Paclobutrazol 

PC Code: 125601 

Dietary Exposure and Risk Assessment DPNumber: D419143 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Office of Chemical Safety 

and Pollution Prevention 

MEMORANDUM 

Date: 01/21/2015 

SUBJECT: Paclobutrazol. Acute and Chronic Dietary (Drinking Water Only) Exposure and 

Risk Assessments 

PC Code: 125601 

Decision No.: 486346 

Petition No.: NA 

DP Barcode: D419143 

Registration No.: NA 

Regulatory Action: NA 

Risk Assessment Type: Dietary assessment Case No.: 7002-1 

TXRNo.:N/A CAS No.: 76738-62-0 

MRIDNo.: N/A 40 CFR: 180.220 

FROM: 

THROUGH: 

P. 

Risk 

Health 

Yvonne 

Assessment 

Effects 

Barnes, 

Division 

Branch 

Chemist 

(HED) 

VI (RAB 

(7509P) 

~~ VI) ~ 

Thomas Bloem, Chemi --~ ~ J 1 

William D. Cutchin, Chemist }A_. d'. h[ 

Dietary Exposure Science Advisory Council (DESAC) 

and 

Donna S. Davis, Acting Chief ~a-­ RAB VIIHED (7509P) 

TO: K.hue Nguyen 

Risk Management 

Registration Division (7505P) 

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Paclobutrazol Dietary Exposure and Risk Assessment DP Number: 041 9143 

PC Code: 12560 I 

Executive Summary 

Paclobutrazol acute and chronic dietary exposure assessments were conducted using the Dietary 

Exposure Evaluation Model software with the Food Commodity Intake Database DEEMFCIDTM, Version 3.16, which incorporates consumption data from USDA's National Health and 

Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary 

survey was conducted from 2003 to 2008. These analyses were performed to support the risk 

assessment for paclobutrazol. This memorandum was reviewed by two peer reviewers of the 

DESAC, per DESAC SOP 2012.1. 

Paclobutrazol is a member of the class of compounds known as the triazoles (a.k.a. triazolederivative fungicides., T-D fungicides, conazoles). In 2006, HED issued aggregate human health 

risk assessments for triazole (T) and the conjugated triazole metabolites (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 registered/proposed paclobutrazol uses. There were no dietary risk of concern 

identified for triazole and its regulated metabolites. 

Attached are acute and chronic dietary risk assessments for drinking water only. Although there 

are no registered food uses for paclobutrazol, dietary exposure is possible through drinking 

water; therefore acute and chronic dietary risk assessments were conducted for the parent 

compound and its regulated metabolites, excluding T, TA, T AA, and TP. 

The estimated groundwater estimated drinking water concentrations (EDWCs) were calculated 

using the screening computer model PRZM-GW (Pesticide Root Zone Model for Groundwater, 

version 1.0, August 31, 2012). Ground drinking water modeling was conducted with the highest 

application rate scenario which is 6.1 lbs/ A for nursery production of container-grown 

ornamentals through a soil drench method. This rate was normalized with the lowest fraction 

(0.59) of paclobutrazol retained in the soil column leaching study which resulted in an effective 

modeled drinking water application rate of2.5 lbs./A. These maximum ground water EDWCs 

were used in dietary risk assessment for paclobutrazol. HED notes that EFED completed their 

drinking water assessment prior to the determination that only the parent compound, and its 

ketone analog (CGA 149907) were residues of concern in drinking water. However, EFED' s 

drinking water assessment took a total residue approach and is expected to overestimate residues. 

Since no dietary risks of concern were identified, a revised drinking water assessment, which 

included the appropriate residues of concern and would result in lower estimated risks was not 

conducted. 

Acute Dietary (Drinking Water Only) Exposure Assessment 

An unrefined acute dietary analysis for paclobutrazol was conducted that directly incorporated 

potential drinking water residues. The acute population adjusted dose (aPAD) is 0.3 mglkg/day 

for all populations and population subgroups. Acute risk from the dietary (drinking water) 

exposure to paclobutrazol is not of concern (less than I 00%) for the general U.S. population and 

any population subgroup. At the 951

h percentile, the estimated exposure to the general U.S. 

population is 0.051528 mg/kg/day which is equivalent to an estimated risk of 17 %of the aPAD. 

