7E-03 15,000 10,000

Sewer 718,000 0.00049 0.23 1.2E-03 22,000 15,000

Bagger 718,000 0.00049 0.16 8.0E-04 31,000 22,000

Multiple Activities 718,000 0.00049 1.6 8.0E-03 3,100 2,200

Planter 

(Secondary Handler) 22,000 0.00049 3.4 5.2E-04 48,000 33,000

Sorghum 

Grain

Loader/Applicator 718,000 0.0002 0.34 7.0E-04 36,000 25,000

Sewer 718,000 0.0002 0.23 4.7E-04 53,000 37,000

Bagger 718,000 0.0002 0.16 3.3E-04 76,000 53,000

Multiple Activities 718,000 0.0002 1.6 3.3E-03 7,600 5,300

Planter 

(Secondary Handler) 800 0.0002 3.4 7.8E-06 3,200,000 2,200,000

Triticale

Loader/Applicator 718,000 0.00049 0.34 1.7E-03 15,000 10,000

Sewer 718,000 0.00049 0.23 1.2E-03 22,000 15,000

Bagger 718,000 0.00049 0.16 8.0E-04 31,000 22,000

Multiple Activities 718,000 0.00049 1.6 8.0E-03 3,100 2,200

Planter 

(Secondary Handler) 20,000 0.00049 3.4 4.8E-04 53,000 37,000

Wheat

Loader/Applicator 718,000 0.00049 0.34 1.7E-03 15,000 10,000

Sewer 718,000 0.00049 0.23 1.2E-03 22,000 15,000

Bagger 718,000 0.00049 0.16 8.0E-04 31,000 22,000

Multiple Activities 718,000 0.00049 1.6 8.0E-03 3,100 2,200

Planter 

(Secondary Handler) 30,000 0.00049 3.4 7.1E-04 35,000 24,000

a. HED default for lb seed treated per day from HED Science Advisory Council for Exposure Policy # 15. 

b. Application Rates based on proposed uses on label for Triticonazole HL Fungicide.

c. Unit Exposures from HED Science Advisory Council for Exposure Policy #14. 

d. Baseline Inhalation: No respirator

e. Inhalation Dose (mg/kg/day) = daily unit exposure (μg/lb ai) x application rate (lb ai/lb seed) x amount treated or planted (lb seed/day) x 

conversion factor (1 mg/1,000 μg) x absorption factor (100 %) / body weight (70 kg adult).
31 of 39

f. Inhalation MOE = NOAEL (25 mg/kg/day for short-term exposure and 17.4 mg/kg/day for intermediate-term exposure) / inhalation daily dose 

(mg/kg/day). Level of concern = 100.

9.2 Short-/Intermediate-Term Postapplication Risk

There is the potential for postapplication exposures following the planting of triticonazoletreated seeds. 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 postapplication 

assessment is required for exposure to treated seeds that have already been planted.

The restricted entry interval (REI) is based on the acute toxicity of triticonazole technical 

material. The WPS allows workers to enter treated areas without restriction if there will be no 

worker contact with the treated seeds in the soil or planting media. Certain tasks, even though 

they are not routine, may involve contact with the soil subsurface (e.g. repair of certain irrigation 

equipment) and they are covered by the REI. HED recommends that the Registration 

Division ensure that appropriate language is placed on the product label to require the 

label on treated seed to include the REI following the planting of treated seed.

Triticonazole technical material which is classified as Category III for acute dermal toxicity and 

Toxicity Category IV for primary eye irritation and primary skin irritation. Triticonazole is not a 

dermal sensitizer. Under the WPS for Agricultural Pesticides, the default REI is 12 hours for 

active ingredients classified as acute toxicity categories III or IV for these routes of entry. WPS 

allows workers to enter treated areas without restriction if there will be no contact with anything 

that has been treated with the pesticide. 

10.0 DATA NEEDS AND LABEL RECOMMENDATIONS

10.1 Toxicology

The following deficiencies should be made conditions of the registration of triticonazole for use 

on cereal grains:

 A biliary excretion study. The metabolism study in the rat is classified 

Unacceptable/Guideline and does not satisfy the guideline requirement for a metabolism 

study [OPPTS 870.7485, OECD 417] because the extent of absorption of the test material 

was not determined. It is upgradeable to Acceptable/Guideline if the registrant conducts 

a biliary excretion study with the test compound (compound water solubility is too low 

for intravenous administration). The registrant has submitted this study and the study is 

currently in review by HED. These study results will not affect FQPA determinations.

