Paclobutrazol PC Code: 1 25601 Dietary Exposure and Risk Assessment DPNumber : D419143

UNI TED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

Office of C hemical Safety and Pollution Prevention MEMORANDUM
Date: 01/21/2015 SUBJECT: Paclobutrazol. Acute and Chronic Dietary (Drinkin g Water Only) Exposure and Risk Assessments
PC Code: 125601 Decision No.: 486346 Pet ition No.: NA DP Barcode: D41914 3 Registration No.: NA Regulatory Action: NA Case No.: 7002

- 1 Risk Assessment Type: Dietary assessment TXRNo.:N/A CAS No. : 76738-62-0 40 CFR: 180.220 MRIDNo.: N /A
FROM:

THROUGH: P. Yvonne Barnes, Chemist

# ~~**~** Risk Assessment Branch VI (RAB VI) Health Effects Division (HED) (7509P)

# --**~** Thomas Bloem,**Chemi ~**  

# J 1 William D. Cutchin, Chemist 

## }A_
. d'
. 

# h[ Dietary Exposure Science Adv i sory Counc il (DESA C) and Donna S. Davis, Acting Chief

# ~a-­ RAB VIIHED (7509P) TO: K.hue Nguyen Risk Management Registration Division (7505 P )

Page I of 10Paclobutrazol Dietary Expos ure and Risk Assess ment DP Number: 041 9143 PC Co de: 12560 I Executive Summary Paclobutrazol acute a nd chronic dietary exposure assessment s were conducted u s in g the Dietary Ex p osure Eval uation Mode l softwa re with the Food Commodity Intake Databa se DEEMFCIDTM, Vers ion 3.16, which incorporates consumpt ion data f rom USDA ' s National Health and Nutrition Exami nation Survey , What We Eat in America, (NHANES/ WWEIA). This dietary survey was co ndu cted from 2003 to 2008. Thes e analys es we re perform ed to support the risk assessment for paclobutrazol. Thi s memorandum was review ed by two peer reviewers of the DESAC , per DESAC SOP 2012.1. Paclobutrazol is a member of the class of co mpound s known as the triazoles (a.k.a. triazolederivative fungicides
. , T-D fungicides, conazoles). In 2006, HED i ssued aggregate human health risk assessments for triazole (T) and the conjugated triazo le metabolite s (T A, T AA, and TP) ( 0 322215 , M. Doherty, eta!., 02/07/ 2006). New dietary exposure estimates are available forT and combined residues ofT A, TAA, and TP (D414951, T. Morton, 10 /24/ 2013), which considers all registere d / pro pos ed paclobutrazol use s. There were no dietary risk of concern id entified for triazole and its regulated metabolites. Attached are acute and chronic dietary ri s k assessments for drinking w ate r only. Although there are no registered fo od u ses for paclobutrazol, dietary exposure is possibl e throu gh d rinkin g water ; therefore acute and chroni c dietary ri s k assessments we re conducted for the parent co mpound and its regulated metabolites , excludin g T, TA, T AA, and TP. The estimated groundwater estimated drinking water concentrations (EDWCs) were calculated using the screening compute r model PRZM -GW (Pesticide R oot Zon e Model f or Groundwater , vers i on 1.0 , August 31, 20 1 2). Ground drinking water modeling was conducted with the hi ghest application rate scen ario which i s 6.1 lb s/ A for nursery production of container-grown ornamentals thro ugh a so il drench method. Thi s r ate was norm a lized with the lowest fraction (0
. 59) of paclobutrazol retain ed in the soi l co lumn leaching study which resulted in an effective modeled drinking water application rate of2.5 lbs./A. T hes e maximum ground water EDWCs were u sed in dietary risk assessment for paclobutrazol. HED notes that EFED completed their drinking water assessment prior to the determin at io n that only the parent compound, and it s ketone analog (CGA 149907) were residu es of concern in drinking water. However, EFED ' s drinking water as sess m ent took a total re s idue approach and i s expected to overe stimate residues. Since no dietary risks of concern w ere identified, a revised drinking water assessment, whi c h included the appropriate residues of concern and wo uld re sult in lower estimated risks was not conducted. Acute Di eta ry (Drinkin g Water Only) Exposure Assess ment An unrefin ed acute dietary analysis for paclo bu trazol was conducted th at directly inco rpor ated potential drinking w a ter residue s . The acute popul ation adju sted dose (aPAD) is 0.3 mglkg/day for all popu l ations and population s ub groups. Acute risk from the dietary (drinkin g w ater) exposure to paclobutrazol i s not of concern (less than I 00%) for the general U.S. population and any popul at ion subgroup. At th e 95 1 h percentile , the estimated exposure to the general U.S. population is 0.051528 mg/kg/day which is equivalent to an estimated ri sk of 17 %of the aPAD. The estimat ed exposure for the highest exposed p opulat ion subgroup , all infants