The estimated exposure for the highest exposed population subgroup, all infants 

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Paclobutrazol 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 residues. The chronic population 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 exposure to the highest exposed population subgroup, all infants < 1 year old is 

0.033582 mg/kg/day which is equivalent to an estimated risk of31% of the cPAD . . For 

additional characterization of the primary risk driver (water), acute dietary results for (water 

only) are listed in Table 3. 

Cancer Dietary Exposure 

Paclobutrazol currently has no registered food uses; carcinogenicity studies are not required for 

non-food use pesticides under the 40 CFR Part 158 Toxicology 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 classified the carcinogenic potential of paclobutrazol a cancer aggregate risk 

assessment was not conducted at this time. 

I. Introduction 

Paclobutrazol ( aR, l)R)-rel-P-[( 4-chlorophenyl) methyl]-a-( 1, 1-dimethylethyl)-1 H-1 ,2,4-triazole1-ethanol is a triazole plant growth regulator. There are a number of currently registered labels 

for paclobutrazol with formulations including liquids, wettable powders, and granular. It is 

currently used as a foliar spray for registered turf use patterns; a foliar 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 registered food uses for paclobutrazol. 

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% ofthe 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: 

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Paclobutrazol Dietary Exposure and Risk Assessment DPNumber: 0419143 

PC Code: I 2560 I 

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-l2/6061.pdf or see SOP 99.6 (20-AUG1999). 

The most recent dietary risk assessment for paclobutrazol was conducted by S. Piper 

(09/ 1112013, DP Number: D394230). 

II. Residue Information 

This assessment is for drinking water only as there are no registered/proposed uses which result 

in residues inion food commodities; therefore a discussion of residue information is not relevant 

to this action. 

III. Percent Crop Treated 

The current assessment considers only residues in drinking water; therefore, percent crop treated 

information was not used for this dietary assessment. 

IV. Drinking Water Data 

The drinking ground water EDWCs used in the dietary risk assessment were provided by the 

Environmental Fate and Effects Division (EFED) in the following memorandum: Revised "Tier I 

Drinking Water Assessment for the Registration Review of Paclobutrazol on Turf (commercial, 

ornamental and golf courses), Ornamental and Shade Trees, and Seed Treatment of Tomato, 

Pepper, and Cucurbit," Table 1 (D418301 , F. Kahn, 03/ 13/2014), and incorporated directly into 

this dietary assessment. Worst case scenario for estimated drinking water concentrations were 

provided by PRZM-GW for ground water and used in this assessment. Water residues were 

incorporated in the DEEM-FCIDTM into the food categories "water, direct, all sources" and 

"water, indirect, all sources." 

The residues of concern knowledgebase subcommittee (ROCKS), has recently determined that 

the residues of concern (ROC) in drinking water are the parent compound and its ketone analog 

(CGA 149907). Since EFED completed their drinking water assessment prior to the ROCKS 

determination of the drinking water residues of concern; HED notes that EFED took a total 

residue approach which overestimates residues. However, since no dietary risks of concern were 

identified, a revised drinking water assessment, which included only the recommended residues 

· of concern, was not conducted. 

There are no monitoring data currently available for paclobutrazol or its residues of concern in 

drinking water. Estimated groundwater EDWCs were calculated using computer modeling 

methods, the screening model PRZM-GW model (Pesticide Root Zone Model for Groundwater, 

version 1.0, August 31, 20 12). Ground drinking water modeling was conducted using the 

highest application rate scenario which is 6. 1 lbs/ A for nursery production of container-grown 

ornamentals through a soil drench method. This rate was normalized with the lowest fraction 

(0.59) of paclobutrazol retained in the soil column leaching study which resulted in an effective 

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Paclobutrazol Dietary Exposure and Risk Assessment DPNumber: D419143 

PC Code: 12560 I 

modeled drinking water application 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 current models used in drinking water exposure can be 

obtained from URL link (http://www.epa.gov/oppefed1/models/waterD. 

