UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Da te: 26-AUG-2015 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Tetraconazole; Human Health Risk Assessment Scoping Document in Support of 

Registration Review. 

PC Code: 120603 

Decision No.: 503204 

Petition No.: NA 

Risk Assessment Type: Single 

Chemical/ Aggregate 

TXRNo.: NA 

MRID No.: NA 

DP Barcode: D426702 

Registration No.: NA 

Regulatory Action: Registration Review 

Scoping Document 

Case No.: 7043 

CAS No.: 112281-77-3 

40 CFR: §180 

FROM: Anwar Y. Dunbar, Ph.D., Ph rrn~~ og ~ Th

James 

omas 

Mill

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Ch

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~ 

ental Sci

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entist 

Risk Assessment Branch I (RAB I) 

Health Effects Division (HED; 7509P) 

TO: Veronica Dutch 

Risk Review Manager 

Pesticide Re-Evaluation Division (PRD, 7508P) 

Attached is HED's human health risk assessment scoping document for tetraconazole to support 

Registration Review. 

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Tctraconazole Scoping Document DP# 426702 

Table of Contents 

Executive Summary ........ ............. ................................. .-................................................................ ............. . 3 

1.0 Hazard ldentificationfroxicology ......................................................................................................... 5 

2.0 Residue Che1nistry ................................................... ..................................... ......................................... 6 

3.0 Dietary Exposure ........................................................................................................... ........................ 7 

4.0 Residential Exposure ........................................................................................................................ ... .. 7 

5.0 Aggregate Risk Assessment .. ........ ....... ...................................................................................... ... ........ 8 

6.0 Occupational Exposure .... .............. ....... ................................................................................................. 8 

7 .0 Public Health and Pesticide Epidemiology Data .................................................................... ... .... ... ... 10 

8.0 Human Incident Data: OPP IDS (2012) ............................................................................................. 11 

9.0 Tolerance Assessment and International Harmonization .................................................................... 12 

10.0 Environmental Justice ................... ................................... ............... ........................ ...... ............. ....... 12 

11 .0 Cumulative .................. ....... ....... ........ ........ ........ ....... .............................. ....... ....... ............................. 12 

12.0 Hurnan Studies .......................................................... ................................................. ........................ 12 

13.0 Data Requirements Required Under Registration Review ......................................................... ....... 13 

14.0 References ...................................................................................... ....... ............................................ 13 

15.0 Attachn1ents8 ............................................................................................................. ... .... ... ........... 15 

Attachment 1: Tetraconazole and Its Metabolites Chemical Identity Table ............................................ 16 

Attachment 2: Tetraconazole Endpoint Selection and Toxicity Profile Tables for Tetraconazole 

Technical. ............................................ .......................................................................... ............. ....... ........ 17 

Attachment 3: Registered End-Use Products and Application Scenarios/Rates (information provided by 

BEAD) ........................................................ .................................................................. ... .... ... ................... 26 

. : ... 

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Tetraconazole Scoping Document DP# 426702 

Executive Summary 

HED has prepared a scoping document to support the Registration Review of tetraconazole, (1-(2-(2,4-

dichlorophenyl)-3-( 1, 1,2,2-tetrafluoroethoxy)propyl]-1 H-1,2,4-triazole). Tetraconazole, a conazaole 

containing compound, is a pesticide chemical belonging to the class of chemicals known as the triazol e 

fungicides which inhibit fungal cell wall synthesis and function. Tolerances for residues of 

tetraconazole are established under 40CFR§180.557 in/on a wide variety of crops at levels ranging 

from 0.03-1.0 ppm. Tolerances for residues of tetraconazole are also established in/on hog, poultry, and 

ruminant commodities at 0.01-0.25 ppm. 

The toxicity database for tetraconazole is complete and adequate to support Registration Review 

requirements. The newly submitted cancer mode-of-action data has been reviewed and based on the 

acceptable mitogenic mode of action for the liver tumors in mice, tetraconazole is classified as "not 

likely to be carcinogenic to humans at levels that do not cause increased cell proliferation in the liver" 

and a non-linear approach will be used for quantification of human cancer risk. This methodology using 

the chronic reference dose (RID) will adequately account for all chronic toxicity effects, including 

carcinogenicity, likely to result from exposure to tetraconazole. For future actions, the non-cancer 

endpoints and safety factors for tetraconazole will need to be re-evaluated and updated based upon 

current policies. 

Provided the registered labels are consistent with the labels submitted to HED for review and conform to 

any of the revisions requested by HED, adequate metabolism (crops, livestock, and rotational crops) and 

magnitude of the residue data are available to support the registered uses (no additional residue 

chemistry data is required are needed; current tolerances are adequate). Adequate methods are available 

for enforcement of the currently established tolerances. 

The most recent acute and chronic dietary exposure analyses were conducted in 20 11 using the Dietary 

Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID, ver. 2.03) which 

incorporated food consumption data from the United States Department of Agriculture (USDA) 

Continuing Surveys of Food Intakes by Individuals (CSFII; 1994-1996 and 1998). The unrefined acute 

analysis and refined chronic analysis (refined using data from the processing, field trial, and feeding 

studies and projected percent crop treated estimates) resulted in exposure estimates which did not exceed 

HED's level of concern (~1.8% acute population-adjusted dose (aPAD); . 9% chronic populationadjusted dose (cPAD); considered food and water). As part of Registration Review, a revised dietary risk 

assessment may be necessary to reflect potential revised estimated drinking water concentrations 

(EDWCs), the most recent dietary exposure models, increased tolerances as a result of harmonization, 

and/or revised toxicological points of departure (PODs). 

There are no residential uses proposed or currently registered for tetraconazole. Therefore, a residential 

handler and post-application exposure assessment is not needed to support Registration Review. 

Residential exposures resulting from off-site transport (e.g., spray drift or volatilization) may occur as a 

result of applications of tetraconazole. The need for spray drift and volatilization risk assessments for 

tetraconazole will be examined during Registration Review. 

In accordance with the Food Quality Protection Act (FQPA), HED must consider and aggregate (add) 

pesticide exposures and risks from three major sources: food, drinking water, and residential exposures. 

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Tetraconazole Scoping Document DP# 426702 

Because there are no residential uses for tetraconazole, only food and water were included in previous 

aggregate assessments. There is sufficient information available to assess aggregate exposure; therefore, 

a new aggregate risk assessment will be required during Registration Review to incorporate revised 

dietary exposure analyses. 

Application of tetraconazole also results in potential exposures to the metabolites T (1 ,2,4-triazole), TA 

(triazolylalanine), T AA (triazolylacetic acid), and THP (triazolyl hydroxypropionic acid). These 

compounds are considered to be toxicologically different from tetraconazole. HED recently conducted 

an aggregate risk assessment for these compounds with the resulting exposure estimates less than HED's 

level of concern (0426493, T. Morton, 9-Apr-2015). Finally, application of tetraconazole results in 

exposure to other metabolites which HED has determined are toxicologically identical to propiconazole 

(M 14360-ketone, M 14360-CP(C-1 )-alcohol, and M 14360(C-l )-alcohol). HED has previously 

concluded that the propiconazole risk assessments, which yielded exposures Jess than HED's level of 

concern, did not require revision as the residue estimates incorporated into these analysis were 

protective of the potential residues resulting from the application of tetraconazole. As part of 

registration review, revised triazole and propiconazole risk assessments may be required. 

HED has conducted occupational handler assessments for most of the occupational handler scenarios 

anticipated for the registered uses of tetraconazole. However, during Registration Review, updated 

occupational assessments will be conducted to reflect all currently registered uses, using current 

occupational handler and post-application exposure policies and/or updated toxicological PODs as 

needed. 

The following data deficiencies were identified for tetraconazole: 

• Toxicology: None 

• Residue Chemistry: Provided the registered labels are consistent with the labels submitted to 

HED for review and conform to any of the revisions requested by HED, no additional residue 

chemistry data are required. 

• Occupational Exposure-ORE: A DFR (dislodgcable fol iar residue) study is required (OCSPP 

Guideline # 875.2100). 

In addition, EPA anticipates conducting the following risk assessment updates during Registration 

Review: 

• Toxicology: Reevaluate toxicity endpoint/dose selection, along with the FQPA Safety Factor 

(SF) based on current HED policy. 

• Dietary Exposure: A revised dietary exposure analysis may be required to reflect the most recent 

dietary exposure models, potential revised EDWCs, and/or changes to the toxicological PODs. 

• The need for spray drift and volatilization risk assessments for tetraconazole will be examined 

during Registration Review. 

• Aggregate Exposure: Revised aggregate exposure analyses may be required to reflect revised 

dietary exposure estimates and/or changes to the toxicological PODs. 

• Occupational Exposure: Revised occupational handler and post-application dennal and 

inhalation assessments to reflect all potential exposure scenarios, as well as updated policies and 

exposure data, and updated toxicological PODs if revised, and DFR data. 

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Tetraconazolc Scoping Document DP# 426702 

1.0 Hazard Identificationffoxicology 

Tetraconazole is a systemic fungicide and a member of the conazole/triazole class of pesticides. It 

inhibits fungal sterol production by inhibiting the enzyme lanosterol 14 a-demethylase, a cytochrome 

P450 enzyme. This leads to abnormal fungal cell wall production and function. 

The liver and kidney are the primary target organs of tetraconazole in all species in oral toxicity studies 

of subchronic and chronic durations. Based upon newly submitted in vivo cancer mode-of-action data in 

mice, the Agency has concluded that liver tumors observed in tests with that species are due to 

activation of the constitutive androstane receptor (CAR) in the liver (Rowland el al., TXR # 0056628, 

April 02, 2013). 

ln the acute neurotoxicity study, loss of motor activity in both sexes, and clinical signs including 

hunched posture, decreased defecation, and/or red or yellow material on various body surfaces were 

observed in females. There was no evidence of immunotoxicity or neurotoxicity following subchronic 

exposure. There were no systemic effects observed in the 21-day dermal toxicity study up to the highest 

dose tested. Tetraconazole did not show evidence of mutagenicity in in vitro or in vivo studies. 

