UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHING TON D

. C., 20460

MEMORANDUM

SUBJECT:

TO:

FROM :

THROUGH:

PEER REVIEW: OFFICE OF C H E M ICAL SAFETY A N O POLLUTION PREVE N TIO N

DP Barcode: D426603 PC Code: 114004 Date: September 10

, 2015

Amicarbazone Problem Formulation for Regi s tration Review

Maria Piansay, Chemical Review Manager Linda Arrington, Branch C hief Ri s k Manag e ment an d Implementation Branch 5 Pesticid e Re-ev a luation Di v i sio n (7508P)

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Stephen Carey

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William P. Eckel, S e nior

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Environmental Fate and Effec ts Division (7 507P)

Amy Blankinship

, Senior Biologist Ibrahim Abdel-Saheb, Ph

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, E n v ironmental Scientist E n v ironment a l Ri sk Branch 6 Env ironment a l Fate an d Effec t s Di vision ( 7507P )

The E nvironmental Fate and Effe ct s Divi s ion (EFED) has completed the preliminary problem formu lati o n for the eco logical ri s k and drinking water exposure assessments to b e conducted as part of the regi s tration review of the herbicide amicarbazone (PC Code 114004 ). This document i s int e nd e d to provide an overview of what is currently known regarding th e e nvironmental fate and ecological effects associated with amicarbazone and it s degradation products

, and outlines uncertaintie s r egar ding attributes of the parent compound and it s transformation products. It de scr ibe s the preliminary ecological risk hypothesis and the processes that will be u se d during the completion of the preliminary ecological ri sk a ssess m e nt in s upport of registration review.2

As noted later in this document, additional data wi ll be needed for the environmental fate and transport and ecological effects of amicarbazone to complete the risk assessment and registration review process. For the environmental fate and tran sport of amicarbazone, the following data are needed:

• GDLN 835.4200 Anaerobic soil metabolism

• GDLN 835.4300 Aerobic aquatic metabolism

• GDLN 835.4400 Anaerobic aquatic metabolism

With regard to the ecological effects database, add itional studies EFED recommends be requested include passerine acute oral toxicity (GD LN 850.2100) and honey bee toxicity studies.

A definitive NOAEC has not been established for chr onic exposure to estuarine/marine invertebrates, which normally results in a presumpt ion of risk for estuarine/marine invertebrates until available data show differently; however, in the absence of such data, EFED is not requiring a mysid chronic toxicity study to establi sh a definitive NOAEC because the lowest test concentration of 2400 μg a.i./L in the study needs to be 320x more toxic than to Daphnia to result in a chronic LOC exceedance when using the h ighest 21-day EEC of 7.5 μg a.i./L (EEC used in this calculation was obtained from the Augu st 30, 2010 risk assessment for new use on turf grasses; D384516), which is unlikely.

No data for the alkaline metabolite, decarboxamide, are available; however, because current labels bear language prohibiting application to coa rse-textured soils (sand, loamy sand and sandy loam soils), or on soils with pH >7.4 (such as calc areous soils), data on the effect of the alkaline metabolite to aquatic organisms is not needed at th is time.

• Amicarbazone may cause exposure of pollinators visi ting off-site plants that are contaminated by spray drift. Acceptable toxicity da ta to honey bee adults and larvae have not been submitted for amicarbazone and are now nee ded under EPA’s recent policy on pollinator protection 1 . Thus, the following six Tier I, II and III honey bee studies, yet to be submitted for amicarbazone, are needed:

o Honeybee larval acute oral toxicity study (followin g OECD 237)

o Honeybee adult 10-day chronic oral (special study)

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

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

o Field trial of residues in pollen and nectar (speci al study, Tier II)

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

• In addition, GDLN 850.2100 acute avian acute oral t oxicity data (passerine species), per the 40 CFR Part 158 data requirements, are needed.

