# 2 

# REGISTRATION REVIEW

PROBLEM FORMULATION

______________________________________________________________________________



# Propargite

CAS Number 2312-35-8

US EPA PC CODE 097601

Prepared by:

Robin Sternberg, Ph.D., Wildlife Biologist

Stephen Wente, Ph.D., Biologist

Environmental Risk Branch 1

Reviewed by:

Meghan Radtke, Ph.D., Biologist

Harry Zhong, Ph.D., Biologist

Environmental Risk Branch 1 U.S. Environmental Protection Agency

Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch I

1200 Pennsylvania Ave., NW

Mail Code 7507P

Washington, DC 20460 O O S O

O

C

CH CH 3 

# CH 3



# H 3 

# C

# 3 

# 1 Executive Summary

The Environmental Fate and Effects Division (E FED) has completed the preliminary problem

formulation for the ecological risk, environmenta l fate, endangered species, and drinking water

assessments to be conducted as part of the Re gistration Review of propargite. The problem

formulation describes the methods planned to be used during the completion of drinking water

and ecological risk assessments in support of Re gistration Review and provides an overview of

the environmental fate, ecological effects, and potential risks associat ed with the use of

propargite as well as uncertainties unique to risk assessment of propargite. This document also

identifies additional studies that would be be neficial to the conduct of an ecological risk

assessment.

Major findings include the fo llowing data needs for propargit e and degradate TBPC and the

uncertainty described below:

Propargite

 OCSPP 850.6100: Independent laboratory valid ation (ILV) for the environmental

chemistry method (ECM) used in the soil analyses (TGAI)

 OCSPP 850.6100: ECM and ILV for the ECM used in the water analyses (TGAI)

 OCSPP 850.1500: Fish life cycle toxi city test, freshwater (TGAI)

 OCSPP 850.2100: Acute oral toxicity test, passerine species (TGAI)

 OCSPP 850.4100: Seedling emergence and seed ling growth, sorghum, ryegrass, onion,

carrot, radish, tomato, and soybean (TEP)

 OCSPP 850.4150: Vegetative vigor, ryegra ss, sorghum, and radish (TEP)

 Non-guideline chronic whole sedime nt invertebrate toxicity te sts, freshwater and marine

(TGAI)

 Non-guideline honey bee acute or al toxicity test (TGAI)

TBPC

 OCSPP 850.1010: Aquatic invertebrate acute toxi city test, freshwat er daphnids (TGAI)

 OCSPP 850.1075: Fish acute toxicity test, rainbow trout (TGAI)

 OCSPP 850.4500: Algal toxic ity, marine diatom ( Skeletonema costatum ) (TGAI)

Justifications for these data needs as well as as sumptions that will be made in the absence of

these data are provided in Section 11

.

There is uncertainty as to whether TBPC shoul d be considered a stressor of concern in the

aquatic assessment. There are no toxicity data available for TBPC. Based on ECOSAR

analyses, TBPC may be only slightly less toxic to aquatic organisms than propargite, but it

appears to be more persistent. The above da ta needs for TBPC will be used to determine

whether TBPC should be considered an aquatic st ressor of concern. In th e absence of toxicity

data for TBPC, the stressors of concern for aquatic organisms will be propargite and TBPC; a

conservative method of considering th e stressors of concern in total, i.e. , the total toxic residue

(TTR) approach, will be used; and exposure to pr opargite and TBPC will be estimated from the

existing fate data for propargite and TBPC.

# 4 

# 2 Introduction

Propargite is an organosulfite insecticide (acaricide/miticide) used to control mites on a variety

of field, fruit, and vegetable crops, as well as ornamentals. Propargite inhibits oxidative

phosphorylation via disrupting ATP formation.

EFED evaluated the most recent ecological risk assessments for propargite in association with

updated toxicity, exposure, and usage information to determine if sufficient data are available

and if further updates are needed to support Re gistration Review. Recent risk assessments by

EFED include a 2008 litigation assessment for the California red-legged frog ( Rana aurora

draytonni ) (USEPA, 2008) 1 

# and the EFED chapter (DP 231322, 250220, 265823) for the

Reregistration Eligibility Document (RED) (o riginal RED signed in 2001; revised/amended

versions issued in 2005 and 2007; addendum issued in 2008) 2 

# . In addition, EFED considered the

latest Agency science policies and risk assessment methodologies. The structure of propargite,

as well as the chemical names and other identifiers can be found in Table 5-2

.



# 3 Use Characterization

Propargite is registered for a large numb er of agricultural and nursery uses ( Table 3-1 ).

Propargite is formulated as an emulsifiable concentrate and wettable powder. Treatment

equipment includes airblast, aircraft, boom sprayer, and sprinkler irrigation.

EFED will use application scenarios that result in maximum exposure scenarios for a given use

for the risk assessment. Table 3-1 lists the maximum single application rate, the maximum

number of applications per cr op cycle, the annual maximum rate allowed (lb a.i./yr), and the

minimum application interval for each register ed use that occurs on any registration. This

information is necessary for both the pesticide app licator as well as the EFED risk assessor. Any

missing information indicated by “ NS ” in Table 3-1 will result in conservative assumptions

(higher application rates, more applications, shorter re-applicati on intervals) being made in the

risk assessment. To help registrants work w ith the Agency to clarify the label application

information, Appendix A provides the same information as Table 3-1 broken out by registration

number, which summarizes the information pres ent and absent from each registered label.

Table 3-1. Propargite Labe l Application Restrictions

Site Description Max Single App

Rate (Lbs./A) Max # Apps per

Crop Cycle Max App Rate

per Year (Lbs./A) Minimum

Retreatment

Interval (Days)

Alfalfa 2.50 NS NS NS

Almond 3.2 2 NS 21

Apple 1.92 2 NS 21

Beans, dried-type 2.50 NS 4.57 21

Carrot (including tops) 2.50 NS NS NS

Cherry 1.92 2 NS 21

Christmas tree plantations 2.4 2 NS 7

1 

# http://epa.gov/espp/litstatus/effects/redleg-frog/index.html

2 

# http://www.epa.gov/oppsrrd1/reregistration/propargite/

# 5 Site Description Max Single App

Rate (Lbs./A) Max # Apps per

Crop Cycle Max App Rate

per Year (Lbs./A) Minimum

Retreatment

Interval (Days)

Citrus 1.92 2 NS 21

Clover 2.50 NS NS NS

Conifers (plantations/nurseries) 2.4 2 NS 7

Corn (unspecified) 2.57 NS 2.57 21

Corn, field 2.60 1 2.60 NA

Corn, pop 2.57 NS 2.57 21

Corn, sweet 2.57 2 2.57 21

Cotton (unspecified) 1.71 2 3.34 21

Currant 1.92 2 NS 21

Date 1.92 2 NS 21

Fig 1.92 2 NS 21

Filbert (hazelnut) 1.92 2 NS 21

Grapefruit 3.36 1 5.76 28

Grapes 2.88 2 NS 21

Hops 1.56 2 NS 21

Jojoba 1.67 2 NS 10

Macadamia nut (bushnut) 1.92 2 NS 21

Mint 2.28 2 4.23 14

Nectarine 2.88 2 NS 21

Orange 3.36 1 5.76 28

Ornamental herbaceous plants 0.48 3 NS 14

Ornamentals (unspecified) 0.32 3 NS 14

Peanuts (unspecified) 1.71 2 NS 14

Pear 1.92 2 NS 21

Pecan 1.92 2 NS 21

Persimmon 1.92 2 NS 21

Pistachio 1.92 2 NS 21

Potato, white/Irish 2.28 2 4.23 14

Quince 1.92 2 NS 21

Rose 1.6 3 NS 14

Small fruits 1.92 2 NS 21

Sorghum 1.71 1 NA NA

Stone fruits 1.92 2 NS 21

Walnut (English/black) 4.61 2 6.92 21

NA = Not Applicable; NS = Not Specified.



# 4 Conclusions from Previous Risk Assessments

4.1 Ecological Risk Assessments

EFED has conducted ecological risk assessments on propargite that serve as a basis for this

problem formulation, including the RED (ori ginal RED signed in 2001; revised/amended

versions issued in 2005 and 2007; addendum issued in 2008) 3 

# and a 2008 litigation assessment

for the California red-legged frog (CRLF; Rana aurora draytonni ) 4 

# . Risk concerns identified in

the RED are provided in Table 4-1 . The following environmental fa te and ecological studies for

conventional chemicals were identified as data gaps and called in as a result of the RED:

3 

# http://www.epa.gov/oppsrrd1/reregistration/propargite/

4 

# http://epa.gov/espp/litstatus/effects/redleg-frog/index.html

# 6 Environmental fate studies:

 OPPTS 835.1410: Laboratory vo latilization from soil

 OPPTS 835.2370: Photodegradation of parent and degradates in air

 OPPTS 835.6200: Aquatic field dissipation

 OPPTS 835.6400: Combination products and tank mixes dissipation

 OPPTS 835.8100: Field volatility from soil

 OPPTS 835.7200: Surface drinking water monitoring study

Ecological effects studies:

 OPPTS 850.1350: Mysid chr onic toxicity test

 OPPTS 850.1500: Fish life cycle toxicity

 OPPTS 850.2150: Avian feeding study

 OPPTS 850.3030: Honey bee toxicity of residues on foliage

For the environmental fate studies, a waiver request was submitted for the laboratory

volatilization, photodegradati on in air, and field volatility studies based on the low vapor

pressure of propargite. EFED agreed to this waiver request (DP234284). The aquatic field

dissipation data were needed because propargite had one aquatic use on cranberries. However,

the cranberry use was subsequently removed from propargite labels. Theref ore, these data were

no longer required. The surface drinking wa ter monitoring study was submitted (MRID

47314101) and classified as “acceptable.” No data were submitted in regard to the “combination

products and tank mixes dissipation” data gap

.

For the ecological effects studies, a mysi d chronic study (MRID 46335701) was submitted and

classified as “acceptable.” No studies have b een submitted to fulfill the remaining ecological

effects data gaps.

Table 4-1. Ecological Risk Co ncerns as Identified in the RED for Propargite

Taxon Acute LOC Exceedance? Chronic LOC Exceedance?

Listed Non-Listed Listed and Non-Listed

Birds Yes Yes Yes

(except strictly seed-eating

birds)

Mammals Yes

(small herbivorous/

insectivorous mammals

[up to 35 g]

and large herbivorous

mammals [1000 g]) Yes

(small herbivorous/

insectivorous mammals) Yes

(herbivorous/insectivorous

mammals)

Terrestrial plants No

(aside from concerns for phytotoxicity to certai n plant species as clearly stated on labels)



# Honey bees No

Freshwater fish Yes No* Yes

Estuarine/marine fish Yes Yes Risk from chronic exposure

not assessed due to lack of

chronic toxicity data

Freshwater invertebrates Yes No* Yes

Estuarine/marine

invertebrates Yes No* Risk from chronic exposure

not assessed due to lack of

# 7 Taxon Acute LOC Exceedance? Chronic LOC Exceedance?

Listed Non-Listed Listed and Non-Listed

chronic toxicity data

Aquatic plants Yes**

LOC = Level of Concern

* The assessment noted that although the LOC was not exce eded, adverse effects could occur in shallow bodies of

water that are not represented by standard modeling scenarios for exposure.

** Based on exceedance using most sensitiv e aquatic nonvascular plant endpoint.



# For the litigation assessment, the Agency ma de a Likely to Adversely Affect (LAA)

determination for the CRLF from the use of propa rgite. Additionally, the Agency determined

that there is the potential for modification of CRL F designated critical habitat from the use of

propargite. These determinations were based on : 1) direct effects to the CRLF and 2) adverse

effects expected to the prey ba se of aquatic and terrestrial-pha se CRLF for all the modeled uses.

4.2 Drinking Water Exposure Assessments

A comprehensive drinking water exposure assessme nt was performed for propargite as part of

the RED in 2000 (DP 265823). No record wa s found of a more recent drinking water

assessment. Exposure estimates of propargit e from currently labe led uses that produce

maximum exposure (cotton) were 34.3 μg/L (1-i n-10-year peak), 8.7 μg/L (1-in-10-year annual

mean), and 4.8 μg/L (30-year mean) for surface water and 0.006 μg/L for ground water.

According to the Health Effects Division’ s Metabolism Assessment Review Committee (DP

256182), the parent is the only dri nking water residue of concern.

4.3 Clean Water Act Programs

Propargite is not identified as a cause of impairment for any wa ter bodies listed as impaired

under section 303(d) of the Clean Water Act. No Total Maximum Daily Load (TMDL) criteria

have been developed for propargit e. Aquatic benchmarks have been established for propargite

and are available at http://www.epa.gov/oppefed1/ecoris k_ders/aquatic_life_benchmark.htm

. Any data submitted or otherwise located as part of the registration review process may be used to

update aquatic life benc hmarks, if applicable.



# 5 Environmental Fate and Transport

Propargite [2-(4-tert-butylphenoxy)cyclohexyl prop-2-ynyl sulphite; CAS No. 2312-35-8; PC

code 097601] is moderately persistent (metabol ism half-lives = 38-168 days) and immobile (K d 

# ranged from 113 to 427 L/kg, while K OC 

# ranged from 5293 to 95,918 L/Kg OC 

# ). Its vapor

pressure and Henry’s law constant indicate that propargite has a low potential to volatilize under

field conditions. It degrades ra pidly under alkaline hydrolytic c onditions (half-life = 2.2 days)

and is moderately persistent to persistent under neutral (half-live s = 75 days) and acid (pH 5 halflife = 120 days) hydrolytic conditions. Soil and aquatic photolysis and aerobic and anaerobic

metabolism occur at moderate rates (half-live s = 39-168 days). Major degradates are carbon

dioxide, unextracted residues, and TBPC (tert- butylphenoxy cyclohexanol). Minor degradates

are BGES (bis-[2-(4-(1,1-dimethylethyl)-phenoxy ) cyclohexyl] sulfite), OMT-B (2,2-dimethyl4-(2-hdroxy-cyclohexoxy) phenylethanol), OGE- acid, and PTBP (p-t-butylphenol) (see Table

# 8 5-2 for structures). Because of its high affinity for soil and sediment, pr opargite has the potential

to move off the site of applic ation during rainfall/irrigation by erosion/runoff on soil particles

and by drift. Given the modera te to slow degradation rates for metabolism and photolysis, and

the high K OC 

# values, propargite will probably be predominantly adsorbed to sediments and

organic material if transported to surface waters.