Jn contrast to the oral studies where the most sensitive effects were in the liver and kidney, inhalation 

exposure of tetraconazole to rats resulted in portal of entry effects including; squamous cell metaplasia 

of the laryngeal mucous, mono-nuclear cell infiltration, goblet cell hyperplasia, hypertrophy of the nasal 

cavity and nasopharyngeal duct, and follicular hypertrophy of the thyroid in males. At the highest 

concentration tested, there were treatment-related increases in absolute lung weights in both sexes. 

Oral rat and rabbit prenatal developmental studies showed no evidence for increased quantitative 

susceptibility of the fetus to tetraconazole exposure in ulero. Developmental effects were seen in the 

presence of maternal effects in rats, while no developmental effects were seen in rabbits. A twogeneration rat reproduction study also revealed no evidence for increased quantitative susceptibility in 

offspring. Decreased litter and mean pup weights and increased liver weights were noted in offspring at 

a dose higher than that which caused mortality in adult females. Effects in parental animals that 

survived the duration of the study were consistent with other studies in the database. 

Tetraconazole has low acute toxicity via the oral, dermal, and inhalation routes (Categories III and IV). 

It is a slight eye irritant (Category III), but is not a dermal irritant or a dermal sensitizer (Category IV). 

The tetraconazole endpoint tables and toxicological profile tables can be found in Attachment 2. 

Conclusions: The toxicity database for tetraconazole is complete and adequate to support Registration 

Review requirements. The endpoints presented in Attachment 2 are from the most recent risk 

assessment for tetraconazole (Memo, 14-April-2011 , A. Nowotarski, el al., 0380618). The hazard 

profi le table containing all newly submitted and reviewed data are presented Attachment 2 as well. 

Based on the acceptable mitogenic mode of action for the mice liver tumors, tetraconazole is classified 

as "not likely to be carcinogenic to humans at doses that do not cause increased cell proliferation in the 

liver·'; a non-linear approach will be used for quantification of human cancer risk (Rowland et al., TXR 

# 0056628, April 02, 2013). For future actions, the non-cancer endpoints and safety factors for 

tetraconazole will need to be re-evaluated and updated based upon current policies. 

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Tctraconazole Scoping Document DP# 426702 

2.0 Residue Chemistry 

Registered Use Patterns: Tetraconazole is registered for foliar application to soybean, field corn, 

popcorn, corn grown for seed, sugar beet, peanut, pecan, fruit, small, vine climbing subgroup l 3-07F, 

and subgroup l 3-07G (except cranberry). Tetraconazole end-use products are registered for application 

to these crops with a maximum seasonal application rate of 0.50 lb ai/acre. See Attachment 3 for a 

summary of the registered end-use products and application scenarios. 

For several crops, the field trial studies were conducted without the addition of adjuvants and HE D 

required label restrictions prohibiting the addition of adjuvants to the spray solution. The HEO 

Chemistry Science Advisory Council (Chem SAC) has since concluded that the use of adjuvants in field 

trials is unnecessary (see Conclusions and Recommendations Regarding the Requirement for Inclusion 

of Adjuvants in Crop Field Trials; l 3-Aug-2012). Therefore, label restrictions prohibiting the addition 

of adjuvants are unnecessary. In addition, ChemSAC has concluded that peanut hay is not a significant 

livestock feed commodity, therefore previously required language prohibiting the feeding of peanut hay 

to livestock is unnecessary (see Revisions of Feed Stuffs in Table I of OPPTS 860.1000; 30-Jun-2008). 

Residue Chemistry a11d To/era11ce Assess111e11t: Based on sugar beet, grape, wheat, goat, and poultry 

metabolism studies and the confined rotational crop study, HED concluded that the residues of concern 

are as defined in Table l. HEO concluded that the toxicological effects resulting from exposure to T, 

TA, TAA, THP, and all labile conjugates of these compounds and Ml4360(C-1)-alcohol are different 

from that resulting from exposure to tetraconazole; HEO concluded that the toxicity of the remaining 

metabolites is identical to that of tetraconazole. For a discussion concerning these conclusions, see 

032175 l (M. Clock-Rust et al., 26-Jan-2007). 

Provided the registered labels are consistent with the labels submitted to HEO for review and conform to 

any of the revisions requested by HEO, the currently established tolerances and the residue chemistry 

database are sufficient to support all registered uses. Adequate methods are available to enforce the 

currently established plant and livestock tolerances (0280006, W. Donovan, I O-Jan-2002, 0267481 , 12-

0ct-2000; 0 278236, W. Donovan, 22-0ct-2001; 0 386650, T. Bloem, 14-Apr-20 11 ). No additional residue 

chemistry data are needed. 

Table I : Resid ues for Tolerance Expr ession and Risk Assessment.1 

Matrix Residues Included in Risk Assessment Residues Included in 

Tolerance Expression 

Shelled Pea tctraconazole and 1,2,4-lriazole {T), triazolyl alanine (TA), triazolyl 

and Bean acetic acid (T AA). and all labile conjugates of these compounds 

Remaining Registered telraconazole, M 14360-alcohol (free and conjugated), M 14360-acid, 

Primary Crops M 14360-DF A, M 14360-hydroxydctriazolyl-0-malonyldiglucosidc, 

and T, TA. TAA and all labile conjuaates oflhcse compounds 

tetraconazole. M 14360-alcohol (free and conjugated). M 14360-acid. Tclraconazolc 

Livestock M 14360-DFA, M 14360(C-1 )-alcohol (free and conjugated), 

M 14360-hydroxydctriazolyl-O-malonyldiglucoside, and T, TA, 

Tl IP, and T AA and all labile coniu1.?.atcs of these compounds 

tetraconazolc, M 14360-acid, M 14360-DFA, M 14360(C-l )-alcohol 

Rotational Crops (free and conjugated). and TA, Tl-IP, and TAJ\ and all labile 

conjugates of these compounds 

Drinking Water tctraconazolc not aoolicabll: 

1 .. HED concluded that the 1ox1colog1cal effects resulting from exposure to I. TA. TAA. TI IP. and all labile conjugates of these compounds and 

MI 4360(C-1 )-alcohol are difforenl from that resulting from exposure 10 tclraconazolc: HED concluded that the toxicity of the remaining 

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Tetraconazole Scoping Documenr DP# 426702 

metabolites is identical to that oftctraconazolc. For a discussion concerning these conclusions, sec 032175 1 (M. Clock-Rust et al., 26-Jan2007). 

EDWCs: EFED has provided modeled ground water (Screening Concentration In Ground Water 

(SCIGROW); ver. 2.3) and surface water (Pesticide Root Zone Model (PRZM ver. 3.12.2) and Exposure 

Analysis Modeling System (EXAMS ver. 2.98.04.06)) EDWCs for tetraconazole per se (0347805, I. 

Maher, l-Jul-2008). The application scenarios which yielded the highest acute and chronic EDWCs are 

summarized in Table 2 and were incorporated directly into the dietary exposure analysis via the water 

sources direct (all sources) and indirect (all sources) commodities. The water models and their 

description are available at the EPA internet site: http://w,.vw.epa.gov/oppefed l/models/water/. 

Table 2: Summary of Modeled Water Estimates. 

Scenario Tetraconazole oer se Concentration (ug/L: oob) 

Peak Yearly Average 

Minnesota - sugar beets aerial spray (PRZM/EXAMS)1 6.68 4.68 

Georgia - oceans aerial sorav (PRZM/EXAMS)2 10.45 3.48 1 EDWCs assumed 0.87 of the basin cropped (assumes 100% of the crop treated). 2 EDWCs assumed 0.85 to account for percent of basin cropped (assumes 100% of the crop treated). 

Conclusions: As part of registration review, revised EDWCs may be generated using the current 

modeling software. 

3.0 Dietary Exposure 

Dietary Exposure: The most recent acute and chronic dietary exposure analyses were conducted in 

20 11 and considered all currently registered uses (D38 J 9 l 2, T. Bloem, 4-Apr-2011 ). The analyses were 

conducted using DEEM-FCID (ver. 2.03) which incorporated food consumption data from the USDA 

CSFII (1994-1996 and 1998). The unrefined acute analysis (food and water) resulted in exposure 

estimates less than HED's level of concern (S l.8% aPAD; children 1-2 years old were the most highly 

exposed population subgroup). The chronic analysis (food and water) was refined through the 

incorporation of empirical processing factors, average field trial residues, average residues from the 

feeding studies, and projected percent crop treated estimates. The resulting exposure estimates are less 

than HED's level of concern (all exposures were 4.9% cPAD; all infants < I-year old were the most 

highly exposed population subgroup). 

Conclusions: As part of Registration Review, a revised dietary risk assessment may be necessary to 

reflect potential revised EDWCs, the most recent dietary exposure models, and/or revised toxicological 

PO Os. For information concerning exposure to the metabolites of concern that HED has determined to 

be toxicologically different from tctraconazole, see the aggregate section. 

4.0 Residential Exposure 

There are no residential uses proposed or currently registered for tetraconazole. Therefore, residential 

handler and post-application exposure/risk were not assessed. 

Spray Drift and Volatilization: Residential exposures resulting from off-site transport (e.g., spray drift 

or volatili zation) may occur as a result of applications of tetraconazole. The Agency is in the process of 

evaluating these types of exposures and may, as appropriate. develop policies and procedures to identify 

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Tetraconazole Scoping Document DP# 426702 

the need for and, subsequently, the way to incorporate these post-application exposures into the 

Agency's risk assessments. The need for spray drift and volatilization risk assessments for tetraconazole 

will be examined during Registration Review. 