Page 2 of 10Paclobutrazol Dietary Exposure and Risk Assessment DP Number: 0419143 PC Code: 12560 I



### < 1 year old, is 0.161395 mg/kg/day which is equivalent to an estimated risk of 54% of the aPAD. Chronic Dietary (Drinking Water only) Exposure Assessment An unrefined chronic dietary analysis for paclobutrazol was conducted that directly incorporated potential drinking water re sidues
. Th e chronic popu l ation adjusted dose (cP AD) is 0.11 mg/ kg /day for all populations and population subgroups. Chronic risk from the dietary (drinking water) exposure to paclobutrazol is not of concern (less than 1 00%) for the general U.S. population and any population subgroup. The estimated exposure to the general U.S
. population is 0
. 013024 mg/kg/day which is equivalent to an estimated risk of 12% ofthe cPAD. The estimated expos ure to the highest exposed population subgroup, all infants < 1 year old is 0.033582 mg/kg/day which i s equivalent to an estimated risk of31% of the cPAD
. . For additional characterization of the primary risk driver (water), acute dietary result s for (water only) are li sted in Table 3. Cancer Dietary Exposure Paclobutrazol currently has no registered food uses; carcinogenicity studies are not required for non - food use pestic i des under the 40 CFR Part 158 Tox i cology Data Requirements
. However, carcinogenicity studies were reviewed by the RID Peer Committee (TXR 0011081 ). At that time the Agency was unable to determine the potential carcinogenicity of paclobutrazol because the maximum tolerated dose (MTD) was not achieved in the 2-year carcinogenicity / chronic study in rats and in mice. The carcinogenic potential of paclobutrazol and the need for a cancer dietary assessment will be re-evaluated if the use pattern changes (i.e., food uses are proposed). Since the Agency has not classifi ed the carcinogenic potential of paclobutrazol a cancer aggregate risk assessment was not conducted at this time.
I. Introduction Paclobutrazo l (

### aR, l)R) -rel-P-[( 4

- ch lorophenyl) methy l]

- a-( 1 , 1-dimethyl ethyl)-1 H-1 ,2,4-triazole1-ethanol i s a triazole plant growth regulator. There are a number of currently registered label s for paclobutrazol with formulations including liquids, wettable powders, and granular. It is currently used as a foliar spray for registered turf use patt erns; a fo liar spray for ornamentals in greenhouses and nurseries; as a tree injection; as a tree root drench; and as a seed treatment. There are currently no re g istered food use s for paclobutrazol. Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assess ments, the risk is expressed as a percentage of a maximum acceptable dose (i .e. , the dose that HED has concluded will r esult in no unreasonable adverse health effects). Thi s 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 unc ertaint y or safety factors. For acute and non - cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% ofthe PAD. References that discuss the acute and chronic risk assessments in more detail a re available on the EP A/pestic ides web site: "Available Information on Assessing Exposure from Pesti cides, A Use r's Guide ," 21-JUN-2000, Web-link: Page 3 of 10Paclobutrazol Dietary Exposure and Ri sk Assessment DPNumber: 0419143 PC Code: I 2560 I http: //www.epa.gov /fedrgstr /EPA -PE S T / 2000/Ju ly/Day-l2/6061.pdf or see SOP 99.6 (20-AUG

19 99). Th e most recent dietary risk assess ment for paclobutrazol was conducted by S. Piper (09/ 1112013, DP Number : D394230).


