Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

Page 1 of 16

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDE

AND TOXIC SUBSTANCES

MEMORANDUM

Date: October 30, 2009

SUBJECT: Triticonazole. Application for New Seed Treatment Uses on Cereal Grains

(Except Rice) (PP#8F7420). Amendment to Label and Request for Removal of 

Plant Back Interval Restrictions Requirement

PC Code: 125620 DP Barcodes: DP325956, DP370705

Decision No.: 399231 Registration No.: 7969-xxx

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

Risk Assessment Type: NA Case No.: NA

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

MRID No.: None 40 CFR: §180.583

Ver.Apr.08

From: Stephen Funk, Senior Science Advisor

Risk Assessment Branch 3

Health Effects Division (7509P)

Through: Paula Deschamp, Branch Chief

Risk Assessment Branch III

 Health Effects Division (7509P)

To: Shaja Joyner, RM #20

 Fungicide Branch

 Registration Division (7505P)

Background

The Registration Division has requested HED reevaluation of a BASF Crop Protection 

application (PP#8F7420) for new seed treatment uses on Cereal Grains (Except Rice). The HED 

review (A. Acierto, 06/12/2009, D325956, D353372, D360624): concluded that (1) 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; (2) To support a proposed 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; (3)
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

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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; (4) A revised Section F must 

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; (5) 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 

must be submitted.

In response to conclusions #1 and #2 (above) only, the registrant has proposed reduction in the 

application rate and reconsideration of the conditional requirement for limited field rotational 

crop studies and associated plant back restrictions.

Executive Summary

Triticonazole is a systemic triazole fungicide that is currently registered for seed treatment on 

barley and wheat for the control of various seed-borne diseases. Triticonazole is formulated as 

liquid flowable formulations. The first food/feed use was requested under PP#9F6051 in 2001 

by Aventis Crop Science (EPA Company No. 264); the Aventis products have since been 

transferred to BASF (EPA Company No. 7969).

BASF Crop Protection previously submitted a tolerance petition, PP#8F7420, and Section 3 

request to register Triticonazole HL Fungicide (EPA Reg. No. 7969-xxx, a 4.17 lb ai/gal liquid 

flowable formulation) for seed treatment uses on cereal grains (except rice) at a maximum rate of 

0.05 lb ai/100 lb seed.

HED RAB3 reviewed the petition and recommended for the conditional registration for the 

requested seed treatment uses on cereal grain crops (except rice) and the establishment of 

tolerances for residues of the fungicide triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-

2,2-dimethyl-1-(1H -1,2,4-triazol-1-ylmethyl)cyclopentanol, from the treatment of seed prior to 

planting in/on (A. Acierto, 06/12/2009, D325956, D353372, D360624): 

Grain, cereal, group 15 (except rice).......................................0.01 ppm

Grain, cereal, forage, fodder, and straw, group 16 (except rice) ......0.25 ppm

RAB 3 also recommended that upon establishment of the above tolerances for grain, cereal, 

group 15 (except rice) and grain, cereal, forage, fodder, and straw, group 16 (except rice), the 

existing tolerances listed in 40 CFR 180 (a) should be removed: barley, grain; barley, hay; 

barley, straw; wheat, forage; wheat, grain; wheat, hay; wheat, straw.

HED recommended for a conditional registration until two deficiencies were satisfied (A. 

Acierto, 06/12/2009, D325956, D353372, D360624): First, the adequacy of the additional triazole 

storage stability data to support the storage durations of cereal grain forages, fodders and/or 

straws, corn kernel plus cob with husk removed (K+CWHR), and sorghum stalks from the cereal 
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

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grain field trial studies need to 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.

Second, limited field rotational crop studies are needed. The confined rotational crop study 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 originally 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, HED 

previously concluded that 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 prohibit the planting of all other crops not listed on the label.

