Trinexapac-ethyl Dietary Exposure Assessment DP Barcode: 394830 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND

 POLLUTION PREVENTION

MEMORANDUM

DATE: September 13, 2011

SUBJECT: Trinexapac-ethyl: Acute and Chronic Dietary Exposure and Risk 

Assessment for the Proposed Uses on Cereal Grains, Sugarcane 

and Grasses Grown for Seed. 

PC Code: 112602 DP Barcode: D394830

Decision No.: 432768 and 

433096

Registration No.: 100-727, 100-

949, and 100-1241

Petition No.: 0F7719 and 

0F7720

Regulatory Action: Section 3 

First Food Use Registration

Risk Assessment Type: 

Dietary

Case No.: NA

TXR No.: NA CAS No.: 95266-40-3

MRID No.: NA 40 CFR: NA

FROM: Sheila Piper, Chemist

Risk Assessment Branch VI

Health Effects Division (7509P)

THROUGH: Douglas Dotson, Ph.D., Chemist

Julie Van Alstine, MPH, Environmental Health Scientist

Dietary Exposure SAC (7509P)

and

Felecia Fort, Branch Chief

Risk Assessment Branch VI

Health Effects Division (7509P)

TO: Bethany Benbow, Risk Manager Reviewer

Kathryn Montague, Risk Manager

Herbicide Branch

Registration Division (7505P)
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Executive Summary

At the request of the Registration Division, an acute and chronic dietary risk assessment

for trinexapac-ethyl was conducted using the Dietary Exposure Evaluation Model 

(DEEM-FCIDTM, Version 2.03). The analyses were performed to support petitions

(PP#0F7719 and 0F7720) for the establishment of tolerances including free and 

conjugated residues of both the parent and its acid metabolite, trinexapac. These analyses 

were performed to estimate acute and chronic dietary (food and drinking water) risk 

resulting from use of trinexapac-ethyl on cereal grains, sugarcane, and grasses grown for 

seed. 

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization

An unrefined, acute dietary exposure assessment using the recommended tolerance levels

and assuming 100% crop treated (CT) for the proposed commodities was conducted for the 

general U.S. population and various population subgroups. The estimated drinking water 

concentration (EDWC) of trinexapac-ethyl was provided by the Environmental Fate and 

Effects Division (EFED) and incorporated directly into the acute assessment. The drinking 

water estimate was based on the use of trinexapac-ethyl on sugarcane in LA. The acute 

drinking water concentration in surface water is 10.92 ppb.

For food and drinking water, the acute dietary risk estimate is below HED’s level of 

concern (<100% of the acute population adjusted dose (aPAD)) at the 95

th percentile of 

exposure. The acute dietary exposure was estimated for females 13-49 years old only,

since an acute endpoint of concern was not identified for the general U.S. population. 

The acute dietary exposure estimate for females 13-49 years old is 0.014310 mg/kg/day 

(2% of the aPAD). 

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

The chronic dietary exposure and risk estimates are conservative since they assume that 

100% of crops are treated and that the residues are present at the recommended tolerance 

levels. The chronic surface water EDWC for trinexapac-ethyl is 0.98ppb. Combined 

chronic dietary exposure estimates for food and drinking water are well below HED’s level 

of concern. Using the DEEM-FCID software, dietary exposure is estimated at 

0.007871mg/kg/day for the general U.S. population, which is equivalent to 2.5% of the 

chronic Population Adjusted Dose (cPAD), and 0.019478 mg/kg/day, equivalent to 6% of 

the cPAD for children 1-2 years old, the population subgroup with the highest estimated 

chronic dietary exposure to trinexapac-ethyl. 