### II
. Residue Information This assessment i s for drinking water only as there are no registered/proposed uses which result i n residues inion food commod ities ; therefore a discussion of residue information is not re levant to this ac tio n.


### III. Percent Crop Treated The current ass ess ment consider s only resi dues in drinking water; th eref ore, perce nt crop tre ate d informat ion was not us ed for this dietary assessment.


### IV
. Drinking Water Data The drinking g round water EDWCs used in the dietary ri s k assessment were provided by the Envi ronmental F ate and Effec ts Division (EFED ) in the followi n g memorandum : Revised " Tier I Dri nki ng Water Assessme nt for the Registration Revi ew of Paclobutrazol on T urf (co mmerc ial , orn ame ntal and gol f courses), Ornamental and Shade Trees, and Seed Treatment of Tomato, Pepper, and Cucurb it ," T ab le 1 (D418301 , F. Kahn, 03 / 1 3/20 14), and incorporated directly into this dietary assessment. Wo rst case scena r io for estimated drinki ng water co ncentrations were p rovided by PRZM-GW for groun d water and used in this assessment. Water residues were incorporated in th e DEEM-F C ID TM into the food categorie s "water , direct , all sources" and "water, indirect, a ll source s." Th e residues of concern knowledgebase subcommi ttee (ROCKS), has recentl y determined t h at th e residues of concern (ROC) in drinking water are the parent compound and its ketone analog (CGA 1 49907 ). Since EFED completed their drinkin g water as sess ment prior to the ROCK S determination of t h e drinking water re s idu es of concern; HED no tes that E FED took a total residue approach whic h overest imates residues. H owever, s in ce no dietary risks of concern were identified, a re vised drinki ng wat er asse ssment, which included only the recommended residues
· of concern, was not conducted.

Th ere are no monitoring d ata curre ntl y avai lable for paclobutrazol or its residues of co nc ern in drinking water. Estim ated groundwater EDWCs were calcula t ed u sing comp uter model in g metho ds , the sc reen ing m ode l PRZM-GW model (Pesticide Root Zone Model for Ground wate r, version 1.0, August 31, 20 12)
. Ground drinking water modeling was conducted u si ng the highest application rate scenario whi ch is 6. 1 lbs/A fo r nursery production of co ntainer-grow n ornament als through a soil drench method. This rate was normali zed wit h the lowest fraction (0
. 59) of pacl obutrazo l retained in the so il column leaching study which resul ted in an effective Page 4 of 10Paclobutrazol Dietary Exposure and Risk Assessment DPNumber : D419143 PC Code: 12560 I modeled drinking water app lication rate of 2.5 lbs/A. The maximum ground water EDWCs used in the dietary risk assessment for paclobutrazol including the two soil degradates are shown in Table 1
. Descriptions of all executable versions of curre nt models used in drinkin g water exposure can be obta ined from URL link (http: //www.epa.gov/oppefed1 /mode l s / water D
. Table 1. Estimated Maximum Drinking Water Environmental Con centrations (EDWCs) for Paclobutrazo l Drinking Water Average Source (model) Use Application Acute Chronic Simulation (modeled rate) Method (pg/L) (pg!L) Breakthrough Time (days) Total Res idue (Paclobutrazol plus CGA 149907 and N OA 457654) Surface Water Nursery: Drench 255.3 b 166.2 b (F IRST) (lap p . X 2.50 lbs a i/acre) Ground Water Nursery : Drench 25.0 25.0 (SC IGROW) (lap p . X 2.50 lb s ai/acre) G roundwater Nursery: Drench 945.0b 622.0b 868 (PRZ M-GW) ( lap p. X 2.50 lbs ai/ acre) High sol ubility (760000 mg/L) and very low KJ (0.16 Ukg) ofNOA457654 are the drivers of hi g h concentrations for total toxic residue B Bolded values are recomm ended for human health concern s . 