Propargite might be expected to bioc oncentrate in fish based on its log K OW 

# of 5.7. A log K OW 

# of

5.7 indicates that propargite has a concentration in octanol (a n on-polar solvent) that is over

500,000× higher than in water (a polar solven t) at equilibrium. However the highest

bioaccumulation factor in the registrant-subm itted fish bioconcentration study is 1550× (nonedible tissue). There is potential for progargit e’s major degradate, TBPC, to leach to ground

water in vulnerable aquifers, such as those with coarse-textured soils low in organic matter due

to TBPC’s higher mobility. However, the H ealth Effects Division’s Metabolism Assessment

Review Committee (DP 256182) did not consider TBPC to be a residue of concern for drinking

water. A selection of environmental fate and tr ansport properties of propa rgite is summarized in

Table 5-1

.

Table 5-1. Chemical Properties and Enviro nmental Fate Parameters of Propargite

Parameter Value Description Source

Selected Physical/Chemical Parameters

Molecular mass (molecular

formula) 350.47 g/mol (C 19 

# H 26 

# O 4 

# S) -- Calculated

Vapor pressure (25°C) 4.49 x 10 -8 

# torr Limited volatility MRID 41003603

Aqueous solubility (25  C) 0.215 mg/L Limited solubility MRID 45905508

Henry’s Law Constant (25°C) 3.28 x10 -8 

# atm-m 3 

# /mol Limited volatility MRID 41003603

Log octanol-to-water partition

coefficient (log K O W 

# ) 5.7 Hydrophobic MRID 45905507

Persistence

Hydrolysis half-life (25  C) 120 days @ pH 5

75 days @ pH 7

2.2 days @ pH 9 Rapid degradation

pathway only under basic

conditions MRID 40358401

Aqueous photolysis half-life (25  C) 134 - 140 days @ pH 5 Stable (same as dark

control; slower than

hydrolysis @ pH 5) MRID 40358401

Soil photolysis half-life (25  C) 91 days Stable (similar to aerobic

soil half-lives) MRID 40358401

MRID 42319301

MRID 42319307

Aerobic soil metabolism half-life

(25°C) 53.3 days (In review) A



# 168 days Less than twice as fast as

abiotic hydrolysis for all

metabolism studies other

than the 168 day soil

metabolism half-life. MRID 43851401

MRID 43851402

Anaerobic soil metabolism half-life

(25°C) 64.4 days MRID 41003602

Anaerobic aquatic metabolism halflife (25  C) 47 days MRID 43139401

Aerobic aquatic metabolism halflife (25  C) 38 days MRID 42688801

# 9 Parameter Value Description Source

Mobility

Propargite soil-water partition

coefficients (K d 

# ); organic carbonnormalized coefficients (K OC 

# ) 113,162, 165, 172, 318, 427

L/kg;

5293, 23415, 39344, 48853,

90125, 95918 L/kg OC 

# Hardly mobile MRID 42908402

Degradate TBPC soil-water

partition coefficients (K d 

# ); organic

carbon-normalized coefficients

(K OC 

# ) 0.65, 0.66, 6.7, 1.17, 1.47,

8.39 L/kg;

187, 215, 284, 418, 460,

551, L/kg OC 

# Moderately mobile MRID 42908401

Field Dissipation

Terrestrial field dissipation half-life Florida citrus – 67 days -- MRID 41307301

California citrus – 87 days -- MRID 41731501

California cotton – 94 days -- MRID 41325901

California bare-ground – 78

and 99 days -- MRID 40969501

Fish Bioconcentration

Fish bioconcentration factors

(steady-state); depuration rate 260 (edible), 1550 (nonedible), 775 (whole); 82%

depuration in 14 days High bioconcentration

potential based on log k OW



# of 5.7 MRID 40494001 /

40916601

A 

# Studies are in review. The results are provisional pending the review.



# 5.1 Transformation Products (Degradates)

The only major degradate of propargite (other than CO 2 

# and unextracted residues) in submitted

environmental fate studies was TBPC. This degr adate was a major degradate in the hydrolysis

(max. 86%), soil photolysis (max. 21%), anaerobi c soil (max. 18%), aerobic aquatic (max. 28%),

and anaerobic aquatic metabolism (max. 62%) st udies. Only in the aquatic photolysis and

aerobic soil metabolism studies wa s it a minor degradate. However in those studies in which

TBPC was a major degradate, it tended to be persistent. For example, in the propargite

anaerobic aquatic metabolism study, TBPC was greater than 50% of applied radioactivity in one

replicate on day 30 and was measured at 42% in one replicate on day 365. A single fate study

(adsorption/desorption ) 

# was submitted for TBPC. Comparison of this study with the parent batch

equilibrium study indicates that TB PC is much more mobile than the parent. A variety of minor

degradates (BGES, OMT-B, OGE-acid, and PT BP) were observed in the photolysis and

metabolism studies. Table 5-2 summarizes the transformation products of propargite and the

maximum amounts formed.10Table 5-2. Propargite and ItsMajor Environmental DegradatesCode Name/ SynonymChemical NameChemical StructureStudy TypeReference(MRID)Maximum %AR(day)AFinal %AR(study length)PARENTPropargite (Omite)SMILES Code:O=S(OCCC)OC2CCCCC2Oc1ccc(cc1)C(C)(C)C2-(4-tert-butylphenoxy)cyclohexyl prop-2-ynylsulphiteCAS No.:2312-35-8Formula:C19H26O4SMW:350.47 g/molMAJOR TRANSFORMATION PRODUCTSBGESSMILES Code:O=S(OC2CCCCC2Oc1ccc(cc1)C(C)(C)C)OC2CCCCC2Oc1ccc(cc1)C(C)(C)Cbis-[2-(4-(1,1-dimethylethyl)-phenoxy)cyclohexyl] sulfiteFormula:C32H46O5SMW:542.78 g/molSoil photolysis 40358402 0.72% (59 d) 0.70% (365 d)Anaerobicaquatic43139401 1.72% (179 d) 0.45% (365 d)OMT-BSMILES Code:OC2CCCCC2Oc1ccc(cc1)C(C)(C)CO2,2-dimethyl-4-(2-hdroxy-cyclohexoxy)phenylethanolFormula:C16H24O3MW:264.37 g/molSoil photolysis 40358402 0.38% (30 d)0.17% (365 d)Aerobic aquatic 42688801 0.26% (30 d) 0.26% (30 d)Anaerobicaquatic43139401 4.72% (270 d) 4.48% (365 d)OGE-AcidOGE-AcidFormula:C16H22O4MW:278.35 g/molAerobic aquatic 42688801 1.54% (21 d) 1.00% (30 d)PTBPSMILES Code:Oc1ccc(cc1)C(C)(C)Cp-t-butylphenolFormula:C10H14OMW:150.22 g/molAquaticphotolysis40358401 4.2% (27 d) 4.2% (27 d)Soil photolysis 40358402 0.53% (7 d) 0.27% (365 d)Anaerobic soil 41003602 0.6% (60 d) 0.6% (60 d)Aerobic aquatic 42688801 0.89% (30 d) 0.89% (30 d)Anaerobicaquatic43139401 1.57% (270 d) 1.20% (365 d)OO SOOCCHCH3CH3H3COO SCH3CH3H3CO OCH3CH3CH3OOHOCH2CH3H3CHOOHOCCH3H3CHOOOHCH3CH3H3C11Code Name/ SynonymChemical NameChemical StructureStudy TypeReference(MRID)Maximum %AR(day)AFinal %AR(study length)TBPC (Omite Glycolether)SMILES Code:OC2CCCCC2Oc1ccc(cc1)C(C)(C)Ctert-butylphenoxycyclohexanolFormula:C16H24O2MW:248.37 g/molHydrolysis 40358402pH 5 –32%(69 d, 0.5 M buf)pH 7 –47%(47 d, 0.005 M buf)pH 9 –86%(6 d, 0.005 M buf)pH 5 –32%(69 d)pH 7 –47%(47 d)pH 9 –86%(6 d)Aquaticphotolysis40358401 8.0% (19 d) 6.4% (27 d)Soil photolysis4035840121.3% (19.9 d)21.3% (19.9 d)4231930720.8% (15.28 d)20.8% (15 d)Aerobic soil 40358402 2.33% (7 d) 1.65% (365 d)Anaerobic soil 4100360218.2% (60 d)18.2% (60 d)Aerobic aquatic 4268880127.66% (30 d)27.66% (30 d)Anaerobicaquatic4313940162.44% (270 d)42.21% (365 d)Terrestrial fielddissipation40969501 0.35ppm (21 d) 0.16ppm (354 d)412256010.0048ppm (pond, 0 d)0.073ppm (tile drain 1stdischarge)41307301 <0.10ppm <0.1ppm (358 d)41325901 0.10ppm (91 d) <0.1ppm (367 d)41432501 0.22ppm (4 d) <0.1ppm (364 d)41731501 0.113ppm (3 d) <0.1ppm (370 d)Unextracted ResiduesNA NASoil photolysis 42319307 6% (15 d) 6% (15 d)Aerobic soil4538240225.79% (100 d)25.79% (100 d)4035840237.49% (365 d)37.49% (365 d)Anaerobic soil 4100360214.9% (1 d)14.1% (60 d)Aerobic aquatic 42688801 6.53% (14 d) 4.78% (30 d)Anaerobic Aq. 4313940139.75% (120 d)27.12% (365 d)Carbon Dioxide CO2O – C – OSoil photolysis 4231930734.17% (365 d)34.17% (365 d)Aerobic soil4538240241.85% (100 d)41.85% (100 d)4035840234.13% (365 d)34.13% (365 d)Anaerobic soil 41003602 1.1% (60 d) 1.1% (60 d)Aerobic aquatic 42688801 0.68% (30 d) 0.68% (30 d)Anaerobicaquatic43139401 7.19% (365 d) 7.19% (365 d)ABolded values indicates the value exceeds 10% of the applied radioactivity.OHOCH3CH3H3C

# 12 

# 6 Receptors

6.1 Propargite

Summaries of the most sensitiv e endpoints used to characterize the toxicity of propargite to

aquatic and aquatic organisms are provided in Tables 6-1 and 6-2 , respectively. Summaries of

all submitted propargite toxic ity data can be found in Appendix B

.

For propargite, no data is available for the following:

 acute toxicity to mysid shrimp;

 life cycle toxicity to fish;

 toxicity to benthic invertebrates;

 acute oral toxicity to a passerine species; and

 dietary (oral) toxicity to adult honey bees.

Propargite is classified as highly to very highly toxic to fish; up to very highly toxic to aquatic

invertebrates; practically non-toxic to birds on an acu te oral basis; up to sli ghtly toxic to birds on

a sub-acute dietary basis; and practically non-toxic to honey bees on an acute contact basis.

6.2 Degradate TBPC

TBPC is the only major degradate of propargite. There are no toxicity da ta available for TBPC.

In the absence of toxicity data, predicted acute and chronic toxicity values for TBPC were

generated using EPA’s ECOSAR tool (v 1.11) wh ich is based on quantitative structure activity

relationships (QSAR) for effects on fish, daphnids , mysid shrimp, and green algae. Predicted

toxicity values were also ge nerated for propargite and compared to observed endpoints from

registrant-submitted studies to assess confidence in the ability of ECOSAR to predict the toxicity

of TBPC. ECOSAR-predicted and observed to xicity values for propargite and TBPC are

provided in Table 6-3

.

ECOSAR exactly predicts the chronic toxi city of propargite to mysid shrimp ( i.e. , the observed

and predicted toxicity values are equal). For a ll other taxa, ECOSAR-predicted toxicity values

for propargite are greater than observed toxi city endpoints implying that ECOSAR underpredicts toxicity to propargite. With the excepti on of acute toxicity to daphnids where ECOSAR

under-predicts toxicity to propargite by an orde r of magnitude, ECOSAR-p redicted values are

less than an order of magnitude greater (range: two to six times greater) than observed toxicity

endpoints for propargite.

TBPC-predicted toxicity values are greater than propargite-predicted toxi city values, but only by

less than an order of magnitude (range: two to nine times greater) implying that TBPC may be

only slightly less toxic to aquatic organisms than propargite. Given the uncertainty associated

with the ability of ECOSAR to predict toxi city (based on the comparison of observed and

predicted toxicity values for propa rgite), aquatic toxicity data fo r TBPC are needed to determine

whether TBPC should be considered a stressor of concern in the Registration Review ecological

