UNITED STATES ENVIRONMENT AL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

DATE: 23-APR-2015 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Propanil: Registration Review Human Health Scoping Document 

PC Code: 028201 

MRIDNo.: NA 

Petition No.: NA 

Assessment Type: Single Chemical/ 

Aggregate 

DP Barcode: D424441 

Registration No.: NA 

Regulatory Action: Registration Review 

Reregistration Case No.: 226 

TXR No.: NA CAS No.: 709-98-8 

REVIEWERS: Mohsen Sahafeyan, Chemist and Risk Assessor ,,,//<:'L JLL.eEv1sabel Craig, Ph.D.,DABT, Tox1colog1st fo y. , ~ ./ 

Shalu Shel at, Industrial Hygienist {)tG Pu,., '-. . · ~ 

Risk Assessment Branch VI W 0 

Health Effects Division (7509P) 

THROUGH: Donna Davis, Acting Branch Chief 

Risk Assessment Branch VI 

Health Effects Division (7509P) 

TO: Joel Wolf, Chemical Review Manager 

And 

Kevin Costello, Branch Chief 

Risk Management and Implementation Branch II 

Pesticide Re-Evaluation Division (7508P) 

Executive Summary 

The Health Effects Division (HED) Propanil Registration Review Team has evaluated the 

status of the human health assessments for propanil to determine the scope of work 

necessary to support Registration Review. Propanil is a selective postemergence 

herbicide registered for use on rice. The HED Revised chapter for Registration 

Eligibility Decision (RED) for propanil was completed on February 28th, 2002. 

Propanil is available as an emulsifiable concentrate liquid, water dispersible granule (dry 

flowable), soluble concentrate liquid, and flowable concentrate liquid and is applied as a 

broadcast treatment by ground and aerial equipment. The principal toxic effect of 

Page 1 of24 
Page 2 of 24

propanil is methemoglobinemia and hemolytic anemia, which is seen in different species

(rats, mice and dogs) in oral studies of varying durations. 

The current toxicology database for propanil is incomplete. The subchronic inhalation 

and acute neurotoxicity studies are required but have not been submitted. A waiver for 

the inhalation and acute toxicity studies was not granted and thus, these studies are still 

outstanding (J. Leshin, TXR# 0057107, 2/27/2015). Once new data are submitted, the 

propanil registration review team will re-evaluate the toxicity database and update the 

points of departure (PoDs) and safety factors/uncertainty factors (SFs/UFs) used in the 

most recent risk assessment for this chemical, as needed.

The residue chemistry database for propanil is adequate to support the registration review 

process for propanil. However, the dietary risk assessment may need to be updated to 

directly incorporate estimated drinking water concentrations, include updated percent 

crop treated and consumption information, using updated PoDs and SFs/UFs. 

There are no residential uses for propanil. There is the potential for non-occupational 

exposure from nearby agricultural applications of propanil to rice. The need for spray 

drift and volatilization risk assessments for propanil will be examined during Registration 

Review.

The current occupational exposure database for propanil is incomplete. A chemicalspecific DFR study in rice as well as a worker exposure study for a closed mixing and 

loading system with the dry flowable formulation is required. In the 2011 assessment, 

HED estimated the risks to mixers/loaders, groundboom applicators, aerial applicators, 

and flaggers who are involved in applications of propanil to rice. The risk estimates were 

based on a propanil-specific use survey and updated surrogate exposure data. For many 

scenarios, the resulting risk estimates were of concern, particularly for individuals 

handling higher amounts of propanil. The post-application risk estimates calculated in 

2002 were based on transfer coefficients and default fraction of available residue that 

have since been updated. Post-application risk estimates based on the current inputs also 

result in risk estimates of concern. The occupational handler and post-application

exposure assessment may need to be updated during the registration review process to 

include changes in use pattern, the inclusion of additional data, and also to comply with 

new guidelines and policies. 

As there are no residential uses for propanil, the aggregate risk assessment includes food 

and water only. As noted above, updated assessments may be required for registration 

review.

Current tolerances are for rice and livestock are established under 40 CFR §180.274 and 

are adequate. The tolerance expression should be updated in accordance with HED’s 

current guidance. As there are no international maximum residue limits (MRLs)

established for propanil, there is no issue with harmonization of US tolerances with 

international MRLs. 
Page 3 of 24

1.0 Introduction

Propanil N-(3,4-dichlorophenyl)propanamide is a selective postemergence herbicide 

registered for use on rice to control broadleaf and grass weeds. Propanil is available as 

an emulsifiable concentrate (EC), a liquid or dry flowable (DF), and a low volume (LV) 

formulation and is typically applied as a broadcast treatment by ground and aerial 

equipment. There are currently 35 active end use product registrations and one

experimental use permit. Propanil belongs to the acetanilide class of pesticides and, 

acting primarily in the leaves, is a strong inhibitor of the Hill reaction, disrupting normal 

photosynthesis. The chemical structure and nomenclature of propanil and the 

physicochemical properties of technical grade propanil are presented in Attachment 1. 

The Reregistration Eligibility Decision (RED) document for propanil was signed on 

9/30/2003. The Agency amended the Propanil RED in March 2006 as a result of its 

review of the public comments and review of additional data submitted by the Propanil 

Task Force to refine the exposure estimates for workers handling propanil. By 2006, uses

on barley, oats, and wheat had also been voluntarily cancelled. The most recent human 

health risk assessment was performed in 2003 (R. Griffin, D289785, 3/14/2003) and a 

follow up addendum was completed in 2011 (C. Smith, D293904, 6/14/2011). There are 

currently no pending PRIA actions for propanil. HED has reviewed the most recent 

exposure and risk assessments for propanil, as well as toxicity data, exposure and usage 

databases, and the latest Agency science policy and risk assessment methodologies to 

determine if sufficient data are available and if updates are needed to support registration 

review. 

2.0 Hazard Identification/Toxicology

The toxicology database for propanil is incomplete (See Attachment 2). Although the 

current 40 CFR Part 158 Toxicology Data Requirements include subchronic inhalation, 

and neurotoxicity (acute and subchronic) studies, these studies were not submitted for 

propanil. Based on a weight-of-evidence (WOE) approach that considers all the available 

hazard and exposure information for propanil,, the Hazard and Science Policy Council 

(HASPOC) determined that the subchronic inhalation, and acute neurotoxicity studies are 

required to support the registered uses of propanil. The Council also determined that the 

subchronic neurotoxicity study for propanil is not required at this time (J. Leshin, TXR#

0057107, 2/27/2015).