### V. DEEM

-FCIDTM Program and Consumption Information P aclob utrazol acute and chronic dietary exposure assessments were conducted using the Dietary Expos ure Evaluation Model softw are with the Food Commodity Intake D atabase DEEMFC IDTM , Version 3.16, which incorporates con s umption data from USDA's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary s urvey was conducted from 2003 to 2008. The data are based on the reported consumption of more than 20,000 individuals over two non-con secutiv e survey days. Foods "as consumed" (e
. g., apple pie) are linked to EP A-defmed food commodities (e.g. apples , peeled fruit- cooked ; fresh or N/ S ; baked; o r wheat flour

- cooked; f res h or N/ S, baked) usin g publicly available recipe trans lation flie s developed j ointly by US D A/ARS and EPA. For chronic exposure assessment , consumption data are averaged for the entire U.S. popu l ation and w ithin populat ion subgroup s, but for acute exposure assessment are retained as individual consumption events. Based on analysis of the 200 3 -2008 WWEIA consumption data , which took into account di etary pattern s and survey respondent s, HED concluded that it i s mo st 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 1 3-49, and adults 50-99 years old. For chronic dietary exposure assessment , an est imate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for t hat food/food form to produc e a resi du e intake estimate. The resulting re s idue intak e estimate for each food/food form is summed with the res idue intake Page 5 of 10Paclobutrazol Dietary Exposure and Risk Assessment DPNumber: 0419143 PC Code: 12560 I 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 percent of the cPAD
. This procedure is performed for each population subgroup. For acute exposure assessments , individua l one-day food consumption data are use d on an individual-by-individual basi s. The reported consumption amount s of each food item can be mul tiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or "matched" in multip le random pairings with residu e values and then summed in a probabilistic assessment. The resulting 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 i d not) basis . In accordance with HED po licy, per capita exposure and risk are reported for analyses performed at all levels of refinement. However, for deterministic assessments, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.
VI. Toxicological Information The toxicology database is complete for this non - food use chemical. The registrant has submitted an acceptable/guideline acute neurotoxicity study, which has been incorporated into the revised Registration Review risk assessment. In addition, based on the weight of the evidence (W OE) approach it was further recommended that the subchronic neurotoxicity , the subchronic inhalation and the immunotoxicity studies can each be granted data waivers ( Leshin , 2014, TXR # 0056914). Acute Dietary (General Population): Quantification of acute dietary (drinking water only) risks was performed u si ng the acute neurotoxic ity study in rats (MRID 49211902) with a NOAEL of 30 mg/kg, The acute refere nce dose (aRID) for the general population was calculated to be 0.3 mg/kg/day Acute Dietary (Females 13-49): The most sensitive point of departure was 10 mglkg/day from the developmental rat study (MRI D 00143158), with a LOAEL of 40 mglk g/day. The acute reference dose (aRID) for f emales 13

- 49 was calculated to be 0.1 mg/kg/ day. Chronic Dietary: Quantification of chronic dietary (drinking water only) risk s was performed using the 2-year chronic/ carcinogenicity feeding study in rats with a NOAEL of 10.8 mglkg/day and the LOAEL of 54.2 mglkg/day. The chronic reference dose (cRfD) was calculated to be 0.11 mg/kg/day. An Uncertainty Factor (UF) of 100 was applied to account for inters pecies extrapolation ( 1 OX) and intraspecies variability (I 

### OX). An Uncertainty Factor (UF) of 100 was applied to account for inter species extrapo l ation (1 

### OX) and intraspecies variability ( 1 

### OX).

Page 6 of 10Pacl o butrazol Dietary Exposure and Risk Assessment DPNumbe r : 0419143 PC Code: 12560 I

Table 2. Summary of Tox i co logic al Points of Departure and Endpoints Used for Dietary (Drinking Water OnI)) and Nonoccupational Expos ure to Paclobutrazol Exposure/ Point of Unce rtai Level of Concer n for Scenario Departure nty Risk Assessment Study and Toxicological Effects Factors Acute Neurotoxi city S tu dy ( Rats) NOAEL=30 U FA=IOx 30 mglkg NQAEL MRI D 4921 1902 LOAEL = 15 0 mg/kg , Acute Dietary m g/

kg/day UFH = IO x 100 (UF) bas ed on transient alterations in motor General Population activity (decreased re a ring and decrease d aRID = 0.3 mg/kg/day subsession distances in females 3-4 hours after dosing) D evelopmental T oxicity in Rats I 0 m!llkg/d ay NOAEL MRIO 00 143158 ) De ve lop mental NOAE L= 10 UFA= I Ox LO AEL = 40 m g/kg/day, based on p a rtial Acute D ietary mg/kg/day UFH=IOx 100 (UF) ossification of the 7 1h verte bra and an Females 13-49 yrs . increased inciden ce of 14th rib on a feta l aRID = 0.1 mg/kg/day and litter basis at a dose that was not maternally toxic
. C hronic (2-Year Rat) Feeding T oxicity NOAEL=10
. 8 UFA= IOx 10 .8 mg/kg!day NOAEL MRIO 4073430 1 LOAEL 