Table 1. Estimated Maximum Drinking Water Environmental Concentrations (EDWCs) for 

Paclobutrazol 

Drinking Water Average 

Source (model) Use Application Acute Chronic Simulation 

(modeled rate) Method (pg/L) (pg!L) Breakthrough 

Time (days) 

Total Residue (Paclobutrazol plus CGA 149907 and NOA 457654) 

Surface Water Nursery: Drench 255.3b 166.2 b (FIRST) (lapp. X 2.50 lbs ai/acre) 

Ground Water Nursery: Drench 25.0 25.0 (SCI GROW) (lapp. X 2.50 lbs ai/acre) 

Groundwater Nursery: Drench 945.0b 622.0b 868 (PRZM-GW) ( lapp. X 2.50 lbs ai/acre) 

High solubility (760000 mg/L) and very low KJ (0.16 Ukg) ofNOA457654 are the drivers of high concentrations for total toxic residue 

B Bolded values are recommended for human health concerns. 

V. DEEM-FCIDTM Program and Consumption Information 

Paclobutrazol acute and chronic dietary exposure assessments were conducted using the Dietary 

Exposure Evaluation Model software with the Food Commodity Intake Database DEEMFCIDTM, Version 3.16, which incorporates consumption data from USDA's National Health and 

Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary 

survey was conducted from 2003 to 2008. The 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 EP A-defmed 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 flies 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, 

but for acute exposure assessment 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 chronic dietary exposure assessment, an estimate 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 that food/food form to produce a residue intake estimate. 

The resulting residue intake estimate for each food/food form is summed with the residue intake 

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Paclobutrazol 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, 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 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 did not) basis. In accordance with HED policy, 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 (WOE) 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 using the acute neurotoxicity study in rats (MRID 49211902) with a NOAEL of 

30 mg/kg, The acute reference 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 (MRID 00143158), with a LOAEL of 40 mglkg/day. The acute 

reference dose (aRID) for females 13-49 was calculated to be 0.1 mg/kg/day. 

Chronic Dietary: Quantification of chronic dietary (drinking water only) risks 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 interspecies extrapolation ( 1 OX) 

and intraspecies variability (I OX). An Uncertainty Factor (UF) of 100 was applied to account for 

interspecies extrapolation (1 OX) and intraspecies variability ( 1 OX). 

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Paclobutrazol Dietary Exposure and Risk Assessment DPNumber: 0419143 

PC Code: 12560 I 

Table 2. Summary of Toxicological Points of Departure and Endpoints Used for Dietary (Drinking 

Water On I)) and Nonoccupational Exposure to Paclobutrazol 

Exposure/ Point of Uncertai Level of Concern for 

Scenario Departure nty Risk Assessment Study and Toxicological Effects 

Factors 

Acute Neurotoxicity Study (Rats) 

NOAEL=30 UFA=IOx 30 mglkg NQAEL MRI D 4921 1902 LOAEL = 150 mg/kg, 

Acute Dietary mg/kg/day UFH= IOx 100 (UF) based on transient alterations in motor 

General Population activity (decreased rearing and decreased 

aRID = 0.3 mg/kg/day subsession distances in females 3-4 hours 

after dosing) 

Developmental Toxicity in Rats 

I 0 m!llkg/day NOAEL MRIO 00 143158) Developmental 

NOAEL= 10 UFA= IOx LOAEL = 40 mg/kg/day, based on partial Acute Dietary mg/kg/day UFH=IOx 100 (UF) ossification of the 71

h vertebra and an Females 13-49 yrs. increased incidence of 14th rib on a feta l aRID = 0.1 mg/kg/day and litter basis at a dose that was not 

maternally toxic. 

Chronic (2-Year Rat) Feeding Toxicity 

NOAEL=10.8 UFA= IOx 10.8 mg/kg!day NOAEL MRIO 40734301 LOAEL = 54.2 

Chronic Dietary mg/kg/day , based on increased liver 

All Populations mglkg/day UFH= IOx 100 (UF) weights (both sexes), hypertrophy, and 

cRfO = 0.1 1 mg/kglday steatosis (both sexes) and decreased 

triglycerides (females) 

Cancer (oral, Not required for non-food use pesticides. dermal, inhalation) 

NOAEL- no observed adverse effect level. LOAEL - lowest observed adverse effect level. UF = uncertamty factor. UFA - extrapolation from 

animal to human (interspccies). UFH = potential variation in sensitivity among members of the human population (intra-species). MOE= margin 

of exposure. RID= reference dose. PAD = population adjusted dose (acute = aPAD and chronic= cPAD) 

VII. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 

100% of the PAD. The DEEM-FCIDTM analyses estimate the dietary exposure ofthe U.S. 

population and all population subgroups. The results reported in Table 3 are for the general U.S. 