The present submission addresses the second deficiency (rotational crop requirement) and the 

associated plant back restrictions on the label. The registrant has responded with a request to 

amend the label to delete the high seed treatment rates (0.05 lbs ai/100 lbs seed) for wheat, 

barley, rye, and oats and to retain only the 0.005 lbs ai/100 lbs seed treatment rates for wheat, 

barley, rye, and oats. The registrant also presents an extrapolation of the new seed treatment 

rates to equivalent ground application rates and contends that these rates would not lead to 

quantifiable residues (<0.01 ppm) in rotational crops at a 30 day plant back interval. 

The reduction in the application rate by a factor of 10 for the seed treatment of wheat, rye, barley

and oats has no effect on the previous recommendation of tolerance for cereal grains (except 

rice). 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. 

The reduction in the application rate by a factor of 10 for the seed treatment of wheat, rye, barley

and oats does have an effect on the previous recommendation of tolerance for forage and 

stover of cereal grains (except rice). Residues of triticonazole were 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. Highest 

residues were observed in the wheat feed commodities, where the application rate was 10X the 

label specification. Appropriate tolerance levels were determined from the highest residues 
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

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observed. The residue data for rice straw was excluded because the petitioner is not applying for 

use on rice. HED recommends a crop group tolerance of 0.10 ppm based on the highest 

observed residue value for wheat feed commodities from the 10X study. This is in agreement 

with the petitioner’s proposal and replaces the previous HED recommendation of 0.25 ppm 

(A. Acierto, 06/12/2009, D325956, D353372, D360624)

Further consideration of the confined rotational crop study with the proposed label change 

(maximum seed treatment rate reduced from 0.05 to 0.005 lb ai/100 lbs seed) leads to the 

conclusion that residues are not anticipated (<0.01 ppm) on rotational crops from use of 

triticonazole as a seed treatment under the revised label conditions. Therefore, limited field 

rotational crop studies are not required. This deficiency from the previous memo (A. Acierto, 

06/12/2009, D325956, D353372, D360624) is resolved.

Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry database for triticonazole and concludes that pending 

submission of a revised Section B (see requirements under Directions for Use) and a revised 

Section F (see requirements under Proposed Tolerances), there are no residue chemistry issues 

that would preclude granting conditional registration for the requested seed treatment uses on 

cereal grain crops (except rice) and the establishment of tolerances for residues of the fungicide 

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

ylmethyl)cyclopentanol, from the treatment of seed prior to planting in/on: 

Grain, cereal, group 15 (except rice).......................................0.01 ppm

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

Moreover, upon establishment of the above tolerances for grain, cereal, group 15 (except rice) 

and grain, cereal, forage, fodder, and straw, group 16 (except rice), the existing tolerances listed 

in 40 CFR 180 (a) should be removed: barley, grain; barley, hay; barley, straw; wheat, forage; 

wheat, grain; wheat, hay; wheat, straw.

A human health risk assessment has been conducted (N. Tsaur et al, D358614, 08/07/2009). 

The changes recommended herein have no effect on that assessment and it remains valid.

860.1200 Directions for Use

• The previous recommendation for a label change to add various plant back intervals 

is 

 withdrawn. The existing plantback interval (30 days) for Triticonazole HL Fungicide is 

adequate. This change results from the proposal to reduce the maximum application 

rate for seed treatment to 0.005 lbs. ai/100 lbs seed.

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 
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

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recommendation of 0.10 ppm for grain, cereal, forage, fodder, and straw, group 16 

(except rice); and to reflect the correct commodity definitions as listed in Table 7.

HED recommends conversion of conditional registration to unconditional registration for 

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

stability.

Tolerance Expression:

The tolerance expression in 40CFR180§583(a) should be modified to the following:

“Tolerances are established for residues of the fungicide triticonazole, including its metabolites 

and degradates, from the treatment of seed prior to planting, in or on the commodities in the 

table below. Compliance with the tolerance levels specified below is to be determined by

measuring only 5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-

ylmethyl)cyclopentanol.”

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 (A. Acierto, 06/12/2009, D325956, D353372, 

D360624) .