### = 54
.2 Ch ro nic Dietar y mg/kg/ day , based on increased liver All Populations mglkg/day UFH= IOx 1 00 (U F) weights ( both sexes) , hypertrophy, and cRfO = 0.1 1 mg/kglday steatosis (both sexes) and decreased trigl yce rides (females) Ca ncer ( ora l, Not requi re d for non-food use pestic ides
. dermal, inhalation) NOA EL- no observed adve r se effect l evel. LOAE L - l owes t observed adverse effect level. U F = un certamty fact or. UFA - extrapolation f r o m animal t o human (interspccies)
. UFH = potential variation in sensitivity among members of the hum an popu lation (intra - species)
. MO E= margin of expos ure . RID = referen ce dose
. PAD = po pulation adjusted dose (acute = aPAD and ch r onic= cPAD)


### VII. Results/Discussion As stated above , fo r acute and chronic assessme nts, HED is concern ed w hen d ietary risk exceeds 10 0% of the PAD. The DEEM-FCIDTM a n a lyses estimate the di eta ry exposure oft h e U.S. population and all population subgroup s. The result s re ported in Table 3 are for the ge n eral U.S. Population, a ll in fants (<1 year old), chi ldren 1

- 2, children 3-4, chi ldren 6 -1 2, youth 13-19 , females 13

- 49 , adu lt s 20-49 , and adults 50 -99 years. At the 95 th percentile, the acute dietary exposure (drinking water only) to general US population is 0.051528 mg/kg/day which is equivalent to an estimated risk of 17 %of the aPAD , and th e mo st highly expose d subgroup , all infants 

### < 1 year o ld , is 0.161395 mglkg/day which is equivalent to an esti mated ri s k of 54% of the aPAD. Th e chronic dietary expo s ure to general US population is 0. 013024 mg/kg/ day which is equivalent to an estimated risk of 12 % of the cPAD , and the mo s t hi ghl y exposed subgroup , all infants < 1 year old is 0.03358 2 mg/kg/day w hi c h is equi va lent to an estimated risk of 3 1 % of the cPAD. All of the dietary ri sk estimate s are below 1 00% o f the PAD s.

Page 7 of 10Paclobutr azo l Di etary Expo s ure and Ris k A sse ssment DP Numb er : 0419143 PC Code : 1 25 601 A summary of the dietary exposure analyses is given in Tab le 3. Tab le 3. Summa ry o f Di et a r y Ex po s ure a nd Ri s k for Paclobu t r azol DRINKING W ATE R O NLY a P A D A cu te R es ults C hro ni c R es ults Ca n ce r R es u lts 95 1 h P er ce ntil e P o pul ation Sub g r o u p ( m g/kg Expo s ur e % Exp os ure % Ex p os ure 

## I % /da y) ( mg/ke/ da y } aPAD (mg/ kg/ d ay) a PAD ( mg/ ke/ d a y) aPAO General U
. S
. Population 0.051528 1 7 0.0 13024 12 All Inf a nt s (< I year old ) 0.161395 54 0.033582 31 Children 1-2 years old 0.0 7 9458 27 0.018788 17 Children 3- 5 years old 0.3 0
.064474 22 0.0158 2 9 14 Children 6-12 years old 0.049263 16 0.011416 10 Not Appl icabl e Youth 13-19 years old 0.042913 14 0.009498 9 Adult s 20-49 years o l d 0.050707 17 0
.012994 12 Adult s 50-99 ye ars o l d 0.045169 15 0
.01 2 846 12 Fema les 1 3 -49 years old 0
. 1 0.051429 51 0.01294 7 12 1 Valu es f o r th e populat1on wtth th e h1ghes t nsk are bold ed
. 2 Not Appli cabl e; no acute dietary e ndpoint was identifi ed for these population s ubgroup s 

### VIII. C h aracterization of Inputs There are no food uses for thi s chemical ; accordingly the dietary risk assessment c o nsidered residues in drinking water only. This assessment used health protective, screening level, modeled estima te s of drinking water concentrations. Th e drinking water concentration estimates could be further refined, however , since no risks of concern were identifi ed, no further refineme nt is required.


