### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON

, D.C. 20460

OFF I CE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM

Date: February 11, 20 l 5



### SUBJECT: Trinexapac-ethyl: Acute and Chronic Aggregate Dietary and Drinking Water Exposure and Risk Assessments to Support new use on Rice and Rye.



### PC Co de: 112602 

### Decision No.: 488373 

### Petition No.: NA 

### DP Barcode: D4 j 4893 

### Registration No.: NA 

### Regulatory Action: Registration Review 

### Case No. : NA 

### Risk Assessment Type: Dietary 

### TXRNo.: NA 

### CAS No.: 95266-40-3 

### 40 CFR: §180.662 MRIDNo.:NA



### FROM:

THROUGH:

TO: Sumitra Bose Biswas

, Chemist Risk Assessment Branch VI Health Effects Division (7509P)

Sheila Piper

,

# Chemis**~~ ~**  ldeliz Negron-Encarnacion

, Chemist .::;./,,

## L'~----- Dietary Exposure Science Adviso ry Counc (DESAC) And ' Donna S. Davis

, Acting Branch Chief

# ~ R i sk Assessment Branch VI

, HED (7509P)

Bethany Benbow, Ri sk Manager Reviewer Kathryn Montague, Risk Manager Dan Kenny, Branch Chief Risk Management and Implementation Branch 3 Pesticide Re-Evaluation Division (7508P)

Page I of 12Trinexapac

- ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 2 of 12 

### Executive Summary

Acute and chronic aggregate dietary f ood and drinking water exposure and risk assessments for trinexapac

- ethyl were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM

- FCID) Version 3.16 . This software uses 2003

- 2008 food consumption data from the U.S. Depar tment of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA ). This dietary analysis is updated to reflect the new uses on rice and rye

. This memorandum was reviewed by two peer reviewers o f the DE SAC per the current DESAC Standard Operating Procedure (SOP).

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

An unrefined, acute dietary expo sure assessment using tolerance

- level residue s, default DEEM processing factors, and assuming 100% crop treated (CT) for the registered commodities was conduct ed . The estimated drinking water concentration (EDWC) of trinexapac

- ethyl was provided by the Environmental Fate and Effects Division (EFED) and incorporated dir ectly into the acute assessment. The Tier I Rice Model was used to generate EDWCs for residues of trinexapac

- ethyl on surface water which were obtained modeling the rice use. The acute drinking water concentration in surface water is 31.68 ppb.

There were no appropriate toxicological effects attributable to a single exposure (dose) for the general population or any other population subgroups except females 13

- 49 years old ; therefore

, these population subgroups were not included in this assessment. For food an d 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 estimate for females 13

- 49 years old is 0.014667 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 tolerance level residue s, default DEEM processing factors , and 100% CT

. The chronic EDWC in surface water for trinexapac

- ethyl is 31.68 ppb.

C ombined chronic dietary exposure estimates for food and drinking water are well below HED’s level of concern. Using the DEEM

- FCI D software, dietary exposure is estimated at 0.008293 mg/kg/day for the U.S. population which is equivalent to 3 % of the chronic Population Adjusted Dose (cPAD), and 0.020596 mg/kg/day , equivalent to 6 % of the cPAD for children 1

- 2 years old, the population with highest estimated chronic dietary expo sure to trinexapac

- ethyl.

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

Trinexapac

- ethyl is classified as “not likely to be carcinogenic to humans.” Therefore, a cancer dietary exposure analysis is not required.Trinexapac

- ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 3 of 12 

### 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 (i.e., the dose that HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non

- cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD. References that 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,” 21

- JUN

- 2000, web link: http://www.epa.gov/fedrgstr/EPA

- PEST/2000/J uly/Day

- 12/6061.pdf ; or see SOP 99.6 (20

- AUG

1999).

The most recent dietary risk assessment for tri nexapac

- ethyl was conducted by S. Piper ( 0 9 / 1 2 /20 13 , D 413986 ).

