### Page 1 of 46 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460

PC Code: 12 2101 DP Barcode: 4290 77

MEMORANDUM December 9 , 2015

Subject: Registration Review: Problem Formulation for Propiconazole

To: Linsey Walsh , Chemical Review Manager Avivah Jakob, Team Leader Kelly Sherman

, Branch Chief Risk Management and Implementation Branch 3 Pesticide Re

- Evaluation Division (7508P)

Sandra O’Neill, Chemical Review Manager Rose Kyprianou, Team Leader Lance Wormell, Branch Chief Regulatory Management Branch 2 Antimicrobials Division (7510P)

From: Stephen Carey, Biologist Ibrahim Abdel

- Saheb

, Ph.D., Environmental Scientist Environmental Risk Branch 6 Environmental Fate and Effects Division (7507P)

James Breithaupt, Agronomist Daniel Cherry, Biologist Siroos Mostaghimi, Ph

. D., Senior Scientist Risk Assessment and Science Support Branch (RASSB) Antimicrobials Division (7510P)

Through: Mark Corbin, Branch Chief Monica Wait, RAPL William P. Eckel , Ph.D., Senior Science Advisor Nathan Miller

, Biologist Environmental Risk Branch 6 Environmental Fate and Effects Division (7507P)

Laura Parsons, Associate Branch Chief Risk Assessment and Science Support Branch (RASSB) Antimicrobials Division (7510P)

### Page 2 of 46 

### The Environmental Fate and Effects Division (EFED) and the Antimicrobials Division (AD) ha ve completed the problem formulation (PF) for the environmental fate

, ecological risk, and endangered specie s for the registration review of the triazole fungicide: Propiconazole (PC Code 122101).

Propiconazole is registered for use on a wide variety of agricultural and non

- agricultural uses in many states. The agricultural uses include wheat, seed crops, rice , pecans, peaches, sweet corn, dry beans, peanuts, barley, and celery, and there are several pending proposed uses. The non

agricultural uses of propiconazole include turf, ornamentals, lawn s , ground cover, and sod farms. Propiconazole is also registered for antimicrobial uses including adhesives , paints, stains, coatings , rubber and plastic products, inks, metalworking fluids

, lumber, log buildings, roof shingles, wood siding , millwork, plywood, wallboard, ceiling tiles, fencing , and textiles/canvas

.

As the first stage of the risk assessment process for Registration Review, this problem formulation provides an overview of what is currently known about the environmental fate and ecological effects associated with the parent compound . It also describes th e preliminary ecological risk hypothesis and analysis plan for evaluating and characterizing risk to non

- target species and the environment in support of Registration Review.
Data Gaps

– Conventional Uses

The ecological effects and environmental fate database is largely complete for p ropiconazole except for the following required studies under 40 CFR Part 158:

Environmental Fate:

- None.

Ecological Effects:

- Acceptable avian acute oral toxicity (Guideline 850.2100) data have not been submitted for a passerine species exposed to propiconazole, which is now required under the 40 CFR Part 158 data requirements.

- Propiconazole may cause exposure of pollinators visiting off

- site plants that are c ontaminated by spray drift. A complete set of toxicity data to honey bee adults and larvae have not been submitted for propiconazole and these data are needed to fulfill EPA’s recent policy on pollinator protection 1 

### . A T ier I study on the toxicity of resi dues on foliage (OCSPP 850.3030) is not needed since results of the honey bee acute contact LD 50 

### is > 25 μg a.i./bee, above the 11 μg a.i./bee trigger criterion. Thus, the following seven Tier I, II and III honey bee studies, yet to be submitted for propico nazole, are needed:

o Honeybee larval acute oral toxicity study (following OECD 237, Tier I)

o Honey bee adult oral toxicity test (OECD 213, Tier I)

o Honeybee adult 10

- day chronic oral (special study; Tier I)

1 (Guidance for Assessing Pesticide Risks to Bees, 06.23.2014; signed by Donald Brady, Director, EFED; http://www2.epa. gov/sites/production/files/2014

- 06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf )

### Page 3 of 46 

### o Honeybee larval repeated dose study (special study renamed as honeybee larval chronic oral toxicity study, Tier I)

o Semi

- field testing for pollinators (special study, Tier II).

o Field testing for pollinators (OCSPP 850.3040, Tier III)

o Field trial of residu es in pollen and nectar (special study, Tier III)

- Currently, an acute to chronic ratio (ACR) for estuarine/marine fish from the freshwater data is not appropriate because the acceptable acute and chronic studies used different freshwater species that preve nted the calculations. EFED is in need of a fathead minnow acute toxicity study (OCSPP 850.1075) to obtain an acute toxicity value in order to calculate an ACR using freshwater data on the same species (e.g., fathead minnow) to estimate the No Observed Adv erse Effect Concentration ( NOAEC ) for estuarine/marine fish. Without an acute toxicity study with the fathead minnow, chronic risk to estuarine/marine fish will be presumed

. However, EFED has no reservations if a Fish Early Life

- Stage chronic toxicity stud y (OCSPP 850.1400) with an estuarine/marine fish is submitted instead of the fathead minnow acute toxicity study to get the NOAEC directly for estuarine/marine fish.

- Acceptable avian reproduction toxicity data (OSCPP 850.2300) were not submitted for a

wa terfowl species exposed to propiconazole

. A new avian reproduction toxicity study for mallard ducks is necessary to satisfy standard data requirements since the previous ly submitted mallard reproduction study submitted was classified as invalid.

Data Gaps

— Antimicrobial Uses

Environmental Fate:

- Guideline 850.3300: Activated sludge respiration inhibition (ASRI)

- Guidelines 835.3110, 835.3220, 835.3240, 835.3280 (WWTP biodegradation studies) 2



### - Guideline 835.1110, Activated Sludge Sorption Isotherm (ASSI) 3



### Ecological Effects:

- The chemical and physical properties of propiconazole indicate that it may pose risk to sediment

- dwelling invertebrates when used as an antimicrobial pesticide. To assess the toxicity and bioaccumulation potenti al of propiconazole in sediment fauna, the Agency requires three whole sediment chronic invertebrate studies: two in freshwater and one in saltwater. These are special studies for which there is not yet a guideline number.

1 The results of the Ac tivated Sludge Respiration Inhibition Test (ASRI) will determine which of these four

biodegradation tests is/are anticipated to be required.

• If the ASRI test EC50 is less than or equal to 20 mg/L, then either the (i) Biodegradation in Activated Sludge

Stu dy or (ii) Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units or (iii) the Porous Pot Test is required. If the ASRI test EC50 is greater than 20 mg/L, then the registrant must conduct either: (i) Ready Biodegradability or (ii) a) Biodegr adation in Activated Sludge or b) Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test.

• If the Ready Biodegradability study is conducted and passes, then no further testing is required. If, however, the

antimicro bial fails the Ready Biodegradability study, then the a) Biodegradation in Activated Sludge or b) Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units, or c) the Porous Pot study is required.

3 The log Kow is greater than 3 (3.72), and AS SI data are required.

### Page 4 of 46 

# Problem Formulation of the Environmental Fate and Ecological Risk in Support of the Registration Review of Propiconazole

[1

- [[2

- (2,4

- dichlorophenyl)

- 4

- propyl

- 1,3

- dioxolan

- 2

- yl]methyl]

- 1H

- 1,2,4

- triazole] CAS Registry No.: 60207

- 90

- 1 PC Code: 122101

Prepared by: Environmental Fate and Effects Division: Environmental Risk Branch VI Stephen Carey, Biologist Ibrahim Abdel

- Saheb, Ph.D., Environmental Scientist U. S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division Environmental Risk Branch VI 1200 Pennsylvania Ave., NW Mail Code 7507P Washington, DC 20460

A ntimicrobials Division : Risk Assessment and Science Support Branch James Breithaupt, Agronomist Daniel Cherry, Biologist Siroos Mostaghimi, Ph.D, Senior Scientist

Reviewed by: Laura Parsons, Associate Branch Chief Reviewed by: William P. Eckel , Ph.D., Senior Science Advisor Nathan Miller

, Biologist Monica Wait

, RAPL Mark Corbin, ERB6 Chief



### December 9 , 2015 

## Office of Chemical Safety and Pollution Prevention

### Page 5 of 46 

## Contents
1. Introduction

................................ ................................ ................................ .............................. 6 2. Conclusions

................................ ................................ ................................ .............................. 7 2.1. Ecological Risk Assessments

................................ ................................ ........................... 7 2.3. Clean Water Act Programs

................................ ................................ ............................... 7 3. Environmental Fate and Transport

................................ ................................ ........................... 8 3.1. Transformation Products

................................ ................................ ................................ . 10 4. Receptors

................................ ................................ ................................ ................................ .. 8 4.1. Effects to Aquatic Organisms

................................ ................................ ......................... 10 4.2. Effects to Terrestrial Organisms

................................ ................................ ..................... 11 4.3. Ecological Incidents

................................ ................................ ................................ ........ 12 5. Exposure Pathways of Concern

................................ ................................ ............................. 14 6. Analysis Plan

................................ ................................ ................................ ........................... 15 6.1. Stressors of Concern

................................ ................................ ................................ ....... 15 6.2. Measures of Exposure

................................ ................................ ................................ .... 15 6.3. Measures of Effect

................................ ................................ ................................ .......... 16 6.4. Endangered Species Assessments

................................ ................................ ................. 16 6.5. Endocrine Disruptor Screening Program

................................ ................................ ........ 17 7. Environmental Fate and Ecological Effects Data

................................ ................................ .. 17 7.1. Environmental Fate

................................ ................................ ................................ ............ 17 7.2. Effects

................................ ................................ ................................ ................................ 19 8. References

................................ ................................ ................................ ................................ 26

### Page 6 of 46 

# 1. Introduction

EFED and AD evaluated the most recent ecological risk assessments for p ropiconazole in association with the updated toxicity, exposure, and usage information to determine if sufficient data are available and if further updates are needed to support registration review. EFED and AD will use application scenarios that result in upper bound exposure scenarios for the registered uses of propiconazole for the risk assessment.

The active ingredient propiconazole is a triazole fungicide that has protective, curative, and systemic activity. Propiconazole is a racemic mixture of four stereoisomers. All of which appear to be active. T he fate and toxicity of the isomers will be assumed to be equal if no data are available

.