### IX. Conclusions No acute or chronic dietary (drinking water on ly) risks of concern were identified for paclobutrazol. The acute and chronic dietary exposure and risk assessments are based on conservative inputs and are unlikely to underestimate risk to the general U.S. population or any population subgroup. Thi s analysis is an unrefined assessment based on drinking water only
. 

### X. List of Attachments Attachment I. Acute Water Input file and Acute Results file ( General Population and Female s 13-49 yrs. ) Attachment 2. Chronic Water Input file and Chronic Results file

Page 8 of 10Paclobutrazol D ietary Exposure and Ri s k Assessment DP Number: 0419143 PC Code : 12560 I 

### Attachment 1 Acute Water Input file 

### (General Populations and Females 13-49 y ears) US EPA Ver. 3.18, 03-08- d DEEM-FCID Acute ana l ysis for PAC L O

BUTRAZOL Re si due file na me: C:\Users\pbarnes\Document s\DEE M RES U LTS\PACLOBUTRAZOL\Pa cl obutrazo l Acute Gen_Pop and Females 13_49 yrs wat er_on ly.r08 Analysis Date 10

- 22

- 2014 R esidue file dated: 10

- 22-2014/09:47:00 Reference dose: aRfD 

### = 0.3 mg/kg bw/day NOEL 

### = 30 mg/kg bw/day Comment: Gen_Pop 0 .3 mg/kg body wt/day and Females 13-49 yrs. 0.1 mg/kg body wt/day Water only EPA Crop Def Res Adj.Factors Comment Co de Grp Food N ame (ppm) # 1 #2

- --- - - --- - 

### ------- ---- ------------- --- ---- ---------- 

## ------- 8601000000 86A Water, direct, all sources 0.945000 1.000 1.00 0 8602000000 868 Water, indirect , all sources 0.945000 l. 000 1.000 

### Acute Results file (General Population and Females 13- 49 yea rs) US EPA Ver. 3.18, 03

- 08 -d DEE M -FCID ACU TE Analy s i s for P A

CLO BU TRAZOL NHANES 2003-2008 2 -Day Residue file: Paclo b utrazol Acute Gen

_ Pop and Fe m ales 13_49 yrs wa ter_only.r08 Adjustment factor #2 used. Analysis Date: 10

- 22-2014/09:49:16 Residue file dated: 10 -22- 2014/09:47:00 NOE L (Acute ) 

### = 30.000000 mg/kg body-wt / day Acute Pop Ad ju sted Dose (aPAD ) varies with population; see individual report s RAC/FF intake summed over 24 hours Run Comment: "G en

_ Pop 0.3 mg/kg body wt/day and F emales 13-49 yrs. 0.1 mg/kg body wt /day Wate r onl yR 

### =========== == =========== === ==== === ==== === === == = ======= == == ==== ==== = === ==== ==== = Summary calculat ions --p er capita : 95th Perc entile

---- 99th Percentile----

-- -99.9th Percentile---

- Exposure % a PAD MOE Exposure % a PAD MOE Exposure % a PAD MOE



### - --------- ---- - -- ---- ---- -- ------ -- 

### --- --- - 

## -- ------ -- -------- ------- - - ----- - Total 

### us Pop u lation : 0
. 051528 17 .18 582 0. 084971 28.32 353 0. 16 1414 53 .8 0 185 A ll Infants: 0
. 161395 53.80 185 0
. 218607 72.87 137 0 .320395 106.80 93 Children 1-2: 0.079458 26 .49 377 0
. 119648 39.88 250 0 .294659 98 .2 2 101 Children 3-5: 0.064474 21.49 465 0.098744 32
. 91 303 0. 1 58497 52.83 189 Children 6-12 : 0. 049263 16.42 608 0.080847 26.95 371 0
. 124610 41. 5 4 240 Youth 13-19: 0
. 042913 14.30 699 0
. 070679 23.56 424 0.10 6 713 35.57 281 Adults 20-49: 0.050707 16.90 591 0
. 075460 25
. 15 397 0.109780 36.59 273 Adults 50-99: 0.045169 15.06 664 0
. 068488 22.83 438 0.107958 35 .99 277 Female 13