Population, all infants ( <1 year old), children 1-2, children 3-4, children 6-12, youth 13-19, 

females 13-49, adults 20-49, and adults 50-99 years. 

At the 95th 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 the 

most highly exposed subgroup, all infants < 1 year old, is 0.161395 mglkg/day which is 

equivalent to an estimated risk of 54% of the aPAD. The chronic dietary exposure to general 

US population is 0.013024 mg/kg/day which is equivalent to an estimated risk of 12 % of the 

cPAD, and the most highly exposed subgroup, all infants < 1 year old is 0.033582 mg/kg/day 

which is equivalent to an estimated risk of 31 % of the cPAD. All of the dietary risk estimates 

are below 100% of the PADs. 

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Paclobutrazol Dietary Exposure and Risk Assessment DP Number: 0419143 

PC Code : 125601 

A summary of the dietary exposure analyses is given in Table 3. 

Table 3. Summa ry of Dieta ry Exposure and Risk for Paclobutrazol DRINKING WATER ONLY 

a PAD Acute Results Chronic Results Cancer Results 951

h Percentile 

Population Subgroup (mg/kg Exposure % Exposure % Exposure I % /day) (mg/ke/day} aPAD (mg/kg/day) a PAD (mg/ke/day) aPAO 

General U.S. Population 0.051528 17 0.0 13024 12 

All Infants (<I year old) 0.161395 54 0.033582 31 

Children 1-2 years old 0.079458 27 0.018788 17 

Children 3-5 years old 

0.3 

0.064474 22 0.015829 14 

Children 6-12 years old 0.049263 16 0.011416 10 Not Applicable 

Youth 13-19 years old 0.042913 14 0.009498 9 

Adults 20-49 years old 0.050707 17 0.012994 12 

Adults 50-99 years old 0.045169 15 0.01 2846 12 

Females 13-49 years old 0.1 0.051429 51 0.012947 12 

1 Values for the populat1on wtth the h1ghest nsk are bolded. 2 Not Applicable; no acute dietary endpoint was identified for these population subgroups 

VIII. Characterization of Inputs 

There are no food uses for this chemical; accordingly the dietary risk assessment considered 

residues in drinking water only. This assessment used health protective, screening level, 

modeled estimates of drinking water concentrations. The drinking water concentration estimates 

could be further refined, however, since no risks of concern were identified, no further 

refinement is required. 

IX. Conclusions 

No acute or chronic dietary (drinking water only) 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. This 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 Females 

13-49 yrs.) 

Attachment 2. Chronic Water Input file and Chronic Results file 

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Paclobutrazol Dietary Exposure and Risk Assessment DP Number: 0419143 

PC Code: 12560 I 

Attachment 1 

Acute Water Input file (General Populations and Females 13-49 years) 

US EPA Ver. 3.18, 03-08-d 

DEEM-FCID Acute anal ysis for PACLOBUTRAZOL 

Re sidue file name: C:\Users\pbarnes\Documents\DEEMRESULTS\PACLOBUTRAZOL\Paclobutrazol 

Acute Gen_Pop and Females 13_49 yrs water_only.r08 

Analysis Date 10 - 22 - 2014 Residue 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 

Code Grp Food Name (ppm) #1 #2 

---------- ------------------------------- ---------- ------- 8601000000 86A Water, direct, all sources 0.945000 1.000 1.000 

8602000000 868 Water, indirect, all sources 0.945000 l. 000 1.000 

Acute Results file (General Population and Females 13- 49 years) 

US EPA Ver. 3.18, 03 - 08 -d 

DEEM-FCID ACUTE Analys i s for PACLOBUTRAZOL NHANES 2003-2008 2 -Day 

Residue file: Paclobutrazol Acute Gen_ Pop and Females 13_49 yrs water_only.r08 

Ad justment factor #2 used. 