1 (Guidance for Assessing Pesticide Risks to Bees, 0 6.23.2014; signed by Donald Brady, Director, EFED; http://www2.epa.gov/sites/production/files/2014- 06/documents/pollinator_risk_assessment_guidance_06 _19_14.pdf )3



### INTRODUCTION

Amicarbazone is a selective herbicide used to contr ol annual broadleaf weeds in field and silage corn at several stages of crop development, conifer s, and turf grasses. Amicarbazone belongs to the triazolinone class of compounds and is a photos ystem II (PS II) inhibitor with burndown activity. Current label language indicates that thi s herbicide is not to be used on coarse-textured soils (sand, loamy sand and sandy loam soils), or o n soils with pH >7.4, such as calcareous soils.

The chemical structure of amicarbazone and several chemical identifiers are provided in Table 1.

Table 1. Amicarbazone Chemical Identifiers
Chemical Name 4

- Amino

- 4,5

- dihydro

- N

- (1,1

- dimethylethyl)

- 3

- (1

- methylethyl)

- 5

- oxo

- 1H

- 1,2,4

- triazole

- 1

- carboxamide

Chemical Structure

Chemical Abstracts Service (CAS) Registry Number 129909-90-6

Smiles Code NN(C(C(C)C)=NN1C(NC(C)(C)C)=O)C1=O Empirical Formula C10H19N5O2

The use information for amicarbazone is provided in Table 2 . There are currently three active end-use product registrations for amicarbazone.

Table 2. Summary of Current Uses of Amicarbazone Parameter Registration # 66330-46 Registration # 66330-415 Registration #

66330-416 Restricted use? No Advisories Ground & surface water Sites Field corn, corn for silage Turf (golf course tees, fairways, roughs; sod; residential; parks; etc.) Turf (golf course

tees, greens, fairways, roughs; sod; residential; parks; etc.) Turf (golf course, seed & sod production, residential, parks etc.)

Conifers (nursery and field plantings)4

Table 2. Summary of Current Uses of Amicarbazone Parameter Registration # 66330-46 Registration # 66330-415 Registration #

66330-416 Target weeds Broadleaf including ALS

resistant weeds; won’t control triazine resistant weeds; grasses Broadleaf; grasses

Formulation type Water dispersible granule (70%

a.i.) Suspension concentrate (4 lb a.i./gal) Suspension

concentrate (2 lb a.i./gal) Application method No aerial, no chemigation

Corn: broadcast surface/incorporated Turf: broadcast, spot treatment Conifer: over-the-top or directed spray under canopy No aerial, no chemigation Turf: broadcast, spot treatment Conifer: over-the-top or directed spray under canopy

Application equipment Corn: broadcast boom

Turf broadcast: sprayer (type not specified) Turf spot: backpack or compression sprayer Conifer: sprayer (type not specified); do not use mechanically pressurized handgun for Christmas trees Turf broadcast: spray boom or spraywand/gun Turf spot: backpack or compression
sprayer

Conifer: sprayer (type not specified); do not use mechanically pressurized handgun for Christmas trees

Application timing Corn: IA, MN, ND, SD, WI, &

northern NE, IL, & OH: from Oct. 15 until ground freezes (can follow w/spring application); KS, OK, TX; from November to w/in 30d of spring planting (can follow w/spring application); Eastern corn belt: spring Turf: spring only Conifer: unspecified Turf: weed post-emergence to actively growing weeds

Conifer: when weeds are actively growing

Max # apps/year Corn: 1, but if spring

application follows fall application, total for both must not exceed 0.45 lb a.i./A Turf: varies w/rate (e.g., up to 4); Conifer: 2 Turf: varies with rate (up to 4) Conifer: 2

Application rates in lb a.i./A Max single Corn: 0.45

Turf broadcast: 0.44 Turf spot: unspecified Turf broadcast: 0.45 Turf spot: 0.13 Conifer: 0.455

Table 2. Summary of Current Uses of Amicarbazone Parameter Registration # 66330-46 Registration # 66330-415 Registration #

66330-416 Conifer: 0.44 Max annual Corn: 0.45

Turf & Conifer: 0.45 Turf & Conifer: 0.45

Minimum
retreatment interval Corn: (1 app only)

Turf broadcast: 7d Turf spot: unspecified Conifer: unspecified Turf broadcast: 7d Turf spot: unspecified Conifer: unspecified