Some trade names for conventional products containing propiconazole include Banner ® 

### , Benit ®



### , Desmel ® 

### , Orbit ® 

### , Radar ® 

### , Tilt ® 

### , Fidis ® 

### , Alamo ® 

### , Spire ® 

### , Practis ® 

### , Bumper ® 

### , Mantis ® 

### , Restore ®



### , Banner Maxx ® 

### , Taspa ® 

### , Juno ® 

### , Novel ® 

### and Break ® 

### . End

- use products are formulated as emulsifiable concentrates (EC) and wettable powders (WP). Some propiconazole end

- use products are co

- formulated with other pesticides. Depending on the crop being treated, products containing propiconazole as an active ingredient can be applied by aerial or ground broadcast spray, chemigation, sprinkler irrigation, hose

- end and pump

- up sprayer, backpack a nd mist blower, and dip tank.

Some trade names for antimicrobial products containing propiconazole include Premier ® 

### , Kop

Coat ® 

### , Britewood ® 

### , Wocosen ® 

### , Preventol ® 

### , Wolman ® 

### , and Mycostat ® 

### . Some propiconazole end

use products are co

- formulated with other pesticides.

To support the assessment of risks for propiconazole, this document is dealing with propiconazole parent compound only

. The registration review risk assessment will focus on characterizing potential risks resulting from the registered uses, wh ich have been identified in the Screening Level Usage Analysis (SLUA; dated 17 April 2015 ). The uses can be categorized as agricultural or non

- agricultural uses. Agricultural uses include use on cereals (wheat, barley, rye, oats, and triticale), corn (swe et, field and popcorn), stone fruits (Apricot, peach, cherry, nectarine, prune and plum), seed crops, rice, wild rice, pecans, peanuts, dry beans and celery. Non

- agricultural uses include use on turf, ornamentals, lawn, ground cover, golf courses, and sod farms. The maximum annual application rate ranges from a high of 7.2 pounds of active ingredient per acre (lb a.i./A) for turf use (based on 4 applications at 1.78 lb a.i./A) to a low of 0.1125 lb a.i./A for barley, oats, rye, and triticale.

### Page 7 of 46 

# 2. Conclus ions from Previous Assessments

2.1. Ecological Risk Assessments

The Agency has conducted multiple ecological risk assessments on propiconazole that serve as a basis fo r this problem formulation

. These assessments are briefly summarized below.

The most recent risk assessment s for propiconazole is the ‘ Ecological Risk Assessment for Proposed New Uses on Dill, Radish, Leafy Brassica Subgroup 5B, Watercress, Ti palm; Crop Group Conversions for Stone Fruit Group 12 to 12

- 12 and Tree Nut Group 14 to 14

- 12 (Da ted 10/27/2015 ; D 425282 )

. A R eregistration E ligibility D ecision (RED) for propiconazole was conducted in 2006.

The major ecological conclusions pre sented in previous risk assessment s for propiconazole use s were as follows:

Table 1. Summary of Risk Concerns Identified for Propiconazole in Previous Assessments

Taxa with Acute LOC Exceedances Taxa with Chronic LOC Exceedances Taxa with No LOC Exceedances BCF Persistence Degradates of Concern

Terrestrial plants, freshwater fish, aquatic non

vascular plants Freshwater invertebrates 1



### , estuarine/marine fish 1 

### , birds, and mammals Terrestrial invertebrates 2



### , and aquatic vascular plants No Yes Not an ecological

concern

1 Chronic risk presumed for these taxa due to lack of data.

2 B ased on acute contact and oral toxicity with adult bees; were not assessed quantitatively

. 

# D rinking Water Exposure Assessment

2.2. Previous Drinking Water Assessments

The most recent drinking water assessment (DWA) for propiconazole n ew use on Dill, Radish, Leafy Brassica Subgroup 5 B , Watercress, Ti palm and Crop Group conversions for Stone Fruit Group 12

- 12 and Tree Nut Group 14

- 12 , was conducted in 2015 (D 423648 )

.

The estimated groundwater concentrations of propiconazole were calculated using the Tier II
PRZM

- GW 

### model. The surface water EDWCs were lower than the groundwater EDWCs

. The maximum concentrations of propiconazole in groundwater were estimated to be 37.9 μg/L

.
The most recent EDWCs for 1,2,4

- triazole, 1,2,4

- triazole alanine, and 1,2,4

- triazole acetic acid were calculated in support of the 2006 aggregate assessment for triazole

- derivative fungicides (USEPA, 2006 a.; USEPA, 2006 b.). The highest 1,2,4

- triazole, 1,2,4

- triazole alanine, and 1,2,4

- triazole acetic acid EDWCs calculated in this asses sment were for the turf use, which resulted in the surface water EDWCs peak of 55.8 μg/L (using PRZM

- EXAMS). A groundwater EDWC of 1.06 μg/L was calculated for 1,2,4

- triazole using SCI

- GROW.

### Page 8 of 46 

## 2.3. Clean Water Act Programs

Propiconazole is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. No Total Maximum Daily Load (TMDL) criteria have been developed for propiconazole

. A quatic benchmarks have been established fo r p ropiconazole and are available at http://www2.epa.gov/pesticide

- science

- and

- assessing

pesticide

- risks/aquatic

- life

- benchma rks

- pesticide

- registration . Any data submitted or otherwise located as part of the registration review process may be used to update aquatic life benchmarks if applicable.



# 3. Environmental Fate and Transport

Propiconazole appears to be persistent and m oderately mobile to relative immobile in most soil and aqueous environments. Propiconazole degradation in the aquatic environment appears to be dependent solely on aqueous photolysis in the presence of photosensitizers. In soil environments, propiconazol e dissipation appears to be dependent on incorporation or binding to soil organic
matter content.

Laboratory and terrestrial field dissipation data indicate that propiconazole is stable in soil and aqueous environments. Propiconazole was stable to hydrol ysis (t1⁄2 > 30 days), aqueous photolysis (< 10% of applied degraded in 30 days), soil photolysis (< 8% of applied degraded in 30 days), aerobic aquatic metabolism (t1⁄2 > 30 days), aerobic soil metabolism (t1⁄2 = 43 to 70 days), and anaerobic aquatic metabolism (t1⁄2 = 363 days). The terrestrial field dissipation data were consistent with reported half

- lives of > 100 days for four soil textures. However, in supplemental aquatic dissipation data using basin

- irrigation and flow through irrigation systems in rice fields, propiconazole was found to dissipate rapidly (t1⁄2 < 5 days). Aqueous photolysis studies using sensitizers indicated rapid degradation (t1⁄2 < 1 days) of propiconazole, which appears to be the case in rice fields. Furthermore, aquatic metabolism and dissipation studies indicate propiconazole dissipates by incorporation or binding to the organic matter content of soil/sediment.

Propiconazole mobility in soil appears to be dependent on the soil’s organic matter content. In general, propiconazole appea rs to be moderately mobile ( K OC 

### of 685, 436, 382, 604 and 1134 mL/g oc 

### ) in soils with a low organic matter content (< 1%). Therefore, propiconazole may reach ground water in soils with low organic content. More importantly, propiconazole may contaminate su rface water through off

- site runoff and spray drift.

Bioaccumulation and biomagnification should not be a significant concern for propiconazole, because it has an octanol/water partition coefficient (log K ow 

### ) of 3.72 and bioconcentration factor (BCF) values of 24x, 138

- 516x, and 68

- 203x, respectively for edible, viscera, and whole body of bluegill.

### Page 9 of 46 

### A selection of propiconazole environmental fate and transport properties are summarized in Table 2 below.

Table 2. Physical Chemical and Environmental Fate Properties of Propiconazole.

Parameter Value Source Selected Physical/Chemical Parameters
Chemical Structure

Empirical Formula C 15 H 17 Cl 2 N 3 O 2 http://pubchem.ncbi.nlm.nih.gov/compound/4323 4

IUAPC Name 1

- [[2

- (2,4

- dichlorophenyl)

- 4

- propyl

- 1,3

- dioxolan

- 2

- yl]methyl]

- 1,2,4

- triazole http://pubchem.ncbi.nlm.nih.gov/compound/4323 4

CAS No. 60207

- 90

- 1 http://pubchem.ncbi.nlm.nih.gov/compound/43 23 4

PC Code No. 122101 http://pubchem.ncbi.nlm.nih.gov/compound/4323 4
SMILES string: CCCC1COC(O1)(CN2C=NC=N2)C3=C (C=C(C=C3)Cl)Cl http://pubchem.ncbi.nlm.nih.gov/compound/4323 4 Molecular Weight 342.22 g/mol http://pubchem.ncbi.nlm.nih.gov/compound/4323 4 Physical state Yellowish odorless liquid. Non corrosive http://pubchem.ncbi.nlm.nih.gov/compound/4323 4 Vapor pressure 1.0 x 10

- 6 (torr) http://pubchem.ncbi.nlm.nih.gov/compound/4323 4 Aqueous solubility 100 mg/L at 25 deg C Tomlin CDS, ed; The e

- Pesticide Manual: a world compendium. Propiconazole. 13th ed. British Crop Protection Council, (2003) Henry’s Law Constant 9.1X10

- 5 atm

- m 3 /mole Foot Print Pesticides Properties Database @ http://sitem.herts.ac.uk/aeru/iupac/Reports/551.ht

m log Kow 3.72 Foot Print Pesticides Properties Database @ http://sitem.herts.ac.uk/aeru/ppdb/en/Reports/551 .htm Persistence Hydrolysis half

life (pH 5, 7, 9) Stable MRID: 00067901 , 42238201

Aqueous photolysis half

life Stable MRID: 41811901

Aerobic soil metabolism half

life (range in days) 43, 47, and 70 days MRID: 129912, 129914

Anaerobic 363 days MRID: 42347902

### Page 10 of 46 

### Table 2. Physical Chemical and Environmental Fate Properties of Propiconazole.

Parameter Value Source aquatic metabolism half

life Aerobic aquatic metabolism half

life (total system) >30 days MRID: 42347901

Mobility Adsorption/ desorption K d (Avg): 5.34 (mL/g) K oc (Avg): 648 (mL/g O.C.) MRID 41727001; K d values were 1.2, 2.81, 4.49, 8.88 and 9.34. K OC values of 685, 436, 382, 604 and 1134.