860.1900 Field Accumulation in Rotational Crops

• The previous deficiency is resolved. Data from limited field accumulation studies on 

rotational crops are not required, because the confined rotational crop study shows that 

quantifiable residues are unlikely in rotated commodities from use of triticonazole as a 

seed treatment for cereal grains (except rice) in accordance with the use instructions of 

the revised label for Triticonazole HL Fungicide. 

Background

The chemical structure and nomenclature of triticonazole and triazole-related metabolites, and 

the physicochemical properties of the technical grade of triticonazole are, respectively, presented 

in Tables 1 and 2.

Table 1. Triticonazole Nomenclature.
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

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Table 1. Triticonazole Nomenclature.

Chemical structure

H C3

H3C

OH

N

N

N

Cl

Common name Triticonazole

Company experimental name BAS 595 F (formerly RPA 4000727)

IUPAC name (±)(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-

ylmethyl)cyclopentanol

CAS name 5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-

ylmethyl)cyclopentanol

CAS registry number 131983-72-7

End-use product (EP) Triticonazole HL (4.17 lb ai/gal flowable liquid; EPA Reg. No. 7969-xxx)

Chemical structure of T

metabolite

HN

N

N

1,2,4-Triazole

Chemical structure of TA

metabolite

N

N

N

HO

NH2

O

Triazole alanine or triazolylalanine

Chemical structure of TAA

metabolite

N

N

N

HO

O

Triazole acetic acid or triazolylacetic acid

Table 2. Physicochemical Properties of Chemical: Triticonazole.

Parameter Value Reference

Melting point/range 140 oC; PAI displays two crystalline forms 

melting at 137 and 141 oC

BASF document number 

2002/1016091 1

pH Not available

Density 1.21 g/mL (PAI) BASF document number 

2002/1016091 1

Water solubility 8.4 mg/L at 20 oC

Solvent solubility (at 20 oC) Hexane 0.12 g/L

Methanol 18.2 g/L

Acetone 74.5 g/L

Toluene 12.6 g/L

Dichloromethane 191 g/L

Ethyl acetate 48.6 g/L

n-Octanol 6.2 g/L

Vapor pressure <0.1 x 10-5PA at 50 oC
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

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Table 2. Physicochemical Properties of Chemical: Triticonazole.

Parameter Value Reference

Dissociation constant, pKa Does not dissociate

Octanol/water partition coefficient, 

Log(KOW)

Log P = 3.29 at 20 oC

UV/visible absorption spectrum Not available

1 As referenced in MRID 47470203.

860.1200 Directions for Use

A summary of the revised proposed use directions is presented in Table 3. Information 

pertaining to the proposed use pattern was obtained from a September 2009 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 except rice. 

Table 3 shows that Triticonazole HL Fungicide Seed Treatment is proposed for seed treatment on 

cereal grains (except rice) at a maximum rate of 0.005 lb ai/100 lb seed for oats, rye, barley, and 

wheat; at 0.01 lbs ai/100 lbs seed for sweet corn; at 0.050 lbs ai/a00 lbs seed for field corn, and at 

0.020 lbs ai/100 lbs sorghum. The end-use product 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 3. Summary of Proposed Seed Treatment Use of Triticonazole.

Application 

Type

Formulation

[EPA Reg. No.]

Seed Treatment 

Application Rate

(lb ai/100 lb seed)

Maximum 

Seeding Rate 1

(lb seed planted/A)

Maximum Equivalent 

Field Application Rate, 

2

lb ai/A

(kg ai/ha)

Barley

Seed 

Treatment

4.17 lb/gal FS

[7969-xxx] 0.005 96 0.0048(0.0054)

Field Corn and Popcorn (includes seed production)

Seed 

Treatment

4.17 lb/gal FS

[7969-xxx] 0.005-0.050 15

0.0075

(0.0084)

Sweet Corn

Seed 

Treatment

4.17 lb/gal FS

[7969-xxx] 0.010 15

0.0015

(0.0017)

Oats

Seed 

Treatment

4.17 lb/gal FS

[7969-xxx] 0.005 128 0.0064(0.0072)

Rye

Seed 

Treatment

4.17 lb/gal FS

[7969-xxx] 0.005 112 0.056(0.0063)

Sorghum

Seed 

Treatment

4.17 lb/gal FS

[7969-xxx] 0.010-0.020 10 0.0020(0.0022)

Wheat and Triticale
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

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Table 3. Summary of Proposed Seed Treatment Use of Triticonazole.