risk assessment (see Section 11 ).13Table 6-1. Summary of the Most Sensitive Endpointsfrom Aquatic ToxicityStudies for PropargiteTaxonStudy TypeTest chemical (% a.i.)SpeciesToxicity Endpoints*, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationFreshwaterfish(surrogate foraquatic-phaseamphibians)21-day flow-throughexposurePropargite (88.4)Rainbow trout(Oncorhynchus mykiss)Preliminary endpoints as presented in the study report:96-hr (4-day) LC50(95% C.I.) = 43 (38-49) μg a.i./L (mm)21-day LC50(95% C.I.) = 24 (21-32) μg a.i./L (mm)21-day NOAEC = 14 μg a.i./L (mm)21-day LOAEC = 21 μg a.i./L (mm)Very highly toxicMRID 41458301In reviewAcute: 96-hr flowthrough exposurePropargite (90.2)Bluegill sunfish(Lepomis macrochirus)Preliminary endpoints as presented in the study report:LC50= 81 μg a.i./L (mm)NOAEC = 40 μg a.i./L (mm)LOAEC = 60 μg a.i./L (mm)(NOAEC based on sublethal effects)Very highly toxicMRID 46073301In reviewEarly life stage: 35-dayflow-through exposurePropargite (86.3)Fathead minnow(Pimephales promelas)NOAEC = 16 μg a.i./L (mm)LOAEC = 28 μg a.i./L (mm)(based on reduced post-hatch survival, length, and wet weight)MRIDs 00126739and 00132605AcceptableEstuarine/marine fishAcute: 96-hr, staticexposurePropargite (87.4)Sheepshead minnow(Cyprinodonvariegatus)LC50(95% C.I.) = 55 (32-100) μg a.i./L (mm)NOAEC = 32 μg a.i./L (mm)LOAEC = 60 μg a.i./L (mm)(NOAEC based on no mortality at 32 μg a.i./L)Very highly toxicMRID 40514001AcceptableEarly life stage(chronic)Estuarine/marine fish No dataNAAquaticinvertebratesAcute: 48-hr flowthrough exposurePropargite (90.2)Water flea(Daphnia magna)Preliminary endpoints as presented in the study report:EC50(95% C.I.) = 14 (11-19) μg a.i./LNOAEC = 4 μg a.i./LLOAEC = 13 μg a.i./LVery highly toxicMRID 46015901In review14TaxonStudy TypeTest chemical (% a.i.)SpeciesToxicity Endpoints*, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationLife cycle (chronic): 21-day flow throughexposurePropargite (86.3)Water flea(Daphnia magna)NOAEC = 9 μg a.i./L (m)LOAEC = 14 μg a.i./L (m)(based on growth [length])MRID 00142594AcceptableEstuarine/marineinvertebratesAcute Mysid shrimpNo dataAcute toxicity may be characterized using toxicity data forfreshwater invertebrates (i.e.,D. magna). For example:Estimated acute LC50(mysid)= Chronic NOAEC(mysid)* Acute-to-Chronic Ratio(D. magna)= 0.46 μg/L * 1.6= 0.74 μg/LWhere:Acute-to-Chronic Ratio(D. magna)= Acute LC50(D. magna)/ Chronic NOAEC(D. magna)= 14 μg/L /9 μg/L= 1.6NAAcute: 48-hr flowthrough exposurePropargite (87.4)Quahog clam embryolarvae(Mercenariamercenaria)EC50(95% C.I.) = 81.0 (41.8-infinity) μg a.i./L (m &estimated)bNOAEC < 7.3 μg a.i./L (m & estimated)aLOAEC = 7.3 μg a.i./L (m & estimated)aVery highly toxicMRIDs 40431601and 41449201AcceptableLife cycle (chronic)Propargite (91.9)Mysid shrimp(Americamysis bahia)NOAEC = 0.46 μg a.i./L (mm)LOAEC = 0.85 μg a.i./L (mm)(based on reductions in reproductive output)MRID 46335701AcceptableBenthicinvertebratesSediment acute/chronic Sediment-dwellinginvertebrateNo data NAAquaticvascular plantTier II, 14-day staticrenewal exposurePropargite (76.2)Duckweed(Lemna gibba)EC50= 75 mg a.i./L (mm)bNOAEC = 28 mg a.i./L (mm)(based on reductions in frond number)MRID 43885805Acceptable15TaxonStudy TypeTest chemical (% a.i.)SpeciesToxicity Endpoints*, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationAquatic nonvascular plantTier II, 5-day staticexposurePropargite (76.2)Marine diatom(Skeletonema costatum)EC50= 19.4 μg a.i./L (mm)bNOAEC = 1.27 μg a.i./L (mm)(based on reductions in cell number)MRID 43885806AcceptableAbbreviations: m = measured; mm = mean measured; NA= not applicableaConcentrations were measured at exposure initiation. Resultsof preliminary stability analysis indicated a 42% reduction of test material over the 48 hrs. 48-hrconcentrations were estimated based on a half-life of 57 hrs (42% reduction 48 hrs). Concentration estimates. Concentrations used for calculation of theendpoints are based on the mean ofthe 0-hr measured concentration andthe 48-hr estimated concentration.bThe raw data for this study may be subjected tonew statistical analysis because the present EC50was determined using probit analysis rather than non-linearregression analysis.Table 6-2. Summary of the Most Sensitive Endpointsfrom Terrestrial Toxicity Studies for PropargiteTaxonStudy TypeTest Chemical (% a.i.)SpeciesToxicity Endpoints, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationBirds(surrogate forreptiles andterrestrialphaseamphibians)Acute oral: single dose,14-day observationPropargite (87.6)Mallard duck(Anas platyrhynchos)LD50> 4640 mg a.i./kg-bw (nom)NOAEL = 2150 mg a.i./kg-bw (nom)(no mortality; NOAEL based on a reduction in feedconsumption and body weight gain at 4640 mg/kg-bw)Practically non-toxicMRID 00082632AcceptableAcute oral Passerine species No data NASub-acute dietary: 5-dayexposure; 3-day postexposure observationPropargite (87.5)Bobwhite quail(Colinus virginianus)LC50(95% C.I.) = 3401 (2494-4639) mg/kg-diet (nom)NOAEC: Not specified(concentration-dependent reduction in body weight gain downto the lowest test concentration, 464 mg/kg-diet)Slightly toxicMRID 00113471AcceptableSub-acute dietary: 5-dayexposure; 3-day postexposure observationPropargite (90)Mallard duck(Anas platyrhynchos)LC50> 4640 mg a.i./kg-diet (nom)NOAEC: Not specified(no mortality; reduction in body weight gain at≥2150 mg/kgdiet)At most slightly toxicMRID 00052454Acceptable16TaxonStudy TypeTest Chemical (% a.i.)SpeciesToxicity Endpoints, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationReproduction (chronic)Propargite (85)Mallard duck(Anas platyrhynchos)NOAEC = 84.7 mg a.i./kg-diet (m)LOAEC = 288 mg a.i./kg-diet (m)(based on reductions in adult body weight, eggs laid/female,viable embryos, live 3-week emrbyos, hatchlings, 14-daysurviving chicks, and weight of 14-day surviving chicks)MRID 41041701AcceptableReproduction (chronic)Propargite (85)Bobwhite quail(Colinus virginianus)NOAEC = 84.7 mg a.i./kg-diet (m)LOAEC = 288 mg a.i./kg-diet (m)(based on most senstive endpoint of reduction in hatchlingweight; female adult body weight, eggs laid/female, and 14-daysurviving chicks also affected)MRID 41041702AcceptableTerrestrialinvertebratesAcute contact: singledose, 48-hr observationPropargite (88.3)Honey bee(Apis mellifera)LD50(95% C.I.) = 15 (13-18) μg/bee (m)NOAEC = 9.8 μg/bee (m)LOAEC = 17 μg/bee (m)(NOAEC based on sublethal effect of lethargy)Practically non-toxicMRID 43185001AcceptableAcute dietary (oral)Adult honey bee(Apis mellifera)No data NAAcute dietary (oral)Comite 3W (30)Larval honey bee(Apis mellifera)LD50> 100 μg/larva(age groups of larvae tested: 1-2 days, 3-4 days, 5-6 days)MRID 00074486AcceptableTerrestrialplantsSeedling emergence: limittestPropargite (76.2)Most sensitive monocot:SorghumEC/IC25= 2.45 lb a.i./ANOAEC < 2.45 lb a.i./A(based on weight)Also, NOAEC < 2.45 lb a.i./A for ryegrass and onion based onemergence and weight, respectively.MRID 43885801Supplemental(due to nondefinitiveNOAECs forsorghum, ryegrass,onion, carrot,radish, tomato,soybean)Most sensitive dicot:Carrot, radish, tomato,soybeanEC/IC25> 2.45 lb a.i./ANOAEC < 2.45 lb a.i./A(based on emergence for carrot,radish, and tomato and lengthfor soybean)Vegetative vigor: limittestPropargite (76.2)Most sensitive monocot:Ryegrass , sorghumEC/IC25> 2.45 lb a.i./ANOAEC < 2.45 lb a.i./A(based on length and weight for ryegrass and sorghum,respectively)MRID 43885802Supplemental(due to nondefinitive17TaxonStudy TypeTest Chemical (% a.i.)SpeciesToxicity Endpoints, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationMost sensitive dicot:RadishEC/IC25> 2.45 lb a.i./ANOAEC < 2.45 lb a.i./A(based on weight)NOAECs forryegrass, sorghum,and radish)Abbreviations: NA = not applicable; nom = nominal; NS = not specified; m = measuredTable 6-3: Comparison of ECOSAR-Predicted and Observed ToxicityTaxonExposureDurationEndpointPropargiteTBPCPredicted*ObservedPredicted*(mg/L)Fish96-hr LC500.180 0.043 0.74430-day Chronic value or NOAEC 0.026 0.016 0.098Daphnid48-hr LC50or EC500.142 0.014 0.543Chronic Chronic value or NOAEC 0.035 0.009 0.106Green algae96-hr 96-hr 0.413 0.066 1.140Chronic Chronic value or NOAEC 0.225 No data 0.522Saltwater fish96-hr LC500.231 0.055 0.952Chronic Chronic value or NOAEC 0.222 No data 0.542Mysid shrimp96-hr LC500.015 No data 0.112Chronic Chronic value or NOAEC 0.00046 0.00046 0.004* based on ECOSAR class neutral organics

# 18 6.3 Ecological Incidents

A preliminary review on March 5, 2014, of the Ec ological Incident Information System (EIIS,

version 2.1), which is maintained by the Agency ’s Office of Pesticide Programs, and the Avian

Monitoring Information System (AIMS), whic h is maintained by the American Bird

Conservancy, indica tes a total of 3 reported ecological incidents a ssociated with the use of

propargite. This total excludes in cidents classified as ‘unlikely’ or ‘unrelated’ and only includes

those incidents with certainty ca tegories of ‘possible’, ‘probabl e’, and ‘highly probable’ (for

EIIS) and ‘possible’, ‘probable’ , ‘likely’, ‘highly likely’ and ‘certain’ (for AIMS). These

incidents are summarized in Table 6-4 . All of the pr opargite incidents occurred between 1997

and 2001 and were classified as “possible” to have been caused by propargite. One incident

affected honey bees and the othe r two involved plants. The two plant incidents involved

additional chemicals besides propargite. In the risk assessment, these incidents will be further

evaluated to determine if the reported incidents re present current patterns of use for propargite.

In addition to the incidents reco rded in EIIS and AIMS, additiona l incidents have been reported

to the Agency in aggregated incident reports. Pesticide registrants re port certain types of

incidents to the Agency as a ggregate counts of incidents occu rring per product per quarter.

Ecological incidents reported in aggregate reports include those cat egorized as ‘minor fish and

wildlife’, ‘minor plant’, and ‘oth er non-target’ incide nts. ‘Other non-target’ incidents include

reports of adverse effects to inse cts and other terrestrial invertebra tes. For propargite, registrants

have reported no minor fish and wildlife incidents, minor plant incidents, or other non-target

incidents as of March 5, 2014.19Table 6-3. Ecological IncidentsAssociated with PropargiteaIncidentNumberTaxaInvolvedEffectsRoute ofExposureMagnitudeYearLocationUseLegality ofUseCertaintyCategorybResiduesOtherChemicalsInvolvedI007740-001 Plants(cotton)Bronzing NotspecifiedNot reported 1997 CA Cotton Registered use Possible NotreportedChlorpyrifosAmitrazI012366-001 Plants(corn,potato)PlantdamageDirectapplication9000 A (corn)65 A (potato)2001 CA NotreportedUndetermined Possible NotreportedSpinosadI020627-034 Terrestrialanimals(bees)Mortality Notspecified2 hives 2001 WA Corn Undetermined Possible NotreportedNonea‘Minor’ incidents aggregately reported by theregistrant(s) are not included in this table.bIncidents classified as ‘unrelated’ and ‘unlikely’ are excluded.

# 20 

# 7 Exposure Pathways of Concern

The environmental fate properties and use patterns of propargite indicate th at direct spray, spray

drift, runoff, and erosion of pesticide-laden soil particles represent potential transport

mechanisms of propargite to aqua tic and terrestrial organisms.

Drinking water and inhalation e xposure pathways were screen ed using the SIP (Screening

Imbibition Program) and STIR (Screening Tool for Inhalation Risk) screening methods and were

found to be exposure pathways of low con cern (no LOC exceedances are expected; see

Appendix C ). SIP and STIR are described in detail at:

http://www.epa.gov/oppefed1/ models/terrestrial/index.htm

.



# 8 Analysis Plan

8.1 Stressors of Concern

8.1.1 Ecological Risk Assessment

The stressors of concern for aquatic organisms are propargite and, pending results of requested

ecotoxicity studies, the degradate TBPC. If TBPC is found to be much less toxic than

propargite, the stressor of concern for aquatic or ganisms will be propargite alone. If TBPC is

found to be similar in toxicity to propargite, th e stressors of concern fo r aquatic organisms will

be propargite and TBPC. In at th e absence of toxicity data for TB PC, the stressors of concern for

aquatic organisms will be propargite and TBPC, and a conservative method of considering the

stressors of concern in total, i.e. , the total toxic residue (TTR) approach, will be used. For the

latter two scenarios, exposure to propargite and TBPC will be estimated from the existing fate

data for propargite and TBPC.

The stressor of ecological concern for te rrestrial organisms is propargite.

8.1.2 Drinking Water Exposure Assessment

The drinking water assessment conducted to suppor t the Registration Review human health risk

assessment of propargite will incorporate model estimates of propargite, which is the only

residue of concern (DP 256182), in surface and ground waters. Th e propargite residues of

concern may be reevaluated pending receipt and review of additional environmental fate and

toxicity data for propargite and its degradates.

8.2 Measures of Exposure

EFED will use standard available models to evaluate potential exposures to aquatic and

terrestrial organisms as described at http://www.epa.gov/pesticides/science/models_db.htm

.

8.2.1 Available Monitoring Data

# 21 The Agency is aware of monitoring conducted by federal and state agenci es and this route of

exposure will be considered in the assessment to th e extent that data on pr opargite are available.

8.3 Measures of Effect

Toxicity data presented in Section 6 of this problem formulation w ill be used to calculate risk

quotients. Any additional information submitted by th e registrant or found in the open literature

prior to conduct of the risk assessment will also be considered. The open literature studies are

identified using EPA’s ECOTOXicology database (ECOTOX 5 

# ), which employs a literature

search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife.

The evaluation of both sources of data can also provi de insight into the dir ect and indirect effects

of pesticides on biotic communities from loss of species that are sensitiv e to the chemicals and

from changes in structure and functional ch aracteristics of the affected communities.



# 9 Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the

Agency will evaluate risks to federally listed th reatened and/or endangere d (listed) species from

registered uses of pesticides in registration re view. The process for evaluating potential risks to

listed species is further described at

http://www.epa.gov/oppfead1/enda nger/litstatus/riskasses.htm

.