In a metabolism study in rats, the majority of propanil and its metabolites were excreted 

in the urine within 24 hours, with only 2-13% excreted in the feces and minimal retention 

in the carcass or internal organs. In addition to the parent compound, six metabolites 

were recovered in the urine (four derivatives of 3,4-dichloroaniline and two derivatives of 

2-hydroxy-4,5-dichloroaniline), which account for >40% of the radioactivity. Four 

metabolites were recovered in feces and two organic solvent soluble compounds were 

recovered from the rat liver. The metabolites 3, 4-dichloroaniline (DCA), and its Nhydroxy and 6-hydroxy derivatives have been associated with methemoglobin formation 

in open literature studies.
Page 4 of 24

The principal toxic effects of propanil are methemoglobinemia and hemolytic anemia, 

which are seen in different species (rats, mice and dogs) in oral studies of varying

durations. Other than slightly decreased fetal body weights (with or without 

accompanying delays in skeletal ossification), there was no apparent adverse effect of in 

utero propanil exposure on the morphological development of the fetuses in the prenatal 

developmental toxicity studies in rats and rabbits. Effects observed in the two generation 

reproduction study in rats included delayed vaginal perforation, delayed balanopreputial 

separation, and decreased mean sperm count. This is consistent with results from an in 

vitro rat prostate androgen receptor competitive binding assay reviewed by EPA in 2012 

(TXR# 0051481), which shows that propanil is a weak binder of the rat androgen 

receptor. Propanil is not immunotoxic or mutagenic. The Health Effects Division (HED)

Cancer Peer Review Committee has classified propanil into the category termed

“Suggestive evidence of carcinogenic potential by all routes of exposure, but not 

sufficient to assess human carcinogenic potential” based on testicular interstitial 

adenomas observed in male rats and malignant lymphomas in female mice.

Propanil has low acute toxicity, with toxicity categories of III (oral) and IV (dermal, 

inhalation and primary skin irritation). No dermal sensitization was observed; however, 

primary eye irritation is observed in rabbits (toxicity category II).

In the previous risk assessment (2002), the point of departure (PoD) for all exposure 

scenarios (chronic dietary; short- and intermediate- term incidental oral; and short, 

intermediate and long-term dermal and inhalation exposures) were based on the LOAEL 

of 9.0 mg/kg/day (methemoglobinemia) from the chronic toxicity/carcinogenicity study 

in rats. A NOAEL was not determined. For dietary and residential exposures, an 

addendum to the 2002 risk assessment, based on a Hazard Identification Assessment 

Review Committee (HIARC) report (dated May 14, 2003; TXR#0051852) set an 

uncertainty factor of 1000X (10X for interspecies extrapolation, 10X for intraspecies 

variability, 3X for LOAEL-to-NOAEL extrapolation and 3X because of the lack of data 

on the potential anti-androgenic activity of propanil). For occupational exposures, the 

uncertainty factor was 300X (10X for interspecies extrapolation, 10X for intraspecies 

variability and 3X for LOAEL-to-NOAEL extrapolation).

In the 2002 risk assessment, the Food Quality and Protection Act safety factor (FQPA 

SF) was reduced to 1X. A 1X FQPA SF was considered appropriate because the 

toxicology database was adequate for assessing FQPA, a developmental neurotoxicity 

study was not required for this chemical and there is was no evidence of increased 

quantitative susceptibility of the young following in utero, pre- or post-natal exposure to

propanil. Although there was evidence in the 2-generation reproduction study in rats 

which indicated qualitative susceptibility of the offspring, the concern was low because 

the effects noted were well characterized, occurred only at the highest dose tested and did 

not appear to have any long-term effects in reproductive function. Also, there was no 

residual uncertainty in the exposure database.

Conclusions: The toxicology database for propanil is incomplete. The subchronic 

inhalation, and acute neurotoxicity studies are required to support registered use of 

propanil. As part of registration review, upon receipt of the required toxicity data, the 
Page 5 of 24

endpoints, doses, and safety factors used in the most recent risk assessment will be reevaluated according to current HED policy.

3.0 Residue Chemistry

The residue chemistry database is adequate for dietary risk assessment for propanil. 

Tolerances are established under 40 CFR §180.274 for the combined residues of the 

herbicide propanil (3′, 4′-dichloropropionanilide) and its metabolites convertible to 3, 4-

dichloroaniline (3,4-DCA), in or on rice, crayfish and livestock commodities. No residue 

chemistry deficiencies were cited in 2003 RED for rice. Since 2003, uses on barley, oats, 

and wheat have been voluntarily cancelled.

The qualitative nature of the residue in plants and livestock is adequately understood 

based on acceptable metabolism studies conducted on rice, wheat, ruminant and poultry

and crayfish. 

The HED Metabolism Assessment Review Committee (MARC) has reviewed the

propanil toxicology and metabolism data (meeting dates of 1/16/96) and concluded that 

for plants and livestock the residues of concern for enforcement and human health risk 

assessment are propanil (parent), 3,4-dichloroaniline, and related residues convertible to 

3,4-dichloroaniline (3,4-DCA). 

Water metabolism was subsequently submitted to the MARC on August 7, 2001. The 

committee concluded that parent and the metabolite 3, 4-DCA should be included in risk 

assessment. 

Based on metabolism data, 3,4-DCA is also a metabolite of two other pesticides, linuron 

and diuron. However, the MARC does not recommend aggregating residues of 3,4-DCA 

for the propanil, linuron and diuron risk assessments. While 3,4-DCA is a potential 

degradate of all three pesticides, it is such a small portion of the terminal residues in 

linuron and diuron (<l% of the TRR), that linuron and diuron-derived 3,4-DCA is not 

likely to contribute significantly to the overall 3,4-DCA exposure The analytical method 

for quantifying residues of concern from linuron and diuron converts all residues to 3,4-

DCA as a convenience, but 3,4-DCA was not a significant residue in any metabolism or 

hydrolysis study. Therefore, the MARC recommended that all residues convertible to 3,4-

DCA would be included in the tolerance expression for linuron and diuron only because 

no validated enforcement method was available for the quantification of individual 

components of the residues of concern.

Adequate residue analytical methods are available for tolerance enforcement. For plants, 

an adequately-validated gas chromatography with nitrogen-phosphoros detector

(GC/NPD) method, designated as EN-CAS Method No. ENC-9/90, or Method TR 34-93-

99 was submitted to EPA by the registrant. Residues are determined as 3,4-DCA, and 

calculated as the parent, propanil; the limit of quantitation (LOQ) is 0.01 ppm for this 

method. The method has been previously described and deemed adequate for data 

collection on rice and wheat matrices. It has been subjected to a successful independent 

laboratory validation (ILV) trial as required by PR Notice 96-1 and was adequately 

radiovalidated using 

14

C-labeled samples from the confined rotational crop study (MRID 
Page 6 of 24

42963001). For livestock commodities, the current preferred enforcement method is the 

gas chromatography with electron-capture detector (GC/ECD) method listed in PAM 

Volume II as Method I. As with the plant analytical enforcement method, residues are 

determined as 3,4-DCA, and calculated as the parent, propanil; the limit of quantitation 

(LOQ) is 0.01 ppm for this method. The reported LOQ of Method I is 0.05 ppm. The 

reregistration requirements for multi-residue method testing for residues of propanil and 

3,4-DCA are satisfied.

Adequate studies on magnitude of residue in rice, processing, storage stability, confined 

rotational crop, and ruminant and poultry feeding studies have been submitted. In 

addition, adequate metabolism, magnitude of residue and storage stability data for 

crayfish have also been submitted. These data support the existing tolerance on rice, 

livestock and crayfish.

As data depicting magnitude of the residue in catfish and in crops irrigated by water from 

treated rice field were not available, in the Addendum to the RED (2006), the registrant 

was required to put restriction on all rice labels for use of water from treated rice fields

for catfish farming, irrigation of other crops, or release to flowing or standing water 

within a 1⁄2 mile of a potable water intake.

Conclusions: The residue chemistry database is adequate to support the current 

registrations for propanil. No additional data are required to support the registration 

review of propanil.