Conclusions: A residential exposure assessment has not been conducted for tetraconazole and therefore 

is not needed to support Registration Review. The need for spray drift and volatilization risk 

assessments for tetraconazole will be examined during Registration Review. 

5.0 Aggregate Risk Assessment 

The most recent aggregate-risk assessment was performed in conjunction with the 2011 HED human 

health risk assessment (Memo, A. Nowotarski et al., I 4-APRIL-2011; 0380618). In this assessment it 

is noted that there are no residential uses for tetraconazole; therefore, only food and water were included 

in aggregate assessments. Since the dietary exposure analysis included the drinking water estimates, the 

discussion and exposure estimates presented represent aggregate acute, chronic, and cancer aggregate 

exposures. All aggregate tetraconazole risk estimates are not of concern to HED. 

Application oftetraconazole also results in exposure to T, TA, TAA, and THP. These compounds are 

considered to be toxicologically different from tetraconazole. HED recently conducted an aggregate risk 

assessment for these compounds with the resulting exposure estimates less than HED's level of concern 

(D426493, T. Morton, 9-Apr-2015). Finally, application oftetraconazole also results in exposure to 

metabolites which HED has determined are toxicologically identical to propiconazole (M 14360-ketone, 

Ml4360-CP(C-l)-alcohol, and Ml4360-(C-l)-alcohol). HED has previously concluded that the 

propiconazole risk assessments, which yielded exposures less than HED's level of concern, did not 

require revision as the residue estimates incorporated into these analysis were protective of the potential 

residues resulting from the application of tetraconazole. 

Conclusions: There is sufficient information available to assess aggregate exposure. However, new 

aggregate risk assessments may be required during Registration Review to incorporate revised dietary 

exposure estimates and/or toxicological PODs. 

6.0 Occupational Exposure 

Occupational handler and post-application exposures are expected based on the registered agricultural 

uses of tetraconazole. The registered end-use products for tetraconazole are all emulsifiable 

concentrates (ECs) and dry flowables. The registered use sites include subgroups I 3-07F and l 3-07G 

(except cranberry), field corn, popcorn, corn grown for seed and soybeans, sugar beets, peanuts and 

pecans (see Table A.3. 1 for details). 

Maximum application rates are 0.08 lb ai/Acre for foliar spray use on soybeans via ground, aerial and 

chemigation equipment; 0.09 lb ai/Acre for foliar spray use on field corn, popcorn and corn grown for 

seed via ground, aerial and chemigation equipment; 0.10 lb ai/ Acre for foliar spray use on sugar beets 

and peanuts via ground, aerial and chemigation equipment; 0.13 lb ai/ Acre for foliar spray use on pecans 

via ground, aerial and chemigation equipment; and 0.04 lb ai/Acre for foliar spray use on crop sub group 

13-07F and 13-07 G (except cranberry) via ground, aerial and chemigation equipment (see Table A.3 .2 

for details). 

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Tetraconazole Scoping Document DP# 426702 

Occupational Handlers: 

Dermal and Inhalation: There is the potential for inJialation and dermal exposure to occupational 

handlers from the currently registered use patterns of tetraconazole. In the most recent exposure 

assessment (Memo, A. Nowotarski, I 4-APRIL-201 1, D380618), all inhalation risks for occupational 

handlers are above the target margin of exposure (MOE) of 300 with baseline protection (i.e., no 

respirator), and all dermal risks for occupational handlers are above the target MOE of l 00 with baseline 

protection or the addition of gloves (required by the label). 

Based on a review of the registered labels for tetraconazole and previous exposure assessments for this 

scoping document, HED has already conducted occupational handler assessments for most of the 

occupational handler scenarios anticipated for the registered uses of tetraconazole. However, the 

scenarios were not assessed based on current ORE policies. An updated assessment will be required 

during Registration Review. 

Occupational Post-Application: 

Dermal: HED expects that post-application dermal exposure will occur since tetraconazole is applied 

post-emergence as a foliar spray. Since no post-application data have been submitted, exposures during 

post-application activities were estimated using default assumptions for percent transferable residue and 

dermal transfer coefficients from HED's Science Advisory Council for Exposure (ExpoSAC) Policy 

Number 3.1 "Agricultural Transfer Coefficients" (August 2000). 

At the time of the assessment, HED determined that short- and intermediate-term risk estimates are not 

of concern (i.e., MO Es 2: I 00) on the day of treatment (i.e., Day 0) for most post-application exposure 

activities. For high contact activities for grapes and for corn, the MO Es are < I 00 on the day of 

treatment. The high contact activities for grapes (girdling, cane tying, and cane turning) are only 

expected to occur for cultivation of table grapes. MO Es are> I 00 on day 7 after treatment. The high 

contact activity for com (detasseling) is only expected to occur for field corn or popcorn grown for seed. 

MO Es are > I 00 on day 20 after treatment. Labels were revised to reflect the appropriate REis. 

Inhalation: There are multiple potential sources of post-application inhalation exposure to individuals 

performing post-application activities in previously treated fields. These potential sources include 

volatilization of pesticides and re-suspension of dusts and/or particulates that contain pesticides. The 

agency sought expert advice and input on issues related to volatilization of pesticides from its Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) in December 

2009, and received the SAP's final report on March 2, 20 I 0 

(http://www.epa.gov/scipoly/SAP/meetings/2009/ 120 I 09meetin!!.html). The agency has evaluated the 

SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization 

Screening Analysis (http://www.regulations.gov/#!docketDetail:D=EPA-HQ-OPP-2014-0219). During 

Registration Review, the agency will utilize this analysis to determine if data (i.e., flux studies, routespecific inhalation toxicological studies) or further analysis is required for tetraconazole. 

In addition, the Agency is continuing to evaluate the available post-application inhalation exposure data 

generated by the Agricultural Reentry Task Force. Given these two efforts, the Agency will continue to 

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Tetraconazole Scoping Document DP# 426702 

identify the need for and, subsequently, the way to incorporate occupational post-application inhalation 

exposure into the agency's risk assessments. 

Conclusions: The occupational exposure database is adequate to support the Registration Review 

process for tetraconazole. The most recent occupational handler did not identify risks of concern, but 

are not reflective of current exposure policies and data. For occupational post-application, MO Es of 

concern were observed. Based on a review of previous assessments and current registered labels, HED 

has already conducted occupational assessments for most of the occupational handler and postapplication scenarios anticipated for the registered uses of tetraconazole. However, during Registration 

Review, updated occupational assessments will be conducted to reflect all currently registered uses, 

using current ORE policies and/or updated toxicological POOs as needed. 

DFR: In accordance with 40 CFR 158, DFR data are required for occupational (e.g., crop, nursery, and 

greenhouse use sites) or residential (e.g., ornamental and vegetable gardens, pick your own farms and 

retail tree farms) uses that could result in post-application exposure to foliage. In the absence of 

chemical-specific DFR data, EPA uses default values. 

Based on a review of the registered uses and maximum application rates, the highest estimated 

occupational post-application exposure using default DFR values for tetraconazole is not minimal in 

comparison to the level of concern (i.e., the calculated MOE is not greater than 2 times higher than the 

level of concern for com, grapes, sugar beets and peanuts (MO Es range from 23 to 160 compared to the 

LOC of 100). Therefore, HEO is recommending that DFR data be required to facilitate any necessary 

exposure assessments refinements. This recommendation was also noted in a response to a DFR data 

waiver request (D4265 l 1 ). 

7.0 Public Health and Pesticide Epidemiology Data 

The Agricultural Health Survey (Al-IS) is a high quality, prospective epidemiology study evaluating the 

link between pesticide use and various health outcomes including cancer. The AHS includes private and 

commercial pesticide applicators and their spouses. If there are AHS findings relevant to a particular 

pesticide going through registration review, the Agency will ensure they are considered in the problem 

formulation/scoping phase of the process and, if appropriate, fully reviewed in the risk assessment phase 

of the process. The AHS includes information on use of 80 different pesticide active ingredients 

commonly used in agriculture. Tetraconazole is not included in the AHS, and therefore this study does 

not provide information for this report. 

The Sentinel Event Notification System for Occupational Risk (SENSOR)-Pesticides database covers 12 

states from 1998-2011, although reporting varies from state to state. Cases of pesticide-related illnesses 

are ascertained from a variety of sources, including: reports from local Poison Control Centers, state 

Department of Labor workers' compensation claims when reported by physicians, reports from State 

Departments of Agriculture, and physician reports to state Departments of Health. Although both 

occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses 

on occupational pesticide incidents, and is of particular value in providing that information. The state 

coordinator at each of the 12 respective state Departments of Health conducts case follow-up activities 

such as obtaining medical records to verify symptoms and severity. Using standardized protocol and 

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Terraconazole Scoping Document DP# 426702 

case definitions derived from poison center reporting, the state SENSOR-Pesticide coordinator enters 

the incident information into the state-based system which is sent to NIOSH annually to be aggregated. 

A review of SENSOR-Pesticides 1998-20 l 1 identifies two cases, stemming from one event, involving 

tetraconazole. The two cases involve multiple active ingredients. These two cases occurred in North 

Carolina in 2010. Both cases were low in severity. The cases were residential bystanders in their home. 

A certified applicator was making an aerial application to soybeans in a nearby field and the product 

drifted to their home; as they were walking outside of the home "the mist hit them as they were running 

out of the way." They both experienced cough/choke and one also had gastrointestinal symptoms. 

Products used in this aerial application include Headline Fungicide, Demark 230 ME Fungicide and 

Declare. The applicator did receive citations for violating FlFRA, including "use not in accordance with 

label, operating unlicensed equipment, the department of pesticides was in a no deposit zone, and 

depositing in a harmful manner." 

8.0 Human Incident Data: OPP IDS (2012) 

OPP's Incident Data System (IDS) includes reports of all eged human hea lth incidents from various 

sources, including mandatory FIFRA Section 6(a)(2) reports from registrants, other federal and state 

health and environmenta l agencies, and individual consumers. 