Application 

Type

Formulation

[EPA Reg. No.]

Seed Treatment 

Application Rate

(lb ai/100 lb seed)

Maximum 

Seeding Rate 1

(lb seed planted/A)

Maximum Equivalent 

Field Application Rate, 

2

lb ai/A

(kg ai/ha)

Seed 

Treatment

4.17 lb/gal FS

[7969-xxx] 0.005 150 0.0075(0.0084)

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.

Conclusions. The revised submitted label for Triticonazole HL Fungicide Seed Treatment

reduced the maximum treatment rate for wheat, oats, barley, and rye by a factor of 10. The 

submitted confined rotational crop study (see below), which was conducted at 14x to 71x the 

proposed maximum equivalent field application rate for cereal grains, indicates that residues of 

triticonazole will likely be absent at >0.01 ppm in 30-DAT rotated lettuce, radish tops and roots, 

and wheat forage, straw and chaff;, and grain The proposed 30-day plantback interval for all

crops not listed on the label is now acceptable. 

860.1300 Nature of the Residue - Plants

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420)

860.1300 Nature of the Residue - Livestock

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420)

860.1340 Residue Analytical Methods

Enforcement method

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420)

Data-Collection Method

DER Reference: 47511902.der.doc

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420)

860.1360 Multiresidue Methods

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

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Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420)

860.1380 Storage Stability

Storage Stability Study with Triticonazole on Wheat

DER Reference: 45595401.der.doc

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420)

Interim Results of a Storage Stability Data Study with 1,2,4-Triazole (T), Triazolylalanine (TA), 

and Triazolylacetic Acid (TAA) In Apples, Wheat Flour, Peanut Butter, Milk, and Eggs

DER Reference: 46568301.der.doc

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420)

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses relevant to this guideline topic. The petitioner noted that they are not 

seeking to register use on rice, a crop which may be irrigated, at this time.

860.1460 Food Handling

There are no proposed uses that are relevant to this guideline topic. 

860.1480 Meat, Milk, Poultry, and Eggs

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420)

860.1500 Crop Field Trials

DER Reference: 47470203.der.doc

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420)

Wheat, corn, sorghum, and rice crop field trials were previously reviewed. The seed treatment 

application rate for all crop seeds was 50 g ai/100 kg seed. or 0.05 lbs ai/100 lbs seed. This is 

10x the revised maximum proposed seed treatment use on oats, rye, wheat, and triticale. The 

residues found on the mature crop commodities will be elevated relative to those resulting from 

use according to the revised label. 

The summary table of field trial results is repeated below. Residues of triticonazole were <0.01 

ppm on field corn, sweet corn, and sorghum commodities from treatments at 1X to 5X the label 

rate. The maximum triticonazole residues on wheat forage, hay, straw, and grain were 0.10 ppm, 

0.08 ppm, 0.08 ppm, and <0.01 ppm, respectively, from treatments at 10X the label rate.

Table 4. Summary of Residue Data from Crop Field Trials with Triticonazole.

Commodity Applic. DAP Residue Levels (ppm)1
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

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Rate

g ai/100

kg seed

(lb ai/100 

lbs seed)

(days) n Min. Max. HAFT2 Median

(STMdR)

Mean

(STMR)

Std. 