## 3.1. Transformation Products

The major degradates of propiconazole include CGA

- 91305, CGA

- 136735, CGA

- 118244, CGA

118245, and CGA

- 71019. Structures are given in Appendix 5

. 

# 4

. Receptors

Tables 3 and 4 provide an update of the aquatic and terrestrial taxonomic groups, respectively, and most sensitive surrogate species tested to characterize the potential acute and chronic ecological effects of propiconazole

. In addition, the tables provide a preliminary overview of the
p otential acute toxicity of propiconazole by providing the acute toxicity classifications. Additional detail s are included in the following tables.



## 4.1. Effects to Aquatic Organisms

Table 3 . Summary of the Most Sensitive Endpoints from Aquatic Toxicity St udies for Propiconazole

Taxonomic

Group Study Type Surrogate Species Toxicity Value (μ g a.i./L) Acute Toxicity Classification or Adverse Effect Observed Source (Study classification)

Freshwater fish 1 Acute R ainbow t rout LC 50 = 850 Highly toxic 0067923 (Acceptable)

Chronic Fathead minnow NOAEC = 95 Affected Endpoint: Hatchability, fry survival, total survival 133364 ( Acceptable )

Freshwater invertebrates Acute

Water flea EC 50 = 1300 Moderately toxic 132932 (Acceptable)

Chronic NOAEC = 180

-- 49300501 (In review)

### Page 11 of 46 

### Table 3 . Summary of the Most Sensitive Endpoints from Aquatic Toxicity St udies for Propiconazole

Taxonomic

Group Study Type Surrogate Species Toxicity Value (μ g a.i./L) Acute Toxicity Classification or Adverse Effect Observed Source (Study classification)

Estuarine/marine fish Acute Spot LC 50 =2244 Moderately toxic 132921 ( Supplemental )

Chronic No data

-- No data 2

Estuarine/marine invertebrates Acute Mysid shrimp EC 50 = 510 Highly toxic ACC: 260201 (Acceptable)

Chronic NOAEC = 205

-- 133365 (Acceptable) Whole sediment; saltwater invertebrates Chronic Saltwater amphipod No data N/A No data

Whole sediment; freshwater invertebrates Chronic Freshwater amphipod No data N/A No data

Whole sediment; freshwater invertebrates Chronic Freshwater midge No data N/A No data

Aquatic plants and algae Vascular Duckweed EC 50 = 3500 EC 05 = 380 3 -- 133363 (Acceptable)

Non

vascular Marine diatom ( Skeletonema

costatum ) EC 50 = 21 EC 05 = 15 3 -- 132939 (Acceptable)

1 Freshwater fish are surrogates for aquatic

- phase amphibians.

2 The acute

- to

- chronic ratio ( ACR ) could not be employed since acceptable acute and chronic studies used different fish species that prevented the calculations. Freshwater fish data on the same species (e.g. fathead minnow) is needed to estimate the NOAEC for estuarine/marine fish.

3 Per EPA guidelines, the EC 05 is used in lieu of the NOAEC since the NOAEC could not be determined as effects were observed in all levels.



## 4.2. Effects to Terrestrial Organisms

Table 4. Summary of the Most Sensitive Endpoints from Terrestrial Toxicity Studies for Propiconazole

Taxonomic

Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification or Chronic Effects Observed Source (Study classification)

Passerine Acute oral N/A No data N/A No data

Birds 1 Acute oral

Bobwhite quail LD 50 =2,825 mg a.i./kg

bw Practically non

- toxic 79689 (Acceptable) Subacute Dietary LC 50 >5,620 mg a.i./kg

diet Practically non

- toxic 79690 (Acceptable)

Chronic NOAEC = 1000 mg a.i./kg

- diet Affected Endpoint: None. 133369 (Acceptable)

### Page 12 of 46 

### Table 4. Summary of the Most Sensitive Endpoints from Terrestrial Toxicity Studies for Propiconazole

Taxonomic

Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification or Chronic Effects Observed Source (Study classification)

Mammals Acute Oral

Laboratory
rat LD 50 = 1344 mg a.i./kg

bw Slightly toxic 58594

Chronic NOAEL = 500 mg a.i./kg

diet ( 4 2 mg a.i./kg

- bw [F 0 males ) LOAEL = 2500 mg a.i./kg

- diet ( 192 mg a.i./kg bw [ F 0 males ]) Affected Endpoint: Reduced body weight gain in F 0 and F 1 , liver changes in F 0 generation, decreased offspring survival and body weight, hepatic lesions. 00163164

Terrestrial Invertebrates Acute Contact

- Adults

Honey bee LD 50 > 25 μg a.i./bee Practically non

- toxic 43420702 (Acceptable)

Acute Oral

- Adults No data No data No data

Acute Oral

- Larval No data N/A No data

Chronic Oral

– Adults No data N/A No data

Chronic Oral

- Larval No data N/A No data

Terrestrial plants Seedling Emergence Dicot (Cabbage) EC 25 = 0.178 lb a.i./A NOAEC = 0.056 lb a.i./A -- 41673203 ( In process of being updated ) Monocot (Corn) EC 25 = 0.094 lb a.i./A NOAEC = 0.18 lb a.i./A --

Vegetative Vigor Dicot ( Cabbage ) EC 25 = 0. 039 lb a.i./A EC 05 2 = Not reported -- 41673201 ( In process of being updated ) Monocot ( Ryegrass ) EC 25 = 0.315 lb a.i./A NOAEC = 0.0185 lb a.i./A --

1 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

2 Per EPA guidelines, the EC 05 is used in lieu of the NOAEC since the NOAEC is above the EC 25

.


## 4.3. Ecological Incidents

The ecological incident information system (EIIS) is an OPP database that houses ecological incidents that have been reported to the Agency. When available, EIIS includes date and location of an incident, type and magnitude of effects observed in various species, use(s) of pesticides known or suspected of contributing to the incident, and results of any chemical residue analysis or other analyses conducted during incident investigation. EIIS incidents are categorized according to the certainty that the in cident resulted from pesticide exposure. The Avian Monitoring System (AIMS) is a database administered by the American Bird Conservancy that contains publicly available data on reported avian incidents involving pesticides. Many of the incidents listed i n this database are also in the EIIS.

### Page 13 of 46 

### As of October 2015, t here are 27 reported incidents for propiconazole in the EIIS database with 20 incidents classified as ‘possible’, 1 incident ‘ highly probable ’ , and 6 incidents ‘unlikely’ (see Table 5 and Appendix I ).

In the ‘highly probable’ incident ( I022718

- 001 ) that occurred on February 6, 2010, in Somerset, UK by the Glastonbury Canal where hundreds of dead fish including roach, bream, rudd, chub, and perch were observed

. Other dying fish were showi ng signs of distress and behaving erratically including jumping out of the water, swimming in circles and on their sides. Distressed fish were observed as far as Burtle

- - 6 miles from the source of the spill. Analysis of dead fish revealed the presence of the pesticides permethrin, te buconazole, and
p ropiconazole , which are chemical s commonly used as wood preservatives. Tests from the Environment Agency's laboratories showed that the canal was contaminated with wood preservative chemicals, with extremely high levels of pesticides with some fish having more than seven times the lethal limit of chemicals in their gills.

The dates of the incident reports range d from 1998 to 2014

. Most involve damage by treating directly or ingestion ; however, one incident i nvolves spray drift

.
In addition to the incident reports available in EIIS, there were 24 aggregate ‘Other Non

- Target ’ incidents and no AIMs incidents reported to the Agency.

Table 5 . Incident Reports from EIIS

INCIDENT NUMBER YEAR CERTAINTY INDEX STATE LEGALITY USE SITE SPECIES AFFECTED EXPOSURE / MAGNITUDE

I022718

- 001 201 0 Highly probable NR Misuse Wood Fish Spill / hundreds of bream, perch, and

unknown fish I004697

- 061 NR Possible NR Unknown NR Shrimp Unknown

I007644

- 016 1998 Possible CA Unknown Orchard Nectarines Treated directly / 12

acres

I012786

- 002 2001 Possible NR Unknown Ornamen tal Ornamental Treated directly / 19

acres

I014029

- 006 2003 Possible VA Registered Use Wheat Wheat Treated directly / 51

acres

I014538

- 013 2003 Possible IN Misuse (accident) Golf

course Fish Runoff / ~1,500 fish

I015291

- 045 NR Possible ND Registered Use Wheat Wheat Treated directly/ 120 acres

I019130

- 070 200 7 Possible IL Unknown Corn Corn Carryover / 400

acres

I021500

- 074 2009 Possible OH Unknown Corn Corn, field Treated directly / 112 acres

I021500

- 075 20 09 Possible IL Unknown Corn Corn, field Treated directly / 35

acres I021947

- 001 2010 Possible OR Misuse NR Apple NR

I022082

- 030 2010 Possible ND Unknown Wheat Wheat Treated directly / 320 acres

I023082

- 042 2011 Possible ND Unknown Wheat Wheat Treated directly / 404 acres

### Page 14 of 46 

### Table 5 . Incident Reports from EIIS

INCIDENT NUMBER YEAR CERTAINTY INDEX STATE LEGALITY USE SITE SPECIES AFFECTED EXPOSURE / MAGNITUDE

I023390

- 020 2011 Possible WI Registered Use Wheat Wheat Treated directly / 900 acres

I023390

- 021 201 1 Possible WI Registered use Wheat Wheat Treated directly / 1900 acres

I023444

- 039 201 0 Possible NY Unknown Corn Corn Treated directly / 50

acres

I024295

- 031 201 2 Possible IA Registered use Corn Corn Treated directly / 80

acres I026232

- 001 NR Possible CA Registered use NR Bees NR / 100

- 170 hives I026233

- 001 NR Possible CA Unknown Ag area Bees 87 hives I026241

- 001 2014 Possible CA Unknown NR Bees 244 of 460 hives I026297

- 001 NR Possible FL Unknown NR Bees ~6000 hives

I020459

- 023 NR Unlikely WA Unknown Wheat Onion Spray drift / Not reported

I023225

- 006 2011 Unlikely NR Unknown NR Bees Ingestion / 10% area (thousands) I024875

- 001 2013 Unlikely UT Unknown Ag area Bees NR / 3,972 hives

I025162

- 001 2013 Unlikely CA Unknown Almond Bees Treated directly / 12,000 colonies I026789

- 001 2014 Unlikely IL Registered Use Corn Bees and fish NR / 600 dead I027851

- 001 NR Unlikely NC Unknown NR Bees Ingestion / 1 hive NR

– Not reported



# 5

. Exposure Pathways of Concern

The environmental fate and toxicity profile for propiconazole suggests that direct spray, spray drift, leaching and runoff represent the likely exposure pathways for terrestrial and aquatic non

target organisms. Surface water and inhalation exposure pathways for ecological risk w ill be also screened using the SIP ( Screening Imbibition Program) and STIR (Screening Tool for Inhalation Risk) screening methods to determine if they are potential pathways of concern or support requesting data

. As a result of the screening, both exposure pathways are of low concern for pro piconazole, and additional data specific to these exposure pathways are not needed. SIP and STIR are described in detail at: http://www2.epa.gov/pesticide

- science

- and

- assessing

pesticide

- risks/models

- pesticide

- risk

- assessment#terrestrial and the modeling can be found in the Appendices 2 and 3

.