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

Trinexapac-ethyl is classified as a “not likely to be carcinogenic to humans.” Therefore, 

a cancer dietary exposure analysis is not required. 
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I. Introduction

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

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

acceptable dose. This is the population adjusted dose (PAD), which HED has concluded 

will result in no unreasonable adverse health effects. The PAD is the Reference Dose 

(RfD) divided by the FQPA Safety Factor. Dietary risk is expressed as a percentage of 

the PAD. For acute and non-cancer chronic exposures, HED is concerned when 

estimated dietary risk exceeds 100% of the PAD. References which discuss the acute and 

chronic risk assessments in more detail are available on the EPA/pesticides web site: 

“Available Information on Assessing Exposure from Pesticides, A User’s Guide”, 

6/21/2000, web link: 

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

(8/20/99).

This is the first dietary assessment conducted for trinexapac-ethyl.

II. Residue Information

Trinexapac-ethyl is a new unclassified plant growth regulator being proposed by 

Syngenta Crop Protection for use on grasses grown for seed, cereal grain and sugarcane

throughout the U.S. Trinexapac-ethyl inhibits internodal elongation and growth in cereal 

grains, grasses and several dicotyledonous species. It is registered in numerous European 

countries and several Asian and Latin American countries for use on cereal grains and 

sugarcane. In the U.S., trinexapac-ethyl (1 and 2 lb/gal EC formulations) are currently 

registered for use on perennial ryegrass grown for seed in Idaho, Oregon and 

Washington. No tolerances have been established for trinexapac-ethyl residues on any 

food or feed commodities. 

The nature of trinexapac-ethyl residues in grass, cereal grain, and sugarcane commodities 

and ruminants is understood based on the available grass, rice, poultry and goat

metabolism studies. The residues of concern in plants and livestock for tolerance 

enforcement and risk assessment purposes include free and conjugated residues of both 

parent and its acid metabolite, trinexapac (Residues of Concern Knowledgebase 

Subcommittee (ROCKS), D390121, 7/12/11).

The proposed use directions would allow for a single or split application of trinexapacethyl to grasses grown for seed during stem elongation and floral development, at a 

maximum rate of 0.5 lb ai/A, a 35-day preharvest interval (PHI) for mature grass, and a 

49-day PHI for regrowth of forage and hay following harvest. Syngenta has also 

proposed label amendments and tolerances for the use of the 1 and 2 lb/gal EC products 

to include cereal grains (barley, oats, triticale, and wheat) and sugarcane. A maximum 

seasonal rate of 0.11 lb ai/A and a 45-day PHI for cereal grains and a maximum seasonal 

rate of 0.31 lb ai/A and a 28-day PHI for sugarcane are proposed
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Table 1: Tolerance Summary for Trinexapac-ethyl.

Commodity Recommended Tolerance

(ppm)

Comments

Cattle, fat 0.02

Cattle, meat 0.02

Cattle, meat byproducts 0.04 Based on highest residue in 

cattle kidney

Cattle, kidney Not needed Based on the recommended 

tolerance for “cattle, meat 

byproducts” an individual 

tolerance for kidney is not 

needed.

Goat, fat 0.02

Goat, meat 0.02

Goat, meat byproducts 0.04 Based on highest residue in 

cattle kidney

Hog, fat 0.02

Hog, meat 0.02

Hog, meat byproducts 0.03

Horse, fat 0.02

Horse, meat 0.02

Horse, meat byproducts 0.04 Based on highest residue in 

cattle kidney

Sheep, fat 0.02

Sheep, meat 0.02

Sheep, meat byproducts 0.04 Based on highest residue in 

cattle kidney

Barley, grain 2.0 Data translated from wheat 

grain

Barley bran 2.5

Oat, grain 4.0 Data translated from wheat 

grain

Sugarcane, cane 0.8

Sugarcane, molasses 2.5

Wheat, grain 4.0

Wheat bran 6.0

Wheat middling 10.5

III. Drinking Water Data

References: Tier II Drinking Water Assessment for the First Food Use Registration of 

Trinexapac-Ethyl on Cereals (Wheat, Barley, Oats) and Sugarcane; D377936; 

Christopher Koper; 09/09/2011.
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A Tier II screening-level drinking water assessment was conducted to support the human 

health risk assessment for the proposed first food use registration for trinexapac-ethyl. 