Analysis Date: 10 - 22-2014/09:49:16 Residue file dated: 10 -22-2014/09:47:00 

NOEL (Acute ) = 30.000000 mg/kg body-wt/ day 

Acute Pop Adjusted Dose (aPAD ) varies with population; see individual reports 

RAC/FF intake summed over 24 hours 

Run Comment: "Gen_ Pop 0.3 mg/kg body wt/day and Females 13-49 yrs. 0.1 mg/kg body 

wt/day Wate r onlyR 

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

Summary calculations--per capita : 

95th Percentile---- 99th Percentile---- -- -99.9th Percentile--- -

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

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

Total us Popu lation: 

0 . 051528 17 .18 582 0. 084971 28.32 353 0. 16 1414 53 .80 185 

All 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 .22 101 

Children 3-5: 

0.064474 21.49 465 0.098744 32 . 91 303 0. 158497 52.83 189 

Children 6-12 : 

0. 049263 16.42 608 0.080847 26.95 371 0 . 124610 41. 54 240 

Youth 13-19: 

0 . 042913 14.30 699 0 . 070679 23.56 424 0.106713 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. 106061 106.06 282 

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Paclobutrazol Dietary Exposure and Risk Assessment 

PC Code: 12560 I 

Attachment 2 

Chronic Water Input file (All Populations) 

US EPA 

DEEM- FCID Chronic ana l ysis for PACLOBUTRAZOL 

DP Number: 04 19143 

Ver. 3 . 16, 03-08-d 

Residue file: C: \Users\pbarnes\Documents\DEEMRESULTS\PACLOBUTRAZOL\Paclobutrazol 

Chronic Al l _ Popu l ations water_only.r08 

Adjust. #2 used 

Analysis Date 10-16-201 4 Residue file dated: 10- 16- 2014/16 :58: 17 

Reference dose (RfD) = 0.11 mg/kg bw/ day 

Comment :All Populations Water only 

Food Cro p Residue Adj.Factors 

EPA Code Grp Food Name (ppm) #1 #2 

---------- ------------------------------- ---------- 8601000000 86A Wa ter, direct, all sources 0 . 6220 00 1. 000 1 . 000 

8602000000 86B Wa ter, i ndirect, a l l sources 0 . 622000 1.000 1.000 

Chronic Results file (All populations) 

US EPA Ver . 3.16, 03 - 08 - d 

DEEM-FCID Chronic analysis for PACLOBUTRAZOL NHANES 2003-2008 2 - day 

Residue file name: C: \Users\pba rnes\ Documents\DEEMRESULTS\PACLOBUTRAZOL\Paclobutrazol 

Chronic All Populations water _onl y.r08 

Adjustment factor #2 used. 

Analysis Date 10 -16- 2014/16:59:39 Resi due file dated : 10 - 16-2014/16:58 : 17 

Reference dose (RfD, Chronic) = .11 mg/kg bw/day 

COMMENT 1: Al l Popu lations Water o nly 

======== == == ======== ======= =========== === ==a= ============================== === = 

Total e xposure by populati o n subgroup 

Populati on 

Subgroup 

Total US Population 

Hi spani c 

Non-Hisp -White 

Non-Hisp-Black 

Non-Hisp -Other 

Nursing Infa n ts 

Non-Nurs ing Infants 

Fema l e 13+ PREG 

Children 1-6 

Children 7 -12 

Male 13 - 19 

Female 13 - 19/NP 

Male 20 + 

Fema le 20 +/NP 

Seniors 55+ 

All Infants 

Female 13 - 50 

Children 1 - 2 

Children 3 - 5 

Children 6 - 12 

Youth 13-19 

Adults 20-49 

Adults 50 - 99 

Female 13 -4 9 

Total Exposure 

mg/kg 

body wt/day 

0 .0 13024 

0 .0 12435 

0. 0133 96 

0.010747 

0.015011 

0.011783 

0.043319 

0.012263 

0.016681 

0.010858 

0.008953 

0.010032 

0. 01 2134 

0.013680 

0 . 012592 

0. 03 3 582 

0.012961 

0.018788 

0.015829 

0. 011416 

0.009498 

0 . 012994 

0.012846 

0.012947 

Page 10 of 10 

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% 

11.8%