### Page 15 of 46 

# 6. Analysis Plan

6.1. Stressors of Concern

Ecological Risk Assessment

Based on available toxicity data, it appears that the stressor of ecological concern for terrestrial and aquatic organisms is propiconazole , the parent compound only as the degradates are low in toxicity compared to the parent compound

.
Drinking Water Ass essment

T he assessment of the common triazole degradate, 1,2,4

- triazole

, will be conducted in a separate
assessment. For the parent, propiconazole , s urface water EECs (eco) and EDWCs (human) will be reassessed with SWCC model, g round water EDWCs will be re assessed with PRZM

- GW model ; following updated model input guidance

.



## 6.2. Measures of Exposure

Conventional Uses

EFED will use standard available models to evaluate potential exposures to aquatic and terrestrial organisms and/or exposure routes as described at http://www2.epa.gov/pesticide

science

- and

- assessing

- pesticide

- risks/models

- pesticide

- risk

- assessment

.

Antimicrobial Uses

There are 5 6 active propiconazole labels in OPPIN for two antimicrobial major use patterns : wood preservatives (dip, spray, and pressurized applications) and material preservatives

. Specifically, propiconazole may be used i n adhesives; coatings; plastics ; inks; metalworking fluids; and wood preservatives (above

- ground and ground

- contact) including for use on/in lumber, log buildings, roof shingles, wood siding, a nd fencing ), and textile uses including “canvas” (i.e., awnings , boat covers, carpet backing, cordage, tents, tarpaulins, and wall coverings). 

### On March 8, 2006, the Agency published a Federal Register Notice announcing receipt of a request to cancel apparel, furnishings (except shower curtains), and carpet fiber appl ications of propiconazole and EPA issued cancellation orders for these uses on May 26, 2006. However, the Agency has identified some product labels that still have these uses. EPA is working with registrants to remove these uses; therefore, the apparel, fu rnishings (except shower curtains), and carpet fiber uses will not be considered in registration review.

Based on the registered antimicrobial uses and the physical/chemical and environmental fate properties in Table 2 for parent propiconazole, the Agency has developed conceptual model diagrams for exposure of ecological organisms to propiconazole. Propiconazole is stable to degradation and moderately mobile ( Table 2 ) and therefore environmental exposure to parent propiconazole is expected. Chemicals that are released down

- the

- drain can typically take from a

### Page 16 of 46 

### few to several hours to reach wastewater treatment plant intakes following their discharge and from several hours to roughly a day following their discharge down

- the

- drain to subsequently be discharged from wastewater treatment plants to surface water. Data on WWTP dissipation have not been submitted for propiconazole, however, the primary routes of dissipation are expected to be partitioning to water with minimal degradation and subsequent outflow in e ffluent.

The Agency has created conceptual models for potential routes of environmental exposure which are included in “Conceptual Models for Environmental Exposure Pathways of Antimicrobial Pesticides,” (EPA

- HQ

- OPP

- 2014

- 0638

- 0002), found in the docket at www.regulations.gov

, EPA

- HQ

- OPP

- 2014

- 0638. The Agency does not consider the interior latex paints or coatings to lead to exposure because the treated materia ls are not anticipated to come into contact with
water. The conceptual model for adhesives may be seen in slide 17, and for exterior latex paints and coatings may be seen in slides 24 and 25. The conceptual model for wood preservation, is in slide 29. I n MRID 46074205, the leaching rates of propiconazole from treated wood (μg/cm 2 

### /day) using simulated rainfall were 0.49 (maximum). 0.0026 (minimum), and 0.095 (average). The cumulative leach rate was 9.9 μg/cm 2



### .



## 6.3. Measures of Effect

Toxicity data presented in Section 4 of this problem formulation will be used to calculate risk quotients. Any additional information submitted by the registrant or found in the open literature prior to conduct of the risk assessment also will be considered. The open literature studies are identified using EPA’s ECOTOXicology database ( ECOTOX) (USEPA, 2007 c ), which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife . The publically available database is available at http://www2.epa.gov/chemical

research/ecotoxicology

- database

. The evaluation of both sources of data can also provide insight into the direct and indirect effects of pesticides on biotic communities from loss of species that are sensitive to the chemicals and from changes in structure and functional characteristics of the affected communities.



## 6.4

. Endangered Species Assessmen ts

Consistent with EPA’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally listed threatened and endangered (listed) species from registered uses of pesticides in accordance with the Joint Interim Approaches de veloped to implement the recommendations of the April 2013 National Academy of Sciences (NAS) report, Assessing Risks to Endangered and Threatened Species from Pesticides

. The NAS report outli nes recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA. EPA will address concerns specifi c to propiconazole in connection with the development of its final registration review decision for propiconazole

.
In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries (the Services), and USDA released a white paper contai ning a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. These Interim Approaches were

### Page 17 of 46 

### developed jointly by the agencies in response to the NAS recommendations, and reflect a common approach to risk assessmen t shared by the agencies as a way of addressing scientific differences between the EPA and the Services. Details of the joint Interim Approaches are contained in the November 1, 2013 white paper 4



### , Inte rim Approaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report.

Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, this ecological problem formulation supporting t he Preliminary Work Plan for propiconazole does not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted during registration review. While the agencies continue to develop a common method for ESA analysis, the planned risk assessment for the registration review of propiconazole will describe the level of ESA analysis completed for this particular registration review case. This assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists, once the scientific methods being developed by the agencies have been fully vetted. Once the agencies have fully developed and implemented the scientific methods necessary t o complete risk assessments for listed species and their designated critical habitats, these methods will be applied to subsequent analyses of propiconazole as part of completing this registration review

.



## 6.5

. Endocrine Disruptor Screening Program

Propico nazole was included in the first group of chemicals issued an order to conduct Tier 1 EDSP testing for which EPA has received all of the required Tier 1 assay data. The Agency has reviewed all of the assay data received for the appropriate List 1 chemica ls

, and the conclusions of those reviews are available in the chemical

- specific public dockets ( EPA

- HQ

- OPP

- 2009

- 0634

- 0248 ). For additional information the EDSP program, visit http://www2.epa.gov/endocrine

- disruption/endocrine

- disruptor

- screening

- program

- edsp

overview

.


# 7

. Environmental Fate and Ecological Effects Data

7.1. Environmental Fate

Table 6 identifies environmental fate studies by MRID that offer data for each guideline requirement, as well as study classifications and whether or not further data are needed in order to support risk assessment.

4 http://www2.epa.gov/endangered

- species/interim

- approaches

- pesticide

- endangered

- species

- act

- asses sments

- based

nas

- report

### Page 18 of 46 

### Table 6 . Submitted Environmental Fate Data for Propiconazole

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 00067901 42238201 Acceptable No

835.2240 Aqueous photolysis 41811901 Acceptable No

835.2410 Soil photolysis 41811902 Acceptable No

835.1110 Activated Sludge Sorption Isotherm (ASSI) 5 No data N/A Yes (antimicrobial

uses )

835.3110 6 Ready Biodegradability No data N/A Yes (antimicrobial

uses )

835.3220 9 Porous Pot Test No data N/A Yes (antimicrobial

uses )

835.3240 9 Simulation Test

— Aerobic Sewage

Treatment: A. Activated Sludge Unit No data N/A Yes (antimicrobial

uses )

835.3280 9 Simulation Tests to Assess the Primary and Ultimate Biodegradability of Chemicals Discharged to

Wastewater No data N/A

Yes (antimicrobial

uses )

5 The log Kow is greater than 3 (3.72), and ASSI data are required.

6 The results of the Activated Sludge Respiration Inhibition Test (ASRI) will determine which of these four biodegradation tests is/are anticipated to be required.

• If the ASRI test EC50 is less than or equal to 20 mg/L, then either the (i) Biodegradation in Activated Sludge

Study or (ii) Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units or (iii) the Porous Pot Test is required. If the ASRI test EC 50 is greater than 20 mg/L, then the registrant must conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test.

• If the Rea dy Biodegradability study is conducted and passes, then no further testing is required. If, however, the

antimicrobial fails the Ready Biodegradability study, then the a) Biodegradation in Activated Sludge or b) Simulation Test

- Aerobic Sewage Treatment: A. Activated Sludge Units, or c) the Porous Pot study is required.

### Page 19 of 46 

### Table 6 . Submitted Environmental Fate Data for Propiconazole

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

835.4100 Aerobic soil metabolism 129912 129914 133375 Acceptable No

835.4300 Aerobic aquatic metabolism 42347901 Acceptable No

835.4400 Anaerobic aquatic metabolism 42347902 Acceptable No

835.1230 835.1240 Adsorption/ desorption and leaching 41727001 44701801 Supplemental No

835.6100 Terrestrial field dissipation 155642 159691 45528702 45528703 Acceptable No

835.6200 Aquatic field dissipation 164823 42560501 42560502 Acceptable No

850.1730 Fish bioconcentration 40963502 Acceptable No

850.3300 Activated Sludge Respiration Inhibition Test (ASRI) No data N/A Yes (antimicrobial

uses )
Environmental

Chemistry Method: Water & i ts ILV 850.6100 Analytical method in
water 48697002 48713801 Acceptable No

Environmental

Chemistry Method: Soil & i ts ILV 850.6100 Analytical method in soil 48697002 48713801 Acceptable No



## 7.2. Effects

Tables 7 and 8 identify ecological effects studies by MRID that offer data for each guideline requirement, as well as study classifications and whether or not further data are needed in order to support risk assessment. Only technical gr ade active ingredient ( TGAI ) propiconazole data needs are discussed ; studies with propiconazole formulated products and/or propiconazole transformation products are not being requested at this time

. Rationale s for the additional data requested are presente d below.