IDS records incidents in one of two modules: Main IDS and Aggregate IDS: 

o Main IDS contains incidents resulting in higher severity outcomes and provides more 

detail with regard to case specifics. This system stores incident data for death, major and 

moderate incidents, and it includes information about the location, date, and nature of the 

incident. Main IDS incidents involving only one active ingredient (as opposed to 

pesticide products with multiple active ingredients) are considered to provide more 

certain information about the potential effects of exposure from the pesticide. 

o Aggregate IDS contains incidents resulting in less severe human incidents (minor, 

unknown, or no effects outcomes). These are reported by registrants only as counts in 

what are aggregate summaries. 

For the Main IDS, from January I, 20 l 0 to February 4, 20 15, there were no incidents reported involving 

tetraconazole. 

In Aggregate IDS, from January I, 20 I 0 to February 4, 20 15, there were three incidents reported 

involving tetraconazole. These incidents were classified as minor severity. Overall, there are few 

incidents reported to IDS involving tetraconazole. 

Conclusions: Based on the low frequency and severity of incident cases reported for tetraconazole in 

both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time that would warrant 

further investigation. The Agency will continue to monitor the incident information and if a concern is 

triggered, additional analysis will be included in the risk assessment. 

Page 11 of29 
Tetraconazole Scoping Document DP# 426702 

9.0 Tolerance Assessment and International Harmonization 

Attachment 4 is a summary of the Canadian, Mexican, and Codex maximum residue limits (MRLs) for 

residues of tetraconazole. There are no Codex or Mexican MRLs established for residues of 

tetraconazole. The Canadian and U.S. tetraconazole tolerance expressions are identical as are the 

tolerance values for the common crop commodities. However, the livestock tolerance values are not 

harmonized. As part of registration review, HED will reevaluate the Canadian, Mexican, and Codex 

MRLs and harmonize when possible. 

10.0 Environmental Justice 

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

recent tetraconazole 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'." The 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. 

11.0 Cumulative 

Tetraconazole 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 (EPA, 2002). In 

conazoles, however, a variable pattern of toxicological responses is found; some are hepatotoxic and 

hepatocarcinogenic in mice. Some induce thyroid tumors in rats. 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 conazolcs share common 

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

mechanism of toxi city 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/cumulati ve. 

12.0 Human Studies 

Past tetraconazole risk assessments re ly in part on data from studies in which adult human subjects were 

intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such 

studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases 

1 http://www.epa.gov/compliance/environmentaljustice/resources/policy/exec _order_ 12898.pdf 

Page 12 of29 
Tetraconazole Scoping Document DP# 426702 

such as the Pesticide Handlers Exposure Database (PHED), the Outdoor Residential Exposure Task 

Force (ORETF) Database, the AHETF Database, and the ARTF Database. EPA has reviewed all the 

studies supporting these multi-pesticide generic exposure databases, and has found no clear and 

convincing evidence that the conduct of any of them was either fundan1entally unethical or significantly 

deficient relative to the ethical standards prevailing at the time the research was conducted. All 

applicable requirements of EPA's Rule for the Protection of Human Subjects of Research (40 CFR Part 

26) have been satisfied, and there is no regulatory barrier to continued reliance on these studies. 

13.0 Data Requirements Required Under Registration Review 

The following data deficiencies were identified for tetraconazole: 

• Toxicology: None 

• Residue Chemistry: Provided the registered labels are consistent with the labels submitted to 

HED for review and conform to any of the revisions requested by HED, no additional residue 

chemistry data are required. 

• A DFR study is required (OCSPP Guideline # 875.2100). 

In addition, EPA anticipates conducting the following risk assessment updates during Registration 

Review: 

• Toxicology: Reevaluate toxicity endpoint/dose selection, along with the FQPA SF based on 

current HED policy. 

• Dietary Exposure: A revised dietary exposure analysis may be required to refl ect the most recent 

dietary exposure models, potential revised EDWCs, and/or changes to the toxicological PODs. 

• The need for spray drift and volatilization risk assessments for tetraconazole will be examined 

during Registration Review. 

• Aggregate Exposure: Revised aggregate exposure analyses may be required to reflect revised 

dietary exposure estimates and/or changes to the toxicological PODs. 

14.0 References 

Table 3: Memoranda Relevant to Registration Review. 

Author DP# Barcodc/ Date Title TXR # 

HED - Risk Assessment Documents 

M. Clock-Rust Petition Nos: 5F697 I. 6F7084. 6F6023. 9F5066; Tetrnconazole: I lumanet al. D321751 26-Jan-2007 Health Risk Assessment for Proposed Uses on Soybean, Sugar Beet. Peanut. 

Pecan. and Turf. 

Petition Nos: 435873. 436333; Tctraconazole: Human-Health Risk 

A.Nowatarski D380618 14-April-2011 Assessment for Proposed Uses on Small Fruit Vine Climbing Subgroup 13-

07F. Low-Growin.Q Berry Sub_group I 2-07G, and Field Corn and Popcorn. 

HED- Toxicolo2v Documents 

J. Rowland TXR #0056628 02-April-1 3 Tctraconazole: Report of the Cancer Assessment Review Committee 

HED - Residue Chemistry Documents 

W. Donovan D259205 8-May-2000 PP# 7E04830. Tetraconazole use on Bananas. Evaluation of Residue 

Data and Analytical Methods. MRlD#s 442681-06 thru -11. 

Page 13 of29 
Tetraconazo le Scoping Document DP# 426702 

Table 3: Memoranda Relevant to Registration Review. 

Author 

DP# Barcode/ Date Title TXR # 

PP# 9F06023. Tetraconazole use on Peanuts. Evaluation of Residue 

W. Donovan D259321 I 8-May-2000 Data and Analytical Methods. MRJD#s 448654-03, 448654-07, and 

449005-01. 

PP# 9F05066. Tetraconazole use on Sugar Beets. Evaluation of 

W. Donovan D2544 1 I I 8-May-2000 Residue Data and Analytical Methods. MRID#s 44 7513-1 1 thru -18, 

450684-04, and 450684-05. 

PP# 9F05066. Tetraconazole: Additional Data to Amend 1-IED's 

W. Donovan D267481 I 2-0ct-2000 Residue Data and Analytical Methods Memoranda Concerning 

Sugar Beets, Bananas, and Peanuts. 

PP#s 9F05066, 9F06023, and 7E04830. Tetraconazole. Additional 

W. Donovan D278236 22-0ct-2001 Data to Amend HED's Residue Data and Analytical Methods 

Concerning Sugar Beets, Bananas, and Peanuts (D26748 l, W. 

Donovan, 12-0CT-2000 

Correspondence to Mark Wirtz, Chemist Food and Drug 

W. Donovan 0280006 IO-Jan-2002 Administration Division of Pesticides and Industrial Chemicals 

regarding analytical methodology for residues oftetraconazole. 

PP#s 7E04830, 9F05066, and 9F06023. Tetraconazole in/on 

\V. Donovan D280005 I O-Jan-2002 Bananas, Sugar Beets, and Peanuts. Results of Petition Method 

Validation (PMY). 

PP#s 9F05066, 9F06023, and 7E04830. Tetraconazole. 

Amendments d 19-NOY-2001 , 27-DEC-200 1, 08-FEB-2002, and 

W. Donovan D282558 I 7-May-2002 09-APR-2002. Additional Data to Amend HED's Residue Data and 

Analytical Methods Concerning Sugar Beets, Bananas, and Peanuts 

(D278236, W. Donovan, 22-0CT-2001). 

T. Bloem D310763 24-Nov-2004 !Registration 9F5066. Residue Chemistry Summary for Application 

K>f Tetraconazole to Sugarbeet. 

T. Oloem 0332 139 14-Sep-2006 Multiresidue Method (MRM) test information for tetraconazole sent 

to the FDA 

Tetraconazole. Residue Chemistry Summary for Application of 

Tetraconazole to Peanut and Sugar Beet. Petitioner's Response to 

Deficiencies Identified in the Following Memoranda: D25932 l 

T. Bloem D327489 23-Jan-2007 (peanut -, W. Donovan, 18-May-2000); D2544 1 l (sugar beet - W. 

Donovan, 18-May-2000); D26748 l (W. Donovan, 12-0ct-2000); 

D278236 (W. Donovan, 22-0ct-200 I); D282558 (W. Donovan, 17-

May-2002); and D310763 (T. Bloem, 24-Nov-2004). 

T. Bloem 033 1594 23-Jan-2007 Tetraconazole. Residue Chemistry Summary for Application of 

Tetraconazole to Pecan. 

T. Bloem 0329379 23-Jan-2007 Tetraconazole. Section 3 Registration for Application to Soybeans. 

Summary of Analytical Chemistry and Residue Data. 

Tetraconazole. Residue Chemistry Data for Application of 

Tetraconazole to Peanut and Sugar Beet. Petitioner's Response to 

Deficiencies Identified in the Following Memoranda: D25932 l 

T. Bloem 0342523 22-Aug-2007 (peanut -, W. Donovan, 18-May-2000); D2544 I I (sugar beet - W. 

Donovan, 18-May-2000); D267481 (W. Donovan, 12-0ct-2000); 

D278236 (W. Donovan, 22-0ct-200 I); D282558 (W. Donovan, 17-

May-2002); D3 l 0763 (T. Bloem, 24-Nov-2004); and D327489 (T. 

Bloem, 23-Jan-2007). 

Tetraconazole. Special Local Needs (SLN) Section 24(c) 

Registration to Reduce the Plantback Interval (PBI) for Sugarcane 

T. Bloem 034855 1 8-Apr-2008 Following Application ofTetraconazole to Soybean and Label 

Amendment to Reduce the PBI for Sugarcane and Wheat Following 

Aoolication of Tetraconazole to Soybean. 

Page 14 of29 
Tetraconazole Scoping Document DP# 426702 

Table 3: Memora nda Relevant to Rel!istration Review. 