# 10 Endocrine Disruptors Screening Program

Propargite is on List 1 for which EPA has receiv ed all the required Tier 1 assay data. The

Agency is currently reviewing all of the assay da ta received for the appropriate List 1 chemicals

and planning to make the conclusions of thos e reviews available in early 2015. For additional

information the EDSP program, visit http://www.epa.gov/endo/

.



# 11 Preliminary Identification of Data Gaps

11.1 Environmental Fate

Tables 11-1 and 11-2 identify environmental fate studies that offer data for each guideline

requirement and whether or not fu rther data are needed to suppor t the ecological risk assessment.

Table 11-1. Environmental Fate Data for Propargite

OCSPP

Guideline Data

Requirement Submitted

Studies

(MRID) Study

Classifications Are data

needed to

conduct risk

assessment? Justification and Assumptions EPA

will Make in Absence of Data

835.2120 Hydrolysis 4035 8402 Acceptable No --

835.2240 Aqueous

photolysis 40358401 Acceptable No --

835.2410 Soil photolysis 4 0358401 Acceptable No --

5 

# http://cfpub.epa.gov/ecotox/

# 22 OCSPP

Guideline Data

Requirement Submitted

Studies

(MRID) Study

Classifications Are data

needed to

conduct risk

assessment? Justification and Assumptions EPA

will Make in Absence of Data

42319301 Supplemental

42319307 Supplemental

835.4100 Aerobic soil

metabolism 41003601 Unacceptable No MRID 43851402 is acceptable.

Therefore even if MRID 43851401 (in

review) were to be found unacceptable,

it would not result in a data gap. 42786301 Supplemental

43851401 In review

43851402 Acceptable

835.4200 Anaerobic soil

metabolism 00068368 Supplemental No --

41003602 Acceptable

835.4300 Aerobic aquatic

metabolism 42688801 Acceptable No --

835.4400 Anaerobic

aquatic

metabolism 43139401 Acceptable No --

835.1230

835.1240 Adsorption/

desorption and

leaching 00112414 Acceptable Yes 2 

# This is an un-aged leaching study that

partially fulfills the data requirements.

42908402 Upgradeable 1 

# MRID 42908402 (parent batch

equilibrium study) is not acceptable

b ecause the solubi1ity of propargite may

have been exceeded in this experiment

( i.e ., propargite adsorbed to surfaces in

study). In order to clarify the results, the

solubi1ity of propargite in 0.01 M

calcium acetate solution at 25oC should

be measured and reported. 1



# 835.1410 Volatility –

laboratory Waived – low vapor pressure. No --

835.6100 Terrestrial field

dissipation

(TFD) 40969501 Supplemental Yes 3 

# The maximum length of time that the

soil samples were stored frozen prior to

analysis was not reported. The irrigation

regime was not typical of normal

agricultural practice.

41307301 Acceptable --

41325901 Acceptable

-- 41432501 Supplemental The registrant’s re-examination of the

data from this propargite TFD study

indicates that the detections of

propargite and its degradate TBPC

below the 6 inch depth are more likely

to be the results of contamination of

deeper samples with propargite-treated

soil from the surface layer than leaching

of propargite.

41731501 Acceptable --

41966001 Acceptable Freezer storage stability study.

Environmental

chemistry 44968601 In review If MRID 44968601was found to be

unacceptable, we would need a new

# 23 OCSPP

Guideline Data

Requirement Submitted

Studies

(MRID) Study

Classifications Are data

needed to

conduct risk

assessment? Justification and Assumptions EPA

will Make in Absence of Data

method (ECM)

in soil No Independent Laboratory

Validation (ILV) has been

submitted. --

835.6200 Aquatic field

dissipation Waived – cranberry use

removed from label(s). No --

Environmental

chemistry

method (ECM)

in water No Environmental chemistry

method (ECM) or Independent

Laboratory Validation (ILV)

has been submitted. Yes 4



# --

850.1730 Fish

bioconcentration 40494001 Acceptable No --

40916601 Acceptable

Nonguideline Terrestrial Field

Runoff and

Spray Drift

Monitoring

Studies 40969501 Supplemental (Not

applicable) 41057402 Supplemental

41057401 Supplemental

41153201 Supplemental

41153205 Supplemental

41225601 Supplemental

41184001 Supplemental

41663201 Supplemental

1 

# In MRIDs 40431602, 41449202, 41449203, 41449204, and 41449205, the soil was autoclaved. Autoclaving is

known to change a soil's chemical and physical properties. In MRID 41449206, the study design was not adequately

described; it could not be determined if the study was conducted according to sound scientific practices and

guidelines. Therefore, all of these studies are unacceptable.

2 

# The EFED science chapter for the Propargite RED lists MRID 42908402 as acceptable . However, EFED has no

record of this change in classificati on from upgradeable to acceptable. If th e data requested or documentation of

classification change can be provided to EF ED, the data requirement may be fulfilled.

3 

# For soil, no acceptable ILV has been submitted.

4 

# For water, no acceptable ECM and ILV have been submitted.



# In the soil method document (MRID 44968601), the registrant argues:

...An ILV is suggested by the USA EPA. This has not been done in a formal sense.

However, four field dissipation studies for pr opargite in different US A locations (two for

California, one each for Florida and Georgia) have been done at various times. Although

the same laboratory analyzed the samples, the fact that these analyses were done

successfully over a number of years suggests that the met hod in this report can be

considered as having been independently lab validated. (p. 23 of MRID 44968601)

However, an independent laboratory valid ation study needs to be performed at an independent

laboratory using different labo ratory personnel to determine if the method description is

sufficient as written for other laboratories to pe rform the analyses at the specified levels of

accuracy. Therefore, EPA does not consider th e requirements of an independent laboratory

validation study to be fulfilled.

# 24 Only a single fate study has been submitted for any of the propargite degradates (Table 11-2). No

additional fate studies for TBPC are needed at this time.

Table 11-2. Submitted Environmental Fa te Data for the Degradate TBPC

OCSPP

Guideline Data

Requirement Submitted

Studies

(MRID) Study

Classifications Are data

needed to

conduct risk

assessment? Justification and Assumptions EPA

will Make in Absence of Data

835.1230

835.1240 Adsorption/

desorption and

leaching 42908401 Acceptable No This is a batch equilibrium study of the

TBPC degradate.



# 11.2 Ecological Effects

Tables 11-3 and 11-4 identify ecological effects studies th at offer data for each guideline

requirement and whether further data are need ed to support the ecologi cal risk assessment.

There are no toxicity data available for TBPC , a major degradate of propargite. Based on

ECOSAR analyses, TBPC may be only slightly less toxic to aqua tic organisms. Therefore,

aquatic toxicity data for TBPC are needed to determine whether TBPC should be considered an

aquatic stressor of concern in the ecological risk assessment. The following acute toxicity data

for TBPC are needed to establis h whether TBPC should be consid ered an aquatic stressor of

concern:

 OCSPP 850.1010: Aquatic inverteb rate acute toxicity test , freshwater daphnids

 OCSPP 850.1075: Fish acute toxi city test, rainbow trout

 OCSPP 850.4500: Algal toxic ity, marine diatom ( Skeletonema costatum )

In at the absence of toxicity data for TBPC, the stressors of concern for aquatic organisms will be

propargite and TBPC; a conservative method of cons idering the stressors of concern in total, i.e.

, the total toxic residue (TTR) approach, will be us ed; and exposure to propargite and TBPC will

be estimated from the existing fate data for propargite and TBPC.25Table 11-3. Aquatic Ecological Effects Data for PropargiteOCSPPGuidelineDataRequirementSourceMRIDClassificationDataGap?Are Data Neededto Conduct theRisk Assessment?Justification and Assumptions EPA Will Make in the Absence ofData850.1010 Freshwaterinvertebrateacute toxicity46015901 In review No No --43759002 Acceptable00068752,00112402Acceptable850.1025850.1035850.1045850.1055Saltwaterinvertebrateacute toxicity40431601,41449201(mollusk)Acceptable No No --(mysid) NA Yes No Acute toxicity to mysids may be characterized using an acute-tochronic ratio derived from toxicity data for freshwater invertebrates(i.e.,D. magna; seeTable 6-1for details).850.1075 Freshwater fishacute toxicity41458301(cold water)In review No No00066498(cold water)Acceptable43759001(cold water)Acceptable00043552(cold water)Supplemental46073301(warm water)In review No00003059,00076405,00112368,00029174,00009733(warm water)Supplemental00066498 Acceptable26OCSPPGuidelineDataRequirementSourceMRIDClassificationDataGap?Are Data Neededto Conduct theRisk Assessment?Justification and Assumptions EPA Will Make in the Absence ofData(warm water)850.1075 Saltwater fishacute toxicity40514001Acceptable No No --850.1300 Freshwaterinvertebratelife cycle00142594Acceptable No No --850.1350 Saltwaterinvertebrateslife cycle46335701 Acceptable No No --850.1400 Freshwater fishearly life stage00126739Acceptable No No850.1400 Saltwater fishearly life stageNo data NA Yes Yes Chronic toxicity to estuarine/marine fish may be characterized usingan acute-to-chronic ratio derived from toxicity data for freshwaterfish .850.1500 Freshwater fishlife cycleNo data NA Yes(RED)Yes This study was identified as a data gap in the RED, and a subsequentDCI for this study was issued.According to 40 CFR Part 158, data are required if the end-useproduct is intended to be applied directly to water, or is expected tobe transported to water from the intended use site, and when any ofthe following conditions apply:i. If the estimated environmental concentration (EEC) is≥0.1of the no-observed effect levelin the fish early life stage orinvertebrate life cycle test;ii. If studies of other organisms indicate that the reproductivephysiology of fish may be affected.Propargite is expected to be transported to water from its intendeduse site. In the 2008 CRLF litigation assessment, modeled 60-dayEECs of propargite were up to 5.26 μg/L which is > 0.1 of theNOAEC in the fathead minnow fish early life stage (NOAEC = 16μg/L; MRIDs 00126739 and 00132605). In addition, avian27OCSPPGuidelineDataRequirementSourceMRIDClassificationDataGap?Are Data Neededto Conduct theRisk Assessment?Justification and Assumptions EPA Will Make in the Absence ofDatareproductive studies with propargite (MRIDs 41041701 and41041702) showed effects on multiple reproductive endpoints (seeTable 6-2). Therefore, a fish life cycle study is needed. If the testspecies used in the fish life cycletest is different from the speciesused for the freshwater fish acute toxicity tests, a 96-hr LC50of thespecies used in the fish early life stage test must also be provided.NonguidelineWholesediment:chronicinvertebratesfreshwater andmarineNo data NA Yes Yes Chronic sediment invertebrate toxicity data are required under 40CFR Part 158 if:i.the estimated environmental concentration (EEC) in sedimentis > 0.1 of the acute LC50/EC50values;ii.the half-life of the pesticide in sediment if > 10 days in eitherthe aerobic soil or aquatic metabolism studies and if any ofthe following exist:A.The soil partition coefficient (Kd) is≥50B.The log Kow is≥3.C.The Koc is≥1,000.Modeling via PRZM/EXAMSaindicates pore water EECs of at least3.76 μg/L which is approximately 0.27of the LC50of 14 μg/L forD.magna(MRID 46015901); the 90thpercentile half-lives ofpropargite in the aerobic soil metabolism and aerobic aquaticmetabolism studies are 168 and 38 days, respectively; and the logKow and Koc of propargite are 5.8 and 25,918 mL/g, respectively.Therefore, chronic sediment tests with the midgeChironomusdilutus, freshwater amphipodHyalella azteca, and/orestuarine/marine amphipodLeptocheirus plumulosusare needed. Atiered approach using toxicity data from sub-chronic (10-day)sediment toxicity tests with the three species may be used todetermine which species should undergo chronic toxicity testing.In the absence of these data, sediment-dwelling invertebrate chronictoxicity data for surrogate pesticides – starting with data for closelyrelated pesticides and proceeding to data for less related pesticides –28OCSPPGuidelineDataRequirementSourceMRIDClassificationDataGap?Are Data Neededto Conduct theRisk Assessment?Justification and Assumptions EPA Will Make in the Absence ofDatamay be used to characterize the chronic toxicity of propargite tosediment-dwelling invertebrates.850.4400 Aquatic planttoxicity testusingLemnaspp.43885805 Acceptable No No --850.4500 Algal toxicity 43885804(green alga)Acceptable No No --43885806(marinediatom)Acceptable No43885807(freshwaterdiatom)Acceptable No850.4550 Cyanobacteriatoxicity43885803 Acceptable No No --Abbreviations: NA = not applicableaPRZM/EXAMS scenario alfalfa; first application date: June 27;last application date: July 17; broadcast aerial application modeled as 95% applicationefficiency and 5% spray drift; 2 applications @ 2.456 lb a.i./acre; 20-dayapplication intervalTable 11-4. Submitted Terrestrial Ecological Effects Data for PropargiteOCSPPGuidelineDataRequirementSourceMRIDClassificationDatagap?Are DataNeeded toConduct theRiskAssessment?Justification and Assumptions EPA Will Make in the Absence ofData850.2100 Avian oraltoxicity00082632(waterfowl)Acceptable No No--29OCSPPGuidelineDataRequirementSourceMRIDClassificationDatagap?Are DataNeeded toConduct theRiskAssessment?Justification and Assumptions EPA Will Make in the Absence ofDataNo data(passerine)NA Yes Yes Acute oral toxicity data for a passerine species are required under thenew 40 CFR Part 158. A study has not been submitted for this datarequirement.A guideline-compliant passerine acute oral toxicity test is needed.Acute oral toxicity data are onlyavailable for one avian species (i.e.,mallard duck). Passerine birds may utilize metabolic pathways that aredifferent from larger birds and therefore be more sensitive topropargite. Furthermore, passerines exhibit behavioral responses topesticide dosing that are potential indicators of reduced fitness in thefield (e.g., regurgitation of contaminateddiet) even when directbiochemically-mediated lethal toxicity is not apparent.In the absence of these data, passerine toxicity data for surrogatepesticides – starting with data for closely related pesticides andproceeding to data for less related pesticides – may be used tocharacterize the acute toxicity ofpropargite to passerine species.850.2150 Avian feedingstudyNo data NA Yes(RED)No This study was identified as a data gap in the RED, and a subsequentDCI for this study was issued. This study is not needed to conduct theRegistration Review ecological risk assessment.850.2200 Avian dietarytoxicity00052454(upland game)Acceptable No No --00076407,00112367(upland game)Acceptable00113471(waterfowl)Acceptable No No --850.2300 Avianreproduction41041702(upland game)Acceptable No No --30OCSPPGuidelineDataRequirementSourceMRIDClassificationDatagap?Are DataNeeded toConduct theRiskAssessment?Justification and Assumptions EPA Will Make in the Absence ofData41041701(waterfowl)Acceptable No No --850.3020 Honey bee acutecontact toxicity43185001Acceptable No No --850.3030 Honey beetoxicity ofresidues onfoliage00060628,00091656,00132711Acceptable Yes(RED)No This study was identified as a data gap in the RED, and a subsequentDCI for this study was issued. According to the current 40 CFR Part158, this study is required only when a formulation contains one ormore active ingredients having an LD50< 11 μg/bee as determined inthe honey bee acute contact study andthe use pattern(s) indicate(s) thathoney bees may be exposed to the pesticide. The acute contact LD50of propargite is >11 μg/bee, and formulations of propargite onlycontain one active ingredient. This study is not needed to conduct theRegistration Review ecological risk assessment.NonguidelineHoney bee acuteoral toxicityNo data NA NA Yes The “White Paper in Support of the Proposed Risk Assessment Processfor Bees” as submitted to the FIFRA Scientific Advisory Panel6proposes a screening-level risk assessment process that includes acutecontact and oral toxicity tests with adult bees and an acute oral toxicitytest with larval bees. Honey beeacute oral toxicity data are notavailable.In the absence of these data, honey bee oral toxicity data for surrogatepesticides – starting with data for closely related pesticides andproceeding to data for less related pesticides – may be used tocharacterize the oral toxicity ofpropargite to honey bees.NonguidelineHoney bee acutelarval toxicity00074486Acceptable No No6www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2012-0543-000431OCSPPGuidelineDataRequirementSourceMRIDClassificationDatagap?Are DataNeeded toConduct theRiskAssessment?Justification and Assumptions EPA Will Make in the Absence ofData850.4100 Seedlingemergence andseedling growth43885801Supplemental Yes Yes,for sorghum,ryegrass,onion, carrot,radish,tomato, andsoybeanAcceptable data are not available.The submitted study isclassified as“supplemental” because a definitive NOAEC (i.e., NOAEC < 2.45 lba.i./A) could not be determined for sorghum, ryegrass, onion, carrot,radish, tomato, and soybean. A study that defines a NOAEC (i.e., aconcentration that is not statistically different from the negative controlfor all assessed endpoints) for these species is needed.850.4150 Vegetativevigor43885802Supplemental Yes Yes, forryegrass,sorghum, andradishAcceptable data are not available.The submitted study isclassified as“supplemental” because a definitive NOAEC (i.e., NOAEC < 2.45 lba.i./A) could not be determined for ryegrass, sorghum, and radish. Astudy that defines a NOAEC (i.e., a concentration that is notstatistically different from the negative control for all assessedendpoints) for thesespecies is needed.Abbreviations: NA = not applicable