 An Immunotoxicity Study [OPPTS 870.7800, OECD 407] is currently required. 

This guideline is required to provide information on suppression of the immune system 

which might occur as a result of repeated exposure to triticonazole, after dosing by either 

oral or parental routes. Results are intended to be used along with data from routine 

toxicity testing, to provide more accurate information on risk to the immune system.
32 of 39

10.2 Residue Chemistry

860.1200 Directions for Use

 The label for Triticonazole HL Fungicide must be amended to include the following 

rotational crop restrictions: a 120-day plantback interval for leafy vegetables, a 365-day

plantback interval root and tuber vegetables, and a prohibition of the planting of all other 

crops not listed on the label.

860.1550 Proposed Tolerances

 A revised Section F must be submitted to reflect the tolerance recommendation of 0.01 

ppm for cereal grains, group 15 (except rice); to reflect the tolerance recommendation of 

0.25 ppm for grain, cereal, forage, fodder, and straw, group 16 (except rice); and to 

reflect the correct commodity definitions as listed in the introduction.

(DATA Requirement)

HED recommends conversion of conditional registration to unconditional registration for 

the cereal grains (except rice) upon adequate resolution of data pertaining to storage 

stability and field accumulation in rotational crops.

860.1380 Storage Stability

 To support the reported results for 1,2,4-triazole and the triazole conjugates, the final 

report of the ongoing storage stability study with free triazole and triazole conjugates in 

plant commodities must be submitted.

860.1900 Field Accumulation in Rotational Crops

 Data from limited field accumulation studies on rotational crops are required. 

10.3 Occupational and Residential Exposure

The labeling should state: Seed that has been treated with this product that is then packaged or 

bagged for future use must contain the following labeling on the outside of the seed package or 

bag:

"Treated Seed - Do Not Use for Food, Feed, or Oil Purposes.”

When opening this bag or loading/pouring the treated seed, wear longsleeved shirt, long pants, shoes, socks, and chemical resistant gloves.

After the seeds have been planted, do not enter or allow worker entry into 

treated areas during the restricted-entry interval (REI) of 12 hours. 

Exception: Once the seeds are planted in soil or other planting media, the 

Worker Protection Standard allows workers to enter the treated area 

without restriction if there will be no worker contact with the treated seeds 

in the soil or planting media."
33 of 39

Appendix A: TOXICOLOGY ASSESSMENT

A.1 Toxicology Data Requirements

The requirements (40 CFR 158.340) for food and non food for triticonazole are in the table below. Use of the new 

guideline numbers does not imply that the new (1998) guideline protocols were used.

Test Technical

Required Satisfied

870.1100 Acute Oral Toxicity.......................................................

870.1200 Acute Dermal Toxicity ..................................................

870.1300 Acute Inhalation Toxicity..............................................

870.2400 Primary Eye Irritation....................................................

870.2500 Primary Dermal Irritation ..............................................

870.2600 Dermal Sensitization......................................................

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.3100 Oral Subchronic (rodent)...............................................

870.3150 Oral Subchronic (nonrodent).........................................

870.3200 21-Day Dermal ..............................................................

870.3250 90-Day Dermal ..............................................................

870.3465 90-Day Inhalation..........................................................

yes

yes

yes

no

no

yes

yes

yes

-

-

870.3700a Developmental Toxicity (rodent)...................................

870.3700b Developmental Toxicity (nonrodent).............................

870.3800 Reproduction .................................................................

yes

yes

yes

yes

yes

yes

870.4100a Chronic Toxicity (rodent)..............................................

870.4100b Chronic Toxicity (nonrodent)........................................

870.4200a Oncogenicity (rat)..........................................................

870.4200b Oncogenicity (mouse)....................................................

870.4300 Chronic/Oncogenicity....................................................

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.5265 Mutagenicity—Gene Mutation .....................................

870.5300 Mutagenicity—Cytogenics ...........................................

870.5375 Mutagenicity—Chromosome Aberration .....................

870.5395 Mutagenicity—Micronucleus .......................................

yes

yes

yes

yes

yes

yes

yes

yes

870.6100a Acute Delayed Neurotox. (hen).....................................

870.6100b 90-Day Neurotoxicity (hen)...........................................

870.6200a Acute Neurotox. Screening Battery (rat) .......................

870.6200b 90-Day Neuro. Screening Battery (rat)..........................