Author 

DP# Barcode/ Date Title TXR # 

Tetraconazole. Review of Information Submitted by the Petitioner 

T. Bloem 0349705 4-/\pr-2008 (8-June-2007) in Response to Residue Chemistry Deficiencies 

Identified in 0329379 (T. Bloem, 23-Jan-2007). Decision Nos.: 

381428 and 389483. 40 CFR 180.557. 

T. Bloem 0353020 26-Jun-2008 Tetraconazole. Residue Chemistry Summary for Application of 

Tetraconazole to Grape. 

Tetraconazole. Review of Grape Fruit Storage Stability Data 

T. Bloem 0384213 I 3-Jan-2011 Submitted in Response to Residue Chemistry Deficiencies Identified 

in 0353020 (T. Bloem, 26-Jun-2008). 

T. Oloem 0386650 14-Apr-2011 Tetraconazole - Enforcement method to FDA 

Tetraconazole. Residue Chemistry Summary for Application of 

T. 131oem 0382300 I 4-Apr-201 1 Tetraconazole to Field Corn, Popcorn, Small Fruit Vine Climbing 

(Except Fuzzy Kiwifruit) Subgroup I 3-07F, and Low-growing Berry 

Subgroup I 3-07G (except cranberry). 

Tetraconazole in/on Field Com, Popcorn, Small Fruit Vine Climbing 

(Except Fuzzy Kiwifruit) Subgroup I 3-07F, and Low-growing Berry 

T. Bloem 0399658 12-Dec-2012 Subgroup 13-07G (except cranberry). Review of Storage Stability 

Data Submitted in Response to Residue Chemistry Deficiencies 

Identified in 0382300 (T. Bloem, 14-Apr-201 1). 

T. Bloem 0416020 l 2-Mar-2014 Tetraconazole in/on Sugar Beets (label amendment). Summary of 

Analytical Chemistry and Residue Data. 

HED - Occuoational-Residential Ex1>osure Documents 

K. Lowe 0426511 21-May- 2015 Tetraconazole. Review of lsagro USA 's Dislodgeable Foliar 

Residue (DFR) Study Waiver Request. 

HED - Human Incident Data 

S. Recore 0427419 2l-May-20 15 Tetracona:zole: Tier I Review of Human Incidents for the Scoping 

Document 

15.0 Attachments 

Attachment I: Tetraconazole and Its Metabolites Chemical Identity Table. 

Attachment 2: Tetraconazole Endpoint Selection and Toxicological Profile Tables 

Attachment 3: Registered End-Use Products and Application Scenarios/Rates (information provided by 

BEAD) 

Attachment 4: IRL Sheet 

cc: A. Dunbar(RABI), T. Bloem (RABI), J. Miller (RABI ) 

ROI: RABI ( I l-MAY-20 15), G. Krarner(I 1-MAY-201 5), T. Morton (I I-MAY-2015) 

A. Dunbar:S I 0952:PY-S:(703)603-06 I I :7509P:RAB I 

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Tetraconazole Scoping Document DP# 426702 

Attachment 1: Tetraconazole and Its Metabolites Chemical Identity Table. 

Table A.1.1 : Test Com ound Nomenclature. 

Chemical Structure Cl 

Common name 

Com an ex crimental name 

IUPAC name 

CAS name 

CAS# 

Table A. 1.2: Physicochemica l Properties of the Technical Grade Tetraconazole. 

Meltina ooint/ranl!e Not aoolicable - test is a viscous liquid 

pH 5.48 in DI I hO 

5.47 for saturated solution at 20°C MRID 44268 104: D259842. 

Density 1.4382 g/ml at 20°C B. Kitchens. I l-Apr-2000. 

1.4252 g/ml at 30°C 

Water solubility (PAI >94. 16%) 159.31 ml!./L at 25°C 

Solvent solubility 

Readily in dichloromethane. acetone. and EPA fact sheet methanol 

0.13 x 102 Pa at 35.5°C MRID 44305301: D259842, Vapor pressure (PAJ >99.65%) 0.58 x 102 Pa at 46.5°C B. Kitchens. I l-Apr-2000. 2.985 x I 02 Pa at 60°C 

Dissociation constant (Ka) 0. 158 - 0.3 16 MRlD 46055603; D294 I 98, 

B. Kitchens. 26-Jan-2004. 

Octanol/water partition coefficient (PAI >99.65%) log Pow = 3.53 at 25°C MRI D 4430530 I: D259842. 

B. K itchcns, 1 l-Apr-2000. 

UV /visible absorotion spectrum not available 

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Tetraconazole Scoping Document DP# 426702 

Attachment 2: Tetraconazole Endpoint Selection and Toxicity Profile Tables for Tetraconazolc 

Technical. 

Table A.2.1. Summary of Toxicological Doses and End points for Tetraconazole for Use in Dietary and NonOccupational Human Healt h Risk Assessments. 

Exposure/ Uncertainty/FQPA RfD, PAD, 

Scenario POD Safety Factors LOC for Risk Study and Toxicological Effects 

Assessment 

/\cute Dietary NOAEL = 50 UFA= IOX aRfD = 0.5 Acute neurotoxicity (rat) 

General mg/kg/day UF11 = !OX mg/kg/day LOAEL = 200 mg/kg/day due to 

Population SFFQPA = IX aPAO = 0.5 decreased motor activity on day 0 

mg/kg/day in both sexes, and clinical signs in 

females including hunched posture, 

decreased defecation, and/or red or 

yellow material on various body 

surfaces. 

Acute Dietary NOAEL = UFA= IOX aRfD = 0.225 Developmental toxicity study (rat) 

Females 13-49 22.5 UF11 = !OX mg/kg/day Developmental LOAEL = I 00 

years of age mg/kg/day SFFQPA = IX aPAD = 0.225 mg/kg/day based on increased 

mg/kg/day incidence of small fetuses, 

supernumerary ribs, and 

hydroureter and hydronephrosis. 

Chronic Dietary NOAEL = UFA= IOX cRfD = 0.0073 Chronic oral toxicity (dog) 

(All 0.73 UF11 = IOX mg/kg/day LOA EL = 2.95/3.33 (M/F) 

Populations) mg/kg/day SFFQPA = IX cPAD = 0.0073 mg/kg/day, based on absolute and 

mg/kg/day relative kidney weights and 

histopathological changes in the 

male kidney. 

Cancer (oral, Classification: "Likely to be Carcinogenic to Humans." Q1 • = 2.3 x I 0·2 (mg/kg/day)' 1 based dermal, 

inhalation) on male mouse liver benign and/or malignant combined tumor rates. 

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. NOA EL = no-observed adverse-effect level. LOAEL = lowest-observed adverse-effect level. 

UF = uncertainty factor. UFA= extrapolation from animal to human (interspecies). UF11 = potential variation in 

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

NOAEL. UFs = use of a short-rerm study for long-term risk assessment. UFoo = to account for the absence of key 

date (i.e., lack ofa critical study). FQPA SF = FQPA Safety Factor. PAO = population-adjusted dose (a = acute, c 

= chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. NIA = not applicable. 

Table A2.2. Summary of Toxicological Doses and Endpoints Tetraconazole for Use in Occupational Human 

Health Risk Assessments. 

Exposure/ POD Uncertainty LOC for Risk Study and Toxicological Effects Scenario Facrors Assessment 

Short-Term ( 1- Oral study UFA = IOX LOC = 100 Reproductive toxicity - rat 

30 days) Dermal Parental NOAEL UF11 = !OX (occupational) Parental LOAEL = 4.915.9 

= 0.7 mg/kg/day mg/kg/day (M/F), based on 

(dermal- increased mortality of adult 

absorption rate = females in the P and F 1 

12%1

) generations. 

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Table A2.2. Summary of Toxicological Doses and Endpoints Tetraconazole for Use in Occupationa l Human 

Health Risk Assessments. 

Exposure/ POD Uncertainty LOC for Risk Study and Toxicological Effects Scenario Factors Assessment 

lntermed iate- Oral study UFA= IOX LOC = 100 Chronic oral toxicity - dog 

Tenn (1-6 NOAEL = 0.73 UFH = IOX (occupational) LOAEL = 2.95/3.33 (M/F) 

months) Dermal mg/kg/day mg/kg/day, based on absolute 

(dermal- and relative kidney weights and 

absorption rate = histopathological changes in the 

12%1

) male kidney. 

Short ( 1-30 Occupational 1.3 UFA = 3X LOC = 300 28-Day Inhalation toxicity-rat 

days) and mg/kg/day; HEC UFH = lOX (occupational) LOAEL = 1.3 mg/kg/day 

Intermediate- = 0.0048 mg/L; UFL = lOX (0.0048 mg/kg/L, 0.0548 mg/L 

tenn (1-6 4.84 mg/m3; (rat)) for males and females, 

months) 0.0548 mg/L (rat) based on squamous cell 

Inhalation metaplasia of laryngeal mucous, 

mononuclear cell in filtration, 

goblet hyperplasia and 

hypertrophy of nasal cavity and 

nasopharyngeal duct and 

follicular hypertrophy of thyroid 

in males. 

*NOAEL not established. 

Cancer (oral, Classification: " Likely to be Carcinogenic to Humans." Q1' = 2.3 x 10-

2 (mg/kg/dayy' based dermal, 

inhalation) on male mouse liver benign and/or malignant combined tumor rates. 

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). UF1. =use ofa LOAEL to extrapolate a NOAEL. UFs =use 

ofa short-term study for long-term risk assessment. UFoe = to account for the absence of key date (i.e., lack ofa 

critical study). MOE = margin of exposure. LOC = level of concern. NIA = not applicable. 1 12% dennal-absorption 

factor - Derived from HIARC report TXR NO. 0052657. 

Table A.2.3. Acute Toxicity Profile - Test Substance. 