# 32 

# 12 References

DP 231322, 250220, 265823. EFED Risk Assessment fo r Re-registration Eligibility of

Propargite (Omite, Comite, Ornamite). U.S. Environmental Protection Agency, Office of

Pesticides Programs. 89p.

USEPA. 2008. Risks of Propargite Use to Fede rally Threatened California Red-legged Frog

( Rana aurora draytonii ). Pesticide Effects Determination. Environmental Fate and

Effects Division, Office of Pesticide Pr ograms, Washington, D.C. June 16, 2008.

DP 256182. Propargite. HED Metabolism Assessm ent Review Committee Meeting on 5/18/99.

Residues of Concern in Plants, Animals, and Water. (DP Barcode # D256182). U.S.

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sources; unpublished study received Mar 5, 1976 under 400-82; CDL:226761-A)

00065743 Wong, D.T.L.; Girouard, D.M.; Mec k, R.D. (1978) Hydrolysis Study of

Omite^(R)I-^14IC in Aqueous Soluti on: Project No. 7641. (Unpublished study

received Sep 29, 1978 under 400-89; submitted by Uniroyal Chemical, Bethany,

Conn.; CDL:241988-A)

00068368 Meck, R.D.; Campbell, C.R. (1977) Anaerobic Soil Metabolism of Omite^(R)I at 1

and 10 ppm: Project No. 7526. (Unpublished study received Jul 11, 1977 under

400-104; submitted by Uniroyal Chemical , Bethany, Conn.; CDL:231080-A)

00100290 Dannals, L.E.; Kucharczyk, N.; Smith, A.E. (1972) Fate of Omite^(R)I in the

Environment. Status rept. no. 1. (Unpub lished study received Sep 28, 1972 under

3F1305; submitted by Uniroyal Chemical, Bethany, Conn.; CDL:094120-A)

00100291 Sleight, B.H., III (1972) Exposure of Fish to ^14IC-labeled Omite: Accumulation,

Distribution, and Elimination of Residues. (Un- published st udy received Oct 4,

1972 under 3F1305; prepared by Bionomics, Inc., submitted by Uniroyal Chemical,

Bethany, Conn.; CDL:094120-B)

00112406 Uniroyal Chemical (1975) Environmental Chemistry of Omite, Including

Experimental Data. (Compilation; unpublished study received Mar 5, 1976 under

400-89; CDL:233085-A)

00112411 Tortora, N.; Smilo, A.; Fuller, G.; et al . (1979) Photochemical Fate of Omite in

Solution: Project No. 7644. (Unpublished study received Mar 8, 1979 under 400-

82; submitted by Uniroyal Chemical, Bethany, CT; CDL:241269-A)

00112412 Kuc, W. (1979) 14C-Omite Channel Catf ish Bioconcentration Study: UCES Project

No. 11506-97. (Unpublished study received Mar 8, 1979 under 400-82; prepared by

Union Carbide Corp., sub- mitted by Uniroyal Chemical, Bethany, CT;

CDL:241269-B)

# 33 00112414 Caplan, J. (1979) Absorp tion--Desorption of 14C-Om ite: Laboratory No. 9PL-30-

S. (Unpublished study received Mar 8, 1979 under 400-82; prepared by

Biospherics, Inc., submitted by Uniroyal Chemical, Bethany, CT; CDL:241269-D)

40358401 Nowakowski, M. (1987) Aqueous and So il Photolysis of [Carbon 14] Omite:

Project No. 8766, 87101. Unpublished study pr epared by Uniroyal Chemical Co.,

Inc. 43 p.

40358402 Nowakowski, M. (1987) Omite Hydrol ysis: Project No. 8731. Unpublished study

prepared by Uniroyal Chemical Co., Inc. 33 p.

40431602 Spare, W. (1987) Determination of the Adsorption/Desorption Constants of Omite:

Agrisearch Project No. 1909: Uniroy al Project No. 8791. Unpublished study

prepared by Agrisearch, Inc. 26 p.

40494801 Bioconcentration and Elimination of 14C -Residues by Bluegill Exposed to Omite,

D.C. Suprenant, Jan, 1988

40916601 McManus, J. (1988) Information and Data on Purity of ?Carbon 14|- Propargite

Used in the Study: "Bioc oncentration and Eliminati on of ?Carbon 14|-Residues by

Bluegill Exposed to Omite". Unpublishe d study prepared by Uniroyal Chemical

Co., Inc. 6 p.

40969501 Lengen, M. (1989) Field Di ssipation of Propargite on Tw o Sites in California:

Uniroyal Project 8661. Unpublished study prepar ed by Uniroyal Chemical Co., Inc.

in cooperation with California Agricultura l Research and Morse Laboratories, Inc.

54 p.

40969502 Harned, W. (1989) Omite Residue Leve l Monitoring Runoff Study (Terrestrial

Runoff) from a Missouri Corn Field: Project No. 8718-B: Project Nos. 87015-01,

03, 04, 06, 09, 11. Unpublished study prepared by Stewart Agricultural Research

Services, Inc. in cooperation with Biospherics, Inc. 156 p.

41003601 Dzialo, D. (1988) Omite Aerobic Soil Metabolism: Project No. 8723. Unpublished

study prepared by Uniroyal Chemical Co., Inc. 20 p.

41003602 Dzialo, D. (1988) Omite Anaerobi c Soil Metabolism: Project No. 8853.

Unpublished study prepared by Uniroyal Chemical Co., Inc. 29 p.

41087400 Uniroyal Chemical Co., Inc. (1989) Subm ission of Aquatic Monitoring Data in

Support of Propargite Registration St andard. Transmittal of 2 studies.

41087401 Harned, W. (1989) Omite Residue Leve l Monitoring Runoff Study (Terrestrial

Runoff) from a Missouri Corn Field: (Revised March 21, 1989). Unpublished study

prepared by Stewart Agriculture Research Services, Inc. in cooperation with

Biospherics, Inc. 160 p.

41087402 Harned, W. (1989) Propargite Residue Level Monitoring Runoff Study (Terrestrial

Runoff) From a Georgia Cotton Fiel d. Unpublished study prepared by Landis

Associates, Inc. in cooperation with Biospherics, Inc. 308 p.

# 34 41153201 Harned, W. (1989) Propargite Residue Level Monitoring Runoff Study (Terrestrial

Runoff) in a Corn Field in Texas: Pr oject No. SARS-88-TX-84: Project No. 88014-

03, -07, -17. Unpublished study prepar ed by Biospherics, Inc. 43 p.

41153202 Johnson, D. (1989) Corn Comite (Proparg ite) Aquatic Residue Monitoring Study:

Project No. 88-43: Test No. SARS- 88-TX-84. Unpublished study prepared by

Stewart Agricultural Research Services, Inc. 36 p.

41153204 Brunk, J. (1989) Analysis of Propargite and Omite Glycol Ether Residues in Pond

Water-Texas Study: Laboratory Project ID 88014-17. Unpublished study prepared

by Biospherics, Inc. 30 p.

41153205 Brunk, J. (1989) Analysis of Propargite and Omite Glycol Ether Residues in Pond

Sediment-Texas Study: Laboratory Project ID 88014-03. Unpublished study

prepared by Biospherics, Inc. 13 p.

41184001 Harned, W. (1989) Propargite Residue Le vel Monitoring Study (Terrestrial Runoff)

in a Citrus Grove in Water Garden, Fl orida: Project Nos. 88014-01, -05, -12;

SARS-88-FL-83C. Unpublished study prep ared by Biospherics, Inc., and Others.

160 p.

41225601 Harned, W. (1989) Propargite Residue Le vel Monitoring Study (Terrestrial Runoff)

in a Citrus Grove in Plant City, Florida: Proj. No. 8841. Unpublished study

prepared by Biospherics, Inc. 52 p.

41307301 Harned, W. (1989) Propargite Terrestr ial Field Dissipation Citrus in Winter

Garden, Florida: Project Number 8844; SARS-88-FL-82; ML88-0018-UNI.

Unpublished study prepared by Stewart Ag ricultural Research Services, Inc.,

Florida Pesticide Research Inc. a nd Morse Laboratories, Inc. 110 p.

41325901 Harned, W. (1989) Propargite Terrestria l Field Dissipation on Cotton in Kerman,

California: Lab Project Number: ML88/0016/ UNI: CA R/20/88: 8820. Unpublished

study prepared by Morse Laboratories in a ssociation with California Agricultural

Re- search, Inc. 41 p.

41432501 Harned, W. (1990) Propargite Terrestria l Field Dissipation, Cotton in Winterville,

Georgia: Lab Project Number: SARS-88-GA-81: ML 88-0019-UNI: 8845.

Unpublished study prepared by Morse Laborator ies in co-operation with LFH, Inc.

and Stewart Agricultural Res earch Services, Inc. 55 p.

41449202 Spare, W. (1987) Determination of the Adsorption/Desorption Constants of Omite:

Agrisearch Project No. 1909; Uniroy al Project No. 8791. Unpublished study

prepared by Agrisearch, Inc. 26 p.

41449203 Spare, W. (1987) Determination of the Adsorption/Desorption Constants of Omite

Clycol Ether: Agrisearch Projec t No. 1912; Uniroyal Project No. 8798.

Unpublished study prepared by Agrisearch, Inc. 27 p.

41449204 Korpalski, S.; Nowakowski, M. (1988) Adsorption/Desorption of Propargite

(Omite): Lab Project No.: 88136. Unpublished study prepared by Uniroyal

Chemical Co., Inc., Crop Protection Dept. 108 p.

# 35 41449205 Korpalski, S. (1989) Corrected Kd Values of Adsorption/Desorption Study for

Propargite: Project # 1909; Uniroya l # 8791. Unpublished study prepared by

Agrisearch, Inc. 11 p.

41449206 Korpalski, S. (1989) Clay Soil Adsorpti on/Desorption of Omite Glycol Ether: Lab

Project Number: 8912. Unpublished study prepared by Uniroyal Chemical Co.,

Inc., Crop Protection Dept. 44 p.

41663201 Harned, W. (1990) Propargite Residue Le vel Monitoring Study Terrestrial Runoff)

in a Cotton Field in Hawkinsville, Geor gia: Final Report: Lab Project Number:

89020/01.02.03: SARS-89-GA-85. Unpublished study prepared by Biospheric, Inc.,

in cooperation with Stewart Agric., Res earch Services, Inc. and Henry AgriScientific. 55 p.

41731501 Harned, W. (1990) Propargite Terrestr ial Field Dissipation, Citrus in Fresno,

California: Lab Project Number: 21-88: ML88-0017-UNI. Unpublished study

prepared by California Agricultural Resear ch Inc. in association with Morse

Laboratories. 307 p.

41966001 Harned, W. (1991) Freezer Storage Stabil ity: Supplement To Propargite Terrestrial

Field Dissipation on Cotton in Kerman, California: Lab Project Number: 8820:

ML88-0016-UNI. Unpublished study prepared by Morse Laboratories. 19 p.

42096501 Harned, W. (1991) Additional Data to Support Field Dissipation Study for

Propargite on Cotton in Kerman, CA. Unpublished study prepared by Dellaville

Lab, Inc., and Univ. of California, Fresno. 18 p.