### Page 20 of 46 

### Conventional Uses

• Propiconazole may cause exposure of pollinators visiting off

- site plants that are contaminated by spray drift. Acceptable toxicity data to honey bee adults and larvae have not been submitted for propiconazole and these data are needed to fulfill EPA’s recent policy on pollinator protection. A T ier I study on the toxicity of residues on foliage ( OCSPP 850.3030) is not needed since results of the honey bee acute contact LD 50 

### is > 25 μg a.i./bee, above the 11 μg a.i./bee trigger criterion

. To be consistent with the honey bee risk assessment framework, the following seven Tier I, II and III honey bee studies, yet to be submitted for propiconazole , are required:

o Honeybee larval acute oral toxicity study (following OECD 237, Tier I)

o Honey bee adult oral toxicity test (OECD 213, Tier I)

o Honeybee adult 10

- day chronic oral (special study; Tier I)

o Honeybee larval repeated dose study (special study renamed as honeybee larval chronic oral toxicity study, Tier I)

o Semi

- fiel d testing for pollinators (special study, Tier II).

o Field testing for pollinators (OCSPP 850.3040, Tier III)

o Field trial of residues in pollen and nectar (special study, Tier III)
Note that it is possible to conduct the larval chronic oral study in such a way as to derive both an LD 50 

### (acute endpoint of interest) and a NOAEC (chronic endpoint of interest) from a single study. If the chronic larval toxicity study is conducted in such a way that it derives both an LD 50 

### and NOAEC, then a separate acute larval toxicity study is not needed. For pollinator studies without finalized OECD guidelines, protocols should be submitted for EPA review and comment prior to study initiation.

The need for higher Tier semi

- field and full field pollinator studies for propico nazole will be determined after review of these Tier I studies.

• Acceptable avian acute oral toxicity data were not submitted for a passerine species exposed
to propiconazole , which is now required under the 40 CFR Part 158 data requirements (Guideline 850 .2100) . Though the available bobwhite quail study indicates propiconazole has low toxicity to upland game bird species, it is uncertain whether passerines may be more or less sensitive to this chemical as a result of their higher metabolic rate and differi ng metabolic pathways. An avian oral toxicity study is needed for a passerine species.

• Currently, an acute to chronic ratio (ACR) for estuarine/marine fish from the freshwater data is not appropriate because the acceptable acute and chronic studies used different freshwater species that prevented the calculations. EFED is in need of a fathead minnow acute toxicity study to obtain an acute toxicity value in order to calculate an ACR using freshwater data on the s ame species (e.g., fathead minnow ) to estima te the NOAEC for e stuarine/marine fish. Without an acute toxicity study with the fathead minnow , chronic risk to estuarine/marine fish will be presumed . However, EFED has no reservations if a Fish Early Life

- Stage chronic toxicity study (OCSPP 850.1400) wi th an estuarine/marine fish is submitted instead of the fathead minnow acute toxicity study to get the NOAEC directly for estuarine/marine fish.

### Page 21 of 46 

### • Acceptable avian reproduction toxicity data were not submitted for a waterfowl species exposed to propiconazole

. A new avian reproduction toxicity study for mallard ducks is necessary to satisfy standard data requirements as the previous mallard reproduction study submitted was classified as invalid.

Antimicrobial Uses

• The chemical and physical properties of propiconazole indicate that it may pose risk to sediment

- dwelling invertebrates when used as an antimicrobial pesticide. To assess the toxicity and bioaccumulation potential of propiconazole in sediment fauna, the Ag ency anticipates the need to require three whole sediment chronic invertebrate studies: two in freshwater and one in saltwater.

### Page 22 of 46 

### Table 7 . Submitted Aquatic Ecological Effects Data for Propiconazole

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for assessment? Justification and Assumptions EPA will Make in Absence of Data

850.1010 Freshwater invertebrate acute toxicity 67925 132932 132935 ACC:072209 Acceptable Acceptable Supplemental Acceptable No

--

850.1025 850.1035 Estuarine/Marine invertebrate acute toxicity 132933 132934 ACC:260201 ACC:260201 ACC:260201 Acceptable Acceptable Acceptable Acceptable Acceptable No

--

850.1075 Freshwater fish acute toxicity 67922 67923 67924 132922 132923 132925 132927 132928 132930 133380 ACC : 072209 Acceptable Acceptable Supplemental Acceptable Supplemental Acceptable Supplemental Acceptable Acceptable Acceptable Supplemental Yes (conventional uses) A fathead minnow acute toxicity test ( to generate an ACR to apply to the spot fish acute toxicity value to estimate an estuarine/marine fish NOAEC ) or an estuarine/marine fish chronic toxicity test is necessary to satisfy standard data requirement

.

850.1075 Estuarine/Marine fish acute toxicity 132921 132924 Supplemental Acceptable No

--

850.1300 Freshwater invertebrate life cycle 49300501 In Review

-- --

850.1350 Estuarine/Marine invertebrates life cycle 133365 Acceptable No

850.1400 Estuarine/Marine fish early

- life stage No data N/A Yes (conventional uses) An estuarine/marine fish chronic toxicity
test or a fathead minnow acute toxicity test ( to make a conservative assumption ) is necessary to satisfy standard data requirement

. Without data, risk would be presumed for estuarine/marine fish , including listed species.

### Page 23 of 46 

### Table 7 . Submitted Aquatic Ecological Effects Data for Propiconazole

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for assessment? Justification and Assumptions EPA will Make in Absence of Data

850.1400 Freshwater fish early

- life stage 133364 Acceptable No

--

850.1500 Fish life cycle (None) (N/A) No Not triggered per 40 CFR Part 158 based

on results of 850.1400 studies

Non

Guideline Whole sediment; chronic invertebrate: freshwater and marine No data (N/A) Yes (antimicrobial

uses ) Triggered per 40 CFR Part 158W based on chemical properties and metabolism studies.

850.1735 Whole sediment;
acute invertebrate: freshwater (None) (N/A) No Not triggered per 40 CFR Part 158 based on chemical characteristics 850.1740 Whole sediment;
acute invertebrate: marine (None) (N/A) No

850.4400 Aquatic plant growth: Vascular plants 133363 Acceptable No

--

850.4500 Aquatic Plant Growth: Algal 132937 132938 132939 Acceptable No

--

850.4550 Aquatic Plant Growth: Cyanobacteria 133362 Acceptable No

--

### Page 24 of 46 

### Table 8 . Submitted Terrestrial Ecological Effects Data for Propiconazole

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for assessment? Current Additional Data Need

850.2100 Avian oral toxicity 67926 79689 Acceptable Acceptable Yes (conventional uses) A passerine bird study is necessary to satisfy standard data requirement. Without data, risk would be presumed for small

sized birds, including listed species.

850.2200 Avian dietary toxicity 67927 79690 133366 133367 138267 138268 Acceptable Acceptable Supplemental Supplemental

Acceptable Acceptable No

--

850.2300 Avian reproduction 133369 Acceptable Yes (conventional uses) A mallard duck study is necessary to satisfy standard data requirement. Without data, risk would be presumed for waterfowls, including listed species.

Non

guideline Avian inhalation (None) (N/A) No The STIR model indicates exposure through inhalation is not a concern for birds.

850.3020 Adult h oney bee acute

contact toxicity 43420702 Acceptable No

--

850.3030 Honey bee residue on

foliage No data No data No No data is available; however, EFED is not asking for the toxicity of residue on foliage since the bee contact LD 50 was > 25 μg a.i./bee, which is above the 11 μg a.i./bee criterion that triggers the study. AD will not require toxicity of residue data because propicon azole is not expected to be applied to wood used to construct honey bee enclosures.

### Page 25 of 46 

### Table 8 . Submitted Terrestrial Ecological Effects Data for Propiconazole

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for assessment? Current Additional Data Need

850.3040 Field testing for pollinators No data No data Yes (conventional uses)

Pollinator Tier I, II and III studies with the honeybees are necessary to satisfy standard data requirement. Without data, risk would be presumed for pollinators, including listed species. SS Larval honey bee chronic oral toxicity No data No data Yes (conventional uses)

SS Adult honey bee chronic oral toxicity No data No data Yes (conventional uses)

SS Larval honey bee acute toxicity No data No data Yes (conventional uses)

SS Adult honey bee acute oral toxicity No data No data Yes (conventional uses)

SS Field testing of residues in pollen and

nectar No data No data Yes (conventional uses)

SS Semi

- field testing for pollinators No data No data Yes (conventional uses)

850.4100 Tier I or II seedling
emergence 41673203 47675201 Acceptable Acceptable No

--

850.4150 Tier I or II vegetative

vigor 41673201 47675201 Acceptable Acceptable No

### Page 26 of 46 

# 8. References

MRID 46074205. Maier, M. (2003) Leaching Behaviour of Wolsin FL

- 35 Treated Timber. Project Number: 08/2003. Unpublished study prepared by Dr. Wolman GMBH. 10 p.

United Nations Food and Agriculture Organization. Assessing soil contamination : A reference manual. http://www.fao.org/docrep/003/x2570e/x2570e06.htm

USEPA 2006. Environmental Fate and Effects Division Revise d RED for the Reregistration of Propiconazole. Dated June 30 2006.

USEPA. 2006 a. 1,2,4

- Triazole, Triazole Alanine, Triazole Acetic Acid: Drinking Water Assessment in Support of Reregistration and Registration Actions for Triazole

- derivative Fungicide Compounds. D320682. Office of Pesticide Programs Environmental Fate and Effects Division, Environmental Risk Branch 1. February 28, 2006.

USEPA. 2006 b. 1,2,4

- Triazole, Triazole Alanine, Triazole Acetic Acid: Human Health Aggr egate Risk Assessment in Support of Reregistration and Registration Actions for Triazole

derivative Fungicide Compounds. DP Number 322215. Office of Pesticide Programs Health Effects Division and Environmental Fate and Effects Division. February 7, 2006.