- 49: 0.051429 51.43 583 0.075627 75
. 63 396 0. 1 06061 106.06 282

Page 9 of 10Paclobutrazo l Dietary Exposur e and R isk As sess ment PC Code: 12560 I Atta chment 2 C hronic Water Input file (All Popu lations) US EPA DEE M

- FCID Chroni c ana l ysis for PA C

LOBUTRAZOL DP Number: 04 1 914 3

Ver. 3
. 1 6, 03-08-d Residue file: C: \Users\pbarnes\Docu m ents \DEE MRES U LTS \PACLOBUTRA ZOL\Paclobu trazo l Chron ic Al l
_ Popu l ations water_only.r08 Adjust. #2 used Analysis Date 10-16-2 01 4 Residue file dated: 10

- 16

- 2014/16 :58: 17 Reference dose (RfD) = 0.11 mg/kg bw / day Comment :Al l Po pulations Water only

Food Cro p Residue Adj.Factors EPA Code Grp Food Name (ppm) # 1 #2



## ----- ----- --- --- --- --- - ---- -------------- 

### ------ -- -- 8601000000 86A Wa ter , dir ect, all sources 0
. 6 2 20 0 0 1. 000 1
. 000 86020 000 0 0 86B Wa ter, i ndirect, a l l sou rces 0
. 6 2 2000 1.000 1.000 C h ronic Res ults file (A ll popula tions) US EPA Ver
. 3.16, 03

- 08

- d DEEM-FCID Chronic ana ly sis for PACLOBUTRAZOL NHANES 2003-2008 2

- day Residu e file name: C : \Users\pb a rnes \ Doc uments\DEEMRE SULTS \PACLOBUTRAZOL\Pacl obutraz ol Chroni c Al l Populations wate r _on l y.r 08 Adjustmen t factor #2 used. Analysis D ate 1 0 -16- 2 0 1 4/16:59:39 Res i due fi le date d : 1 0

- 1 6-20 1 4/16:58 : 1 7 R

eference dose (RfD , Chr onic) = .11 mg/kg bw/day COMMENT 1: Al l Pop u lat io ns Water o nl y ======== == == = = ====== ======= = ==== = ===== === ==a= =========== ================== = == = = Total e xposu re by popu lat i o n subgroup

Populat i on

Subgroup Total US Populatio n Hi span i c Non-Hisp

- White Non-Hisp-Black Non-Hisp

- Other N

ursing Infa n ts Non-Nur s ing Infants Fema l e 13+ PREG Children 1-6 Children 7 -12 M

ale 13

- 19 Female 13

- 19/NP Male 20 + Fe ma le 20 +/NP Seniors 5 5+ All Infants Female 13

- 50 Childre n 1

- 2 Children 3

- 5 Children 6

- 12 Youth 13-19 Adults 2 0-49 Adults 50

- 99 Female 13 -4 9 Tot al Exposure mg/kg body wt/day 0 .0 130 24 0 .0 12 435 0. 0 133 96 0.010 747 0.01 5 0 11 0.0 11783 0.043319 0.012263 0.016681 0.010858 0.008953 0.010032 0. 01 2 13 4 0.013680 0
. 012592 0. 03 3 582 0.0129 61 0.018788 0.01 5829 0. 011416 0.009498 0
. 012994 0.012846 0.0129 47

Page 1 0 o f 1 0 Percent of Rfd 11.8% 1 1 .3% 12. 2%

9.8% 13.6% 10
. 7% 39.4% 11.1% 15.2%

9.9% 8.1% 9.1% 1 1 .0% 12.4% 1 1 .4% 30.5% 11.8% 17.1% 14. 4% 10 .4%

8.6% 11. B% 11.7% 1 1.8%