42319301 Nowakowski, M. (1988) Soil Photolysis of carbon 14-Omite: La b Project Number:

8857. Unpublished study prepared by Un iroyal Chemical Co., Inc. 110 p.

42319307 Korpalski, S. (1990) Soil Photolysis of carbon 14-Omite: Amended Report : Lab

Project Number: 9057. Unpublished study prepared by Uniroyal Chemical Co., Inc.

49 p.

42585301 Propargite Review three runoff studies. One concerned citrus in Plant City, Florida,

the second was for citrus in Winter Garden, Florida and the third 'was for a corn

site in Texas. Accession 425853-01. Un iroyal Response on the study review

42688801 Comezoglu, S. (1993) Aerobic Aquatic Metabolism of (carbon 14-U-Phenyl)-

Omite: Lab Project Number: 92038: RP T00112. Unpublished study prepared by

Xenobiotic Labs, Inc. 132 p.

42786301 White, C. (1993) Soil Analyses of Sandy Loam Soil from Propargite Aerobic Soil

Metabolism Study (MRID #41003601). Unpublis hed study prepared by Uniroyal

Chemical Co., Inc. 7 p.

42908401 Spare, W. (1993) Adsorption/Desorption of (Carbon 14)-Omite Glycol Ether: Lab

Project Number: 1922: 9313. Unpublished study prepared by Agrisearch Inc. 80 p.

42908402 Spare, W. (1993) Adsorption/Desorp tion of (Carbon 14)-Omite: Lab Project

Number: 1921: 9312. Unpublished study prepar ed by Agrisearch Inc. 91 p.

# 36 43139401 Comezoglu, S. (1994) Anaerobic Aquatic Metabolism of (U-Phenyl-(carbon 14))-

Omite: Lab Project Number: XBL 92039: RPT00141: 9264. Unpublished study

prepared by XenoBiotic Laboratories, Inc. 165 p.

43851401 Galicia, H. (1990) Degradation of (carbon 14)-Propargite Technical in Soil Speyer

2.2 Incubated Under Aerobic Conditions: Lab Project Number: 245946.

Unpublished study prepared by RCC Umweltchemie AG. 51 p.

43851402 Comezoglu, S.; Ly, V. (1995) Aerobic Soil Metabolism of (U-Phenyl-(carbon 14))-

Omite: Lab Project Number: XBL 94061: RPT00239: 9416. Unpublished study

prepared by XenoBiotic Labs, Inc. 193 p.

44968601 Pierce, J. (1999) Analytical Method for Propargite and its Degradates in Soil: Lab

Project Nos. AC 6006; 99201. Unpublished st udy prepared by Uniroyal Chemical

Co., Inc. 48 p. {OPPTS Guideline 850.7100}

46973201 Balu, K.; Trask, J.; Carver, L. (2006) Pr ogress Update of the Study Entitled: Small

- Scale Drinking Water Monitoring Study fo r Propargite. Project Number: 864/08,

20/089, 2003/081. Unpublished study prepared by Waterborne Environmental, Inc.

(WEI) and North Coast Laboratories, Inc. 44 p.

47048201 Chepega, J.; Balu, K. (2007) Precipitati on Data to Supplement the Progress Update

of the Study Entitled "Small-Scale Drinking Water Monitoring Study for

Propargite". Project Number: 2003 /081, 864/08, 20/089. Unpublished study

prepared by Waterborne Environmental, In c. (WEI) and North Coast Laboratories,

Inc. 10 p.

47314101 Balu, K.; Trask, J.; Chepega, J.; et al. (2007) Small-Scale Drinking Water

Monitoring Study for Propargite. Pr oject Number: 2003/081, 20/089, 864/08.

Unpublished study prepared by Waterborne Environmental, Inc. (WEI) and North

Coast Laboratories, Inc. 455 p.

Cited Ecological Effects Studies

00003059

00009733

00029174

00076405

00112368 Weir, R.J.; Rathbun, F. (1966) Final Repor t: Acute Toxicity in Aqueous Exposure

to Bluegill Sunfish: Project No. 798-100. (Unpublished study received Apr 10,

1967 under 400-82; prepared by Hazleton Labo ratories, Inc., submitted by Uniroyal

Chemical, Bethany, Conn.; CDL:090718-G)

00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R. L. (1075) Toxicity of Pesticides and

Other Agricultural Chemicals to Honey B ees; Laboratory Studies. By University

of California, Dept. of Entomology.: UC, Cooperative Extension, (Leaflet 2287;

published study.)

00043552 McCann, J.A. (1970) Omite 30W: Toxicity to Rainbow Trout: Test No. 264. (U.S.

Agricultural Research Service, Pes ticides Regulation Div., Animal Biology

Laboratory, unpublished st udy; CDL: 104751-A)

# 37 00052454 Fink, R. (1974) Final Report: Eight-Day Di etary LC50-Mallard Ducks: Project No.

117-101. (Unpublished study received Mar 28, 1975 under 5F1609; prepared by

Truslow Farms, Inc., submitted by Uniroyal, Inc., Mishawaka, Ind.; CDL:094398-

D)

00060628 Johansen, C.A. Eves, J. (1965) Bee poi soning Investigations, 1965: report No. G1705; Report No. 17338. (Unpublished study, in cluding letter dated June 12, 1973

from C.A. Johansen to A.D. Cohi ck, received March 27, 1974 under 4F1485.

00060628

00091656 Johansen, C.; Eves, J. (1966) Bee Poisoni ng Investigations, 1965: Report No. G1705; 17338. (Unpublished study received Jan. 18, 1968 under 3125-143; prepared

by Washington State Univ., submitted by Moba y chemical Corp., Kansas City, Mo

00066498 Kuc, W.J. (1977) Acute Toxicity of Om ite Technical, Batch 24 Lot BL 8190 to the

Bluegill Sunfish ( Lepomis macrochirus Rafinesque) and Rainbow Trout ( Salmo

gairdneri Richardson): UCES Project # 11506- 29-02. (Unpublished study received

Dec 29, 1977 under 400-95; prepared by Union Carbide Corp., submitted by

Uniroyal Chemical, Betha ny, Conn.; CDL:233086-G)

00068752

00112402 Vilkas, A.G. (1977) Acute Toxicity of Omite Technical to the Water Flea ( Daphnia

magna Straus): ES Proj. # 11506-29-02. (U npublished study received Jan 19, 1978

under 400-89; prepared by Union Carbide Corp., submitted by Uniroyal Chemical,

Bethany, Conn.; CDL:232723-A)

00074486 Atkins, E.L.: Kellum, D. (1980) Effect of Pesticides on Apiculture: Maximizing the

Effectiveness of Honey Bees as Pollinators; Project No. 1499. 1980 annual rept.

(Unpublished study received June 8, 1981 under s241-259

00076406

00112369 Tsukasaki, S. (1966) Letter sent to U.S. Rubber dated Sep 20, 1966: D014 35% EC

fish toxicological test . (Unpublished study received Apr 10, 1967 under 400-82;

submitted by Uniroyal Chemical, Bethany, Conn.; CDL:090718-H)

00076407

00112367 Weir, R.J.; Mitterer, K. (1967) Final Report: Acute Dietary Toxicity-Bobwhite

Quail: Project No. 798-100. (Unpublished study received Apr 10, 1967 under 400-

82; prepared by Hazleton Laboratories, Inc., submitted by Uniroyal Chemical,

Bethany, Conn.; CDL:090718-I)

00082632 Fink, R.; Beavers, J.B. (1977) Final Report: Acute Oral LD50-Mallard Duck:

Project No. 117-125. (Unpublished study received Dec 29, 1977 under 400-95;

prepared by Wildlife International, Lt d., submitted by Uniroyal Chemical, Bethany,

Conn.; CDL: 233086-F)

00107189 McCann, J. (1970) Omite 30W: Goldfi sh|: Test No. 302. (U.S. Agricultural

Research Service, Pesticides Regul ation Div., Animal Biology Laboratory;

unpublished study; CDL:130317-A)

00112367 Weir, R.; Mitterer, K. (1967) Acute Di etary Toxicity--Bobwhite Quail: Omite 57E:

Project No. 798-100. Final rept. (Unpub lished study received Feb 16, 1967 under

# 38 7F0614; prepared by Hazleton Laboratories , Inc., submitted by Uniroyal Chemical,

Bethany, CT; CDL:092906-B)

00112395 Sleight, B. (1972) Acute Toxicity of Om ite to Grass Shrimp ... and Fiddler Crab

( Uca pugilator ). (Unpublished study receive d Jan 24, 1974 under unknown admin.

no.; prepared by Bionomics, Inc., submitted by Uniroyal Chemical, Bethany, CT;

CDL:131292-A)

00112396 Sleight, B. (1972) Acute Toxicity of Omite to Atlantic Oyster Larvae ( Crassostrea

virginica ). (Unpublished study received Ja n 24, 1974 under unknown admin. no.;

prepared by Bionomics, Inc., submitted by Uniroyal Chemical, Bethany, CT;

CDL:131292-B)

00113471 Fink, R.; Beavers, J. (1977) Eight-d ay Dietary LC50-Bobwhite Quail: Omite

Technical: Project No. 117-124. Final rept . (Unpublished study received Oct 19,

1977 under 400-82; prepared by Wildlife In ternational Ltd., submitted by Uniroyal

Chemical, Bethany, CT; CDL:232341-A)

00126739 Forbis, A.; Franklin, L.; Boudreau, P.; et al. (1983) Early Life Stage Toxicity of

Omite to Fathead Minnows in a Flow-t hrough System: Early Life Stage Final

Report #29634. (Unpublished study receive d Apr 8, 1983 under 400-104; prepared

by Analytical Bio-Chemistry Laboratories, Inc., submitted by Uniroyal Chemi- cal,

Bethany, CT; CDL:249886-A)

00132711 Johansen, C. (1972) Toxicity of field-w eathered insecticide residues to four kinds

of bees. Environmental Entomology 1(3):393- 394. (Also In unpublished

submission received Nov 2, 1983 under 239- 2507; submitted by Chevron Chemical

Co., Richmond, CA; CDL: 251760-C)

00142594 Forbis, A.; Franklin, L. (1984) Chronic Toxicity of Omite to Daphnia magna under

Flow-through Test Conditions: ABC Final Re- port #31133. Unpublished study

prepared by Analytical Bio-Chem istry Laboratories, Inc. 172 p.

40431601 Surprenant, D. (1987) Acute Toxicity of Omite Technical to Embryos-larvae of the

Quahog Clam ( Mercenaria mercenaria ): Bionomics Report #87-11-2554:

Bionomic Study #41.0587.6105.514. Unpublished st udy prepared by Springborn

Life Sciences, Inc. 28 p.

40514001 Surprenant, D. (1987) Acute Toxicity of Omite Technical to Sheepshead Minnow

( Cyprinodon variegatus ): Study No. 41.0587.6106.500. Unpublished study

prepared by Springborn Life Sciences, Inc. 32 p.

41041701 Beavers, J. (1988) Omite Technical Ag ricultural Miticide: A One-Generation

Reproduction Study with the Mallard ( Anas platyrhynchos ): Project No. 117-153.

Unpublished study prepared by Wildlife International Ltd. 233 p.

41041702 Beavers, J. (1988) Omite Technical Ag ricultural Miticide: A One-Generation

Reproduction Study with the Bobwhite ( Colinus virginianus ): Project No. 117-152.

Unpublished study prepared by Wildlife International Ltd. 234 p.

# 39 41449201 Surprenant, D. (1990) Acute Toxicity of Omite Technical to Embryos-larvae of the

Quahog Clam ( Mercenaria mercenaria ): Bionomics Report No.: 87-11-2554.

Unpublished study prepared by Springborn Sciences, Inc. 28 p.

41458301 Sousa, J. (1990) Omite Technica l: Acute Toxicity to Rainbow Trout

( Oncorhynchus mykiss ): Lab Project Number: 89-6-3010: 41.0289. 6117.108.

Unpublished study prepared by Springborn Labs., Inc. 41 p.

43185001 Boeri, R.; Kowalski, P.; Ward, T. (1994) Acute Toxicity of Omite Technical to the

Honey Bee, Apis mellifera: Lab Project Number: 385-UN. Unpublished study

prepared by T.R. Wilbury Labs., Inc. 20 p.

43371502 Davis, J. (1994) The Effect of Soil Sedi ment on the Toxicity of Omite Technical to

Rainbow Trout ( Oncorhynchus mykiss ) and Water Flea ( Daphnia magna ) under

Static Test Conditions: Lab Proj ect Number: J9309001. Unpublished study

prepared by Toxikon Environmental Sciences. 53 p.

43759001 Davis, J. (1995) Comite: Acut e Toxicity to Rainbow Trout ( Oncorhynchus mykiss )

Under Flow-Through Test Condition s: Lab Project Number: J9501010B.

Unpublished study prepared by Toxikon Environmental Sciences. 64 p.

43759002 Davis, J. (1995) Comite: Ac ute Toxicity to Water Flea ( Daphnia magna ) Under

Flow-Through Test Conditions: Lab Pr oject Number: J9501010C. Unpublished

study prepared by Toxikon Environmental Sciences. 64 p.

43885801 Aufderheide, J.; Kranzfelder, J. (1995) Comite: Seedling Emergence-Tier I: Lab

Project Number: J9501011A. Unpub lished study prepared by Toxikon

Environmental Sciences. 125 p.

43885802 Aufderheide, J.; Kranzfelder, J. (199 5) Comite: Vegetative Vigor-Tier I: Lab

Project Number: J9501011B. Unpub lished study prepared by Toxikon

Environmental Sciences. 117 p.

44086801 Dionne, E. (1996) Omite Technical--The Chronic Toxicity to the Fathead Minnow

( Pimephales prom elas) During a Full Life-Cycle Exposure: Final Report: Lab

Project Number: 41.1194.6148.122: 96-2- 6379: 081194/FIFRA/122. Unpublished

study prepared by Springborn Labs, Inc. 563 p.

46015901 Knight, B.; Allan, J. (2002) Determinati on of Acute Toxicity (EC50) of Propargite

to Daphnia magna (48 h, Continous-Flow). Project Number: 20632, 800052.

Unpublished study prepared by Inveresk Research International. 54 p.

46073301 Knight, B.; Allan, J. (2002) Determinati on of Acute Toxicity (LC50) of Propargite

to Bluegill Sunfish (96 h, Continuous-Flow). Project Number: 20480, 800031.