II. Residue Information

Trinexapac

- ethyl is a plant growth regulator being proposed by Sy ngenta Crop Protection for

use on rice and rye

. Trinexapac

- ethyl inhibits internodal elongation and growth in cereal grains, grasses and several dicotyledonous species. Tolerances are currently established for residues of the plant growth inhibitor, trine xapac

- ethyl in/on various plant and animal commodities, at levels ranging from 0.02 to 40.0 ppm as listed in the CFR 40 §180. 662

. The residues of concern in plants and livestock for tolerance enforcement and risk assessment purposes include free and con jugated residues of both parent and its acid metabolite, trinexapac ( Residues of Concern Knowledgebase Subcommittee (ROCKS), D390121, 7/12/11)

.

Residue Data used for the Acute & Chronic Dietary Assessment:

An unrefined, acute dietary exposure assessment using tolerance level residue s, default DEEM
proc essing factors

, and assuming 100 % CT for the register ed commodities. See Table 1.

Table 1: Tolerance Summary for Trinexapac

- ethyl. Commodity HED

- Recommended Tolerance (ppm) Comments


### Rice, grain 0.4 NATrinexapac

- ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 4 of 12 

### Rice, straw 0.07 NA 

### Rice, bran 1.7 NA 

### Rice, wild, grain 0.4 NA 

### Rye, bran 2.5 Extrapolation from the existing tolerances established for small cereal grains. 

### Rye, grain 4 .0 Rye, hay 1.5 Rye, straw 0.9

I I I. Percent Crop Treated Information

The acute and chronic dietary analyses were performed assuming 100% of each crop was treated with trinexapac

- ethyl.

IV. Drinking Water Data

References: Drinking Water Assessment for Trinexapac

- Ethyl new use on rice and rye

, D 421848

, Christopher M. Koper

, 10/01/2014

.

A Tier I rice model for drinking water assessment was conducted to support the human health risk assessment for the new food use registration for trinexapac ethyl on rice and rye. Rye, a cereal will not be modeled in this assessment since application rates are the same as previously assessed rates on cereals (D377936; 08

- 09

- 11). The recommended estimated drinking water concentrations (EDWCs) for the human health risk assessment are based on highest predicted values for surface water and ground water. For surface water, application (1 application at 0.045 lb a.i./acre) to rice yielded the highest EDWCs. The acute and chronic concentrations were estimated to be 31.68 ppb

. For ground w ater, based on the proposed highest annual use rate for turf (8 applications at 0.34 lb a.i./acre), the PRZM

- GW (v.1.07) model estimated an acute concentration of 0.116 ppb and 30

- year average (chronic) concentration of 0.054 ppb

.

Based on the ROCKS memor andum (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.” Table 2 provides a summary of the Tier 2 modeled drinking water concentrations. The model and its description ar e available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/

.

Table 2. Recommended Trinexapac

- Ethyl E s tim a ted Drinking Wat e r Concentrations (EDWCs) for Surface Water and Ground Water based on selected Crop ScenariosTrinexapac

- ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 5 of 12 Pro p osed L a bel Use M o del Me t h o d 1 M a ximum Application R a te (inte r val bet w een

a pplications) 1

- i n - 1 0
year

ac u te ( 

### μg/ L ) 1

- i n - 1 0
year chronic ( 

### μg/ L ) 3 0

- y e ar

ave ra ge ( 

### μg/ L )

Surface Wat e r

Rice Tier 1 Rice Model NA 1 a p p @ 0.04 5 l b a.i./ac re 3 1 .68 ( 12 .6 1 ) 2 3 1 .68

( 1

. 5 6 ) 3 1 .68

( 1

. 0 4 )
Gro u nd Wat e r

T u rf PRZM

- G W G 8 a p p @ 0.3 4 l b a.i./ac re 0

. 1 1 6 ( 0

. 00 9 ) NA 0

. 0 5 4

( 0 .00 9 )

1 G = f o liar, gr o und a pp licati o n, NA = N o t Ap p lica b le.

2 Italicized v al u es g e n erated fr o m t u rf sce n ari o ( p a r e n t D 37 7 93 6 ; s u b D39 5 60 1 ) B o ld n u m b ers de n o te m axi m u m E D W C val u es. Italicized nu m bers d e no t e m axi m

u m E D W C va l u es f

r om prev i ous d r i nk i n g water assess m e n t ( p are n t D 3 77 9 3 6 ; Sub D39 5 60 1 ; 1 0

- 2 8

- 11).