Modeled application rates represent the maximum application rates from the proposed 

labels (Palisade® EC, EPA Reg. No. 100-949 and Palisade® 2EC EPA Reg. No. 100-

1241) for use on cereals (wheat, barley, and oats) and sugarcane. For cereals, the 

proposed maximum application rate is 0.11 lbs. a.i./acre (1 application at 0.11 lbs. 

a.i./acre). For sugarcane, the proposed maximum application rate is 0.31 lbs. a.i./acre (1 

application at 0.31 lbs. a.i./acre). Both of these commodities have split applications; 

however, neither crop exceeds the proposed maximum application rates listed above. In 

addition, aerial and ground foliar spray applications and chemigation techniques are the 

proposed application methods. 

Based on the ROCKS memorandum (D390121, 7/12/11), the parent ester including its 

free acid CGA-179500, CGA-313458, an open chain cyclohexane ring and an 

unidentified hydroproduct M3 should be included in a Total Toxic Residue (TTR) 

approach for the drinking water assessment. 

Water residues were incorporated in the DEEM-FCID into the food categories “water, 

direct, all sources” and “water, indirect, all sources.” The groundwater value was 

generated using the Screening Concentration in Groundwater (SCI-GROW) Model and 

the surface water values were generated using a Tier 2 sugarcane model. The surface 

water estimates were used for the acute (10.92 ppb) and chronic (0.98 ppb) assessments 

because this value was higher than the groundwater value. Table 2 provides a summary 

of the Tier 2 modeled drinking water concentrations. The model and its description are 

available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/. 

Table 2. Recommended Estimated Drinking Water Concentrations (EDWCs)1for Surface Water 

and Ground Water.

Drinking 

Water 

Source

Model

Scenario Method2

Maximum 

Application Rate

(interval between 

applications)

1-in-10 

year 

acute 

(μg/L)

1-in-10 

year 

chronic 

(μg/L)

30- year 

average 

(μg/L)

Surface 

Water

PRZM/EXAMS

LA Sugarcane

(December 03 – foliar)

A 1 app @ 0.31 lb a.i./acre 10.92 0.98 0.59

Ground 

Water

SCI-GROW

Sugarcane -- 1 app @ 0.31 lb a.i./acre 0.001 0.001 0.001

1 For surface water (PRZM/EXAMS), EDWC values adjusted with a Percent Cropped Area (PCA) factor of 0.87. 

For ground water (SCI-GROW), no PCA adjustment was utilized. 

2 A = aerial application

Bolded values were used in the dietary exposure assessment.

IV. DEEM-FCID Program and Consumption Information

Trinexapac-ethyl acute dietary exposure assessments were conducted using the Dietary 

Exposure Evaluation Model software with the Food Commodity Intake Database 
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(DEEM-FCID, Version 2.03), which incorporates consumption data from USDA’s 

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

1994-96, 98 data are based on the reported consumption of more than 20,000 individuals 

over two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) are linked 

to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; 

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

files developed jointly by USDA/ARS and EPA. Consumption data are averaged for the 

entire U.S. population and within population subgroups for chronic exposure assessment, 

but are retained as individual consumption events for acute exposure assessment.

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

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

can be multiplied by a residue point estimate and summed to obtain a total daily pesticide 

exposure for a deterministic exposure assessment, or “matched” in multiple random 

pairings with residue values and then summed in a probabilistic (Tier 3/4) assessment. 

The resulting distribution of exposures is expressed as a percentage of the aPAD on both 

a user (i.e., those who reported eating relevant commodities/food forms) and a per capita

(i.e., those who reported eating the relevant commodities as well as those who did not) 

basis. In accordance with HED policy, per capita exposure and risk are reported for all 

tiers of analysis. However, significant differences in user vs. per capita exposure and risk 

are identified and noted in the risk assessment.