Unpublished study prepared by Inveresk Research International. 52 p.

46335701 Lima, W. (2004) Omite Technical - Life -Cycle Toxicity Test with Mysids

( Americamysis bahia ). Project Number: 41/6181. Unpublished study prepared by

Springborn Smithers Laboratories. 102 p.

# 40 43885803 Liu, H.; Davis, J. (1995) Comite: Acute Toxicity to the Freshwater Blue-Green

Alga, Anabaena flos-aquae , Under Static Test Cond itions: Lab Project Number:

J9501011H. Unpublished study prepared by Toxikon Environmental Sciences. 66

p.

43885804 Cunningham, F.; Davis, J. (1995) Comite: Acute Toxicity to the Freshwater Green

Alga, Selenastrum capricornutum , Under Static Test Conditions: Lab Project

Number: J9501011F. Unpublished study pr epared by Toxikon Environmental

Sciences. 66 p.

43885805 Cunningham, F.; Davis, J. (1995) Comite: Acute Toxicity to Duckweed, Lemna

gibba G3, Under Static Test Conditi ons: Lab Project Number: J9501011J.

Unpublished study prepared by Toxikon Environmental Sciences. 60 p.

43885806 Cunningham, F.; Davis, J. (1995) Comite: Acute Toxicity to the Saltwater Diatom,

Skeletonema costatum , Under Static Test Condi tions: Lab Project Number:

J9501011G. Unpublished study prepared by Toxikon Environmental Sciences. 60

p.

43885807 Liu, H.; Davis, J. (1995) Comite: Acut e Toxicity to the Freshwater Diatom,

Navicula pelliculosa , Under Static Test Conditi ons: Lab Project Number:

J9501011I. Unpublished study prepared by T oxikon Environmental Sciences. 69 p.41APPENDIX A: Summary of Propargite Label Application RestrictionsTable A-1. Summary of Propargite Label Application Restrictions by Registration NumberReg#Site DescriptionMax Single App Rate(Lbs./A)Max # Appsper Crop CycleMax App Rateper Year(Lbs./A)Max App Rate perCrop Cycle(Lbs./A)MinimumRetreatmentInterval (Days)400-104 Almond 3.13 2NS NS21Apple 1.56 2NS NS21Beans, dried-type 2.50NS3.75NS21Citrus 1.56 2NS NS28Conifers (plantations/nurseries) 2.29 2NS NS28Corn (unspecified) 2.50 1NANSNACorn, field 2.50 1NANSNACorn, pop 2.50 1NANSNACorn, sweet 2.50 1NANSNACotton (unspecified) 1.67 2 3.34NS21Currant 1.56 2NS NS21Date 1.56 2NS NS21Fig 1.56 2NS NS21Filbert (hazelnut) 1.56 2NS NS21Grapefruit 2.50NS4.17NS28Hops 1.56 2NS NS21Jojoba 1.67 2NS NS10Macadamia nut (bushnut) 1.56 2NS NS21Mint 2.09 2 4.17NS14Orange 2.50NS4.17NS28Peanuts (unspecified) 1.67 2NS NS14Pecan 1.56 2NS NS21Persimmon 1.56 2NS NS21Pistachio 1.56 2NS NS21Potato, white/Irish 2.09 2 4.17NS21Quince 1.56 2NS NS21Small fruits 1.56 2NS NS21Sorghum 1.67 1NANSNAStone fruits 1.56 2NS NS21Walnut (English/black) 4.59 2 6.88NS21400-154 Beans, dried-type 2.47NS4.57NS21Corn (unspecified) 2.57NS2.57NS2142Reg#Site DescriptionMax Single App Rate(Lbs./A)Max # Appsper Crop CycleMax App Rateper Year(Lbs./A)Max App Rate perCrop Cycle(Lbs./A)MinimumRetreatmentInterval (Days)Corn, field 2.57NS2.57NS21Corn, pop 2.57NS2.57NS21Corn, sweet 2.57NS2.57NS21Cotton (unspecified) 1.71NS3.33NS21Grapefruit 2.47NS4.14NS28Mint 2.28NS4NS14Orange 2.47NS4.14NS28Peanuts (unspecified) 1.71 2NS NS14Potato, white/Irish 2.28NS4NS21Sorghum 1.71 1NANSNA400-427 Almond 3.2 2NS NS21Apple 1.92 2NS NS21Cherry 1.92 2NS NS21Christmas tree plantations 2.4 2NS NS7Citrus 1.92 2NS NS28Conifers (plantations/nurseries) 2.4 2NS NS7Currant 1.92 2NS NS21Date 1.92 2NS NS21Fig 1.92 2NS NS21Filbert (hazelnut) 1.92 2NS NS21Grapefruit 3.36 1 5.76NS28Grapes 2.88 2NS NS21Macadamia nut (bushnut) 1.92 2NS NS21Nectarine 2.88 2NS NS21Orange 3.36 1 5.76NS28Ornamental herbaceous plants 0.48 3NS NS14Ornamentals (unspecified) 0.32 3NS NS14Peanuts (unspecified) 1.6 2NS NS14Pear 1.92 2NS NS21Pecan 1.92 2NS NS21Persimmon 1.92 2NS NS21Pistachio 1.92 2NS NS21Quince 1.92 2NS NS21Rose 1.6 3NS NS14Small fruits 1.92 2NS NS21Stone fruits 1.92 2NS NS2143Reg#Site DescriptionMax Single App Rate(Lbs./A)Max # Appsper Crop CycleMax App Rateper Year(Lbs./A)Max App Rate perCrop Cycle(Lbs./A)MinimumRetreatmentInterval (Days)Walnut (English/black) 4 2 6.4NS21400-83 Rose 1.53NS NS NS14400-89 Almond 3.08 2NS NS21Apple 1.54 2NS NS21Citrus 1.54 2NS NS21Conifers (plantations/nurseries) 2.31 2NS NS28Corn, field 2.60 1 2.60NSNACurrant 1.54 2NS NS21Date 1.54 2NS NS21Fig 1.54 2NS NS21Filbert (hazelnut) 1.54 2NS NS21Hops 1.54 2NS NS21Macadamia nut (bushnut) 1.54 2NS NS21Mint 2.11 2 4.23NS14Pecan 1.54 2NS NS21Persimmon 1.54 2NS NS21Pistachio 1.54 2NS NS21Potato, white/Irish 2.11 2 4.23NS21Quince 1.54 2NS NS21Small fruits 1.54 2NS NS21Stone fruits 1.54 2NS NS21Walnut (English/black) 4.61 2 6.92NS21AR830015 Cotton (unspecified) 1.67NS NS3.34 21AZ000006 Alfalfa 2.50NS NS NS NSCA040013 Clover 1.67NS NS NS NSCA830024 Alfalfa 2.50NS NS NS NSCA940031 Almond 2.50NS NS NS NSWalnut (English/black) 2.50NS NS NS NSCO940006 Corn, sweet 1.71 2NS NS NSID040010 Potato, white/Irish 2.09NS NS NS14ID770005 Carrot (including tops) 2.50NS NS NS NSClover 2.50NS NS NS NSID960016 Alfalfa 2.09NS NS NS NSMS830024 Cotton (unspecified) 1.67NS NS NS NSMT890010 Alfalfa 2.09NS NS NS NSNV880007 Alfalfa 2.50NS NS NS NS44Reg#Site DescriptionMax Single App Rate(Lbs./A)Max # Appsper Crop CycleMax App Rateper Year(Lbs./A)Max App Rate perCrop Cycle(Lbs./A)MinimumRetreatmentInterval (Days)TX940005 Corn (unspecified) 1.71NS NS2.57NSNA = Not Applicable; NS = Not Specified.45APPENDIX B: Summary of Endpoints from Toxicity StudiesTable B-1. Summary of the Endpoints from Aquatic Toxicity Studies for PropargiteTaxonStudy TypeTest chemical (% a.i.)SpeciesToxicity Endpoints*, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationFreshwaterfish(surrogate foraquatic-phaseamphibians)21-day flow-throughexposurePropargite (88.4)Rainbow trout(Oncorhynchus mykiss)Preliminary endpoints as presented in the study report:96-hr (4-day) LC50(95% C.I.) = 43 (38-49) μg a.i./L (mm)21-day LC50(95% C.I.) = 24 (21-32) μg a.i./L (mm)21-day NOAEC = 14 μg a.i./L (mm)21-day LOAEC = 21 μg a.i./L (mm)Very highly toxicMRID 41458301In reviewAcute: 96-hrPropargite (100)Rainbow trout(Oncorhynchus mykiss)LC50(95% C.I.) = 118.0 (96.0-146) μg/L(sublethal effects: disorientation and erratic swimmingbehavior at 100.0 μg/L)Highly toxicMRID 00066498AcceptableAcute: 96-hr flowthrough exposurePropargite (76.2)Rainbow trout(Oncorhynchus mykiss)LC50(95% C.I.) = 143 (105-231) μg a.i./L (mm)NOAEC = 68 μg a.i./L (mm)LOAEC = 105 μg a.i./L (mm)(NOAEC based on no mortality at 68 μg a.i./L)Highly toxicMRID 43759001AcceptableAcute: 96-hr staticexposureOmite 30W (30) –formulated productRainbow trout(Oncorhynchus mykiss)LC50(95% C.I.) = 445 (384-515) μg/LHighly toxicMRID 00043552Supplemental(due to use offormulated product)Acute, sediment: 96-hrstatic exposurePropargite (88.64)Rainbow trout(Oncorhynchus mykiss)Spiked water: 80% mortality at 73.1 μg/L (m)Sediment + spiked water: 700% mortality at 58.9 μg/L (m)Water + spiked sediment: 0% mortality at 3.65 μg/L (m)MRID 43371502Supplemental(due to not fulfilling aguideline requirement)46TaxonStudy TypeTest chemical (% a.i.)SpeciesToxicity Endpoints*, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationAcute: 96-hr flowthough exposurePropargite (90.2)Bluegill sunfish(Lepomis macrochirus)Preliminary endpoints as presented in the study report:LC50= 81 μg a.i./L (mm)NOAEC = 40 μg a.i./L (mm)LOAEC = 60 μg a.i./L (mm)(NOAEC based on sublethal effects)Very highly toxicMRID 46073301In reviewAcute: 96-hr staticexposureOmite 57E (57) –formulated productBluegill sunfish(Lepomis macrochirus)LC50(95% C.I.) = 31 (22-43) μg/LVery highly toxicMRIDs 00003059,00009733, 00029174,00076405, 00112368Supplemental(due to use offormulated product)Acute: 96-hrPropargite (88)Bluegill sunfish(Lepomis macrochirus)LC50(95% C.I.) = 167.5 (137.7-202.2) μg/L(sublethal effects: erratic swimming behavior at 180 μg/L)Highly toxicMRID 00066498AcceptableAcute: 48 hrsOmite (35) – formulatedproductCarp LC50= 330 μg/LHighly toxicMRIDs 00076406,00112369Supplemental(due to: unacceptabletest species; testduration of only 48hrs; and use of aformulated product)Acute: 96-hr staticexposureOmite 30W (30) –formulated productGoldfish(Carrassius auratus)96 hrs: 80% mortality at 3.7 mg/LHighly toxicMRID 00107189U.S. ARSSupplemental(due to use offormulated product)Early life stage: 35-dayflow-through exposurePropargite (86.3)Fathead minnow(Pimephales promelas)NOAEC = 16 μg a.i./L (mm)LOAEC = 28 μg a.i./L (mm)(based on reduced post-hatch survival, length, and wet weight)MRIDs 00126739 and00132605Acceptable47TaxonStudy TypeTest chemical (% a.i.)SpeciesToxicity Endpoints*, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationEstuarine/marine fishAcute: 96-hr, staticexposurePropargite (87.4)Sheepshead minnow(Cyprinodonvariegatus)LC50(95% C.I.) = 55 (32-100) μg a.i./L (mm)NOAEC = 32 μg a.i./L (mm)LOAEC = 60 μg a.i./L (mm)(NOAEC based on no mortality at 32 μg a.i./L)Very highly toxicMRID 40514001AcceptableEarly life stage(chronic)Estuarine/marine fish No dataNAAquaticinvertebratesAcute: 48-hr flowthrough exposurePropargite (90.2)Water flea(Daphnia magna)Preliminary endpoints as presented in the study report:EC50(95% C.I.) = 14 (11-19) μg a.i./LNOAEC = 4 μg a.i./LLOAEC = 13 μg a.i./LVery highly toxicMRID 46015901In reviewAcute: 48-hr flowthrough exposurePropargite (76.2)Water flea(Daphnia magna)EC50(95% C.I.) = 74.6 (66.1-84.7) μg a.i./L (mm)Probit slope (95% C.I.) = 9.1 (5.9-12.3)NOAEC = 23.2 μg a.i./L (mm)LOAEC = 40.9 μg a.i./L (mm)(NOAEC based on no mortality at 23.2 μg a.i./L; sublethaleffects: lethargy at 23.2 μg a.i./L)Very highly toxicMRID 43759002AcceptableAcute: 48-hr exposurePropargite (100)Water flea(Daphnia magna)EC50(95% C.I.) = 92.5 (79.7-115.2) μg/LaProbit slope (95% C.I.) = 7.6 (3.4-11.8)NOAEC = 32 μg/LLOAEC = 56 μg/L(NOAEC based on no mortality at 32 μg/L)Very highly toxicMRIDs 00068752 and00112402AcceptableAcute, sediment: 48-hrstatic exposurePropargite (88.64)Water flea(Daphnia magna)Spiked water: 35% mortality at 48.9 μg/L (m)Sediment + spiked water: 50% mortality at 39.2 μg/L (m)Water + spiked sediment: 0% mortality at 3.68 μg/L (m)MRID 43371502Supplemental(due to not fulfilling aguideline requirement)48TaxonStudy TypeTest chemical (% a.i.)SpeciesToxicity Endpoints*, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationLife cycle (chronic): 21-day flow throughexposurePropargite (86.3)Water flea(Daphnia magna)NOAEC = 9 μg a.i./L (m)LOAEC = 14 μg a.i./L (m)(based on growth [length])MRID 00142594AcceptableEstuarine/marineinvertebratesAcute Mysid shrimpNo dataAcute toxicity may be characterized using toxicity data forfreshwater invertebrates (i.e.,D. magna). For example:Estimated acute LC50(mysid)= Chronic NOAEC(mysid)* Acute-to-Chronic Ratio(D. magna)= 0.46 μg/L * 1.6= 0.74 μg/LWhere:Acute-to-Chronic Ratio(D. magna)= Acute LC50(D. magna)/ Chronic NOAEC(D. magna)= 14 μg/L /9 μg/L= 1.6NAAcute: 48-hr flowthrough exposurePropargite (87.4)Quahog clam embryolarvae(Mercenariamercenaria)EC50(95% C.I.) = 81.0 (41.8-infinity) μg a.i./L (m &estimated)bNOAEC < 7.3 μg a.i./L (m & estimated)bLOAEC = 7.3 μg a.i./L (m & estimated)bVery highly toxicMRIDs 40431601 and41449201AcceptableAcute: 96-hr staticexposurePropargite (100)Grass shrimp(Palaemonetes pugio)LC50(95% C.I.) = 101 (74.8-137) μg/LcNOAEC = 56 μg/LLOAEC = 75 μg/L(NOAEC based on no mortality at 56 μg/L)Highly toxicMRID 00112395AcceptableAcute: 96-hr staticexposurePropargite (100)Fiddler crab(Uca pugilator)LC50> 500 mg/L(no mortality; test concentrations: 10, 25, 50, 75, 100, 250, and500 mg/L; Omite insoluble at >100 mg/L)MRID 00112395Supplemental49TaxonStudy TypeTest chemical (% a.i.)SpeciesToxicity Endpoints*, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationAcute: 48-hr staticexposurePropargite (100)Atlantic oyster larvae(Crassostrea virginica)Endpoint as presented in the study report:LC50(95% C.I.) = 72 μg/L (44-117)Very highly toxicMRID 00112396Not reviewedLife cycle (chronic)Propargite (91.9)Mysid shrimp(Americamysis bahia)NOAEC = 0.46 μg a.i./L (mm)LOAEC = 0.85 μg a.i./L (mm)(based on reductions in reproductive output)MRID 46335701AcceptableBenthicinvertebratesSediment acute/chronic Sediment-dwellinginvertebrateNo data NAAquaticvascular plantTier II, 14-day staticrenewal exposurePropargite (76.2)Duckweed(Lemna gibba)EC50= 75 mg a.i./L (mm)dNOAEC = 28 mg a.i./L (mm)(based on reductions in frond number)MRID 43885805AcceptableAquatic nonvascular plant:Tier II, 5-day staticexposurePropargite (76.2)Marine diatom(Skeletonema costatum)EC50= 19.4 μg a.i./L (mm)dNOAEC = 1.27 μg a.i./L (mm)(based on reductions in cell number)MRID 43885806AcceptableTier II, 5-day, staticexposurePropargite (76.2)Green alga(Selenastrumcarpicornutum)EC50= 66.2 μg a.i./L (mm)dNOAEC = 5 μg a.i./L (mm)(based on reductions in cell number)MRID 43885804AcceptableTier II, 5-day staticexposurePropargite (76.2)Freshwater diatom(Navicula pelliculosa)EC50= 106 μg a.i./L (mm)dNOAEC = 99 μg a.i./L (mm)(based on reductions in cell number)MRID 43885807AcceptableTier II, 5-day staticexposurePropargite (76.2)Cyanobacterium(Anabaena flow-aquae)EC50> 101 mg a.i./L (mm)NOAEC = 101 mg a.i./L (mm)(no effects)MRID 43885803AcceptableAbbreviations: im = initital-measured; m = measured; mm = mean measured; NA = not applicableaThe LC50as calculated by the moving average method(i.e., LC50= 91 μg a.i./L) was previously reportedin the RED and CRLF litigation assessment.bConcentrations were measured at exposure initiation. Resultsof preliminary stability analysis indicated a 42% reduction of test material over the 48 hrs. 48-hrconcentrations were estimated based on a half-life of 57 hrs (42% reduction 48 hrs). Concentration estimates. Concentrations used for calculation of theendpoints are based on the mean ofthe 0-hr measured concentration andthe 48-hr estimated concentration.cEndpoints as reported by study author; a less conservative endpoint (LC50= 105 and 107 μg/L, for moving average and probit methods, respectively) wascalculated by the reviewer.50dThe raw data for this study may be subjected tonew statistical analysis because the present EC50was determined using probit analysis rather than non-linearregression analysis.Table B-2. Summary of the Endpoints from Terrestrial Toxicity Studies for PropargiteTaxonStudy TypeTest Chemical (% a.i.)SpeciesToxicity Endpoints, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationBirds(surrogate forreptiles andterrestrialphaseamphibians)Acute oral: single dose,14-day observationPropargite (87.6)Mallard duck(Anas platyrhynchos)LD50> 4640 mg a.i./kg-bw (nom)NOAEL = 2150 mg a.i./kg-bw (nom)(no mortality; NOAEL based on a reduction in feedconsumption and body weight gain at 4640 mg/kg-bw)Practically non-toxicMRID 00082632AcceptableAcute oral Passerine species No data NASub-acute dietary: 5-dayexposure; 3-day postexposure observationPropargiteBobwhite quail(Colinus virginianus)LC50(95% C.I.) = 3401 (2494-4639) mg/kg-diet (nom)NOAEC: Not specified(concentration-dependent reduction in body weight gain downto the lowest test concentration, 464 mg/kg-diet)Slightly toxicMRID 00113471AcceptableSub-acute dietary: 5-dayexposure; 3-day postexposure observationPropargite (90)Mallard duck(Anas platyrhynchos)LC50> 4640 mg a.i./kg-diet (nom)NOAEC: Not specified(no mortality; reduction in body weight gain at≥2150 mg/kgdiet)At most slightly toxicMRID 00052454AcceptableSub-acute dietary: 5-dayexposure; 3-day postexposure observationOmite 57-E (57) –formulated productBobwhite quail(Colinus virginianus)LC50> 5620 mg a.i./kg-diet (nom)NOAEC: Not specified(10, 0, 30, 10, 10, 10, and 20% mortality at 31.6, 100, 316,1000, 1780, 3160, and 5620 mg/kg-diet; sublethal effects :reduction in body weight gain at all test concentrations ;reduction in food consumption at 3160 and 5620 mg/kg-diet)Practically non-toxicMRID 00076407or 00112367AcceptableReproduction (chronic)Propargite (85)Mallard duck(Anas platyrhynchos)NOAEC = 84.7 mg a.i./kg-diet (m)LOAEC = 288 mg a.i./kg-diet (m)(based on reductions in adult body weight, eggs laid/female,viable embryos, live 3-week emrbyos, hatchlings, 14-daysurviving chicks, and weight of 14-day surviving chicks)MRID 41041701Acceptable51TaxonStudy TypeTest Chemical (% a.i.)SpeciesToxicity Endpoints, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationReproduction (chronic)Propargite (85)Bobwhite quail(Colinus virginianus)NOAEC = 84.7 mg a.i./kg-diet (m)LOAEC = 288 mg a.i./kg-diet (m)(NOAEC based on most senstive endpoint of reduction inhatchling weight; female adult body weight, eggs laid/female,and 14-day surviving chicks also affected)MRID 41041702AcceptableTerrestrialinvertebratesAcute contact: singledose, 48-hr observationPropargite (88.3)Honey bee(Apis mellifera)LD50(95% C.I.) = 15 (13-18) μg/bee (m)NOAEC = 9.8 μg/bee (m)LOAEC = 17 μg/bee (m)(NOAEC based on sublethal effect of lethargy)Practically non-toxicMRID 43185001AcceptableAcute contact, limit:single dose, 48-hrobservationPropargiteHoney bee(Apis mellifera)LD50> 18.13 μg a.i./bee (nom)NOAEL: Not specified(1.85% mortality at 18.13 μg a.i./bee)Practically non-toxicMRID 00036935Atkins et al. (1975)Acute dietary (oral)Adult honey bee(Apis mellifera)No data NAAcute dietary (oral)Comite 3W (30) –formulated productLarval honey bee(Apis mellifera)LD50> 100 μg/larva(age groups of larvae tested: 1-2 days, 3-4 days, 5-6 days)MRID 00074486AcceptableResidues on foliageOmite 8 lb EHoney bee(Apis mellifera)1-2% mortality after 24 hrs of exposure to alfalfa treated with1.5 a.i./A Omite and aged for 3 hrsMRIDs 00060628,00091656,00132711AcceptableTerrestrialplantsSeedling emergence: limittestPropargite (76.2)Most sensitive monocot:SorghumEC/IC25= 2.45 lb a.i./ANOAEC < 2.45 lb a.i./A(based on weight)Also, NOAEC < 2.45 lb a.i./A for ryegrass and onion based onemergence and weight, respectively.MRID 43885801Supplemental(due to nondefinitiveNOAECS forsorghum, ryegrass,onion, carrot,radish, tomato,soybean)Most sensitive dicot:Carrot, radish, tomato,soybeanEC/IC25> 2.45 lb a.i./ANOAEC < 2.45 lb a.i./A(based on emergence for carrot,radish, and tomato and lengthfor soybean)52TaxonStudy TypeTest Chemical (% a.i.)SpeciesToxicity Endpoints, Effects, &Acute Toxicity Classification (If Applicable)Source& StudyClassificationVegetative vigor: limittestPropargite (76.2)Most sensitive monocot:Ryegrass , sorghumEC/IC25> 2.45 lb a.i./ANOAEC < 2.45 lb a.i./A(based on length and weight for ryegrass and sorghum,respectively)MRID 43885802Supplemental(due to nondefinitiveNOAECs forryegrass, sorghum,and radish)Most sensitive dicot:RadishEC/IC25> 2.45 lb a.i./ANOAEC < lb a.i./A(based on weight)Abbreviations: NA = not applicable; nom = nominal; NS = not specified; m = measured