Dev. 3

Proposed Rate on Barley, Oats, Rye, Wheat, and Triticale = 0.0050 lb ai/100 lb seed

Propsed Rate on Corn (Field and Pop) = 0.050 lb ai/100 lb seed

Proposed Rate on Sweet Corn = 0.010 lb ai/100 lb seed

Proposed Rate on Sorghum = 0.020 lb ai/100 lb seed)

Triticonazole

Wheat, forage 50

(0.05)

35-102 30 <0.01 0.10 0.10 0.02 0.04 0.028

Wheat, hay 50

(0.05)

56-135 30 <0.01 0.08 0.08 0.02 0.03 0.026

Wheat, grain 50

(0.05)

90-177 30 <0.01 <0.01 <0.01 0.01 0.01 NA

Wheat, straw 50

(0.05)

90-177 30 <0.01 0.08 0.08 0.03 0.03 0.024

Corn, forage 450

(0.05)

78-155 38 <0.01 <0.01 <0.01 0.01 0.01 NA

Corn, grain 50

(0.05)

112-161 30 <0.01 <0.01 <0.01 0.01 0.01 NA

Corn, stover 450

(0.05)

92-176 38 <0.01 <0.01 <0.01 0.01 0.01 NA

Corn, K+CWHR 50

(0.05)

71-114 18 <0.01 <0.01 <0.01 0.01 0.01 NA

Sorghum, forage 50

(0.05)

61-113 24 <0.01 <0.01 <0.01 0.01 0.01 NA

Sorghum, grain 50

(0.05)

90-199 24 <0.01 <0.01 <0.01 0.01 0.01 NA

Sorghum, stover 50

(0.05)

90-199 24 <0.01 <0.01 <0.01 0.01 0.01 NA

Rice, grain 50

(0.05)

114-182 24 <0.01 0.02 0.02 0.01 0.01 0.003

Rice, straw 50

(0.05)

114-182 24 <0.01 0.04 0.04 0.01 0.02 0.009

Triazole (T)

Wheat, forage 50

(0.05)

35-102 30 <0.05 <0.05 <0.05 0.05 0.05 NA

Wheat, hay 50

(0.05)

56-135 30 <0.05 <0.05 <0.05 0.05 0.05 NA

Wheat, grain 50

(0.05)

90-177 30 <0.01 <0.01 <0.01 0.01 0.01 NA

Wheat, straw 50

(0.05)

90-177 30 <0.05 <0.05 <0.05 0.05 0.05 NA

Corn, forage 450

(0.50)

78-155 38 <0.05 <0.05 <0.05 0.05 0.05 NA

Corn, grain 50

(0.05)

112-161 30 <0.01 <0.01 <0.01 0.01 0.01 NA

Corn, stover 450

(0.05)

92-176 38 <0.05 <0.05 <0.05 0.05 0.05 NA

Corn, K+CWHR 50

(0.05)

71-114 18 <0.01 <0.01 <0.01 0.01 0.01 NA

Sorghum, forage 50

(0.05)

61-113 24 <0.05 <0.05 <0.05 0.05 0.05 NA
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

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Table 4. Summary of Residue Data from Crop Field Trials with Triticonazole.

Commodity Applic.

Rate

g ai/100

kg seed

(lb ai/100 

lbs seed)

DAP

(days)

Residue Levels (ppm)1

n Min. Max. HAFT2 Median

(STMdR)

Mean

(STMR)

Std. 

Dev. 3

Sorghum, grain 50

(0.50)

90-199 24 <0.01 <0.01 <0.01 0.01 0.01 NA

Sorghum, stover 50

(0.05)

90-199 24 <0.05 <0.05 <0.05 0.05 0.05 NA

Rice, grain 50

(0.05)

114-182 24 <0.01 <0.01 <0.01 0.01 0.01 NA

Rice, straw 50

(0.05)

114-182 24 <0.05 <0.05 <0.05 0.05 0.05 NA

Triazolylalanine (TA)

Wheat, forage 50

(0.05)

35-102 30 <0.05 0.12 0.11 0.05 0.05 0.015

Wheat, hay 50

(0.05)

56-135 30 <0.05 0.14 0.13 0.05 0.06 0.021

Wheat, grain 50

(0.05)

90-177 30 <0.05 0.26 0.24 0.06 0.10 0.063

Wheat, straw 50

(0.05)

90-177 30 <0.05 0.07 0.07 0.05 0.05 0.004

Corn, forage 450

(0.05)