870.6300 Develop. Neuro..............................................................

no

no

yes

yes

no

-

-

yes

yes

-

870.7485 General Metabolism ......................................................

870.7600 Dermal Penetration........................................................

870.7800 Immunotoxicity .............................................................

yes

yes 

yes

yes

yes 

no

Special Studies for Ocular Effects

Acute Oral (rat)...........................................................

Subchronic Oral (rat) ..................................................

Six-month Oral (dog)..................................................

 

no

no

no

-

-

-
34 of 39

A.2 Acute Toxicity

Table A.2. Acute Toxicity of Technical Grade Triticonazole.

Guideline No. Study Type MRID No. Results Toxicity 

Category

870.1100 Acute Oral Toxicity 44802028

44802029

LD50 = > 2000 mg/kg

LD50 = > 2000 mg/kg III

870.1200 Acute Dermal Toxicity 44802030 LD50 = > 2000 mg/kg III

870.1300 Acute Inhalation Toxicity 44802031 LC50 = > 2.63 mg/L IV

870.2400 Acute Eye Irritation 44802032 Minimally irritating IV

870.2500 Acute Dermal Irritation 44802033 Not an irritant IV

870.2600 Dermal Sensitization 46817301 Not a sensitizer in the 

Buehler test in guinea pigs N/A

A.3 Toxicity Profile

Table A.3. Toxicity Profile of Triticonazole Technical.

Guideline 

No.

Study Type 

(All Studies 

Acceptable)

Results

870.3100 90-Day oral toxicity 

rodents- rat

NOAEL = M: 2, F: 22.3 mg/kg/day

LOAEL = M: 19.8, F: 1183.5 mg/kg/day based on

M: Increases in the incidence of adrenocortical fatty vacuolation in 

males receiving 250-ppm (19.8 mg/kg/day). See also 870.6200 and 

870.4200 – adrenal vacuolation not seen at low doses.

F: Hair loss, decreased food efficiencies, adrenocortical fatty 

vacuolation, zona reticularis degeneration, centriacinar hepatocytic fatty 

vacuolation, and more severe anisocytosis and spherocytosis in females 

receiving 12,500 ppm.

M and F: decreases in hematocrit, hemoglobin, and red blood cells 

(RBC), and decreased thymus weights, were noted at the high-dose.

870.3150 90-Day oral toxicity in 

nonrodents- dog

Study not available. Refer to 870.4100b below. 

870.3200 28-Day dermal 

toxicity- rat

NOAEL = Dermal and systemic: 1000 mg/kg/day (limit-dose).

LOAELs > 1000 mg/kg/day.

870.3250 90-Day dermal 

toxicity

Study not available. 

870.3465 90-Day inhalation 

toxicity

Request for a waiver granted as per memo from A. Assad dated April 12, 

2006 (TXR # 0054207). 

870.3700a Prenatal 

developmental in 

rodents- rat

Maternal NOAEL = 200 mg/kg/day

LOAEL = 1000 mg/kg/day based on reduction in mean body weight gain 

from GD 12-16.

Developmental NOAEL = 200 mg/kg/day

LOAEL = 1000 mg/kg/day based on increases in unilateral and bilateral 

supernumerary ribs.
35 of 39

Table A.3. Toxicity Profile of Triticonazole Technical.

Guideline 

No.

Study Type 

(All Studies 

Acceptable)

Results

870.3700b Prenatal 

developmental in 

nonrodents- rabbit

Maternal NOAEL = 25 mg/kg/day

LOAEL = 50 mg/kg/day based on decreased body weight gain, reduced 

food consumption, and mortality.

Developmental NOAEL = 50 mg/kg/day

LOAEL = 75 mg/kg/day based on cranial variations, abortion, and 

increased pre- and post-implantation losses.

870.3800 Reproduction and 

fertility effects- rat

Parental/Systemic NOAEL = 37.5 mg/kg/day

LOAEL = 250 mg/kg/day based on reduced body weights of the F0

females and the F1 males and females, F0 maternal mortality, and 

microscopic lesions in the adrenal gland of F0 and F1 males and females.

Reproductive NOAEL = 37.5 mg/kg/day

LOAEL = 250 mg/kg/day based on decreased fertility of the F1 animals, 

reduced F1 and F2 pup survival, and reduced F1 and F2 pup body weight.