4.0 Dietary Exposure and Risks

Dietary exposure and risk were last assessed in 2003 for chronic dietary food using 

Dietary Exposure Evaluation Model software with the Food Commodity Intake Database 

(DEEM-FCIDTM, Version 1.3). Acute dietary risk for propanil was not assessed since no 

appropriate endpoints (effects) attributable to a single exposure (dose) were identified in 

any toxicological study. In the previous dietary assessment, exposure through drinking 

water, modeled for rice application, were assessed by the Drinking Water Level of 

Comparison (DWLOC) method and the estimated environmental concentration (EEC)

estimates for propanil per se and 3,4-DCA (combined) were less than the estimated 

DWLOC.

The 2003 chronic dietary risk for (food only) assessment was partially refined using

anticipated residues from field trial data, percent crop treated for rice (9%CT) and 

processing factor information. That assessment also included barley, oats, and wheat 

uses which were voluntarily cancelled later. The assessment concluded that for all 

supported registered commodities, the estimated chronic dietary risks associated with the 

use of propanil do not exceed HED’s level of concern (<100% chronic population 

adjusted dose (cPAD) for the general U.S. population and all population subgroups 

including the most highly exposed population subgroups, all infants <1 year of age, 

children 1-2 years old, and children 3-5 years old, each at 4% cPAD. 

Subsequent to the 2003 dietary risk assessment, HED has updated the consumption data 

used in DEEM and drinking water estimated exposures are now directly incorporated in 

the dietary exposure assessment. Upon receipt of the required toxicity data, and update 
Page 7 of 24

of the points of departure (PoDs) and safety factors (SFs) for risk assessment, the dietary 

risk assessment may need to be updated to include updated percent crop treated 

information and to directly incorporate updated estimates of residues in drinking water, 

as well as updated consumption information. 

Conclusions: Ann updated dietary exposure and risk assessment, which incorporates 

changes to PoDs and UFs, includes updated drinking water estimates, as well as updated 

percent crop treated information may need to be completed to support registration review. 

5.0 Residential Exposure and Risks

Currently, there are no registered residential uses for propanil, therefore, a quantitative 

residential exposure and risk assessment has not been conducted and will not be required 

for Registration Review.

Spray Drift and Volatilization

Residential bystander exposures resulting from off-site transport (e.g., spray drift or 

volatilization) may occur as a result of applications of propanil. The potential for spray 

drift will be quantitatively evaluated for each pesticide during the Registration Review 

process which ensures that all uses for that pesticide will be considered concurrently. The 

approach is outlined in the revised (2012) Standard Operating Procedures For Residential 

Risk Assessment (SOPs) – Residential Exposure Assessment Standard Operating 

Procedures Addenda 1: Consideration of Spray Drift. This document outlines the 

quantification of indirect non-occupational exposure to drift. In terms of volatilization, 

the agency has developed a Volatilization Screening Tool and a subsequent Volatilization 

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

0219). During Registration Review, the agency will utilize this analysis to determine if 

data (i.e., flux studies, route-specific inhalation toxicological studies) or further analysis 

is required for propanil. 

Conclusions: Currently, there are no registered uses at residential sites, therefore 

residential handler and residential post-application assessments are not required. The 

need for spray drift and volatilization risk assessments for propanil will be examined 

during Registration Review.

6.0 Aggregate Risk Assessment

The aggregate risk assessment evaluates the combined risk from dietary exposure (food 

and water) and any non-occupational (residential) uses. However, there are currently no 

residential uses for propanil; therefore the propanil aggregate risk assessment includes 

only dietary exposure (food and water) which may need to be updated (see dietary 

exposure and risk section). 

Conclusions: The aggregate risk assessments for propanil, which includes food and 

water only, may need to be reassessed during Registration Review as noted in Section 

4.0. 
Page 8 of 24

7.0 Occupational Exposure and Risks

Propanil is currently registered for use on rice, therefore handler and post-application 

exposures are expected. In 2011, HED completed an addendum to the 2002 occupational 

and residential exposure (ORE) assessment for propanil (C. Smith, D293904, 6/14/2011). 

That addendum included two main updates: 1) inclusion of data on typical application 

rates and acres treated per day that were collected during a survey of 50 aerial application 

firms in 2007 and 58 in 2008 and 2) inclusion of HED’s new scenario-specific surrogate 

handler exposure table. 

Occupational Handlers

HED had estimated the risks to mixers/loaders, groundboom applicators, aerial 

applicators, and flaggers who are involved in applications of propanil to rice. The risk 

estimates for the mixer/loader scenarios and an applicator scenario resulted in risk 

estimates of concern. Mixer/loader risk estimates ranged from 32 to 1100 and applicator 

risk estimates ranged from 67 to 1900 at engineering controls. As a result of the previous 

risk assessment, the registrant has agreed to submit a worker exposure study to address 

the occupational handler risk issues identified. In addition, HED’s exposure policies

have been updated since the 2011 assessment was completed, including updates to the 

exposure data used for handler scenarios and body weight assumptions. 

Occupational Post-application:

The most recent post-application assessment for propanil was completed in 2002 (S. 

Recore, D280853, 2/8/2002) which used the default dislodgeable foliar residue (DFR) 

fraction of application rate (FAR) value (20%). At that time, the resulting MOE of 293 for 

the currently registered rice use at the maximum rate (6 lbs ai/acre) exceeded HED’s 

level of concern (LOC) of 300 (MOE < LOC). The current default FAR value for postapplication activities is 25%. With the use of the current FAR value, as well as updated 

transfer coefficient (TC) values, the resulting risk estimates for post-application exposure 

from the rice application at the maximum rate of 6 lbs ai/acre range from 24 to 380. 

Since the highest estimated occupational post-application exposure using default DFR 

and TC values for propanil is not minimal in comparison to the level of concern (i.e., the 

calculated MOE is not greater than 2 times higher than the level of concern, MOE = 600

compared to the LOC of 300; EPA is requiring the 40CFR§158 DFR data. See 

Attachment 6 for additional information regarding updated risk estimates and DFR data 

requirement. 

Conclusions: A chemical-specific DFR study in rice is required for propanil in 

accordance with 40 CFR§158, additionally, the registrant has agreed to submit a worker

exposure study to address the occupational handler risk issues that were previously 

identified. The occupational exposure/risk assessments for propanil may also need to be 

reassessed during Registration Review to address updates to HED’s exposure policies, 

including updates to exposure data used for handler scenarios, post-application transfer 

coefficients, transferable residue assumptions, and assumptions for body weights. 

Occupational exposure/risk assessments may also need to be reassessed if changes to the 

toxicity endpoints or uncertainty factors are made during Registration Review.
Page 9 of 24

8.0 Public Health and Pesticide Epidemiology Data

For the Main Incident Data System (IDS) 2010 - 2014, and Sentinel Event Notification 

System for Occupational Risk-Pesticides (SENSOR-Pesticides) 1998-2010, there has 

been a total of 13 cases involving propanil; only two cases involved single active 

ingredient; other cases involved multiple ingredients. These incidents were classified as 

low to moderate in severity. Propanil is not included in the Agricultural Health Study 

(AHS), and therefore this study does not provide information that needs to be considered 

under registration review.