U .S. EPA, Office of Pesticide Programs, Antimicrobial Division, Risk Assessment and Science Support Branch. August 4, 2014. Conceptual Models for Environmental Exposure Pathways of Antimicrobial Pesticides. EPA

- HQ

- OPP

- 2014

- 0638. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2014

- 0638

- 0002



## Eco logical Effects Bibliography (Acceptable or Supplemental stud ies only)

850.2100 Avian Single Dose Oral Toxicity

MRID Citation Reference

67926 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Acute Oral LD50

-- Mallard Duck: Project No. 108

- 194. (Unpublished study received Jan 28, 1981 under 100

- 618; prepared by Wildlife International, Ltd. and Washington College, submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:244273

- G)

79689 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Acute Oral LD50

-- Bobwhite Quail: Project No. 108

- 193. (Unpublished study received Jan 28, 1981 under 100

- 618; prepared by Wildlife Intern ational, Ltd. and Washington College, submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:244273

- F)

### Page 27 of 46 

## 850.2200 Avian Dietary Toxicity

MRID Citation Reference

67927 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Eight

- day Dietary LC50

-- Mallard Duck: Project No. 108

- 192. (Un

- published study received Jan 28, 1981 under 100

- 618; prepared by Wildlife International, Ltd. and Washington College, submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:244273

- I)

79690 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Eight

- day Dietary LC50

-- Bobwhite Quail: Project No. 108

- 191. (Unpublished study received Jan 28, 1981 under 100

- 618; prepared by Wildlife International, Ltd. and Washington College, submit

- t ed by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:244273

- H)

133366 Ullmann, L. (1978) Report on 8

- day

- feeding Toxicity in the Adult Japanese Quail of Technical CGA 64250: Project No. 785254. (Un

published study received Dec 12, 1983 under 100

- 617; prepared by Ciba

- Geigy Ltd., Switz., submitted by Ciba

- Geigy Corp., Greens

- boro, NC; CDL:072210

- I)

133367 Ullmann, L. (1978) Report on 8

- day

- feeding Toxicity in the 3

- day Old Peking Duck of Technical CGA 64250: Project # 785255. (Un

published study received Dec 12, 1983 under 100

- 617; prepared by Ciba

- Geigy Ltd., Switz., sub mitted by Ciba

- Geigy Corp., Greens

- boro, NC; CDL:072210

- J)

138267 Beavers, J.; Jaber, M.; Joiner, G.; et al. (1983) A Dietary LC50 in the Bobwhite with CGA

- 131013: Project No. 108

- 221. Final rept. (Unpublished study received Apr 4, 1984 under 100

- 617; p repared by Wildlife International Ltd., submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:253013

- B) 1H

- 1,2,4

- Triazole

- 1

- propanoic acid, .alpha.

- amino

138268 Beavers, J.; Jaber, M.; Joiner, G.; et al. (1983) A Dietary LC50 in the Mallard with CGA

- 131013: Project No. 108

- 222. Final rept. (Unpublished study received Apr 4, 1984 under 100

- 617; prepared by Wildlife International Ltd., submitted by Ciba

- Geigy Corp.

, Greensboro, NC; CDL:253013

- C) 1H

- 1,2,4

- Triazole

- 1

- propanoic acid, .alpha.

- amino



## 850.2300 Avian Reproduction

MRID Citation Reference

133368 Fink, R.; Beavers, J.; Joiner, G.; et al. (1981) Subacute Feeding: Reproduction Screening Bioassay

-- Bobwhite Quail: CGA

- 64250 Technical: Project No. 108

- 201. Final rept. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by Wildlife Inter

-

### Page 28 of 46 na tional Ltd., submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072210

- K)

133369 Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) One

- generation Re

production

-- Bobwhite Quail: CGA 64250 Technical: Project No. 108

- 202. Final rept. (Unpublished study rec eived Dec 12, 1983 under 100

- 617; prepared by Wildlife International Ltd., submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072210

- M)



## 72

- 1 850.1075 Acute Toxicity to Freshwater Fish

MRID Citation Reference

67922 Thompson, C.M.; Griffen, J.; Cranor, W. (1980) Acute Toxicity of CGA

64250 to Bluegill Sunfish (~Lepomis macrochirus~): Static Acute Bioassay Report # 26037. (Unpublished study received Jan 28, 1981 under 100

- 618; prepared by Analytical Bio Chemistry Labor atories, Inc., submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:244273

- B)

67923 Thompson, C.M.; Griffen, J.; Cranor, W. (1980) Acute Toxicity of CGA

64250 to Rainbow Trout (~Salmo gairdneri~): Static Acute Bioassay Report # 26038. (Unpublished stud y received Jan 28, 1981 under 100

- 618; prepared by Analytical Bio Chemistry Laboratories, Inc., submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:244273

- C)

67924 Thompson, C.M.; Griffen, J.; Cranor, W. (1980) Acute Toxicity of CGA

64250 to Channel Cat fish (~Ictalurus punctatus~): Static Acute Bioassay Report # 26039. (Unpublished study received Jan 28, 1981 under 100

- 618; prepared by Analytical Bio Chemistry Laboratories, Inc., submitted by Ciba

- Geigy Corp., Greensboro, N.C.; CDL:244273

- D)

132922 Hit z, H.; Kurmann, F.; Mendezu, C.; et al. (1981) Report on the Acute Toxicity of CGA 64250 to Bluegill ...: Test No. 81 03 03. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by Ciba

- Geigy Ltd., Switz., submitted by Ciba

- Geigy Corp., Greensb oro, NC; CDL:072209

- D)

132923 Bathe, R. (1979) Report on Acute Toxicity to Brown Trout and Blue

- gill of CGA 64250 EC 250 (A

- 6097 A): Project No. 785822. (Un

- published study received Dec 12, 1983 under 100

- 617; prepared by Ciba

- Geigy Ltd., Switz., submi tted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072209

- E)

132925 LeBlanc, G.; Sousa, J. (1983) Acute Toxicity of Tilt 3.6E to Blue

- gill ...: Report #BW

- 83

- 2

- 1364. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by EG & G, Bionomics, sub

- mitted by Ciba

Geigy Corp., Greensboro, NC; CDL:072209

- G)

132927 Buchanan, J.; Pell, I. (1980) The Acute Toxicity of 2 Formulations of CGA 64,250 to the Carp and the Rainbow Trout: CBG 276/80961. (Unpublished study received Dec 12, 19 83 under 100

- 617; prepared by Huntingdon Research Centre, Eng., submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072209

- I)

### Page 29 of 46 132928 LeBlanc, G.; Sousa, J. (1983) Acute Toxicity of Tilt 3.6E to Rain

- bow Trout ...: Report #BW

- 83

- 2

- 1362. (Unpublished stud y re ceived Dec 12, 1983 under 100

- 6 17; prepared by EG & G, Bionom ics, submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL: 072209

- J)

132929 De Morsier, A.; Kurmann, F.; Mendezu, C.; et al. (1982) Report on the Test for Acute Toxicity of CGA 64250 to Carp: Project No. 81 03 02. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by Ciba

- Geigy Ltd., Switz., submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072209

- K)

132930 De Morsier, A.; Kurmann, F.; Mendezu, C.; et al. (1982) Report on the Test for Acute Toxicity of CGA 64 250 to Cat Fish: Project No. 81 03 04. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by Ciba

- Geigy Ltd., Switz., submitted by Ciba

- G eigy Corp., Greensboro, NC; CDL:072209

- L)

46074203 Hertl, D. (2003) Acute Toxicity of Wolsin FL

- 35 to Rainbow Trout (Oncorhynchus mykiss) in a 96 hour Semi Static Test: (Final Report). Project Number: 14643230. Unpublished study prepared by Institut fuer Biologische Analytik und. 78 p. Fenpropimorph/Propiconazole/Boric acid

48860604 Gonsior, G. (2010) Chlorothalonil/Propiconazole SE (A13817A)

- Acute Toxicity Testing in Rainbow Trout (Oncorhynchus mykiss) (Teleostei, Salmonidae): Final Report. Project Number: S10/01128/OCR TK0022210. Unpublished study prepared by Eurofins

- GAB GmbH. 44p.

49268903 Gonsior, G. (2011) Fludioxonil/Chlorothalonil/Propiconazole: Fludioxonil/Chlorothalonil/Propiconazole SE (A14036B)

- Acute Toxicity Testing in Rainbow Trout ( Oncorhynchus mykiss): Final Report. Project Number: S09/03026. Unpublished study prepared by Eurofins

- GAB GmbH. 45p.

Accession No. 072209 Hitz, H.R. (1982) Acute Toxicity of CGA

- 64250 to Rainbow Trout. Prepared by Ciba

- Geigy Ltd. Data Acct. No. 072209. Reference 7

Accession No. 072211 MRID 133380 Rufli, H. (1983) Report on the Test for Acute Toxicity of CGA

- 98032 to Rainbow Trout. Project No. 02

- 14

- 18. Ciba

- Geigy Ltd., Basle, Switzerland. Accession No. 072211.



## 850.1010 Acute Toxicity to Freshwater I nvertebrates

MRID Citation Reference

67925 Forbis, A.D.; Boudreau, P.; Cranor, W. (1980) Acute Toxicity of CGA

64250 to Daphnia magna: Static Acute Bioassay Report # 26040. (Unpublished study received Jan 28, 1981 under 100

- 618; prepared by Analytical Bio Chemistry Laboratories, Inc., submit

- ted b y Ciba

- Geigy Corp., Greensboro, N.C.; CDL:244273

- E)

### Page 30 of 46 132931 Hitz, H.; Haas, A. (1981) Report on the Acute Toxicity of CGA 64 250 to Daphnia magna Straus: Test No. 80 19 28. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by Ciba

- Geigy Lt d., Switz., submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072209

- M)

132932 LeBlanc, G.; Surprenant, D. (1983) Acute Toxicity of Tilt 3.6E to the Water Flea ...: Report #BW

- 83

- 2

- 1367. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by EG & G, Bionomics, submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL: 072209

- N)

132935 LeBlanc, G.; Mastone, J.; Elwood, D.; et al. (1981) Acute Toxicity of CGA

- 64250 to Crayfish ...: Report #BW

- 81

- 10

- 1035. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by EG & G, Bionomics, submitted by Ciba

- Geigy Corp., Greensb oro, NC; CDL:072209

- Q)

133381 Rufli, H.; Kurmann, F.; Kurtz, S. (1983) Report on the Test for A

- cute Toxicity of CGA 98032 to Daphnia magna: Project No. 82 14 16. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by Ciba

- Geigy Ltd., Switz., submitted by Ciba

- Geigy Corp.