V. Toxicological Information

On September 30, 2011, HED’s ToxSAC met to consider the endpoints of toxicological 

concern for acute and chronic dietary exposure as well as for occupational and residential 

exposure pursuant to the Food Quality Protection Act (FQPA) of 1996. No acute dietary 

toxicity endpoints were identified for the general population, and the route and duration 

of exposure are appropriate for only females 13-49 years old. Trinexapac-ethyl is 

classified as “Not likely to be carcinogenic to humans,” and therefore, quantification of 

cancer risk is not necessary. Table 3 provides a summary of the toxicological doses and 

endpoints for trinexapac-ethyl for use in the dietary exposure assessment. 

Table 3. Summary of Toxicological Doses and Endpoints for Trinexapac-ethyl for use in Human Health 

Risk Assessments.

Exposure/

Scenario

Point of 

Departure

Uncertainty/ 

FQPA Safety 

Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Toxicological 

Effects

Acute Dietary

(General 

Population, 

including 

Infants and 

Children)

No appropriate endpoint for the general population including infants and children
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Table 3. Summary of Toxicological Doses and Endpoints for Trinexapac-ethyl for use in Human Health 

Risk Assessments.

Exposure/

Scenario

Point of 

Departure

Uncertainty/ 

FQPA Safety 

Factors

RfD, PAD, Level 

of Concern for 

Risk Assessment

Study and Toxicological 

Effects

Acute Dietary

(Females 13-49 

years of age)

NOAEL = 60 

mg/kg

UFA= 10x

UFH = 10x

FQPA SF= 1x

Acute RfD = 0.6 

mg/kg

aPAD = 0.6 mg/kg

Developmental rabbit study

MRID 41869524

LOAEL = 360 mg/kg, based 

on a decrease in mean number 

of fetuses/litter and an increase 

in post-implantation loss

Chronic 

Dietary (All 

Populations)

NOAEL= 31.6 

mg/kg/day

UFA= 10x

UFH = 10x

FQPA SF= 1x

Chronic RfD = 

0.32

mg/kg/day

cPAD = 0.32 

mg/kg/day

Chronic oral toxicity study –

dog

MRID 42779402/ 42779401

LOAEL = 357 mg/kg/day, 

based on elevated serum 

cholesterol values in females, 

mucoid feces in females and 

bloody feces in both sexes, and 

minimal, focal vacuolation of 

the dorsal medial hippocampus 

and/or lateral midbrain in both 

sexes

Cancer (oral, 

dermal, 

inhalation)

Classification: “Not likely to be Carcinogenic to Humans” 

Point of Departure (POD) = A data point or an estimated point that is derived from observed doseresponse data and used to mark the beginning of extrapolation to determine risk associated with 

lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. 

LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation 

from animal to human (interspecies). UFH = potential variation in sensitivity among members of 

the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population 

adjusted dose (a = acute, c = chronic). RfD = reference dose. 

VI. Results/Discussion

As stated above, for dietary assessments, HED is concerned when dietary risk estimates

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

the U.S. population and 26 population subgroups. The results are reported in Table 4 for 

the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 

6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years. 

For food and drinking water, the acute dietary risk estimate is below HED’s level of 

concern at the 95th percentile of exposure. The acute dietary exposure was estimated for 

females 13-49 years old only since an acute endpoint of concern was not identified for 

the general U.S. population. The acute dietary exposure estimate for females 13-49 

years old is 0.014310 mg/kg/day (2% of the aPAD). 

Chronic dietary risk estimates for food and drinking water are well below HED’s level of 

concern. Using the DEEM-FCID software, dietary exposure is estimated at 0.007871 
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mg/kg/day for the general U.S. population equivalent to 2.5% of the cPAD and 0.019478

mg/kg/day, equivalent to 6% of the cPAD for children 1-2years old, the population 

subgroup with the highest estimated chronic dietary exposure to trinexapac-ethyl. 