PHI None specified Do not apply less than 4 weeks before cutting or lifting sod. Replant interval for rotational crop Corn: 0d; Turf: 12 months Turf: 12 months

REI 12h PPE Long sleeved shirt, long pants, chemical resist ant gloves, shoes + socks Comments Corn: conventional,

conservation, & no-till; Turf: don’t use if annual bluegrass is desired turf; don’t use on turf less than 6 months old; don’t use on coarse textured soils (sand, loamy sand and sandy loam soils), or on soils with pH >7.4, such as calcareous soils; water-in Turf: don’t use if annual bluegrass is desired turf; don’t use on turf less than 6 months old; don’t use on coarse textured soils (sand, loamy sand and sandy loam soils), or on soils with pH >7.4, such as calcareous soils; water-in



### Previous Ecological Assessments

Amicarbazone was assessed as a new chemical in 2005 for use on field and silage corn (D288631) and in 2010 for additional uses on turf g rasses and conifers (D384516). EFED reviewed these previous assessments for amicarbazon e in association with the current toxicity, exposure, and use information to determine if suffi cient data are available and if further updates are needed to support registration review. In the p revious assessments, risks were assessed using the parent compound only due to available metabolit e data indicating the metabolites are less toxic than the parent.

A summary of previous risk concerns identified is p rovided in Table 3

.6

Table 3. Summary of Previous Risk Concerns Identifi ed for Amicarbazone

Taxa with Acute LOC Exceeded Taxa with

Chronic LOC Exceeded Taxa with no

LOC Exceedance BCF 2 Persistence Degradates of Concern

Terrestrial and Aquatic Nonvascular Plants Birds and

Mammals Aquatic

Organisms, Aquatic Vascular Plants, and Terrestrial Invertebrates 1 No Yes No

1 Based on acute contact and oral toxicity with adult bees; were not assessed quantitatively.

2 Bioconcentration Factor


### Previous Drinking Water Exposure Assessments

The most recent Drinking Water Assessment for amica rbazone was completed in September 2011 (DP 384659). The surface water and groundwater estimates were calculated using PRZM/EXAMS and SCI-GROW, respectively. Estimates f or surface water and groundwater use the total toxic residues of amicarbazone including the desamino and N-methyl desamino degradates as well as unextracted residues. The gr oundwater Estimated Drinking Water Concentrations (EDWCs) were found to be higher than the surface water EDWCs.


### Clean Water Act Programs

Amicarbazone is not identified as a cause of impair ment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. Total Maximum Daily Load (TMDL) criteria have not been developed for amicarbazone. The link to TM DL reports is provided - ( http://iaspub.epa.gov/tmdl_waters10/attains_impaire d_waters.tmdls?p_pollutant_group_id=885 )

Aquatic benchmarks have not been established for am icarbazone ( http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_li fe_benchmark.htm ). Any data submitted or otherwise located as part of the registration re view process may be used to revise or establish new aquatic life benchmarks, if applicable.



### ENVIRONMENTAL FATE AND TRANSPORT

Physical and Chemical Properties of Amicarbazone

Selected physicochemical properties of amicarbazone are shown in Table 4 . Based on these properties alone, volatility is not expected to be a major dissipation pathway for amicarbazone, and amicarbazone is not expected to bioaccumulate.7

Table 4. Selected Physical/Chemical Parameters of A micarbazone

Chemical name Property Data Source (MRID) Molecular weight 241 451215-01 Aqueous Solubility 4,600 mg/L 451215-01 Melting Point 137.5°C 451215-01 Boiling Point Decomposes above 180°C 451215-01
Vapor Pressure 9.8x10

- 9 mmHg at 20°C 2.2x10 -8 mmHg at 25°C 451215-01

Henry’s Law Constant 1.5x10

- 12 atm m 3 mol

- 1 (calculated from vapor pressure and solubility values) 451512-01

Octanol-water partition coefficient (Kow) 14 unbuffered 15 at pH 4 17 at pH 7 and 9 451512-01

Environmental Fate and Transport of Amicarbazone

Table 5 below summarizes the environmental fate properties of amicarbazone, while Appendix A provides the chemical structure of amicarbazone an d its major degradation products. Due to its persistence and mobility, amicarbazone applicat ions may lead to surface water contamination through spray drift, runoff, and sediment erosion, and groundwater contamination through leaching.