### V. DEEM

- FCID Program and Consumption Information

Trinexapac

- ethyl acute and chronic dietary exposure assessments were conducted using the DEEM

- FCID, Version 3.16 , which incorporates 2003

- 2008 consumption data from USDA’s NHANES/WWEIA. The data are based on the reported consumpti on 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, bak ed) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups . However , for acute
exposure assess ment
, consumption data are retained as individual consumption events. Based on analysis of the 2003

- 2008 WWEIA consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19, adults 20

- 49, females 13

- 49, and adults 50

- 99 years old.

For a chronic dietary exposure assessment, an esti mate of the residue level in each food or food

form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate. The resulting resid ue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a p ercent of the cPAD. This procedure is performed for each population subgroup.

For an acute exposure assessment, individual one

- day food consumption data are used on an individual

- by

- individual basis. The reported consumption amounts of each food item ca n be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for aTrinexapac

- ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 6 of 12 

### deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resu lting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only 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 d id not) basis. In accordance with HED policy, per capita exposure and risk are reported for a nalyses performed at all levels of refinement . However, for deterministic assessments , any significant differences in user vs. per capita exposure and risk are

s pecifically identified and noted in the risk assessment.

VI. Toxicological Information

HED’s ToxSAC met (09/30/2011) 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 was available

Acute Dietary (Females 13

- 49 years of age) NOAEL = 60

mg/kg UF A = 10x

UF H = 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 and early resorptions.Trinexapac

- ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 7 of 12 

### 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

Chronic Dietary (All Populations) NOAEL= 31.6

mg/kg/day UF A = 10x

UF H = 10x FQPA SF= 1x Chronic RfD =

0.32 mg/kg/day

cPAD = 0.32 mg/kg/day C hronic 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 dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no ob served adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = 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.



### VII. Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM

- FCID analyses estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 4 are 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

- 99 years.
For food and drinking water, the acute dietary risk estimate is below HED’s level of concern at the 9 5 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 i s 0.014 667 mg/kg/day (2% of the aPAD).

C hronic 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 0.00 8293 mg/kg/day for the general U.S. population equivalent to 3 % of the cPAD and 0.0 20596 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.Trinexapac

- ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 8 of 12 

### Table 4 . Summary of Dietary (Food and Drinking Water ) Exposure and Risk for Trinexapac

- ethyl

Population Subgroup Acute Dietary 1 

### (95 th 

### % Percentile) Chronic Dietary Cancer

Dietary Exposure (mg/kg/day) %

aPAD Dietary

Exposure (mg/kg/day) %

cPAD Dietary

Exposure (mg/kg/day) Risk

General U.S. Population

N/A N/A 0.00 82 93 2. 6

N/A N/A All Infants (< 1 year old) 0.00 838 7 2

. 6

Children 1

- 2 years old 0.020596 6

. 4

Children 3

- 5 years old 0.01 94 87 6.1

Children 6

- 12 years old 0.013 9 81 4. 4

Youth 13

- 19 years old 0.00 8238 2. 6

Adults 20

- 49 years old 0.00 685 3 2.1

Adults 50

- 99 + years old 0.0058 61 1.8

Females 13

- 49 years old 1 

### 0.0 14667 2 .4 0.0064 66 2.0

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 . Not likely to be carcinogenic to humans.



### VIII. Characterization of Inputs/Outputs

The assumptions made in this acute and chronic dietary assessment are conservative; including tolerance

- level residues and assuming 100% crop treated. A refined analysis incorporating additional refinements, including % crop treated data, is not warranted at this time since the risk estimates are below HED’s level of concern.Trinexapac

- ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 9 of 12 

### IX. Conclusions

Th ese highly conservative, unrefined analys es demonstrate 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.

HED is confident that the assessment does not underestimate risk to the general U.S. popu lation or any population subgroup.

X. List of Attachments

Attachment 1: Acute Residue Input File Attachment 2: Acute Results File Attachment 3: Chronic Residue Input File Attachment 4: Chronic Results File

Attachment 1: Acute Residue Input File

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID Acute analysis for TRINEXAPAC

- ETHYL Residue file name: C: \ DEEM \ Trinex \ Trinexapac_acute2.r08 Analysis Date 02

- 04

- 2015 Residue file dated: 02

- 04

- 2015/11:00:00 Reference dose: aRfD = 0.6 mg/kg bw/day NOEL = 60 mg/kg bw/day

---------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Cod e Grp Food Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ ------- 1500025000 15 Barley, pearled barley 2.000000 1.000 1.000 1500025001 15 Barley, pearled barley