Guideline No. Study Type MRID(s) Results Toxicity Category 

870.1100 Acute oral 44268 11 2 LDso = 1031 111 

mg/kg 

870.1200 Acute dermal 44335501 LDso > 2000 111 

mg/kg 

870.1300 Acute inhalation 44305302 LCso > 3.66 mg/L IV 

870.2400 Acute eye irritation 44335502 Slight eye irritant 11 1 

870.2500 Acute dermal irritation 44335503 Not a dermal IV 

irritant 

870.2600 Skin sensitization 44268 11 3 Not a dem1al NA 

sensitizer 

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Table A.2.4. Subchronic, Chronic, and Other Toxicity Profile. 

Guideline Study Type MRJD No. (year)/ Results 

No. Classification/Doses 

870.3 100 28-Day oral 44751304 (1988) NOAEL was not established. 

toxicity (rat) Acceptable/non-guideline LOA EL = 70 mg/kg/day, based on decreased 

0, 70,200,or500 body weight gains in and increased liver 

mg/kg/day via gavage weights both sexes, and increased kidney 

weights in males and ovary weights in fema les. 

870.3 100 28-Day oral 44751305 (1988) NOAEL = not established (M), 3.8 (F) 

toxicity (rat) Acceptable/nongu idel ine mg/kg/day. 

0, 40, 160, 640, 2500 or LOAEL = 4.4/ 15.3 (M/17) mg/kg/day, based on 

10000 ppm increased liver weights. enlarged livers and 

M: 0, 4.4, 17.5, 68.4, 229 enlarged cenrrilobular hepataocytes. 

mg/kg/day; F: 0, 3.8, 

16.1, 62.3, 2 17 mg/kg/day 

870.3100 28-Day oral 44751306 ( 1989) NOAEL = 4.19 mg/kg/day (M). 

toxicity (rat) Acceptable/nonguideline LOA EL was not established. 

0, 2, 5, 15, or 40 ppm 

M: 0, 0.21, 0.52, 1.57, or 

4. 19 mg/kJ:?/day 

870.3 100 90-Day oral 44335504 ( 1988) NOAEL = 4.1 15.5 mg/kg/day (M/F). 

toxicity (rat) Acceptable/guideline LOAEL = 23.9/28.7 (M/F) mg/kg/day, was 

0, I 0, 60, or 360 ppm based upon increased body weight gains in 

M: 0, 0.7, 4.l , or23.9 males, decreased body weight gains in females, 

mg/kg/day increased absolute and liver weights in both 

F: 0, 0.9, 5.5, or 28.7 sexes, enlarged livers in males, enlarged 

mg/kg/day centrilobular hepatocytes in males and females. 

870.3100 90-Day oral 44778701 (1989) NOA EL = 4 mg/kg/day (M/F). 

toxicity (mice) Acceptable/non-guideline LOAEL = 16/20 mg/kg/day, based on single 

0, 5, 25, 125, or 625 ppm liver cell degeneration in males, and increased 

M : 0, 1, 4, 16, or 85 scrum glutamic pyruvic transaminase (SGPT) 

mg/kg/day and serum glutamic oxaloacetic transaminase 

F: 0, I, 4, 20, or 103 (SGOT), decreased BUN levels, increased 

mg/kg/day absolute and relative liver weights and presence 

hepatocellular single cell necrosis in females. 

870.3150 90-Day oral NA1 NA 

toxicity (dog) 

870.3200 2 1-Day dennal 44751307 (1992) Systemic Toxicity 

toxicity (species) Acceptable/guideline NOAEL = 241 (ai) mg ai/kg/day. 

0,250, 100,or2000 LOAEL was not established. 

(formulation) mg/kg/day Dermal Toxicity 

Actual ai 0, 30. 1, 120.4, NOAEL = not established. 

or 24 1 mg/kg/day LOA EL = 30 (ai) mg/kg/day, based on dermal 

irritation. 

870.3465 90-Day inhalation 46990301 (2006) NOA EL = not established. 

toxicity (rat) Acceptable/non-guideline LOAEL = 0.0548 mg/L (14.3 mg/kg/day) for 

0, 0.0548, 0. 159, or 0.520 males and females, based on squamous cell 

mg/L metaplasia of laryngeal mucosa, mononuclear 

(0, 14.3,43.15,or 141.15 cell infiltration, goblet hyperplasia and 

mg/kg/day) hypertrophy of nasal cavity and nasopharyngeal 

duct and fo ll icular hypertrophy of thyroid in 

males. 

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Tetraconazole Scoping Document DP# 426702 

Table A.2.4. Subchronic, Chronic, and Other Toxicity Profile. 

Guideline Study Type MRID No. (year)/ Results 

No. Classification/Doses 

870.3700a Prenatal 44335505 (1990) Maternal NOA EL = 22.5 mg/kg/day. 

developmental in Acceptable/guideline LOA EL = 100 mg/kg/day, based on decreased 

(rat) F: 0, 5, 22.5, or I 00 body weight gain, and food consumption and 

mg/kg/day (GD 2-15) increased water intake, and increased liver and 

kidney weights. 

Developmental NOAEL = 22.5 mg/kg/day. 

LOA EL= I 00 mg/kg/day, based on increased 

incidence of small fetuses, supranumerary ribs 

and hydroureter and hvdroneohrosis. 

870.3700b Prenatal 44335506 ( 1990) Maternal NOAEL = 15 mg/kg/day. 

developmental in Acceptable/guideline LOA EL= 30 mg/kg/day, based upon decreased 

(rabbit) F: 0, 7.5, 15, or 30 body weight gain. Developmental NOAEL = 

mg/kg/day 30 mg/kg/day. 

LOAEL was not established. 

870.3800 Reproduction and 44305306 (1991) Parental/Systemic NOAEL = 0.7/0.8 mg/kg/day 

fertility effects Acceptable/guideline (M/F). 

(rat) 0, I 0, 70, and 490 ppm Parental LOAEL = 4.915.9 mg/kg/day (M/F), 

M: 0, 0.7, 4.9, and 35.5 based on increased mortality of adult fema les in 

mg/kg/day the P and F 1 generations. 

F: 0, 0.8, 5.9, and 40.6 Reproductive NOA EL = 35.5/40.6 mg/kg/day 

mg/kg/day (M/ F). 

LOAEL = Not established. 

Offspring NOAEL = 4.915.9 mg/kg/day. 

LOAEL = 35.5/40.6 mg/kg/day (M/F), based 

on decreased litter weight and mean pup weight 

in litters of all generations before weaning and 

increased relative liver weights at weaning in 

both sexes of all litters. 

870.4 lOOb Chronic toxicity 44305303 ( 1990) NOA EL= 0.73/0.82 (M/F) mg/kg/day. 

(dog) Acceptable/guideline LOAEL = 2.95/3.33 (M/F), based upon 

M & F: 0, 22.5, 90, or 360 increased absolute and relative kidney weights 

ppm. and histopathological changes in the male 

M: 0, 0.73, 2.95, or 12.97 kidney. 

mg/kg/day At the high dose of 12.97 mg/kg/day, liver 

F: 0, 0.82, 3.33, or 14.5 effects were observed including increased 

mg/kg/day serum levels of alkaline phosphatase, yglutamyltransferase, alanine aminotransferase 

and ornithine carbamoyl transferase in both 

sexes from study week 13 to 52, increased 

absolute and relative liver and kidney weights 

for both sexes, and histopathological changes in 

both organs. 

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Tetraconazole Scoping Document DP# 426702 

Table A.2.4. Subchronic, C hronic, a nd Other Toxicity Profile. 

Guideline Srudy Type MRID No. (year)/ Results 

No. Classi Ii cation/Doses 

870.4200 Carcinogenicity 44305304 (1992) NOAEL = 3.4/4.4 mg/kg/day (M/F). 

(rat) Acceptable/guideline LOAEL = 27.7/39.4 (M/F), based upon 

M:O, 10, 80,640,or 1280 histopathology of the bone (osseous 

ppm hypertrophy of the cranium/parietal bone), pale 

F: 0, 10, 80, 640 ppm and thickened incisors, and decreased absolute 

M: 0, 0.4, 3.4, 27.7, or 59 and relative adrenal and pituitary weights in 

mg/kg/day males; decreased body \Veight (at tenninal 

F: 0, 0.6, 4.4, or 39.4 sacrifice) in females. 

mg/kg/day Dosing was considered adequate. 

No treatment-related increases in tumor 

incidence were observed. 

870.4300 Carcinogenicity 44305305 ( 1998) NOAEL = 1.4/ 1.6 (M/F) mg/kg/day. 

(mouse) Acceptable/guideline LOAEL = 12/ 14.5 (M/F), based upon increased 

0, 10,90,800,or 1250 liver weights and hepatocellular vacuolization 

ppm M: 0, 1.4, 12, 118, or in both sexes and increased kidney weights in 

217 mg/kg/day males. 

F: 0, 1.6, 14.8, 140, or Dosing was considered adequate based on 

224 mg/kg/day above findings. Treatment-related increased 

incidence of combined benign and malignant 

liver tumors in both sexes. 

870.5265 Gene Mutation 443355 11 ( 1987) Cytotoxicity was evident for the majority of 

Acceptable/guideline strains at ?: 1000 μg/p late -S9 and at 2000 

125-2000 μg/plate ± S9 μg/plate +S9. There was no evidence of 

activation. induced mutant colonies over background. 

870.5300 Forward gene 44335508 ( 1988) Cytotoxicity was observed in all trials at ?: I 00 

mutation assay in Acceptable/guideline μg/mL +/-S9. There was no indication that M 

mammalian cells 5-125 μg/mL ± S9 14360 induced a mutagenic response, either in 

activation. the presence of absence of S9 activation. 