Based on the low frequency and low severity of incident cases reported for propanil in 

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

would warrant further investigation. The Agency will continue to monitor the incident 

information and if a concern is triggered, additional analysis will be included in the risk 

assessment.

9.0 Tolerance Assessment and International Harmonization

Permanent Tolerances are established under 40 CFR §180.274 for the combined residues 

of the herbicide propanil (3′, 4′-dichloropropionanilide) and its metabolites convertible to 

3, 4-dichloroaniline (3, 4-DCA), in or on rice, crayfish and livestock commodities.

The tolerance expression should be updated in accordance with HED’s Interim Guidance 

on Tolerance Expressions (5/27/09, S. Knizner) as the following:

Tolerances are established for residues of propanil (3′, 4′-dichloropropionanilide),

including its metabolites and degradates, in or on the commodities in the table 

below. Compliance with the tolerance levels specified below is to be determined 

by measuring only those propanil residues convertible to 3, 4-dichloroaniline (3, 

4-DCA), expressed as the stoichiometric equivalent of propanil, in or on the 

commodity.

The Codex Alimentarius Commission, Canada and Mexico have not established 

maximum residue limits (MRLs) for propanil and therefore there is no issue with 

harmonization of US tolerances with international MRLs. 

10.0 Cumulative Risk Assessment

Propanil has not been included in a cumulative assessment group or cumulative risk 

assessment.

11.0 Risk Assessment Updates and Data Deficiencies

 The subchronic inhalation (guideline 870.3465), and acute neurotoxicity 

(guideline 870.6200) studies are required to support registered use of propanil. 

 A propanil specific worker exposure study using closed-system application 

equipment (guideline 875.1100) had been required during the RED mitigation 

process; Data Call-In (DCI) has already been issued.
Page 10 of 24

 A propanil specific dislodgeable foliar residue study (guideline 875.2100) in rice 

is required.

12.0 References

Memoranda Relevant to Registration Review

Author Barcode/TXR # Date Title

Charles Smith D293904 6/14/2011 Propanil: Addendum to the 2002 

Occupational and Residential Exposure 

Assessment.

S. Recore D280853 2/8/2002 Occupational and Residential Exposure 

Assessment and Recommendations for the

Reregistration Eligibility Decision (RED) 

Document for Propanil (1st Revision)

Sherrie L. 

Kinard

D280854 2/28/2002 Propanil. Revised Residue Chemistry 

Chapter for the Reregistration Eligibility

Decision

Richard Griffin D281147 2/28/2002 Propanil. Human Health Risk Assessment 

(Revised)

Richard Griffin D289785 5/14/2003 Propanil. Addendum to the Revised 

Human Health Risk Assessment

Shanna Recore D424891 1/8/2015 Propanil: Review of Human Incidents

OPP No DP Barcode

Docket ID: EPA-HQ-OPP2003-0348

3/7/2006

Amendment to Reregistration 

Eligibility Decision (RED) for 

Propanil (March 2006) and the 

Propanil RED (September 2003)

J. Leshin TXR# 0057107 2/27/2015 Propanil: Summary of Hazard and 

Science Policy Council (HASPOC) 

Meeting of January 8, 2015: 

Recommendations on the 

requirements of subchronic inhalation 

and neurotoxicity (acute and 

subchronic) studies.

Christina 

Swartz

D222631 2/20/1996 Propanil. List A Reregistration Case 

No. 0226/Chemical ID No. 028201. 

Outcome of the 1/16/96 meeting of 

the HED Metabolism Committee. 

Sherrie L. 

Kinard

D277494 8/31/2001 Propanil. Outcome the HED 

Metabolism Assessment Review 

Committee to discuss degradates in 

drinking water on August 7, 2001. 

Attachments: 

Attachment 1: Chemical Identity Table.

Attachment 2: Toxicology data requirements

Attachment 3: Propanil Toxicity Profile Tables

Attachment 4: Propanil Toxicological Doses and Endpoints for Risk Assessment

Attachment 5: Summary of Occupational Registered Propanil Uses

Attachment 6: Dislodgable Foliar Residue Data Requirement Criteria

Attachment 7: Propanil International Residue Limit Status Sheet
Page 11 of 24

Attachment 1: Chemical Identity Tables.

Attachment Table 1.1: Propanil Nomenclature

Chemical structure

Common name Propanil

IUPAC name 3',4'-dichloropropionanilide 

CAS name N-(3,4-Dichlorophenyl)propanamide

CAS # 709-98-8

Trade Name Stam® and SuperWham®

Attachment Table 1.2; Physicochemical Properties of Technical Grade Propanil

Parameter Value Reference

Melting range 92 °C

ChemIDplus 

(http://chem.sis.nlm.nih.gov/ch

emidplus/rn/709-98-8)

Amendment to the Propanil 

RED (March 7, 2006)

Water solubility 152 mg/L at 25 °C

Vapor pressure 9.08x10-6 mmHg at 25C

Octanol/water partition coefficient 

log (KOW)

3.07

Stability Active ingredient hydrolyzes in strong 

acid or base

Density 1.25 g/ml
Page 12 of 24

Attachment 2. Toxicology Data Requirements

Atttachment 2.1: Toxicology Data Requirements for Propanil

Test Technical

Required Conducted

870.1100 Acute Oral Toxicity

870.1200 Acute Dermal Toxicity

870.1300 Acute Inhalation Toxicity

870.2400 Primary Eye Irritation

870.2500 Primary Dermal Irritation

870.2600 Dermal Sensitization

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.3100 Oral Subchronic (rodent)

870.3150 Oral Subchronic (non-rodent)

870.3200 21/28-Day Dermal

870.3250 90-Day Dermal

870.3465 90-Day Inhalation

yes

yes

yes

no

CR

yes

yes

yes

no

no

870.3700a Developmental Toxicity (rodent)

870.3700b Developmental Toxicity (non-rodent)

870.3800 Reproduction

yes

yes

yes

yes

yes

yes

870.4100a Chronic Toxicity (rodent)

870.4100b Chronic Toxicity (non-rodent)

870.4200a Oncogenicity (rat)

870.4200b Oncogenicity (mouse)

870.4300 Chronic/Oncogenicity

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.5100 Mutagenicity—Gene Mutation (bacterial)

870.5300 Mutagenicity—Gene Mutation (mammalian)

870.5375 Mutagenicity—Structural Chromosomal Aberrations

870.5395 Mutagenicity—Other Genotoxic Effects 

870.5500 Mutagenicity—Other Genotoxic Effects

yes

yes

yes

yes

yes

yes

yes

yes

yes

yes

870.6100a Acute Delayed Neurotoxicity (hen)

870.6100b 90-Day Neurotoxicity (hen)

870.6200a Acute Neurotoxicity Screening Battery (rat)

870.6200b 90-Day Neurotoxicity Screening Battery (rat)

870.6300 Developmental Neurotoxicity

no

no

yes

yes

CR

no

no

no

waived 1

no

870.7485 General Metabolism

870.7600 Dermal Penetration

870.7800 Immunotoxicity

yes

CR

yes

yes

yes

yes

CR = conditionally required

1 Data requirement waived by HASPOC for the subchronic neurotoxicity study (TXR# 0057107).
Page 13 of 24

Attachment 3. Propanil Toxicity Profile Tables

Table 3.1. Acute Toxicity Profile for Propanil

Guideline

No. Study Type MRID # Results Toxicity Category

81-1 Acute Oral [rats] 41360801 LD50 = 1080 mg/kg III

81-2 Acute Dermal [rabbits] 41360901 LD50 > 2000 mg/kg IV

81-3 Acute Inhalation [rats] 41265901 LC50 = 6.1 mg/L IV

81-4 Primary Eye Irritation 

[rabbits]

41360501 Iritis, conjunctivitis present 

in all rabbits, cleared by day 

14; corneal opacity cleared 

by 4 days

II

81-5 Primary Dermal Irritation 

[rabbits]

41360601 Slightly irritating

P.I.I. = 0.2/4.0

IV

81-6 Dermal Sensitization 

[guinea pigs]

40070204 Negative N/A

Table 3.2. Subchronic, Chronic and Other Toxicity Profile for Propanil

Guideline 

No.