, Greensboro, NC; CDL:072211

- U)

163165 LeBlanc, G.; Mastone, J. (1981) The Chronic Toxicity of CGA

- 64250 to the Water Flea (Daphnia magna): Report No. BW

- 81

- 11

- 1043. Unpublished study prepared by EG&G Bionomics. 29 p.

46074204 Hertl, D. (2003) Acute Toxicity of Wolsin FL

- 35 to Daphnia magna in a 48 hour Immobilization Test. Project Number: 14642220. Unpublished study prepared by Institut fuer Biologische Analytik und. 69 p. Fenpropimorph/Propiconazole/Boric acid

48860605 Borrmann, K. (2010) Chlorotha lonil/Propiconazole SE (A13817A)

- Assessment of Toxic Effects on Daphnia magna Using the 48 Hour Acute Immobilisation Test: Final Report. Project Number: S10/01085/OCR, TK0022212. Unpublished study prepared by Eurofins

- GAB GmbH. 44p.

492668906 Borrmann , K. (2011) Fludioxonil/Chlorothalonil/Propiconazole SE (A14036B)

- Assessment of Toxic Effects on Daphnia magna Using the 48 h Acute Immobilisation Test: Final Report. Project Number: S09/03027. Unpublished study prepared by Eurofins

- GAB GmbH. 43p.

Acces sion No. 072209 Suprenant, Donald C. (1983) Acute Toxicity of Tilt 3.6E to the Water Flea (Daphnia magna). Prepared by EG&G Bionomics, Aquatic Toxicology Laboratory, Wareham, Mass. Data Accession No. 072209. Reference 13.



## 850.1025/850.1035 Acute Toxicity to Estuarine/Marine Invertebrates

MRID Citation Reference

### Page 31 of 46 132933 Ward, G. (1983) Acute Toxicity of Tilt 3.6E to Eastern Oysters ...: Report No. BP

- 83

- 3

- 42. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by EG & G Bionomics, submitted by Ciba

Geigy Corp., Greensboro, NC; CDL:072209

- O)

132934 Ward, G. (1983) Acute Toxicity of Tilt 3.6E to Mysid Shrimp ...: Report No. BP

- 83

- 4

- 50. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by EG & G Bionomics, submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072209

- P)

132921 Ward, G. (1981) Acute Toxicity of CGA

- 64250 to Spot ...: Report No. BP

- 81

- 7

- 123R. Rev. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by EG & G Bionomics , submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072209

- C)

132924 Ward, G. (1983) Acute Toxicity of Tilt 3.6E to Spot ...: Report No. BP

83

- 4

- 48. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by EG & G Bionomics, submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072209

- F)

Accession No. 260201 Dionne, E. and D.C. Suprenant (1985) Acute Toxicity of CGA

- 64250 to Embryolarvae of Eastern Oysters (Crassostrea virginica). Prepared by Springborn Bionomics, Inc., Wareham, Mass., Submitte d by Ciba

Geigy Corp., Greensboro, NC. Bionomics Report No. BW

- 85

- 8

- 1815. Bionomics Study No. 1781.0585.6119.514. Accession No. 260201.

Accession No. 260201 Ward, G.S. (1982) Acute Toxicity of CGA

- 64250 to Eastern Oysters (Crassostrea virginica). Prepared by EG&G Bionomics, Pensacola, FL. Submitted by Ciba

- Geigy Corporation, Greensboro, NC. Project No. BP

- 82

- 2

- 12. Accession No. 260201.

Accession No. 260201 Hollister, T.A. (1981) Acute Toxicity of CGA

- 64250 to Mysid Shrimp (Mysidopsis bahia) in a 96

- hr. Fl ow

- through Test. Prepared by EG&G Bionomics, Pensacola, Florida, Submitted by Ciba

- Geigy Corp., Greensboro, NC. Project No. R26, EG&G Report No. BP

- 81

- 8

- 138

- R. Accession No. 260201.



## 850.1300 Aquatic Invertebrate Life Cycle

MRID Citation Reference

49300501 Fournier, A. (2014) Propiconazole

- Full Life

- Cycle Toxicity Test with Water Fleas, Daphnia, magna, Under Static Renewal Conditions: Final Report. Project Number: 1781/6953. Unpublished study prepared by Syngenta Crop Protection, LLC. 55p.



## 850.1350 Estuarine/Marine Invertebrate Life Cycle

MRID Citation Reference

### Page 32 of 46 133365 Hollister, T. (1981) Chronic Toxicity of CGA

- 64250 to Mysid Shrimp: Project No. R26; Report No. BP

- 81

- 9

- 146. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by EG&G Bionomics, submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072210

- E)



## 850.1400 Fish Early Life Stage

MRID Citation Reference

133364 Iley, E.; Naplin, N.; Nimmo, D. (1981) Flow

- through Fathead Minnow Early Life Stage Toxicity Test with CGA

- 64250: PA909. (Unpub lished study received Dec 12, 1983 under 100

- 617; prepared by Environmental Research & Technology, Inc., submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072210

- D)

41720302 Surprenant, D. (1987) The Toxicity of CGA

- 64250 (Propiconazole) to Fathead Minnow (Pimephales Promelas) Embryo and Larvae: Lab Pro ject Number: 87

- 8

- 2476. Unpublished study prepared by Spring

born Life Sciences, Inc. 235 p.



## 850.4100 S eedling emergence

MRID Citation Reference

41673202 Maggio, R. (1990) Tier 2 Seed Germination Nontarget Phytotoxicity Study Using Propiconazole: Lab P roject Number: LR90

- 419. Unpub lished study prepared by Ciba

- Geigy Corp. 58 p.

41673203 Maggio, R. (1990) Tier 2 Seedling Emergence Nontarget Phytotoxicity Study Using Propiconazole: Lab Project Number: LR90

- 420. Unp ub lished study prepared by Ciba

- Geigy Corp. 149 p.

47675201 Gray, J. (2008) Wolsin FL

- 35: Seedling Emergence , Tier I and Vegetative Vigour, Tier II. Project Number: DWM/0002, DWM/0003. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 80 p. Fenpropimorph/Propiconazole/Boric acid



## 850.41 50 Vegetative vigor

MRID Citation Reference

41673201 Maggio, R. (1990) Tier 2 Vegetative Vigor Nontarget Phytotoxicity Study Using Propiconazole: Lab Project Number: LR90

- 418. Unpub lished study prepared by Ciba

- Geigy Corp. 141 p.

### Page 33 of 46 47675201 Gray, J. (2008) Wolsin FL

- 35: Seedling Emergence, Tier I and Vegetative Vigour , Tier II. Project Number: DWM/0002, DWM/0003. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 80 p. Fenpropimorph/Propiconazole/Boric acid



## 850.5400 Aquatic plant growth

MRID Citation Reference

132936 Hitz, H.; Haas, A. (1981) Report on the Growth

- inhibition Test to Algae (Scenedesmus suspicatus) of CGA 64 250 (AFNOR T 90

- 304): Test No. 80 19 29. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by Ciba

- Geigy Ltd., Switz., sub

- mitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072209

- R)

132937 Hollister, T. (1981) The Effect of CGA

- 64250 to the Freshwater Alga Selenastrum capricornutum: Report No. BP

- 81

- 7

- 129

- R. Rev. (Un

published study received Dec 12, 1983 under 100

- 617; prepared by EG & G Bionomics, submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072209

- S)

132938 Hollister, T. (1981) The Effect of CGA

- 64250 to the Freshwater Diatom Navicula seminulum: Report No. BP

- 81

- 8

- 134R. Rev. (Un

- published study received Dec 12, 1983 under 100

- 617; prepared by EG & G Bionomics, submitted by Ciba

- G eigy Corp., Greensboro, NC; CDL:072209

- T)

132939 Hollister, T. (1981) The Effect of CGA

- 64250 to the Marine Alga Skeletonema costatum: Report No. BP

- 81

- 8

- 136

- R. Rev. (Unpub lished study received Dec 12, 1983 under 100

- 617; prepared by EG & G Bionomics, s ubmitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072209

- U)

133362 Hollister, T. (1981) The Effect of CGA

- 64250 to the Blue

- green Alga : Project No. R26; Report No. BP

- 81

- 8

- 137

- R. Rev. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by EG&G Bionomics, submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL:072210

- A)

133363 Hollister, T. (1981) The Ef fect of CGA

- 64250 to D uckweed: Pro ject No. R26; Report No. BP

- 81

- 8

- 139

- R. Rev. (Unpublished study received Dec 12, 1983 under 100

- 617; prepared by EG&G Bionomics submitted by Ciba

- Geigy Corp., Greensboro, NC; CDL: 072210

- B)

47675202 Biester, M. (2008) Wolsin FL

- 35: Phytotoxic ity Test with the Freshwater Duckweed (Lemna gibba), Under Static Conditions. Project Number: 1111/001/410. Unpublished study prepared by Springborn Smithers Laboratories (Europe). 64 p. Fenpropimorph/Propiconazole/Boric acid

47675203 Hudson, B. (2008) As sessment of the Algal Toxicity, Tiers I and II (96th EC 50) of Wolsin FL

- 35 to the Marine Alga Skeletonema costatum, the Freshwater Algae Selenastrum capricornutum and Anabaena flos aquae. Project Number: 1051/27. Unpublished study prepared by Opus Plus Li mited. 69 p.

### Page 34 of 46 Fenpropimorph/Propiconazole/Boric acid

47675204 Biester, M. (2008) Wolsin FL

- 35: Alga, Growth Inhibition Test with Navicula pelliculosa. Project Number: 1111/001/440. Unpublished study prepared by Springborn Smithers Laboratories (Europe). 68 p. Fenpropimorph/Propiconazole/Boric acid

48860602 Dengler, D. (2010) Chlorothalonil/Propiconazole SE (A13817A)

- Testing of Effects on the Single Cell Green Alga Pseudokirchneriella subcapitata: Final Report. Project Number: S10/01086/OCR, TK0022211. Un published study prepared by Eurofins

- GAB GmbH. 63p.



## 850.3020 Honey bee acute contact

MRID Citation Reference

43420702 Palmers, S.; Beavers, J. (1994) Propiconazole Technical: An Acute Contact Toxicity Study with the Honey Bee: Lab Project Number: 108

- 373. Unpublished study prepared by Wildlife International Ltd. 16 p.