Table 4. Summary of Dietary (Food Only) Exposure and Risk for Trinexapac-ethyl

Population Subgroup

Acute Dietary1

(95th% Percentile) Chronic Dietary Cancer2

Dietary 

Exposure 

(mg/kg/day)

% 

aPAD

Dietary 

Exposure

(mg/kg/day)

% cPAD

Dietary 

Exposure

(mg/kg/day)

Risk

General U.S. 

Population 0.007871 2.5

N/A N/A

All Infants (< 1 year 

old) 0.005464 2

Children 1-2 years old 0.019478 6

Children 3-5 years old 0.019272 6

Children 6-12 years old 0.013190 4

Youth 13-19 years old 0.007646 2

Adults 20-49 years old 0.006272 2

Adults 50+ years old 0.005224 2

Females 13-49 years 

old1

0.014310 2

0.005884 2

1

aPAD=0.6 mg/kg/day for females 13-49 only (no appropriate endpoint for general US population including infants 

and children) cPAD=0.32 mg/kg/day

2 Not likely to be Carcinogenic to Humans

VII. Discussion of Uncertainties

HED considers the acute and chronic assessments to be very conservative. The 

assessments are based on recommended tolerance level residues for all commodities. In 

addition, it is assumed that 100% of all crops are treated. Further refinement to the 

analyses could be made through the use of anticipated residues, incorporation of 

percentages of crops treated with trinexapac ethyl, and/or monitoring data that better 

reflect residues at the time of consumption. Since risk estimates are well below HED’s 

level of concern, a more highly refined analysis is not needed at this time.
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VIII. Conclusions

This highly conservative, unrefined analysis demonstrates that the requested uses for 

trinexapac ethyl will not result in acute and chronic dietary risk estimates that exceed 

HED’s level of concern for any of the regulated population subgroups, including those 

comprised of infants and children. The acute dietary exposure was estimated for females 

13-49 years old only (2% of the aPAD) since an acute endpoint of concern was not 

identified for the general U.S. population. The chronic dietary exposure estimate for the

general U.S. population is 2.5% of the cPAD and 6% of the cPAD for children 1-2 years

old.