Study Type MRID No. /(year)/ 

Doses

Results

870.3100

90-Day oral 

toxicity rodents

(Wistar rat)

MRID 00015459, 

00046259 (1961)

0, 0.01, 0.033, 0.10, 1.0, 

5.0 % (diet)

(0, 10, 33, 100, 1000, 

5000 mg/kg/d)

NOAEL = 33 mg/kg/day

LOAEL = 100 mg/kg/day based on increased relative 

spleen weight in females and decreased hemoglobin in 

males.

870.3100

90-Day oral 

toxicity rodents

(CD-1 mouse)

MRID 40402901 (1983)

0, 25, 200, 1600, 12800 

ppm (diet)

(M: 0, 6.6, 49, 442, 5325 

mg/kg/d)

(F: 0, 9.6, 78, 566, 6467 

mg/kg/d)

NOAEL = 6.6/9.6 (M/F) mg/kg/day

LOAEL = 49/78 (M/F) mg/kg/day based on 

histopathological findings in the liver (hepatocytic 

pleomorphism and hepatocytic multifocal necrosis).

870.3200 21-Day dermal 

toxicity (NZW 

rabbit)

MRID 41777001, 

41961800 (1990)

0, 250, 500, 1000 mg/kg/d

6 hrs/day; 5 days/week

NOAEL = 250 mg/kg/day

LOAEL = 500 mg/kg/day based on decreased body 

weight gain (day 20) and decreased food consumption 

(days 14-20).
Page 14 of 24

Table 3.2. Subchronic, Chronic and Other Toxicity Profile for Propanil

Guideline 

No.

Study Type MRID No. /(year)/ 

Doses

Results

870.3700a

Prenatal 

developmental 

toxicity in 

rodents

MRID 00058588 (1980)

0, 0.8, 4.0, 20, 100 

mg/kg/d

Gavage; GD 6-15

Maternal NOAEL = 20 mg/kg/day

LOAEL = 100 mg/kg/day based on decreased body 

weight gain during treatment.

Developmental NOAEL = 20 mg/kg/day

LOAEL = 100 mg/kg/day based on decreased mean fetal 

weight and delayed ossification in the sternebrae and 

cervical vertebrae.

870.3700b Prenatal 

developmental 

toxicity in 

nonrodents 

(NZW rabbit)

MRID 00058589 (1980)

0, 4, 20, 100 mg/kg/d

Gavage; GD 6-18

Maternal NOAEL = 20 mg/kg/day

LOAEL = 100 mg/kg/day based on mortality, clinical 

signs of toxicity, and weight loss during treatment.

Developmental NOAEL = 20 mg/kg/day

LOAEL = 100 mg/kg/day based on slightly decreased 

mean fetal weight.

870.3800

Reproduction 

and fertility 

effects (SD rats, 

2-generations)

MRID 44604301 (1998)

0, 60, 150, 600 ppm (diet)

(F0 M: 0, 4, 11, 43 

mg/kg/d)

(F0 F: 0, 5, 13, 51 

mg/kg/d)

Parental/Systemic NOAEL = 11/13 (M/F) mg/kg/day

LOAEL = 43/51 (M/F) mg/kg/day based on decreased 

body weight, body weight gain, and food consumption, 

increased absolute and/or relative spleen weights, and 

increased incidence and severity of pigmented 

macrophages in the spleen.

Reproductive NOAEL = 11/13 (M/F) mg/kg/day

LOAEL = 43/51 (M/F) mg/kg/day based on delayed 

vaginal perforation and balanopreputial separation in F1 

adolescents, and decreased mean testicular sperm count 

and production rate in F1 adult males.

Offspring NOAEL = 11/13 (M/F) mg/kg/day

LOAEL = 43/51 (M/F) mg/kg/day based on reduced F1 

and F2 pup weights, delayed vaginal perforation and 

balanopreputial separation in F1 adolescents, and organ 

weight changes in F2 weanlings (increased absolute and 

relative spleen weights and decreased relative pituitary 

weights in females, decreased absolute and/or relative 

liver and kidney weights in males and females).

870.4100a Chronic toxicity 

rodents

See 870.4300, Combined chronic toxicity/carcinogenicity
Page 15 of 24

Table 3.2. Subchronic, Chronic and Other Toxicity Profile for Propanil

Guideline 

No.

Study Type MRID No. /(year)/ 

Doses

Results

870.4100b Chronic toxicity 

dogs (beagles, 

1-yr)

MRID 42962901 (1993)

0, 200, 1600, 2300 ppm 

(diet)

(M: 0, 5, 45, 79 mg/kg/d)

(F: 0, 6, 42, 85 mg/kg/d)

NOAEL = < 5/6 (M/F) mg/kg/day

LOAEL = 5/6 (M/F) mg/kg/day based on macrocytic, 

regenerative, methemoglobinemia (decreased 

erythrocytes, hemoglobin, hematocrit, and mean cellular 

hemoglobin concentration; increased mean cell volume, 

methemoglobin, and reticulocytes.; increased Heinz 

bodies in females at week 51), and endogenous pigment 

(hemosiderin) in the kidney of both sexes and the liver 

of males

870.4200 Carcinogenicity 

(CD-1 mice; 

104-wk)

MRID 43391701 (1994)

0, 500, 1000 ppm (diet)

(M: 0, 74.9, 150 mg/kg/d)

(F: 0, 88.6, 174.1 

mg/kg/d)

NOAEL = < 74.9/88.6 (M/F) mg/kg/day

LOAEL = 74.9/88.6 (M/F) mg/kg/day based on 

methemoglobinemia (increased methemoglobin and 

Heinz bodies in males) and blue discoloration of the 

extremities.

Evidence of carcinogenicity: malignant lymphomas in 

females at 174.1 mg/kg/d

870.4300 Combined 

chronic 

toxicity/carcino

genicity (SD 

rat; 104-wk)

MRID 43303201 (1994)

0, 200, 600, 1800 ppm 

(diet)

(M: 0, 9.0, 27.7, 88 

mg/kg/d)

(F: 0, 11.5, 38.3, 145 

mg/kg/d)

NOAEL = < 9.0/11.5 (M/F) mg/kg/day

LOAEL = 9.0/11.5 (M/F) mg/kg/day based on clinical 

chemistry findings in both sexes (increased 

methemoglobin at weeks 13, 26, and 52; decreased 

packed cell volume and red blood cells at weeks 26and 

52), increased spleen weight in females at 52 weeks, and 

gross- and histo-pathological findings at 104 weeks 

(enlarged spleen in females, small seminal vesicles and 

prostate in males, hemosiderosis in spleen of males, 

brown pigment [probably hemosiderin] in proximal 

convoluted tubules of females and endometrial polyps in 

females).