870.4100b Chronic toxicity dogs NOAEL = 25 mg/kg/day

LOAEL = 150 mg/kg/day based on decreased absolute body weights of 

females, decreased weight gain by males and females, and treatmentrelated toxicity to the eye, liver, adrenals, and transient neurological 

signs (tremors, hyperactivity or hypoactivity, convulsions, and ataxia)

870.4300 Carcinogenicity

Rats

NOAEL = M: 203.6, F: 38.3 mg/kg/day

LOAEL = M - Not established. F: 286.6 mg/kg/day based on decreased 

body weight and body weight gain, adrenal cortical and liver toxicity.

No evidence of compound-induced carcinogenicity as per CARC report 

June 15, 2006).

870.4200b Carcinogenicity mice NOAEL = M: 17.4; F: 20.1 mg/kg/day.

LOAEL = M: 202.2, F: 209.5 mg/kg/day based on decreased body 

weight gain and liver toxicity. No significant increase in the incidence of 

neoplastic lesions.

No evidence of compound-induced carcinogenicity as per CARC report 

June 15, 2006.

870.5265 Gene Mutation There was no evidence of induced mutant colonies over background.

870.5300 Cytogenetics There was no consistent evidence of chromosomal aberrations induced 

over background.

870.5375 Chromosome 

aberration

There was no significant increase in the frequency of micronucleated 

polychromatic erythrocytes in bone marrow after any tested triticonazole 

dose at any harvest time. 

870.5395 Micronucleus There was no evidence that unscheduled DNA synthesis, as determined 

by radioactive tracer procedures [nuclear silver grain counts] was 

induced. 

870.6200a Acute neurotoxicity 

screening battery- rat

NOAEL = 400 mg/kg/day

LOAEL = 2000 mg/kg/day (limit-dose) based on increases in motor 

activity in both sexes.
36 of 39

Table A.3. Toxicity Profile of Triticonazole Technical.

Guideline 

No.

Study Type 

(All Studies 

Acceptable)

Results

870.6200b Subchronic 

neurotoxicity 

screening battery-rat

NOAEL = M: 695; F 820 mg/kg/day (Highest doses tested). 

LOAEL > 695mg/kg/day.

870.6300 Developmental

Neurotoxicity

Request for a waiver was granted (Triticonazole (PC Code 125620) 

Developmental Neurotoxicity Study Waiver Request. S. Dapson, 

TXR#0053424, 11/13/2006).

870.7485 Metabolism and 

pharmacokinetics - rat

This metabolism study in the rat is classified Unacceptable/Guideline

and does not satisfy the guideline requirement for a metabolism study 

[OPPTS 870.7485, OECD 417] because the extent of absorption of the 

test material was not determined. It is upgradeable to 

Acceptable/Guideline if the registrant conducts a biliary excretion study 

or provides data that will help determine the extent of absorption. 

870.7600 Dermal penetration –

rat

Dermal Absorption Factor [C14]: 2 %.
37 of 39

Appendix B: INTERNATIONAL RESIDUE LIMIT STATUS

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name: (1RS)-

(E)-5-[4-chlorophenyl)

methylene]-2,2-dimethyl1-(1H-1,2,4-triazol1ylmethyl)cyclopentanol

Common Name:

Triticonazole

X Proposed tolerance

□ Reevaluated tolerance

□ Other

Date: 02/2009

Codex Status (Maximum Residue Limits) U. S. Tolerances

X No Codex proposal step 6 or above

□ No Codex proposal step 6 or above for the crops 

requested

Petition Number: PP#8F7420

DP#360624

Other Identifier: Decision #399232 

Residue definition (step 8/CXL): N/A Reviewer/Branch: P. Deschamp, A. Acierto/RAB3

Residue definition: triticonazole per se

Crop (s) MRL (mg/kg) Crop(s) Tolerance (ppm)

Grain, cereal, group 15 (except 

rice)

0.05

Grain, cereal, forage, fodder 

and straw, group 16 (except 

rice)

0.01

Limits for Canada Limits for Mexico

□ No Limits

□ No Limits for the crops requested

X No Limits

□ No Limits for the crops requested

Residue definition: 5-[(4-chlorophenyl)methylene]-2,2-

dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

Residue definition: N/A

Crop(s) MRL (mg/kg) Crop(s) MRL (mg/kg)

Barley 0.01

Wheat 0.01

Oats 0.01

Notes/Special Instructions: S.Funk, 02/19/2009.
38 of 39

Appendix C: METABOLISM ASSESSMENT

Table C. Major Metabolites and Degradates

Common Name (codes)

Chemical Name

Structure Matrices

Triticonazole

(RPA 400727)