870.5375 Cytogenetics 44335507 ( 1989) Cytotoxicity was observed at ?:31.3 μg/mL -S9 

Acceptable/guideline (6-hr. treatment and 24-hr. cell harvest or 24 

0.5-250 μg/mL ± S9 hours of continuous treatment before 

activation. sampling); 2: 15 ~1 g/mL-S9 (48 hrs of 

continuous treatment before sampling) and at 

2: 15.6 ~tg/mL +S9 (6-hr. treatment and a 24-hr. 

cell harvest). Not clastogenic with or without 

S9 activation, at any dose tested. 

870.5395 in vivo 44335507 ( 1989) Cytotoxicity was observed at 2:31.J ~tg/mL -S9 

mammalian Acceptable/guideline (6-hr. treatment and 24-hr. cell harvest or 24 

cytogenetic assay 0.5-250 μg/mL ± S9 hours of continuous treatment before 

activation. sampling); 2: 15 ~t g/mL -S9 (48 hrs of 

continuous treatment before sampling) and at 

2: 15.6 μg/mL +S9 (6-hr. treatment and a 24-hr. 

cell harvest). Not c lastogenic with or without 

S9 activation, at any dose tested. 

870.5550 UDS synthesis in 44335510 ( 1989) Cytotoxicity was evident in all trials at 2:64 

mammalian cell Acceptable/guideline ~t g/mL +/-S9. The positive controls induced 

culture 0.25-512 μg/mL ± S9 significant and dose-related increases in UDS. 

activation No evidence of genotoxic effect under any test 

condition. 

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Tetraconazole Scoping Document DP# 426702 

Table A.2.4. Subchronic, Chronic, and Ot her Toxicity Profile. 

Guideline Study Type MRJD No. (year)/ Results 

No. Classification/Doses 

870.6200a Acute 4804940 I (20 I 0) NOAEL = 50 mg/kg/day. 

neurotoxicity Acceptable/guideline LOAEL = 200 mg/kg/day due to decreased 

screening battery 0, 50, 200, or800 motor activity on day 0 in both sexes, and 

mg/kg/day clinical signs in females including hunched 

posture, decreased defecation, and/or red or 

yellow material on various body surfaces. 

870.6200b Subchronic 48049402 (20 I 0) Systemic NOAEL = 120 ppm (8.7/9.5 

neurotoxicity Acceptable/guideline mg/kg/day [M/F]). 

screening battery 0, 40, 120 and 640 ppm Systemic LOAEL = 640 ppm (45.9/50.7 

(0, 2.89/3 .13' 8.6919 .46, mg/kg/day [M/F]) based on absolute decreased 

or 45.92/50.67 mg/kg/day body weights in females. 

[M/F]) The neurotoxicity NOAEL is 640 ppm 

(45.9/50.7 mg/kg/day (M/F]). The 

neurotoxicity LOAEL was not observed. 

870.7485 Metabolism and 44305307 ( 1993) About 92.0-100. 7% of the administered dose 

pharrnacokinetics Acceptable/guideline was recovered in urine, feces. and tissues 

(rat) M & F: ~C within 72 hours of dosing. Absorption of 

phenyl]tetraconazole or [ 1'

1

C]tetraconazole from the G. I. tract of rats 

[ •~c-triazo le ]tetraconazole was evident in both low- and high-dose animals 

were given single gavage based on the high level of urinary excretion, 

dose of 5 or 60 mg/kg. which ranged from 50.7-71.0% by48 hours 

post-dose. Only minor differences were noted 

in the pattern of excretion between the sexes, 

labels, and dose levels. About 3-6% of the 

dose was recovered in the carcass/tissues. 

Differences were noted maximum blood 

concentrations between the doses, sexes, and 

label. No differences were noted in the halflife. 

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Tetraconazole Scoping Document DP# 426702 

Table A.2.4. Subchronic, Chronic, and Other Toxicity Profile. 

Guideline Study Type MR1D No. (year)/ Results 

No. Classification/Doses 

870.7485 Metabolism and 45068403 ( 1992) Total recovery of radioactivity ranged from 

pharmacokinetics Acceptable/guideline for 95% to I 02% of the administered dose. Most 

(rat) excretion, distribution and of the dose (75%) was recovered in the urine 

metabolic identification after 7 days. Feces accounted for 15 to 18% of 

portion of the study. the administered dose. Triazole was the major 

Single oral doses of ~C] metabolite identified in the urine and feces. In 

triazole ring labeled M- the urine M-14360 acid along with minor 

14360 administered at metabolite of M-14360 alcohol and its 

dose levels of 5 or 60 glucuronide conjugate (M3) were isolated. In 

mg/kg, urine and feces the feces, minor amounts of parent M-14360, 

were collected from five the acid, and alcohol were isolated. Data 

rats/sex/dose for 168 suggest M- 14360 or its metabolites do not 

hours at which time these accumulate in the tissues following single oral 

animals were killed and administration. 95-98% of the urinary and 

their tissues and organs fecal metabolites were identified. There is a 

were harvested. The qualitative and quantitative difference in the 

remaining five metabolites in the males and females and the 

animals/sex/group were dose levels. Male rats produced more triazole 

killed at peak blood levels than females (65-67% of the administered dose 

of radioactivity occurring (AD) vs. 48% in females) in the urine, while 

at 8-28 hours of post urine of females had more of M-14360 acid. 

dosing and their tissues The same pattern was also seen in the multiple 

and organs were dosing studies, although the differences were 

harvested. Radioactivity not pronounced. In the multiple dosing studies, 

was measured in urine, triazole (3.2-3.9% of the AD for males and 

feces, blood, tissues, females at the low dose vs. 6.5-6.8% for the 

organs, carcasses and cage high dose), M-14360 acid, M-14360 alcohol, 

washes from all animals. M-14360, M6 and others were reported while 

in the single dosing only triazole (5.6-10.4% of 

the administered low and high doses in both 

sexes), M-14360 acid and M-14360 were 

reported. Based on the results, the study 

authors postulated that cleavage of M-14360 to 

yield triazole appears to be a major step 

through glutathione mediated path. A 

metabolic pathway was proposed where the 

initial step is the formation of an aldehyde 

intermediate of M-14360 following 

dealkylation of the fluoro-alkyl group of the 

molecule. 

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Tetraconazole Scoping Document DP# 426702 

Table A.2.4. Subchronic, Chronic, and Other Toxicity Profile. 

Guideline Study Type MRID No. (year)/ Results 

No. Classi ti cation/Doses 

870.7485 Metabolism and 44268114 ( 1990) Total recovered radioactivity ranged from 99% 

pharmacokinetics Acceptable/guideline for to I 14% for the phenyl label and 96% to I 09% 

(rat) single dose excretion and for the triazole label of the AD. Most of the 

distribution. radioactivity was recovered in the urine, 

Single oral doses of 14C- particularly the triazole label. In the triazole 

Tetraconazole phenyl study, males excreted the radiolabel into the 

labeled or triazole ring urine more and faster than in the females. 

labeled were administered Compared to the phenyl label, more of the 

at dose levels of 5 or 60 triazole label was excreted at both doses in the 

mg/kg, urine, feces and urine. Radioactivity in the tissues was minimal 

expired air were collected and accounted for less than I% in the phenyl 

for 168 hours and label. For the rriazole label 0.9% to 1.4% 

radioactivity in blood, radioactivity was recovered in tissues. In the 

tissues, organs, carcass feces, more phenyl label (21-32%) than in the 

and cage washes were triazole label ( 12-16% of the AD) radioactivity 

detennined. was excreted. Male rats generally excreted the 

radiolabel into the feces faster than in the 

females for both labels. 

870.7485 Metabolism and 44268119 (1994) The test material was readily absorbed and 

pharmacokinetics Acceptable/guideline for distributed in the body within 8 hours after 

(rat) excretion and distribution dosing and about 100.9 ± 4.0% of the 

oftriazole labeled M- administered dose was recovered. Urine was 

14360 following repeated the major route of excretion accounting for 

oral administration. nearly 87% of the AD after 7 days of exposure. 

Groups of rats received Most of the urinary radioactivity was excreted 

single oral dose of non- during the first 48 hours. Fecal elimination of 

radiolabeled M 14360 at 5 the radioactivity was the next major route 

or 60 mg/kg for 14 days accounting for 12-16% of the AD after 7 days 

followed by single oral of exposure. Less than I% of the AD was 

dose of[ 14C] triazole ring recovered in tissues. Sex has no effect on 

labeled M 41360; animals excretion and distribution. 

were placed metabolism 

cages where urine and 

feces were collected and 

radioactivity in blood, 

tissues, organs, carcass 

and cage washes were 

detennined upon sacrifice. 

870.7800 lmmunotoxicity 48439401 (2011) Systemic NOAEL = 125 ppm (10 mg/kg/day). 

Acceptable/guideline Systemic LOA EL = 1000 ppm (82 f/AFC 

0, 20, 125, I 000 ppm groups and 77 f/NK groups) based upon 

(0, 2/2, IO/ I 0, 82177 decreased mean body weight and food 

[AFC Group/ NK Group], consumption. 

[F]) lmmunotoxicity NOAEL = 1000 ppm (82 

f/AFC groups and 77 FINK groups). 

lmmunotoxicity LOAEL was not established. 

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Tetraconazole Scoping Document DP# 426702 

Table A.2.4. Subchronic, Chronic, and Other Toxicity Profil e. 

Guideline Study Type MRID No. (year)/ Results 

No. Classification/ Doses 

Non- Liver enzyme 4475 1310 ( 1998) Dietary administration oftetraconazole for 4 

guideline- induction Acccptable/nonguideline weeks results in liver enzyme induction at dose 

rats In dietatdosesofO, 10, levels of 80 and 640 ppm. Induction at the 

80, 640 ppm; the positive 640-ppm dose level was similar to that induced 

control was Phenobarbital by phenobarbital at 75 mg/kg/day. 

(Na) salt, 75 mg/kg/day 

for 4 weeks. 