Evidence of carcinogenicity: testicular interstitial cell 

adenomas in males at 27.7 and 88 mg/kg/d.

870.5100 Gene Mutation

Bacterial 

reverse gene 

mutation assay

MRID 00155085 (1980) Propanil was negative in Salmonella typhimurium

strains TA1535, TA1537, TA1538, TA98 and TA100 

and in Escherichia coli WP2 up to cytotoxic doses 

(1,000 μg/plate +/-S9) in independent trials.

870.5100 Gene Mutation

Bacterial 

reverse gene 

mutation assay

MRID 00028625 (1979) Independent trials were negative in Salmonella

typhimurium strains TA1535, TA1537, TA1538, TA98 

and TA100 up to cytotoxic doses (1,000 μg/plate +/-

S9) and in Escherichia coli WP2 up to the highest dose 

tested (1,000 μg/plate +/-S9). 
Page 16 of 24

Table 3.2. Subchronic, Chronic and Other Toxicity Profile for Propanil

Guideline 

No.

Study Type MRID No. /(year)/ 

Doses

Results

870.5300 Gene Mutation

In vitro

mammalian cell 

gene mutation 

test

MRID 00155084 (1984) In a Chinese Hamster Ovary (CHO)/HGPRT cell 

forward gene mutation assay, independent tests were 

negative up to cytotoxic doses without S9 activation 

(125 μg/mL) and with S9 activation (175 μg/mL).

870.5385 Cytogenetics 

Mammalian 

bone marrow 

chromosome

aberration test

MRID 00155083 (1983) An in vivo bone marrow cytogenetic assay was negative

in CD-1 male mice administered 0, 26.5, 106, or 265 

mg/kg/day by oral gavage once or once daily for 5 

consecutive days. Doses selected for this study 

represented 1/4, 1/10 or 1/40 of the acute LD50, 

respectively. Overt toxicity was manifested as decreased 

spontaneous motor activity, lethargy and piloerection in 

animals receiving 106 mg/kg/day in both dosing 

regimens. No data were provided to support the claim of 

decreased metaphases in the high dose animals, and this 

deficiency compromised the acceptability of the study. 

However, since there was a clear indication of toxicity to 

the test animals, and no differences in LOAELs between 

male and female mice were seen in the subchronic or 

chronic studies, the doses should be considered 

adequate.

870.5500 Other 

Genotoxicity 

Bacterial DNT 

damage or 

repair tests

MRID 00028625 (1979) Propanil was negative for differential cytotoxicity in 

Escherichia coli strains W3110/p3478 (pol A +/-) up to 

an equivalent cytotoxic dose (5 μg - S9) but was 

positive for the induction of preferential inhibition of 

repair-deficient Bacillus subtilis M45 (rec-) at 0.01-5 μg 

without S9: S9 activation was not included in this study. 

870.5550

Other 

Genotoxicity 

Unscheduled 

DNA synthesis 

in mammalian 

cells in culture

MRID 00028625 (1979) In an unscheduled DNA synthesis assay in WI-38 

human fibroblasts, propanil was negative up to an 

insoluble level (1000 μg/mL). 
Page 17 of 24

Table 3.2. Subchronic, Chronic and Other Toxicity Profile for Propanil

Guideline 

No.

Study Type MRID No. /(year)/ 

Doses

Results

870.5575 Other 

Genotoxicity 

Mitotic gene 

conversion in 

Saccharomyces 

cerevisiae

MRID 00028625 (1979) In a D3 mitotic recombination assay, propanil was 

negative for the induction of mitotic recombinants at 

doses up to 0.1 % with or without S9 mix. Independent 

trials were performed.

870.7485 Metabolism and 

pharmacokineti

cs (SD rat)

MRID 41796400, 

41796402 (1991)

A: single oral low dose 

(2.5 mg/kg)

B: multiple oral low dose 

(2.5 mg/kg for 15 days)

C: single oral high dose 

(300 mg/kg)

D: intravenous dose (0.7 

mg/kg in saline)

The majority of the radioactivity (78-90%) was excreted 

in the urine, and 2-13% was excreted in the feces. Most 

of the radioactivity was eliminated within 24 hours for 

all except the high oral dose where it took 48 hours to 

eliminate 90%. For the i.v. data, females excreted 10% 

in the feces, while males excreted 2%. The carcass 

contained 0.18-0.71% of the radioactivity, with the liver 

having the highest residue.

Of the total of 13 metabolites identified, three major 

metabolites accounted for 17-44% of the radioactivity 

and were involved in hydroxylation and oxidation of the 

propanamide moiety. Other metabolites included 3,4 

dichloroaniline, and its N-hydroxy and 6-hydroxy 

derivatives, which are associated with methemoglobin 

formation. 

870.7800 Immunotoxicity

(SD rats)

MIRD 47162901 (2007)

0, 50, 200, 600 ppm (diet)

(M: 0, 4, 16, 48 mg/kg/d)

(F: 0, 5, 19, 56 mg/kg/d)

Systemic NOAEL = 200 ppm (16/19 mg/kg/d)

Systemic LOAEL = 600 ppm (48/56 mg/kg/d) based on 

significantly decreased body weight in both sexes and 

mild anemia in females.

Immunotoxicity NOAEL = 600 ppm (48/56 mg/kg/d)

Immunotoxicity LOAEL = not determined
Page 18 of 24

Attachment 4. Propanil Toxicological Doses and Endpoints for Risk Assessment

Point of departure (PoD) = a data point or an estimated point that is derived from observed dose-response 

data and used to mark the beginning of extrapolation to determine risk associated with lower 

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

Table 4.1. Summary of Toxicological Doses and Endpoint for Propanil for Use in Dietary and NonOccupational Human Health Risk Assessments

Exposure

Scenario

PoD

Uncertainty/

FQPA SFs

RfD, PAD, Level of 

Concern for Risk 

Assessment

Study and Toxicological Effects

Acute Dietary

females 13-50 

years of age

No appropriate endpoint attributed to a single dose was identified. An acute RfD was no 

established.

Acute Dietary

general population

including infants 

and children

Not applicable

Chronic Dietary

all populations

LOAEL = 9.0 

mg/kg/day 

UFA = 10x

UFH = 10x

 UFL = 3x

 UFDB = 3x 

Chronic RfD = 0.009

mg/kg/day

cPAD = 0.009 

mg/kg/day

Chronic toxicity/carcinogenicity 

study in rats (MRID 43303201) 

Increased methemoglobin in both 

sexes, increased spleen weight in 

females and small seminal 

vesicles/prostate in males.

Incidental oral

Short-term and 

intermediate term

LOAEL = 9.0 

mg/kg/day 

UFA = 10x

UFH = 10x

 UFL = 3x

UFDB = 3x 

LOC for MOE = 1000 Chronic toxicity/carcinogenicity 

study in rats (MRID 43303201) 

Increased methemoglobin in both 

sexes, increased spleen weight in 

females and small seminal 

vesicles/prostate in males.