78-155 38 <0.05 <0.05 <0.05 0.05 0.05 NA

Corn, grain 50

(0.05)

112-161 30 <0.05 0.35 0.31 0.05 0.07 0.065

Corn, stover 450

(0.05)

92-176 38 <0.05 <0.05 <0.05 0.05 0.05 NA

Corn, K+CWHR 50

(0.05)

71-114 18 <0.05 0.26 0.24 0.05 0.07 0.061

Sorghum, forage 50

(0.05)

61-113 24 <0.05 0.10 0.08 0.05 0.05 0.010

Sorghum, grain 50

(0.05)

90-199 24 <0.05 0.39 0.38 0.05 0.08 0.091

Sorghum, stover 50

(0.05)

90-199 24 <0.05 0.26 0.25 0.05 0.07 0.057

Rice, grain 50

(0.05)

114-182 24 <0.05 0.29 0.29 0.05 0.07 0.066

Rice, straw 50

(0;05)

114-182 24 <0.05 <0.05 <0.05 0.05 0.05 NA

Triazolyl-acetic acid (TAA)

Wheat, forage 50

(0.05)

35-102 30 <0.05 <0.05 <0.05 0.05 0.05 NA

Wheat, hay 50

(0.05)

56-135 30 <0.05 0.13 0.11 0.05 0.06 0.016

Wheat, grain 50

(0.05)

90-177 30 <0.01 0.20 0.20 0.04 0.05 0.046

Wheat, straw 50

(0.05)

90-177 30 <0.05 0.10 0.10 0.05 0.05 0.011

Corn, forage 450

(0.05)

78-155 38 <0.05 <0.05 <0.05 0.05 0.05 NA

Corn, grain 50

(0.05)

112-161 30 <0.01 <0.01 <0.01 0.01 0.01 NA
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

Page 12 of 16

Table 4. Summary of Residue Data from Crop Field Trials with Triticonazole.

Commodity Applic.

Rate

g ai/100

kg seed

(lb ai/100 

lbs seed)

DAP

(days)

Residue Levels (ppm)1

n Min. Max. HAFT2 Median

(STMdR)

Mean

(STMR)

Std. 

Dev. 3

Corn, stover 450

(0.05)

92-176 38 <0.05 <0.05 <0.05 0.05 0.05 NA

Corn, K+CWHR 50

(0.05)

71-114 18 <0.01 <0.01 <0.01 0.01 0.01 NA

Sorghum, forage 50

(0.05)

61-113 24 <0.05 0.07 0.06 0.05 0.05 0.004

Sorghum, grain 50

(0.05)

90-199 24 <0.01 0.37 0.35 0.01 0.04 0.095

Sorghum, stover 50

(0.05

90-199 24 <0.05 <0.05 <0.05 0.05 0.05 NA

Rice, grain 50

(0.05)

114-182 24 <0.01 0.50 0.50 0.03 0.07 0.134

Rice, straw 50

(0.05)

114-182 24 <0.05 0.34 0.34 0.05 0.08 0.082

860.1520 Processed Food and Feed

DER Reference: 47511901.der.doc

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420)

860.1650 Submittal of Analytical Reference Standards

Analytical standards for triticonazole are currently available in the EPA National Pesticide 

Standards Repository (personal communication with Dallas Wright, ACB, 2/23/09), expiration 

date 7/8/2014. 

860.1850 Confined Accumulation in Rotational Crops

DER Reference: 47399201.der.doc

Residue Chemistry Memo DP# 262566, 6/6/2001, N. Dodd (PP#9F6051)

Residue Chemistry Memo DP# 325956, 353372, 360624; A. Acierto (PP#8F7420)

The results from the previously reviewed confined rotational crop study are summarized in Table 

5 (DP# 262566, 6/6/2001, N. Dodd). The application rate to the soil was 120 g ai/ha. (0.107 lb 

ai/acre)

Table 5. Total Radioactive Residues and Triticonazole in Rotated Lettuce, Radish, and Wheat Matrices 

Matrix Plantback Interval 

(days)