(1RS)-(E)-5-[(4-

chlorophenyl)methylene]-2,2-

dimethyl-1-(1H-1,2,4-triazol-1-

ylmethyl)cyclopentanol

(1RS)-(E)-2-(4-

chlorobenzylidene)-5,5-dimethyl1-(1H-1,2,4-triazol-1-

ylmethyl)cyclopentan-1-ol

H3C

H3C

N

N

N

Cl

OH

Primary crops: wheat and barley 

(up to 93% TRR)

Rotational crops: lettuce, radish, 

and wheat

Livestock commodities: cow liver 

(<10% TRR) and kidney (11% 

TRR), poultry liver (11% TRR), 

eggs (30% TRR), and peritoneal 

fat (<10% TRR)

Rat feces: up to 74% of applied 

dose

RPA 406341

(E)-2-(4-chlorobenzylidene)-trans1,3-dihydroxy-5,5-dimethyl-1-

(1H-1,2,4-triazol-1-yl methyl)-

cyclopentane 

RPA 404766

(Z)-2-(4-chlorobenzylidene)-5,5-

dimethyl-1-(1H-1,2,4-triazol-1-yl 

methyl)-1,3-cyclopentanediol 

H C3

H C3

N

N

N

Cl

OH

OH

Primary crops: wheat and barley 

(up to 12-25% TRR, 37% TRR 

total)

Rotational crops: lettuce and 

wheat

Livestock commodities: poultry 

eggs (<10% TRR 404766, 16% 

406341) and peritoneal fat (<10% 

TRR 406341); and cow liver 

(<10% TRR, both) and kidney 

(<10% TRR, both)

Rat urine: 404766 identified at 

levels too low to be detected by 

radio-HPLC, 406341 possibly 

identified

Fate and effects: identified in soil 

photolysis, aerobic soil and 

anaerobic soil studies

RPA 406780

2-(4-chlorobenzylidene)-1,4-

dihydroxy-5,5-dimethyl-1-(1H1,2,4-triazol-1-yl methyl)-

cyclopentane 

H C3

H C3

N

N

N

Cl

OH

HO

Primary crops: wheat and barley 

(<10% TRR)

Livestock commodities: eggs 

(<10% TRR) and cow liver 

(30.8% TRR)

Rat urine: identified at levels too 

low to be detected by radio-HPLC

Fate and effects: identified in 

aerobic and anaerobic soil studies
39 of 39

RPA 404886

(E)-2-(4-chlorobenzylidene)-5-

methyl-5-hydroxymethyl-1-(1H1,2,4-triazol-1-ylmethyl)-1-

cyclopentanol

H C3

N

N

N

Cl

OH

HO

Primary crops: wheat and barley 

(up to 25% TRR)

Rotational crops: wheat

Livestock commodities: cow liver 

(<10% TRR) and kidney (67.8% 

TRR); and poultry liver (12% 

TRR), eggs (16% TRR) and 

peritoneal fat (<10% TRR)

Rat urine: identified at levels too 

low to be detected by radio-HPLC 

(and RPA 405826)

Rat feces: present (and RPA 

405826)

Fate and effects: identified in 

aerobic and anaerobic (and RPA 

405826) soil studies 

RPA 406203

z-isomer of parent

(Z)-2-(4-chlorobenzylidene)-5,5-

dimethyl-1-(1H-1,2,4-triazol-1-

ylmethyl)cyclopentan-1-ol H3C

N

N

N

OH

H3C

Cl

Primary crops: barley (<10% 

TRR)

Fate and effects: identified in 

aqueous photolysis and soil 

photolysis studies

RPA 406972

(E)-2-methyl-2-carboxylate-5-(4-

chlorobenzylidene)-1-(1H-1,2,4-

triazol-1-ylmethyl)-1-

cyclopentanol

H3C

N

N

N

Cl

OH

HOOC

Livestock commodities: cow liver 

(<10% TRR), and kidney (<10% 

TRR), poultry eggs (<10% TRR) 

and liver (19% TRR).

Rat urine: diastereomers up to 

25% of applied dose

Rat feces: present

1,2,4-Triazole or free triazole

N

N

HN

Not identified in wheat and/or 

barley grain

Fate and effects: data limited, from 

<10% to up to 30% of the applied 

radiolabeled parent remained 

unidentified in different studies

Triazole acetic acid N

N

N

HOOC

Not identified in wheat and/or 

barley grain

Fate and effects: data limited, from 

<10% to up to 30% of the applied 

radiolabeled parent remained 

unidentified in different studies