Dermala

Short-term and 

intermediate term

LOAEL = 9.0 

mg/kg/day 

UFA = 10x

UFH = 10x

 UFL = 3x

 UFDB = 3x 

LOC for MOE = 1000 Chronic toxicity/carcinogenicity 

study in rats (MRID 43303201) 

Increased methemoglobin in both 

sexes, increased spleen weight in 

females and small seminal 

vesicles/prostate in males.

Inhalationb

Short-term and 

intermediate term

LOAEL = 9.0 

mg/kg/day 

UFA = 10x

UFH = 10x

 UFL = 3x

UFDB = 3x 

LOC for MOE = 1000 Chronic toxicity/carcinogenicity 

study in rats (MRID 43303201) 

Increased methemoglobin in both 

sexes, increased spleen weight in 

females and small seminal 

vesicles/prostate in males.

Cancer (oral, 

dermal, inhalation)

Classification: "Suggestive evidence of carcinogenic potential by all routes of exposure, but 

not sufficient to assess human carcinogenic potential”.
Page 19 of 24

observed adverse effect level. UF = uncertainty factor. FQPA SF = FQPA Safety Factor. PAD = population adjusted 

dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern.

aAn oral endpoint was used for dermal exposure: dermal absorption factor of 20% of oral exposure shall 

be used.

bAn oral endpoint was used for inhalation exposure: inhalation exposure assumed equivalent to oral 

exposure; a 100% absorption rate is applied.

Table 4.2. Summary of Toxicological Doses and Endpoints for Propanil for Use in 

Occupational Human Health Risk Assessments

Exposure/ 

Scenario

Point of 

Departure

(PoD)

Uncertaint

y Factors

Level of 

Concern for 

Risk 

Assessment

Study and Toxicological Effects

Dermala

Short-term 

and 

intermediate 

term

LOAEL = 

9.0 

mg/kg/day 

UFA=10x

UFH=10x

UFL=3x

Occupational 

LOC for MOE 

= 300

Chronic toxicity/carcinogenicity study 

in rats (MRID 43303201) 

Increased methemoglobin in both 

sexes, increased spleen weight in 

females and small seminal 

vesicles/prostate in males.

Dermala

Long-term

(> 6 months)

LOAEL = 

9.0 

mg/kg/day 

UFA=10x

UFH=10x

UFL=3x

Occupational 

LOC for MOE 

= 300

Chronic toxicity/carcinogenicity study 

in rats (MRID 43303201) 

Increased methemoglobin in both 

sexes, increased spleen weight in 

females and small seminal 

vesicles/prostate in males.

Inhalationb

Short-term 

and 

intermediate 

term

LOAEL = 

9.0 

mg/kg/day 

UFA=10x

UFH=10x

UFL=3x

Occupational 

LOC for MOE 

= 300

Chronic toxicity/carcinogenicity study 

in rats (MRID 43303201) 

Increased methemoglobin in both 

sexes, increased spleen weight in 

females and small seminal 

vesicles/prostate in males.

Inhalationb

Long-term

(> 6 months)

LOAEL = 

9.0 

mg/kg/day 

UFA=10x

UFH=10x

UFL=3x

Occupational 

LOC for MOE 

= 300

Chronic toxicity/carcinogenicity study 

in rats (MRID 43303201) 

Increased methemoglobin in both 

sexes, increased spleen weight in 

females and small seminal 

vesicles/prostate in males.

Cancer (oral, 

dermal, 

inhalation)

Classification: "Suggestive evidence of carcinogenic potential by all routes of 

exposure, but not sufficient to assess human carcinogenic potential”.

Point of departure (PoD) = a data point or an estimated point that is derived from observed dose-response 

data and used to mark the beginning of extrapolation to determine risk associated with lower 

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

observed adverse effect level. UF = uncertainty factor. FQPA SF = FQPA Safety Factor. PAD = population adjusted 

dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern.

aAn oral endpoint was used for dermal exposure: dermal absorption factor of 20% of oral exposure shall 

be used.

bAn oral endpoint was used for inhalation exposure: inhalation exposure assumed equivalent to oral 

exposure; a 100% absorption rate is applied.
Page 20 of 24

Attachment 5: Summary of Occupational Registered Propanil Uses

Attachment Table 5.1 Summary of Occupational Registered Propanil Uses1

EPA Reg 

No.

Use 

Site

Application 

Equipment Application Timing

Max App 

Rate

(lb ai/A)

REI Comments

19713-576 RICE

Aircraft.

Weed postemergence. 6.00696 24 hr PHI: 60 day(s) preharvest interval.

Ground.

71085-16 RICE

Aircraft.

Weed postemergence. 6 24 hr

PHI: 60 day(s) preharvest interval.

PGI: 80 day(s) pregrazing interval.,80 day(s) 

Ground. prefeeding interval.

71085-2 RICE

Aircraft.

Weed postemergence. 5.800725 24 hr PHI: 60 day(s) preharvest interval.

Ground.

71085-20 RICE

Aircraft.

Weed postemergence. 5.905125 24 hr PHI: 60 day(s) preharvest interval.

Ground.

71085-22 RICE Aircraft.Weed postemergence. 6 24 hr PHI: 60 day(s) preharvest interval.

Ground. PGI: 60 day(s) pregrazing interval.

71085-23 RICE

Aircraft.

6 24 hr

PHI: 80 day(s) preharvest interval.

Ground. PGI: 80 day(s) pregrazing interval

Aircraft. PHI: 60 day(s) preharvest interval.

Ground. PGI: 60 day(s) pregrazing interval.

71085-25 RICE Ground.

Early postemergence.

6.07986 24 hr

PHI: 65 day(s) preharvest interval.,270 day(s) 

preharvest interval.

PGI: 270 day(s) pregrazing interval

Weed preemergence.

Early postemergence.

Weed preemergence.

71085-26 RICE

Aircraft.

Weed postemergence. 6.4887 24 hr PHI: 60 day(s) preharvest interval.

Ground.

71085-29 RICE

Aircraft.

Low pressure Weed postemergence. 6.128715 48 hr PHI: 60 day(s) preharvest interval.

ground 

sprayer.

71085-3 RICE

Aircraft.

Weed postemergence. 6 24 hr PHI: 60 day(s) preharvest interval.

Ground.

71085-30 RICE

Aircraft.

Weed postemergence. 4.368525 24 hr PHI: 60 day(s) preharvest interval.

Ground.

71085-31 RICE

Aircraft.

Weed postemergence. 6.04404 24 hr PHI: 48 day(s) preharvest interval.

Ground.

71085-32 RICE

Aircraft.

Weed postemergence. 6 24 hr PHI: 69 day(s) preharvest interval.

Ground. PGI: 60 day(s) pregrazing interval.

Aircraft.

Weed postemergence. 6 24 hr PHI: 60 day(s) preharvest interval.

PGI: 60 day(s) pregrazing interval. Ground.

71085-36 RICE

Aircraft.

Weed postemergence. 5.99424 24 hr

PHI: 60 day(s) preharvest interval.

PGI: 60 day(s) prefeeding interval.,60 day(s) 

Ground. pregrazing interval.

71085-38 RICE Aircraft. Weed postemergence. 6.075 24 hr PHI: 60 day(s) preharvest interval.

PGI: 60 day(s) pregrazing interval.

71085-39 RICE

Aircraft.

Weed postemergence. 6.0858 24 hr

PHI: 60 day(s) preharvest interval.