### Page 35 of 46 

# Appendix 1 . Incidents



# EIIS Pesticide Summary Report: General Information

Propiconazole (122101)

Incident # Date County State Certainty Legal. Formul. Appl. Method Total Magnitude



### AQUATIC Golf course

I014538

- 013 8/1/2003 Hamilton IN 2 MA Spill Approx. 1500 fish



### N/R
I004697

- 061 2 UN N/R UNKNOWN UNKNOWN


### Wood

I022718

- 001 2/6/2010 4 M N/A Hundreds



### PLANTS

Corn
I019130

- 070 9/10/2007 La Salle IL 2 UN Broadcast 400 acres

I021500

- 074 7/21/2009 Clark OH 2 UN Broadcast 112 acres

I021500

- 075 8/29/2009 Greene IL 2 UN Broadcast 35 acres

I023444

- 039 10/8/2010 Cayuga NY 2 UN N/R N/R 100% of 50 acres 

### Corn, field
I024295

- 031 6/9/2012 Clinton IA 2 RU Post

- broadcast 100% of 80 acres



### N/R
I021947

- 001 5/24/2010 Linn OR 2 M 1

Wednesday, October 07, 2015 Certainty Code: 0=Unrelated, 1=Unlikely, 2=Possible, 3=Probable, 4=Highly Probable. Page 1 of 3 Legality Code: RU=Registered Use, M=Misuse, MA=Misuse (Accidental), MI=Misuse (Intentional), U=Unknown.

### Page 36 of 46 Incident # Date County State Certainty Legal. Formul. Appl. Method Total Magnitude



### ORCHARD

I007644

- 016 7/1/1998 TULARE CA 2 UN N/R 12 ACRES OUT OF 16



### Ornamental

I012786

- 002 5/15/2001 2 UN 19


### Wheat

I023082

- 042 6/7/2011 Sargent ND 2 UN Post

- broadcast 100% of 404 acres 

### Wheat, spring
I015291

- 045 Cass ND 2 RU EC Broadcast 120 acres

I022082

- 030 6/7/2010 Hettinger ND 2 UN Broadcast 100% of 320 Acres

I023390

- 021 7/6/2011 Clark WI 2 RU Post

- broadcast 100% of 1900 acres

I023390

- 020 9/1/2011 Clark WI 2 RU Post

- broadcast 100% of 900 acres 

### Wheat, winter
I020459

- 023 Walla Walla WA 1 UN Spray

I014029

- 006 4/5/2003 King William VA 2 RU Broadcast 51 acres



### TERRESTRIAL

No Data
I026297

- 001 FL 2 UN ~6000 hives

I027851

- 001 Haywood NC 1 UN 1 hive

I026232

- 001 Kern CA 2 RU 70% loss

Wednesday, October 07, 2015 Certainty Code: 0=Unrelated, 1=Unlikely, 2=Possible, 3=Probable, 4=Highly Probable. Page 2 of 3 Legality Code: RU=Registered Use, M=Misuse, MA=Misuse (Accidental), MI=Misuse (Intentional), U=Unknown.

### Page 37 of 46 Incident # Date County State Certainty Legal. Formul. Appl. Method T otal Magnitude

I023225

- 006 4/17/2011 1 UN Thousands

I026241

- 001 3/3/2014 Kern CA 2 UN 244 of 460 affected

I028065

- 001 7/22/2014 Washington ME 2 UN 

### Agricultural area

I026233

- 001 San Joaquin CA 2 UN 87 hives damged

I024875

- 001 7/1/2013 UT 1 UN N/R 3,972 hives


### Almond

I025162

- 001 5/3/2013 Madera CA 1 UN


### Corn
I026789

- 001 8/1/2014 Woodford IL 1 RU SC 600

Wednesday, October 07, 2015 Certainty Code: 0=Unrelated, 1=Unlikely, 2=Possible, 3=Probable, 4=Highly Probable. Page 3 of 3 Legality Code: RU=Registered Use, M=Misuse, MA=Misuse (Accidental), MI=Misuse (Intentional), U=Unknown.

### Page 38 of 46 

# EIIS Pesticide Summary Report: Species Information Propiconazole (122101)

Incident # Species Scientific Name Magnitude Response Rt. Exposure



### AQUATIC

Golf course
I014538

- 013 unknown fish 1500 mortality Runoff

N/R

I004697

- 061 shrimp Decapoda unknown mortality UNKNOWN

Wood

I022718

- 001 bream Notemigonus crysoleucas hundreds mortality Treated directly perch Percidae hundreds mortality Treated directly
unknown fish hundreds mortality Treated directly



### PLANTS

Corn

I019130

- 070

corn Zea mays 400 acres plant damage Carryover
I021500

- 074 corn, field Zea mays 112 acres plant damage Treated directly
I021500

- 075

Wednesday, October 07, 2015 Page 1 of 4

### Page 39 of 46 Incident # Species Scientific Name Magnitude Response Rt. Exposure corn, field Zea mays 35 acres plant damage Treated directly
I023444

- 039

corn Zea mays 100% of 50 acres plant damage Treated directly Corn, field

I024295

- 031

corn Zea mays 100% of 80 plant damage Treated directly

N/R

I021947

- 001 apple Melus domestica 1 plant damage N/R

ORCHARD

I007644

- 016 nectarines 12 acres out of 16 plant damage Treated directly

Ornamental

I012786

- 002 ornamental 19 plant damage

Wheat

I023082

- 042 wheat 100% of 404 acres plant damage Treated directly Wheat, spring

I015291

- 045 wheat, spring 120 acres plant damage Treated directly
I022082

- 030 wheat, spring 100% of 320 acres plant damage Treated directly
I023302

- 026

Wednesday, October 07, 2015 Page 2 of 4

### Page 40 of 46 Incident # Species Scientific Name Magnitude Response Rt. Exposure wheat, spring 51.3% plant damage Treated directly
I023390

- 020 wheat, spring 100% of 900 acres plant damage Treated directly
I023390

- 021 wheat, winter 100% of 1,900 acres plant damage Treated directly
Wheat, winter

I014029

- 006 wheat, winter 51 acres plant damage Treated directly
I020459

- 023 onion plant damage Drift, spray



### TERRESTRIAL

No Data
I023225

- 006 honey bee Apis millifera 10% area beekeepers mortality Ingestion
I026232

- 001 honey bee Apis millifera 100

- 170 hives affect mortality
I026241

- 001 honey bee Apis millifera 244 of 460 mortality N/R
I026297

- 001 honey bee Apis millifera 6000 colonies + mortality
I027851

- 001 honey bee Apis millifera 1 hive mortality Ingestion
I028065

- 001 honey bee Apis millifera 3,500 colonies mortality

Wednesday, October 07, 2015 Page 3 of 4

### Page 41 of 46 Incident # Species Scientific Name Magnitude Response Rt. Exposure
Agricultural area

I024875

- 001 honey bee Apis millifera 3,972 hives mortality N/R
I026233

- 001 honey bee Apis millifera 75% of 87 hives mortality

Almond

I025162

- 001 honey bee Apis millifera 12,000 colonies mortality Treated directly

Almonds

I026333

- 008 honey bee Apis millifera mortality

Corn

I026789

- 001 brook trout Salyelinus fontinalis mortality honey bee Apis millifera 600 mortality rainbow trout Onchorhynchus mykiss 600 mortality

Wednesday, October 07, 2015 Page 4 of 4

### Page 42 of 46 

# Appendix 2 . STIR

Input

Application and Chemical Information
Enter Chemical Name Propiconazole Enter Chemical Use All Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) air Enter Chemical Molecular Weight (g/mole) 342.33 Enter Chemical Vapor Pressure (mmHg) 1.00E

- 06 Enter Application Rate (lb a.i./acre) 1.8

Toxicity Properties

**Bird** Enter Lowest Bird Oral LD 50 (mg/kg bw) 2825 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178 **Mammal**
Enter Lowest Rat Oral LD 50 (mg/kg bw) 729
Enter Lowest Rat Inhalation LC 50 (mg/L) 5.84 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 ) 1.84E

- 02 Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 2.32E

- 03 Adjusted Inhalation LD 50 1.26E+02 Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.84E

- 05 Exposure not Likely Significant Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 1.73E

- 01 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 1.37E

- 03 Exposure not Likely Significant



### Results Mammalian (0.015 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 1.84E

- 02 Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 2.91E

- 03 Adjusted Inhalation LD 50 3.48E+02 Ratio of Vapor Dose to Adjusted Inhalation LD 50 8.37E

- 06 Exposure not Likely Significant Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 2.17E

- 01 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 6.25E

- 04 Exposure not Likely Significant

### Page 43 of 46 

# A ppendix 3 . SIP

Table 1. Inputs Parameter Value Chemical name Propiconazole Solubility (in water at 25 o C; mg/L) 100

Mammalian LD 50 (mg/kg

- bw) 729 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg

- bw) 43 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg

- bw) 2825 Avian test species northern bobwhite quail Body weight (g) of "other" avian species Mineau scaling factor 1.15

Mallard NOAEC (mg/kg

- diet) no data Bobwhite quail NOAEC (mg/kg

- diet) 1000 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) 17.2000 17.2000 Adjusted toxicity value (mg/kg

- bw) 560.7181 33.0739 Ratio of exposure to toxicity 0.0307 0.5200

Conclusion* Surface water exposure alone is NOT a potential

concern for mammals Surface water exposure alone is NOT a potential

concern for mammals

Table 3. Avian Results Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 81.0000 81.0000 Adjusted toxicity value (mg/kg

- bw) 2035.2134 106.2983 Ratio of exposure to acute toxicity 0.0398 0.7620

Conclusion* Surface water exposure alone is NOT a potential concern for birds Exposure through Surface water alone is a potential concern for birds

*Conclusion is for Surface 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 Surface water may contribute to a total exposure that has potential for effects to non

- target animals.

### Page 44 of 46 

# Appendix 4 . Degradate Structures

Photo propiconazole (photoproduct I) CAS Reg. No. 71769

- 74

- 9

Photoproduct II (phenylurea) CAS Reg. No. 64

- 10

- 8

### Page 45 of 46 

# Appendix 5

. Parent Propiconazole and Degradate Structures

### Page 46 of 46