IX. Appendix: List of Attachments

· Attachment 1: Trinexapac-ethyl Acute Residue Input File-Food + Water

· Attachment 2: Trinexapac-ethyl Acute Result File-Food + Water

· Attachment 3: Trinexapac-ethyl Chronic Residue Input File-Food + Water

· Attachment 4: Trinexapac-ethyl Chronic Result File-Food + Water

CC: S.Piper

S.Piper: S-10216: Potomac Yard1 (PYI): 703-308-2717: 7509P: RABVI

Attachment 1: Trinexapac-ethyl Acute Residue Input File-Food + Water

U.S. Environmental Protection Agency Ver. 2.02

DEEM-FCID Acute analysis for TRINEXAPAC-ETHYL

Residue file name: C:\Deemfcid\Trinexapac\Trinexapac.R98

Analysis Date 09-22-2011 Residue file dated: 09-21-2011/15:10:23/8

Reference dose: aRfD = 0.6 mg/kg bw/day NOEL = 6 mg/kg bw/day

Comment: food + drinking water

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

 EPA Crop Def Res Adj.Factors Comment

 Code Grp Food Name (ppm) #1 #2 

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

15000250 15 Barley, pearled barley 2.000000 1.000 1.000

15000251 15 Barley, pearled barley-babyfood 2.000000 1.000 1.000

15000260 15 Barley, flour 2.000000 1.000 1.000

15000261 15 Barley, flour-babyfood 2.000000 1.000 1.000

15000270 15 Barley, bran 2.500000 1.000 1.000

21000440 M Beef, meat 0.020000 1.000 1.000

21000441 M Beef, meat-babyfood 0.020000 1.000 1.000

21000450 M Beef, meat, dried 0.020000 1.920 1.000

21000460 M Beef, meat byproducts 0.040000 1.000 1.000

21000461 M Beef, meat byproducts-babyfood 0.040000 1.000 1.000

21000470 M Beef, fat 0.020000 1.000 1.000

21000471 M Beef,fat-babyfood 0.020000 1.000 1.000

21000480 M Beef, kidney 0.040000 1.000 1.000

21000490 M Beef, liver 0.040000 1.000 1.000

21000491 M Beef, liver-babyfood 0.040000 1.000 1.000

23001690 M Goat, meat 0.020000 1.000 1.000

23001700 M Goat, meat byproducts 0.040000 1.000 1.000
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23001710 M Goat, fat 0.020000 1.000 1.000

23001720 M Goat, kidney 0.040000 1.000 1.000

23001730 M Goat, liver 0.040000 1.000 1.000

24001890 M Horse, meat 0.020000 1.000 1.000

15002310 15 Oat, bran 6.100000 1.000 1.000

15002320 15 Oat, flour 4.000000 1.000 1.000

15002321 15 Oat, flour-babyfood 4.000000 1.000 1.000

15002330 15 Oat, groats/rolled oats 4.000000 1.000 1.000

15002331 15 Oat, groats/rolled oats-babyfood 4.000000 1.000 1.000

25002900 M Pork, meat 0.020000 1.000 1.000

25002901 M Pork, meat-babyfood 0.020000 1.000 1.000

25002910 M Pork, skin 0.030000 1.000 1.000

25002920 M Pork, meat byproducts 0.030000 1.000 1.000

25002921 M Pork, meat byproducts-babyfood 0.030000 1.000 1.000

25002930 M Pork, fat 0.020000 1.000 1.000

25002931 M Pork, fat-babyfood 0.020000 1.000 1.000

25002940 M Pork, kidney 0.030000 1.000 1.000

25002950 M Pork, liver 0.030000 1.000 1.000

26003390 M Sheep, meat 0.020000 1.000 1.000

26003391 M Sheep, meat-babyfood 0.020000 1.000 1.000

26003400 M Sheep, meat byproducts 0.040000 1.000 1.000

26003410 M Sheep, fat 0.020000 1.000 1.000

26003411 M Sheep, fat-babyfood 0.020000 1.000 1.000

26003420 M Sheep, kidney 0.040000 1.000 1.000

26003430 M Sheep, liver 0.040000 1.000 1.000

95003620 O Sugarcane, sugar 0.800000 1.000 1.000

95003621 O Sugarcane, sugar-babyfood 0.800000 1.000 1.000

95003630 O Sugarcane, molasses 2.500000 1.000 1.000

95003631 O Sugarcane, molasses-babyfood 2.500000 1.000 1.000

15003810 15 Triticale, flour 4.000000 1.000 1.000

15003811 15 Triticale, flour-babyfood 4.000000 1.000 1.000

86010000 O Water, direct, all sources 0.010920 1.000 1.000

86020000 O Water, indirect, all sources 0.010920 1.000 1.000

15004010 15 Wheat, grain 4.000000 1.000 1.000

15004011 15 Wheat, grain-babyfood 4.000000 1.000 1.000

15004020 15 Wheat, flour 4.000000 1.000 1.000

15004021 15 Wheat, flour-babyfood 4.000000 1.000 1.000

15004030 15 Wheat, germ 4.000000 1.000 1.000

15004040 15 Wheat, bran 6.000000 1.000 1.000

Attachment 2: Trinexapac-ethyl Acute Result File-Food + Water

U.S. Environmental Protection Agency Ver. 2.02

DEEM-FCID ACUTE Analysis for TRINEXAPAC-ETHYL (1994-98 data)

Residue file: Trinexapac.R98 Adjustment factor #2 NOT used.