PGI: 60 day(s) prefeeding interval.,60 day(s) 

Ground. pregrazing interval.

71085-5 RICE Aircraft. Weed postemergence. 6 24 hr
Page 21 of 24

Attachment Table 5.1 Summary of Occupational Registered Propanil Uses1

EPA Reg 

No.

Use 

Site

Application 

Equipment Application Timing

Max App 

Rate

(lb ai/A)

REI Comments

Ground.

71085-6 RICE

Aircraft.

Weed postemergence. 6 24 hr PHI: 60 day(s) preharvest interval.

Ground. PGI: 60 day(s) pregrazing interval.

71085-9 RICE

Aircraft.

Weed postemergence.

6.00696 24 hr

PHI: 80 day(s) preharvest interval.

PGI: 80 day(s) pregrazing interval.

Ground.

Aircraft.

Weed postemergence. PHI: 60 day(s) preharvest interval.

Ground. PGI: 60 day(s) pregrazing interval.

86363-19 RICE

Aircraft.

Weed postemergence. 6.075 24 hr PHI: 60 day(s) preharvest interval.

PGI: 60 day(s) pregrazing interval. Ground.

87290-17 RICE

Aircraft.

Weed postemergence. 6.075 24 hr PHI: 60 day(s) preharvest interval.

Ground. PGI: 60 day(s) pregrazing interval.

87290-18 RICE

Aircraft.

Weed postemergence. 6.04854 24 hr PHI: 60 day(s) preharvest interval.

Ground. PGI: 60 day(s) pregrazing interval.

87290-32 RICE

Aircraft.

Weed postemergence. 6.01398 24 hr PHI: 60 day(s) preharvest interval.

Ground. PGI: 60 day(s) pregrazing interval.

1. Propanil (028201) Label Use Report Package in Support of Registration Review, L. Dobbins, 

12/2/2014
Page 22 of 24

Attachment 6: Dislodgeable Foliar Residue Data Requirement Criteria

Updated post-application exposure and risk estimates were calculated to evaluate the 

impact of updates to the FAR and transfer coefficient values since the last occupational 

and residential assessment was completed. The values are presented below:

Attachment Table 6.1 Occupational Post-application Non-Cancer Exposure and Risk Estimates for Propanil

Crop/Site Activities Max Application 

Rate

Transfer Coefficient 

(cm2/hr) DFR/TTR1 Dermal Dose (mg/kg/day)2 MOE3

Short-term/ Intermediate-term

Rice

Scouting

4 lbs ai/acre

1100

11.2

0.247 36

Wedding, Hand 70 0.016 570

Scouting

6 lbs ai/acre

1100

16.83

0.370 24

Wedding, Hand 70 0.024 380

1 DFR = Application Rate × F × (1-D)t × 4.54E8 μg/lb × 2.47E-8 acre/cm2; where F = 0.25 and D = 0.10 per day 

2 Daily Dermal Dose = [DFR (μg/cm2) × Transfer Coefficient × 0.001 mg/μg × 8 hrs/day × dermal absorption (20%)]  BW (80kg).

3 MOE = POD (9 mg/kg/day) / Daily Dermal Dose. Daily Dermal Dose = [DFR/TTR (μg/cm2) × TC × 0.001 mg/μg × 8 hrs/day ×

dermal absorption factor (20%)]  BW (80kg).

In accordance with 40CFR§158, DFR data are required for all occupational (e.g., crop, 

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

your own farms, retail tree farms) uses that could result in post-application exposure to 

foliage. In the absence of chemical-specific DFR data, EPA uses default values. The 

2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment 

includes an analysis of a number of DFR studies, which resulted in the selection of a 

revised default values for the fraction of the application rate available for transfer after a 

foliar application (FAR). This value is based on an analysis of 19 DFR studies. Since that 

time, the Agricultural Re-entry Task Force has submitted information (MRID 49299201) 

that corrects an application rate error made in the original submission of “ARF039 –

Determination of Dermal and Inhalation Exposure to Reentry Workers During 

Chrysanthemum Pinching in a Greenhouse” (EPA MRID 45344501). As a result of this 

submission, the default value of 25% was not changed as it still reflects a high-end, 

conservative value. However, it is important to note that the range of FAR values was 

revised from 2% - 89% to 2% - 47%. In the data, a large range of transferability is 

observed and this variability can potentially be attributable to many factors such as active 

ingredient; formulation; field conditions in the studies; weather conditions (e.g., 

humidity); or many other difficult to quantify factors. Although witnessed across 

multiple chemicals, this range in FAR values is not expected when considering DFR data 

for a single chemical. Because DFR data are not available for propanil, EPA is using the 

default value of 25%. Although there may be a small degree of uncertainty in the use of 

the default DFR value for propanil (i.e., there is a small chance that the FAR value may 

exceed the applicable default value), it is likely that the health-protective aspects of 

EPA’s occupational post-application assessment methodology will more than compensate 

for this potential uncertainty. For example, when assessing residential and occupational

post-application exposure to gardens and ornamentals, EPA assumes the following: 

exposures occur to zero-day (i.e., day of application ) residues every day of the assessed 

exposure duration (i.e., EPA assumes that no dissipation or degradation occurs, it doesn’t 

rain, etc); individuals perform the same post-application activities performed in the 
Page 23 of 24

transfer coefficient study day after day (e.g., weeding, harvesting, pruning, etc.); and 

individuals engage in these post-application activities for a high-end amount of time 

every day (represented by data reflecting time spent gardening based on survey data).

Given the conservatisms discussed above and the potential compounding nature of these 

conservatisms, EPA is able to rely upon the calculated exposure estimates with 

confidence that exposure is not being underestimated. 

Since the highest estimated occupational post-application exposure using default DFR 

values for propanil is not minimal in comparison to the level of concern (i.e., the 

calculated MOE is not greater than 2 times higher than the level of concern, MOE = 600

compared to the LOC of 300; EPA is requiring the 40CFR DFR data. Therefore, EPA is 

requiring the 40CFR DFR data requirement to facilitate any necessary exposure 

assessments refinements and to further EPA’s general understanding of the availability of 

dislodgeable foliar pesticide residues.
Page 24 of 24

Attachment 7: Propanil International Residue Limit Status Sheet

Propanil (PC Code 028201; 12/18/14)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico1 Codex

40CFR§180.274

combined residues of the herbicide 

propanil (3′, 4′-dichloropropionanilide) 

and its metabolites convertible to 3, 4-

dichloroaniline (3, 4-DCA)

None None

Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico1 Codex

Cattle, fat 0.10

Cattle, meat 0.05

Cattle, meat byproducts 1.0

Crayfish 0.05

Egg 0.30

Goat, fat 0.10

Goat, meat 0.05

Goat, meat byproducts 1.0

Hog, fat 0.10

Hog, meat 0.05

Hog, meat byproducts 1.0

Horse, fat 0.10

Horse, meat 0.05

Horse, meat byproducts 1.0

Milk 0.05

Poultry, fat 0.05

Poultry, meat 0.10

Poultry, meat byproducts 0.50

Rice, bran 40

Rice, grain 10

Rice, hulls 30

Rice, straw 75

Sheep, fat 0.10

Sheep, meat 0.05

Sheep, meat byproducts 1.0

Completed: M. Negussie; 12/30/2014

1 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.