Non- Liver enzyme 44751309 (1996) Tetraconazole administration for 4 weeks 

guideline - induction Acceptable/nonguideline results in liver enzyme induction. At doses 2'. 

rats In diet at doses ofO, 20, 20 ppm in females an apparent increases in 

800, 1250 ppm in the diet; microsomal protein, cytochrome P450, and 

the positive control was ethylmorphine N-demethylase were observed. 

Phenobarbital (Na) salt, At all dose levels in males and females, 7-

75 mg/kg/day for 4 pentoxyresorufin 0-depentylase values were 

weeks. statistically elevated. At 800 and 1250 ppm, 

statistically significant findings were typically 

noted. However, dose-response increases were 

not apparent in these findings at the 1250 ppm 

level as compared to the lower 800 ppm leve l. 

Non- In Vivo 28-Day 4893040 I (20 12) NOAEL = 69 mg/kg/day. 

guideline - Mode of Action Acceptable/nonguidline LOAEL = 132.6 mg/kg/day based upon 

111 ice Study (mouse) 0, 90, 400, or 800 ppm (0, increased cell proliferation in the liver. 

14.1-17.2, 57.6-78.4, and 

I 14.2-158.9 mg/kg 

bw/day [Ml) 

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Terraconazole Scopin!!. Document DP/1 426702 

Attachment 3: Registered End-Use Products and Application Scenarios/Rates (information provided by BEAD) 

Table A.3.I: Summary of End-Use Products. 

Product Type Trade Names (EPA Reg. No.) Tetraconazole Use Sites Application Type: REI Target 

Concentration Equipment Pests 

EC Affiance® (I 0163-332) 0.667 lbs ai/iaal 

micro-emulsion Zolera with aBpro (66330-422) I. 75 lbs ai/eal field com. popcorn. com foliar spray: 12 hours for all activities with the exception of20 days for 

EC Tetraconazole 210 ME (80829-20) I. 75 lbs ail gal grown for seed, soybean ground/acrial/chcmigation detasscling corn grown for seed 

EC Do mark® 230M E (80289-7) I. 9 I bs ai/gal 

EC Eminent® 125 SL (60063-12) I lb ai/gal sugar beet. peanut. pecan fo liar spray 12 hours EC Eminent® ESP (80829- 18) I lb ai/izal ground/aerial/chcmigation fungus 

EC Priaxor® D (7969-361) 1.9 lbs ai/gal soybean foliar spray: ground/aerial 12 hours 

EC Menlc® 125 ME (80289-8) I lb ai/gal subgroups I 3-07F and foliar spray; 12 hours for all activities with the exception of7 days for 

13-07G (except cranberry) 1?.round/aerial/chemigation table !!.rape activities of airding. cane tying. and cane tuminl! 

nowable Minerva DuoTM (83070- 11 ) 0. 73 lb ai/gal pecan and sugar beet foliar spray: ground/aerial 48 hours concentrate 

Table A.3.2: Summary of Ap plication Scenario. 

Formulation App. Rate Max. Seasonal 

App. Type/Timing App. Rate (lb Use Directions and Limitations (EPA Reg. No.) (lb ai/acre) ai/acrc) 

soybean 

REI = 12 hours: RT12=not specified (app. for control of soybean rust) to 7-21 days; Pl-ll1 = 

EC (10163-332: 80829-20: 80289-7; 7969-361); foliar spray/up to R5 1 0.05-0.08 0.12-0. 15 not specified to 14 or 21 days; maximum of2-3 applications per season: do not graze/feed 

micro-emulsion (66330-422) soybean foragen1ay 10 livestock; do not use on soybean varieties harvested for the immature 

pod 

field com. popcorn, com grown for seed 

EC ( l 0163-332: 80829-20: 80289-7): REI = 12 hours for all activities with the exception of20 days for detasseling com grown for 

micro-emulsion (66330-422) foliar spray/up to R3 0.05-0.09 0.09 seed; RTI = not specified to 7 days; Pf-Ill = not specified to 7 days (2 1 days for si lage); 

maximum of2 applications per season 

sugar beet 

EC (60063-12: 80829-18) foliar spray/not specified 0.06-0. 10 0.10 REI = 12 hours: PHI = 14 days; maximum of I application per season nowablc concentrate (83070-1 1) 

Peanut 

EC (60063-1 2: 80829-18) foliar spray/not specified 0.06-0. 10 0.4 1

4 REI= 12 hours: RTI = 14 days; PH I= 14 days (do not apply within 14 days of digging); 

maximum of 4 application per season; do not feed peanut hay to livestock 

Pecan 

EC (60063-12; 80829-18) fol iar spray/various 0.05-0. 13 0.50 REI= 12 hours; RTI = 14 days; Pl-I I= 30 days: maximum of 4 application per season nowable concentrate (83070-11 ) 

13-07F 

EC (80829-8) foliar spray/various 0.02-0.04 0.08 REI = 12 hours for all activities with the exception of7 days for table grape activities of 

Page 26 of29 
Tetraconazo le Scopin ~ Document DP# 426702 

Table A.3.2: Summa ry of Application Scena rio. 

Fonnulation /\pp. Rate Max. Seasonal 

(EP/\ Reg. No.) App. Typeffiming (lb ai/acre) App. Rate (lb Use Directions and Limitations 

ai/acre) 

girdling, cane tying and cane tuming: RTI = 10-21 days; PHI = 14 days; maximum of 3 

applications per season 

I 3-07G (except cranberry) 

REI = 12 hours for all activities with the exception of 7 days for table grape activities of 

EC (80829-8) foliar spray/various 0.02-0.04 0.16 girdling. cane tying and cane turning; RTI = 14-2 1 days: Pl II = 0 days: maximum of 4 

applications per season 1 All labels, excluding the Priaxor® D (7969-36 1) label, prohibit application after the R5 crop stage; a revised Priaxor® D label prohibiting application after the R5 crop stage is 

requested. Only the Priaxor® D (7969-361: 21 days) and Affiance® {l0163-332: 14 days) labels specify a PHI. 2 Based on the available fi eld trail data, revised labels specifying a minimum retreatmcnt interval of I 0 days arc requested (0329379. T. Bloem, 23-Jan-2007; 4682620 I .der). 3 Only the Affiance® (10163-332) label specifics a PHI: all labels prohibit application after the R3 crop stage. 

~ ll1c Eminent® ESP (80829-18) label needs to be revised to specify a maximum seasonal application rate of 0.41 lb ai/acre rather than 0.81 2 lb ai/acrc. 

Page 27 of 29 
Tetraconazole Scoping Document DP# 426702 

Attachment 4: IRL Sheet 

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition: 

us Canada Mexico' Codex 

40 CFR I 80.557(a): tctraconazolc ( l-[2-(2,4- l-[2-(2,4-dichlorophenyl)-3-( I, 1,2,2- -- None 

dichlorophenyl)-3-( 1, 1,2,2- tctrafluoroethyoxy)propyl]-1 H-1,2,4-triazole 

tetrafluorocthoxy)propyl]-1 H-1 ,2,4-triazole) 

Tolerance (pom) /Maximum Residue limit (m1;lk?.) 

Commodity us Canada Mexico ' Codex 

Aspirated grain fractions 1.0 -- -- -- Beet sugar, dried pulp 0. 15 -- -- -- Beet sugar, molasses 0. 15 0. 15 -- -- C3eet sugar, root 0.05 0.05 -- -- Cattle. fat 0. 15 0.02 -- -- Cattle, liver 1.5 0.05 -- -- Cattle. meat 0.01 0.02 -- -- Cattle. meat byproducts (except liver) 0. 15 0.02; 0.02 kidney -- -- Com. field. forage I.I -- -- -- Com. fi eld, grain 0.0 1 -- -- -- Com, field, stover 1.7 -- -- -- Com. pop, grain 0.01 -- -- -- Corn, pop, stover 1.7 -- -- -- Eggs 0.02 -- -- -- Goat, fat 0. 15 0.02 -- -- Goat. liver 1.5 0.05 -- -- Goat. meat 0.01 0.02 -- -- Goat, meat byproducts (except liver) 0. 15 0.02; 0.02 kidney -- -- I log. fat 0.01 0.02 -- -- Hog, liver 0.05 0.05 -- -- Hog, meat 0.0 1 0.02 -- -- Hog. meat byproducts (except liver) 0.01 0.02; 0.02 kidney -- -- Horse, fat 0.15 0.02 -- -- Horse. liver 1.5 0.05 -- -- I lorse. meat 0.01 0.02 -- -- I lorse. meat byproducts (except liver) 0. 15 0.02; 0.02 kidney -- -- Low growing berry subgroup I 3-07G, 0.25 bearberries, bilberries, lowbush blueberries, 

except cranberry 0.25 cloudberries, cranberries, lingonberries, -- -- muntrics, partridgeberries, strawberries 

Milk 0.03 0.01 -- -- Milk. fat 0.75 -- -- -- Peanut 0.o3 -- -- -- Peanut. oil 0. 10 -- -- -- Pecan 0.04 -- -- -- Poultry. fat 0.05 -- -- -- Poultry. meat 0.01 -- -- -- Poultry meat byproducts 0.05 -- -- -- Sheep, fat 0. 15 0.02 -- -- Sheep. liver 1.5 0.05 -- -- Sheep, meat 0.0 1 0.02 -- -- Sheep, meat byproducts (except liver) 0. 15 0.02; 0.02 kidney -- -- Small fruit vine climbing. except fu zzy 0.2 0.2 amur river grapes, gooseberries, grapes, 

kiwifruit. subgroup I 3-07F hardy kiwifruit, maypop, schisandra berries -- --

Soybean, refined oil 0.80 -- -- -- Soybean, seed 0. 15 -- -- --

Page 28 of29 
Tetraconazole Scoping Document DP# 426702 

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition: 

us I Canada I Mexico• I Codex 

Completed: M. Negussie; 06/ 11 /15 1 Mexico adopts US tolerances and/or Codex MRLs for its export purposes. 

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