- babyfood 2.000000 1.000 1.000 1500026000 15 Barley, flour 2.000000 1.000 1.000 1500026001 15 Barley, flour

- babyfood 2.000000 1.000 1.000 1500027000 15 Barley, bran 2.50 0000 1.000 1.000 3100044000 31 Beef, meat 0.020000 1.000 1.000 3100044001 31 Beef, meat

- babyfood 0.020000 1.000 1.000 3100045000 31 Beef, meat, dried 0.020000 1.920 1.000 3100046000 31 Beef, meat byproducts 0.040000 1.000 1.000 3100046001 31 Beef, meat byproducts

- babyfood 0.040000 1.000 1.000 3100047000 31 Beef, fat 0.020000 1.000 1.000 3100047001 31 Beef, fat

- babyfood 0.020000 1.000 1.000 3100048000 31 Beef, kidney 0.040000 1.000 1.000 3100049000 31 Beef, liver 0.040000 1.000 1.000 3100049001 31 Beef, liver

- babyfood 0.040000 1.000 1.00 0 3200169000 32 Goat, meat 0.020000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.040000 1.000 1.000 3200171000 32 Goat, fat 0.020000 1.000 1.000 3200172000 32 Goat, kidney 0.040000 1.000 1.000 3200173000 32 Goat, liver 0.040000 1.000 1.000 3300189000 33 Horse, meat 0.020000 1.000 1.000 1500231000 15 Oat, bran 6.000000 1.000 1.000 1500232000 15 Oat, flour 4.000000 1.000 1.000 1500232001 15 Oat, flour

- babyfood 4.000000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 4.000000 1.000 1.000Trinexapac

- ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 10 of 12 1500233001 15 Oat, groats/rolled oats

- babyfood 4.000000 1.000 1.000 3400290000 34 Pork, meat 0.020000 1.000 1.000 3400290001 34 Pork, meat

- babyfood 0.020000 1.000 1.000 3400291000 34 Pork, skin 0.030000 1.000 1.000 3400292000 34 Pork, meat byproducts 0.030000 1.000 1.000 3400292001 34 Pork, meat byproducts

- babyfood 0.030000 1.000 1.000 3400293000 34 Pork, fat 0.020000 1.000 1.000 340 0293001 34 Pork, fat

- babyfood 0.020000 1.000 1.000 3400294000 34 Pork, kidney 0.030000 1.000 1.000 3400295000 34 Pork, liver 0.030000 1.000 1.000 1500323000 15 Rice, white 0.400000 1.000 1.000 1500323001 15 Rice, white

- babyfood 0.400000 1.000 1.000 1500324000 15 Rice, brown 0.400000 1.000 1.000 1500324001 15 Rice, brown

- babyfood 0.400000 1.0 00 1.000 1500325000 15 Rice, flour 0.400000 1.000 1.000 1500325001 15 Rice, flour

- babyfood 0.400000 1.000 1.000 1500326000 15 Rice, bran 1.500000 1.000 1.000 1500326001 15 Rice, bran

- babyfood 1.500000 1.000 1.000 1500328000 15 Rye, grain 4.000000 1.000 1.000 1500329000 15 Rye, flour 4.000000 1.000 1.000 3500339000 35 Sheep, meat 0.020000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.020000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.040000 1.000 1.000 3500341000 35 Sheep, fat 0.020000 1.000 1.000 3500341 001 35 Sheep, fat

- babyfood 0.020000 1.000 1.000 3500342000 35 Sheep, kidney 0.040000 1.000 1.000 3500343000 35 Sheep, liver 0.040000 1.000 1.000 9500362000 O Sugarcane, sugar 0.800000 1.000 1.000 9500362001 O Sugarcane, sugar

- babyfood 0.800000 1.000 1.000 9500363000 O Sugarcane, molasses 2.500000 1.000 1.000 9500363001 O Sugarcane, molasses

- babyfood 2.500000 1.000 1.000 8601000000 86A Water, direct, all sources 0.031680 1.000 1.000 8602000000 86B Water, indirect, all sources 0.031680 1.000 1.000 1500401000 15 Wheat, grain 4.000000 1.000 1.000 1500401001 15 Wheat, gr ain