TRR Phenyl Label (ppm) TRR Triazole Label (ppm) Triticonazole 

(ppm)

Combustion Calculated1 Combustion Calculated1

Lettuce 30 0.020 0.024 0.065 0.065 0.017

120 0.014 0.014 0.026 0.025 0.006
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

Page 13 of 16

365 0.005 0.004 0.029 0.024 0.003

Radish, roots 30 0.009 0.009 0.099 0.094 0.007

120 0.006 0.006 0.055 0.056 0..003

365 0.003 0.003 0.031 0.029 0.002

Radish, tops 30 0.072 0.067 0.279 0.256 0.049

120 0.052 0.040 0.331 0.286 0.016

365 0.011 0.009 0.128 0.043 0.003

Wheat, forage 30 0.067 0.042 0.199 0.129 0.041

120 0.049 0.035 0.155 0.095 0.019

365 0.029 0.015 0.141 0.107 0.025

Wheat, straw 30 0.209 0.181 0.629 0.580 0.133

120 0.345 0.298 0.675 0.576 0.150

365 0.282 0.198 0.520 0.455 0.086

Wheat, chaff 30 0.181 0.174 0.509 0.571 0.139

120 0.151 0.141 0.848 0.786 0.114

365 0.106 0.095 0.562 0.549 0.133

Wheat, grain 30 0.008 0.008 0.453 0.948 0.00

120 0.054 0.053 0.689 0.706 0.00

365 0.025 0.028 0.682 0.773 0.00

1 Calculated by the summation of extractable and nonextractable radioactivity; these values were used by the petitioner for all

further calculations.

The application rate used in the confined rotational crop study is significantly higher than the 

equivalent application rate achieved from the proposed seed treatment rates. The comparison is 

given in Table 6.

Table 6. Equivalent Field Rates from Proposed Label for Triticonazole Seed Treatment

Crop Maximum seed 

treatment rate

(lbs ai/100 lbs 

seed)

Maximum 

seeding rate (lb 

seed/acre)

Maximum 

Equivalent Field 

Application Rate 

(lbs ai/acre)

Exaggeration 

Factor from 

Confined 

Rotational Crop1

Field corn 0.050 15 0.0075 14

Sweet corn 0.010 15 0.0015 71

Sorghum 0.020 10 0.0020 54

Wheat 0.005 150 0.0075 14

Barley 0..05 96 0.0048 22

Rye 0.005 112 0.0056 19

Oat 0.005 128 0.0064 17

1 Confined rotational crop application rate (0.107 lb ai/acre) / maximum equivalent field 

application rate from seed treatment.

The confined rotational crop study was conducted at a minimum exaggerated rate of 14X. 

Assuming a proportionality between the concentration of triticonazole in the soil and the 

triticonazole residue in the rotated crop commodities, all triticonazole residues on all 

commodities would be <0.01 ppm at all plant back intervals with the exception of wheat straw 

and wheat chaff. These commodities might contain about 0.01 ppm triticonazole at all plant 

back intervals, e.g., 0.150 ppm wheat straw at 120 days / 14 = 0.0107 ppm. However, given 

that a confined study represents the worst possible case, it is likely that triticonazole residues on 
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

Page 14 of 16

wheat chaff and straw would not achieve a level of 0.01 ppm under field conditions.

Conclusion. . The application rate used in the confined rotational crop study reflects 14 to 71X 

the equivalent per acre rate proposed for cereal grain crops. It is unlikely that quantifiable 

residues of triticonazole (>0.01 ppm) will be found in rotated crop commodities at plant back 

intervals of 30 days or greater when triticonazole is used as a seed treatment at the label rates 

proposed.

860.1900 Field Accumulation in Rotational Crops

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 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. 

However, when the exaggerated treatment rate of the confined study (14X minimum) is taken 

into consideration, it is likely that triticonazole residues will be < 0.01 ppm on rotated food 

commodities. 