Analysis Date: 09-22-2011/14:16:30 Residue file dated: 09-21-2011/15:10:23/8

NOEL (Acute) = 6.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "food + drinking water"

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

Summary calculations (per capita):

 95th Percentile 99th Percentile 99.9th Percentile

Exposure % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE 

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

Females 13-49 yrs:

 0.014310 2.38 419 0.019946 3.32 300 0.028086 4.68 213 

Attachment 3: Trinexapac-ethyl Chronic Residue Input File-Food + Water

U.S. Environmental Protection Agency Ver. 2.00

DEEM-FCID Chronic analysis for TRINEXAPAC-ETHYL 1994-98 data

Residue file: C:\Deemfcid\Trinexapac\Trinexapac_chronic.R98Adjust. #2 NOT used
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Analysis Date 09-22-2011 Residue file dated: 09-22-2011/14:20:38/8

Reference dose (RfD) = 0.32 mg/kg bw/day

Comment:food + drinking water

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

Food Crop Residue Adj.Factors Comment

EPA Code Grp Food Name (ppm) 

 #1 #2 

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

15000250 15 Barley, pearled barley 2.000000 1.000 1.000 

15000251 15 Barley, pearled barley-babyfood 2.000000 1.000 1.000 

15000260 15 Barley, flour 2.000000 1.000 1.000 

15000261 15 Barley, flour-babyfood 2.000000 1.000 1.000 

15000270 15 Barley, bran 2.500000 1.000 1.000 

21000440 M Beef, meat 0.020000 1.000 1.000 

21000441 M Beef, meat-babyfood 0.020000 1.000 1.000 

21000450 M Beef, meat, dried 0.020000 1.920 1.000 

21000460 M Beef, meat byproducts 0.040000 1.000 1.000 

21000461 M Beef, meat byproducts-babyfood 0.040000 1.000 1.000 

21000470 M Beef, fat 0.020000 1.000 1.000 

21000471 M Beef,fat-babyfood 0.020000 1.000 1.000 

21000480 M Beef, kidney 0.040000 1.000 1.000 

21000490 M Beef, liver 0.040000 1.000 1.000 

21000491 M Beef, liver-babyfood 0.040000 1.000 1.000 

23001690 M Goat, meat 0.020000 1.000 1.000 

23001700 M Goat, meat byproducts 0.040000 1.000 1.000 

23001710 M Goat, fat 0.020000 1.000 1.000 

23001720 M Goat, kidney 0.040000 1.000 1.000 

23001730 M Goat, liver 0.040000 1.000 1.000 

24001890 M Horse, meat 0.020000 1.000 1.000 

15002310 15 Oat, bran 6.100000 1.000 1.000 

15002320 15 Oat, flour 4.000000 1.000 1.000 

15002321 15 Oat, flour-babyfood 4.000000 1.000 1.000 

15002330 15 Oat, groats/rolled oats 4.000000 1.000 1.000 

15002331 15 Oat, groats/rolled oats-babyfood 4.000000 1.000 1.000 

25002900 M Pork, meat 0.020000 1.000 1.000 

25002901 M Pork, meat-babyfood 0.020000 1.000 1.000 

25002910 M Pork, skin 0.030000 1.000 1.000 

25002920 M Pork, meat byproducts 0.030000 1.000 1.000 

25002921 M Pork, meat byproducts-babyfood 0.030000 1.000 1.000 

25002930 M Pork, fat 0.020000 1.000 1.000 

25002931 M Pork, fat-babyfood 0.020000 1.000 1.000 

25002940 M Pork, kidney 0.030000 1.000 1.000 

25002950 M Pork, liver 0.030000 1.000 1.000 

26003390 M Sheep, meat 0.020000 1.000 1.000 