- babyfood 4.000000 1.000 1.000 1500402000 15 Wheat, flour 4.000000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 4.000000 1.000 1.000 1500403000 15 Wheat, germ 4.000 000 1.000 1.000 1500404000 15 Wheat, bran 6.000000 1.000 1.000



### Attachment 2: Acute Results File

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for TRINEXAPAC

- ETHYL NHANES 2003

- 2008 2

- Day Residue file: Trinexapac_acute2.r08 Adjustment factor #2 NOT used. Analysis Date: 02

- 04

- 2015/11:10:17 Residue file dated: 02

- 04

- 2015/11:00:00 NOEL (Acute) = 60.000000 mg/kg body

- wt/day
RA C/FF intake summed over 24 hours Run Comment: ""

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

Summary calculations

-- per capita:

--- 95th Percentile

---- --- 99th Percentile

---- --- 99.9th Percentile

---- Exposur e % aRfD MOE Exposure % aRfD MOE Exposure % aRfD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Female 13

- 49: 0.014667 2.44 4090 0.022173 3.70 2706 0.032025 5.34 1873Trinexapac

- ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 11 of 12 

### Attachment 3: Chronic Residue Input File

US EPA Ver. 3.16, 03

- 08

- d
DEEM

- FCID Chronic analysis for TRINEXAPAC

- ETHYL Residue file: C: \ DEEM \ Trinex \ Trinexapac_chronic2.r08 Adjust. #2 NOT used Analysis Date 02

- 04

- 2015 Residue file dated: 02

- 04

- 2015/10:59:06 Reference dose (RfD) = 0.32 (NOEL) = 31.6 mg/kg bw/day

---------------------------------------------------------------------------------- Food Crop Residue Adj.Factors EPA Code Grp Food Name (ppm) #1 #2

---------- ---- --- ---------------------------- ---------- ------ ------ 1500025000 15 Barley, pearled barley 2.000000 1.000 1.000 1500025001 15 Barley, pearled barley

- babyfood 2.000000 1.000 1.000 1500026000 15 Barley, flour 2.000000 1.000 1.000 1500026001 15 Barley, flour

- babyfood 2.000000 1.000 1.000 1500027000 15 Barley, bran 2.500000 1.000 1.000 3100044000 31 Beef, meat 0.020000 1.000 1.000 3100044001 31 Beef, meat

- babyfood 0.020000 1.000 1.000 3100045000 31 Beef, meat, dried 0.020000 1.920 1.000 3100046000 31 Beef, meat byproducts 0 .040000 1.000 1.000 3100046001 31 Beef, meat byproducts

- babyfood 0.040000 1.000 1.000 3100047000 31 Beef, fat 0.020000 1.000 1.000 3100047001 31 Beef, fat

- babyfood 0.020000 1.000 1.000 3100048000 31 Beef, kidney 0.040000 1.000 1.000 3100049000 31 Beef, liver 0.040000 1.000 1.000 3100049001 31 Beef, liver

- babyfood 0.040000 1.000 1.000 3200169000 32 Goat, meat 0.020000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.040000 1.000 1.000 3200171000 32 Goat, fat 0.020000 1.000 1.000 3200172000 32 Goat, kidney 0.040000 1.000 1.000 3200173000 32 Goat, liver 0.040000 1.000 1.000 3300189000 33 Horse, meat 0.020000 1.000 1.000 1500231000 15 Oat, bran 6.000000 1.000 1.000 1500232000 15 Oat, flour 4.000000 1.000 1.000 1500232001 15 Oat, flour

- babyfood 4.000000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 4.000000 1.000 1.000 1500233001 15 Oat, groats/rolled oats

- babyfood 4.000000 1.000 1.000 3400290000 34 Pork, meat 0.020000 1.000 1.000 3400290001 34 Pork, meat

- babyfood 0.020000 1.000 1.000 3400291000 34 Pork, skin 0.030000 1.000 1.000 3400292000 34 Pork, meat byproducts 0.030000 1.000 1.000 3400292001 34 Pork , meat byproducts

- babyfood 0.030000 1.000 1.000 3400293000 34 Pork, fat 0.020000 1.000 1.000 3400293001 34 Pork, fat