# 53 

# Appendix C: Results of SIP and STIR

SIP (v 1.0)

Table 1. Inputs

Parameter Value

Chemical name propargite

Solubility (in water at 25 o 

# C; mg/L) 0.63

Mammalian LD 50 

# (mg/kg-bw) 2639

Mammalian test species laboratory rat

Body weight (g) of "other" mammalian

species

Mammalian NOAEL (mg/kg-bw) 4

Mammalian test species laboratory rat

Body weight (g) of "other" mammalian

species

Avian LD 50 

# (mg/kg-bw) 4640

Avian test species mallard duck

Body weight (g) of "other" avian species

Mineau scaling factor 1.15

Mallard NOAEC (mg/kg-diet) 43.2

Bobwhite quail NOAEC (mg/kg-diet) 84.7

NOAEC (mg/kg-diet) for other bird species

Body weight (g) of other avian species

NOAEC (mg/kg-diet) for 2nd other bird

species

Body weight (g) of 2nd other avian species

Table 2. Mammalian Results

Parameter Acute Chronic

Upper bound exposure (mg/kg-bw) 0.1084 0.1084

Adjusted toxicity value (mg/kg-bw) 2029.8147 3.0766

Ratio of exposure to toxicity 0.0001 0.0352

Conclusion* Drinking water exposure

alone is NOT a potential

concern for mammals Drinking water exposure

alone is NOT a potential

concern for mammals

Table 3. Avian Results

Parameter Acute Chronic

Upper bound exposure (mg/kg-bw) 0.5103 0.5103

Adjusted toxicity value (mg/kg-bw) 2409.2059 2.1433

Ratio of exposure to acute toxicity 0.0002 0.2381

Conclusion* Drinking water exposure

alone is NOT a potential

concern for birds Drinking water exposure

alone is NOT a potential

concern for birds

# 54 *Conclusion is for drinking water exposure alone. This does not combine all routes of exposure.

Therefore, when aggregated with other routes ( i.e ., diet, inhalation, dermal), pesticide exposure through

drinking water may contribute to a total exposure that has potential for effects to non-target animals.



# STIR (v. 1.0 )



# Welcome to the EFED

Screening Tool for Inhalation Risk

This tool is designed to provide the risk assessor with a rapid method for determining

the potential significance of the inhalation exposure route to birds and mammals in a

risk assessment.



# Input

Application and Chem ical Information

Enter Chemical Name propargite

Enter Chemical Use avocados

Is the Application a Spray? (enter y or n) y

If Spray What Type (enter ground or air) ground

Enter Chemical Molecu lar Weight (g/mole) 350.5

Enter Chemical Vapor Pressure (mmHg) 4.49E-08

Enter Application Rate (lb a.i./acre) 4.8

Toxicity Properties

Bird

Enter Lowest Bird Oral LD 50 

# (mg/kg bw) 4640

Enter Mineau Scaling Factor 1.15

Enter Tested Bird Weight (kg) 1.58

Mammal

Enter Lowest Rat Oral LD 50 

# (mg/kg bw) 2639

Enter Lowest Rat Inhalation LC 50 

# (mg/L) 0.89

Duration of Rat Inhalation Study (hrs) 4

Enter Rat Weight (kg) 0.35



# Output

Results Avian (0.020 kg )

Maximum Vapor Concentration in Air at Saturation

(mg/m 3 

# ) 8.47E-04

Maximum 1-hour Vapor Inhalation Dose (mg/kg) 1.06E-04

Adjusted Inhalation LD 50 

# 6.29E+00

Ratio of Vapor Dose to Adjusted Inhalation LD 50 

# 1.69E-05 Exposure not Likely

Significant

Maximum Post-treatment Spray Inhalation Dose (mg/kg) 5.07E-01

Ratio of Droplet Inhalation Dose to Adjusted Inhalation

LD 50 

# 8.07E-02 Exposure not Likely

Significant

# 55 Results Mammalian (0.015 kg )

Maximum Vapor Concentration in Air at Saturation

(mg/m 3 

# ) 8.47E-04

Maximum 1-hour Vapor Inhalation Dose (mg/kg) 1.34E-04

Adjusted Inhalation LD 50 

# 5.30E+01

Ratio of Vapor Dose to Adjusted Inhalation LD 50 

# 2.53E-06 Exposure not Likely

Significant

Maximum Post-treatment Spray Inhalation Dose (mg/kg) 6.38E-01

Ratio of Droplet Inhalation Dose to Adjusted Inhalation

LD 50 

# 1.20E-02 Exposure not Likely

Significant