Although significant triticonazole was quantitated at >0.01 ppm in the rotated livestock feed 

commodities wheat straw, forage, and chaff planted at the 30-, 120- and 365-day PBIs from a 

confined rotational crop study conducted at an exaggerated rate of 14X, the levels of 

triticonazole anticipated from 1X treatment are estimated to be <0.01 ppm. . 

Conclusion. Field accumulation in rotational crops studies will not be required. The confined 

study indicates that residues of triticonazole will be non-quantifiable in rotated crops resulting 

from the use of triticonazole as a seed treatment for cereal grains (except rice) used according to 

the proposed label application rates.

860.1550 Proposed Tolerances

Tolerances have been established under 40 CFR §180.583(a) for residues of the fungicide 

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

ylmethyl)cyclopentanol, from the treatment of seed prior to planting in/on barley grain, hay and 

straw, and wheat grain, forage, hay and straw, each at 0.05 ppm. HED has previously determined 

that triticonazole is the residue of concern in barley and wheat from seed treatment uses. This 

regulatory decision may be extended to include all crop commodities in the cereal grains crop 

group. The petitioner has not specified the tolerance expression with the proposed tolerances in 

Section F of the petition. 

The submitted residue data for field corn grain, sweet corn K+CWHR, sorghum grain, and wheat 

grain, which are the representative commodities of the cereal grain group, do not support the 

proposed tolerance for the ‘Grain, cereal, group 15 (except rice)’ at 0.05 ppm. The data do 

support a tolerance for ‘Grain, cereal, group 15 (except rice)’ at 0.01 ppm. A revised Section F 

must be submitted to reflect the tolerance recommendation of 0.01 ppm for “Grain, cereal, 

group 15 (except rice)” at 0.01 ppm. The established individual tolerances for wheat grain and 

barley grain must be deleted when the crop group tolerance is established.
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

Page 15 of 16

The submitted residue data for corn forage and stover, sorghum forage and stover, and wheat 

forage, hay, and straw are adequate to determine a tolerance level for the forage, fodder, and 

straw of cereal grains crop group (except rice). The residues in wheat commodities were highest, 

but resulted from a 10X exaggerated rate study. The HAFT residues resulting from the study 

were used to establish, the tolerance levels for wheat forage, wheat hay, and wheat straw. The 

data support the proposed Section F tolerance of 0.10 ppm for “Grain, cereal, forage, fodder, 

and straw, group 16 (except rice).” The established individual tolerances for barley hay and 

straw, and wheat forage, hay and straw must be deleted when the crop group tolerance is 

established.

The considerations for processed commodities and livestock commodities remain unchanged 

from the previous review (A. Acierto, 06/12/2009, D325956, D353372, D360624) 

A summary of the recommended tolerances for the petition is listed in Table 7

Table 7. 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 Barley 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 

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.

Wheat, straw 0.05 Remove

Tolerances to be established under 180.583(a)

Grain, cereal, group 15 

(except rice)

0.05 0.01 .

Grain, cereal, forage, 

fodder, and straw, group 

16 (except rice)

0.10 0.101.

1 The only change from the previous tolerance summary (A. Acierto, 06/12/2009, D325956, 353372, 360624) is 

the replacement of 0.25 with 0.10 ppm.
Triticonazole Addendum to Summary of Analytical Chemistry and Residue Data DP #370705

Page 16 of 16

References

DP#: 262566

Subject: PP#9F6051. Triticonazole Seed Treatment on Barley and Wheat. Review of 

Analytical Methods and Residue Data. First Food Use Review.

From: N. Dodd

To: S. Gardner-Jenkins/M. Waller

Dated: 6/6/2001

MRIDs: 44904515-25, 44995701-06

DP# 325956; 353372; 360624

Subject: Triticonazole. Application for New Seed Treatment Uses on Cereal Grains 

(Except Rice) (PP#8F7420). Summary of Analytical Chemistry and Residue 

Data.. 

From: A. Acierto

To: S. Joyner

Dated: 6/12/2009

MRIDs: 47511902; 45595401; 46568301; 47470203; 47511901; 47399201

Template Vers.,ion September 2005