- babyfood 0.020000 1.000 1.000 3400294000 34 Pork, kidney 0.030000 1.000 1.000 3400295000 34 Pork, liver 0.030000 1.000 1.000 1500323000 15 Rice, white 0.400000 1.000 1.000 1500323001 15 Rice, white

- babyfood 0.400000 1.000 1.000 1500324000 15 Rice, brown 0.400000 1.000 1.000 1500324001 15 Rice, brown

- babyfood 0.400000 1.000 1.000 1500325000 15 Rice, flour 0.400000 1.000 1.000 1500325001 15 Rice, flour

- babyfood 0.400000 1.000 1.000 1500326000 15 Rice, bran 1.500000 1.000 1.000 1500326001 15 Rice, bran

- babyfood 1.500000 1.000 1.000 1500328000 15 Rye, grain 4.000000 1.000 1.000 1500329000 15 Rye, flour 4.000000 1.000 1.000 3500339000 35 Sheep, meat 0.020000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.020000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.040000 1.000 1.000 3500341000 35 Sheep, fat 0.020000 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.020000 1.000 1.000Trinexapac

- ethyl Dietary Exposure and Risk Assessment DP Number: D424893

Page 12 of 12 3500342000 35 Sheep, kidney 0.040000 1.000 1.000 3500343000 35 Sheep, liver 0.040000 1.000 1.000 9500362000 O Sugarcane, sugar 0.800000 1.000 1.000 9500362001 O Sugarcane, sugar

- babyfood 0.800000 1.000 1.000 9500363000 O Sugarcane, molasses 2.500000 1.000 1.000 9500363001 O Sugarcane, molasses

- babyfood 2.500000 1.000 1.000 8601000000 86A Water, direct, all sources 0.031680 1.000 1.000 8602000000 86B Water, indirect, all sources 0.031680 1.000 1.000 1500401000 15 Whea t, grain 4.000000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 4.000000 1.000 1.000 1500402000 15 Wheat, flour 4.000000 1.000 1.000 1500402001 15 Wheat, flour

- b abyfood 4.000000 1.000 1.000 1500403000 15 Wheat, germ 4.000000 1.000 1.000 1500404000 15 Wheat, bran 6.000000 1.000 1.000



### Attachment 4: Chronic Results File

US EPA Ver. 3.16, 03

- 08

- d
DEEM

- FCID Chronic analysis for TRINEXAPAC

- ETHYL NHANES 2003

- 2008 2

- day Residue file name: C: \ DEEM \ Trinex \ Trinexapac_chronic2.r08 Adjustment factor #2 NOT used. Analysis Date 02

- 04

- 2015/11:00:27 Residue file dated: 02

- 04

- 2015/10:59:06 Reference dose (RfD, Chronic) = .32 mg/kg bw/day NOEL (Chronic) = 31.6 mg/kg bw/day

============================================= ================================== Total exposure by population subgroup

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

Total Exposure

----------------------------------- Population mg/kg Margin of Percent Subgroup body wt/day Exposure of RfD

-------------------------------------- ------------- ---------- ---------- Total US Population 0.008293 3,811 2.6% Hispanic 0.008242 3,834 2.6%
Non

- Hisp

- White 0.008420 3,753 2.6%
Non

- Hisp

- Black 0.007520 4,202 2.4%
Non

- Hisp

- Other 0.008555 3,694 2.7% Nursing Infants 0.005042 6,268 1.6%
Non

- Nursing Infants 0.009880 3,198 3.1% Female 13+ PREG 0.006940 4,553 2.2% Children 1

- 6 0.019833 1,593 6.2% Children 7

- 12 0.013088 2,414 4.1% Male 13

- 19 0.008971 3,522 2.8% Female 13

- 19/NP 0.007540 4,191 2.4% Male 20+ 0.00 7001 4,513 2.2% Female 20+/NP 0.005903 5,354 1.8% Seniors 55+ 0.005766 5,481 1.8% All Infants 0.008387 3,768 2.6% Female 13

- 50 0.006434 4,911 2.0% Children 1

- 2 0.020596 1,534 6.4% Children 3

- 5 0.019487 1,622 6.1% Children 6

- 12 0.013981 2,260 4.4% Youth 13

- 19 0.008238 3,836 2.6% Adults 20

- 49 0.006853 4,611 2.1% Adults 50

- 99 0.005861 5,391 1.8% Female 13

- 49 0.006466 4,887 2.0%