26003391 M Sheep, meat-babyfood 0.020000 1.000 1.000 

26003400 M Sheep, meat byproducts 0.040000 1.000 1.000 

26003410 M Sheep, fat 0.020000 1.000 1.000 

26003411 M Sheep, fat-babyfood 0.020000 1.000 1.000 

26003420 M Sheep, kidney 0.040000 1.000 1.000 

26003430 M Sheep, liver 0.040000 1.000 1.000 

95003620 O Sugarcane, sugar 0.800000 1.000 1.000 

95003621 O Sugarcane, sugar-babyfood 0.800000 1.000 1.000 

95003630 O Sugarcane, molasses 2.500000 1.000 1.000 

95003631 O Sugarcane, molasses-babyfood 2.500000 1.000 1.000 

15003810 15 Triticale, flour 4.000000 1.000 1.000 

15003811 15 Triticale, flour-babyfood 4.000000 1.000 1.000 

86010000 O Water, direct, all sources 0.000980 1.000 1.000 

86020000 O Water, indirect, all sources 0.000980 1.000 1.000 

15004010 15 Wheat, grain 4.000000 1.000 1.000 

15004011 15 Wheat, grain-babyfood 4.000000 1.000 1.000 

15004020 15 Wheat, flour 4.000000 1.000 1.000 

15004021 15 Wheat, flour-babyfood 4.000000 1.000 1.000 

15004030 15 Wheat, germ 4.000000 1.000 1.000 

15004040 15 Wheat, bran 6.000000 1.000 1.000 

Attachment 4: Trinexapac-ethyl Chronic Result File-Food + Water
Trinexapac-ethyl Dietary Exposure Assessment DP Barcode: 394830 

Page 12 of 12

U.S. Environmental Protection Agency Ver. 2.00

DEEM-FCID Chronic analysis for TRINEXAPAC-ETHYL (1994-98 data)

Residue file name: C:\Deemfcid\Trinexapac\Trinexapac_chronic.R98

 Adjustment factor #2 NOT used.

Analysis Date 09-22-2011/14:21:10 Residue file dated: 09-22-2011/14:20:38/8

Reference dose (RfD, Chronic) = .32 mg/kg bw/day

COMMENT 1: food + drinking water

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

 Total exposure by population subgroup

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 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

U.S. Population (total) 0.007871 2.5%

U.S. Population (spring season) 0.007976 2.5%

U.S. Population (summer season) 0.007598 2.4%

U.S. Population (autumn season) 0.007924 2.5%

U.S. Population (winter season) 0.007998 2.5%

Northeast region 0.008330 2.6%

Midwest region 0.008367 2.6%

Southern region 0.007336 2.3%

Western region 0.007780 2.4%

Hispanics 0.007156 2.2%

Non-hispanic whites 0.008093 2.5%

Non-hispanic blacks 0.007394 2.3%

Non-hisp/non-white/non-black 0.007303 2.3%

All infants (< 1 year) 0.005464 1.7%

Nursing infants 0.003066 1.0%

Non-nursing infants 0.006375 2.0%

Children 1-6 yrs 0.018960 5.9%

Children 7-12 yrs 0.012508 3.9%

Females 13-19 (not preg or nursing) 0.006776 2.1%

Females 20+ (not preg or nursing) 0.005372 1.7%

Females 13-50 yrs 0.006125 1.9%

Females 13+ (preg/not nursing) 0.006438 2.0%

Females 13+ (nursing) 0.007433 2.3%

Males 13-19 yrs 0.008456 2.6%

Males 20+ yrs 0.006416 2.0%

Seniors 55+ 0.005182 1.6%

Children 1-2 yrs 0.019478 6.1%

Children 3-5 yrs 0.019272 6.0%

Children 6-12 yrs 0.013190 4.1%

Youth 13-19 yrs 0.007646 2.4%

Adults 20-49 yrs 0.006272 2.0%

Adults 50+ yrs 0.005224 1.6%

Females 13-49 yrs 0.005884 1.8%

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