Amicarbazone is moderately persistent in the enviro nment as it eventually transforms by biotic mechanisms (t1⁄2= 87 days; aerobic soil metabolism). Under acidic and neutral environments, amicarbazone is stable to hydrolysis, but it transf orms slowly under alkaline conditions. Photolysis also occurs slowly for amicarbazone in w ater and on soil with half-lives on the order of about two months, estimated for outdoor environm ental conditions. The primary transformation products of amicarbazone are Desamino: N-(1,1-dimethylethyl)-4,5-dihydro-3- (1-methylethyl)-5- oxo-1H-1,2,4-triazole-1-carboxam ide; N-methyl Desamino: N-(1,1- dimethylethyl)-4,5-dihydro-4-methyl-3-(1-methylethy l)-5-oxo-1H-1,2,4-triazole-carboxamide; and Decarboxamide: 4-amino-2,4-dihydro-5-(1-methylethyl)-3H-1,2,4-tria zol-3-one.

Amicarbazone has a low vapor pressure and Henry’s L aw constant; therefore, volatilization from water and soil surfaces is not expected to be an im portant environmental fate process. The moderate persistence and high mobility of amicarbaz one in soil make leaching of this compound to lower soil horizons and groundwater possible. Li kewise, leaching and possible groundwater contamination with amicarbazone’s major three metab olites are possible due to their apparent long persistence and high mobility.

All three amicarbazone end-use product labels inclu de a use restriction that amicarbazone is not to be applied on soils with pH values higher than 7 .4. Therefore, the fate of the chemical under neutral and acidic conditions only will be consider ed in the risk assessment. In such environments, two major amicarbazone transformation products (Desamino and N-methyl8

Desamino) are expected to be formed. In metabolism studies, these metabolites increase in concentration to the end of study. Given the moder ate persistence/high mobility and solubility of the parent compound and the apparent high persisten ce/high mobility of the two transformation products, both amicarbazone and its first two trans formation products are expected to dissipate slowly and at the same time be vulnerable to leachi ng/run-off. Hydrolysis studies on the desamino and N-methyl desamino metabolites indicate stability at environmentally relevant temperatures and pH (MRIDs 48073601 and 48237506). If amicarbazone is transported into alkaline groundwater, surface water bodies, and/or soils, the third transformation product (Decarboxamide) may be formed; it is the only major metabolite identified in the base-catalyzed hydrolytic transformation of amicarbazone.

Terrestrial field dissipation studies yielded half- lives (25 – 30 days) within the range obtained from laboratory aerobic metabolism studies (5 – 158 days). The desamino degradate was detected as a major degradate, indicating that micr obial metabolism was likely a dissipation mechanism.

Parent amicarbazone only will be considered in the risk assessment due to: 1) a freshwater green algae study indicating the desamino metabolite is l ess toxic than parent; 2) four avian reproduction studies indicating the metabolites, de samino and N-methyl, are less toxic than the parent; and 3) seedling emergence and vegetative vi gor studies indicating the metabolites, desamino and N-methyl, are less toxic than the pare nt.

Table 5. Amicarbazone (Parent) Environmental Fate Summary

Parameter Value Source (MRID) Study Status

Hydrolysis half-life 1 Stable pH 5 & 7

66.6 days pH 9 @ 25 °C 451217-30 Acceptable

Aqueous photolysis half-life 1 66.8 days Latitude: Phoenix, AZ @ 25 °C 45121803 Acceptable

Soil photolysis half-life 1 58.9 days Latitude: Phoenix, AZ @ 21 °C 45121714 Supplemental

Aerobic soil metabolism half-life 1 At 20 °C Clay Loam Soil - 76.4 days Sandy Loam Soil - 5.1 days Loamy Sand Soil - 42.1 days Loam Soil - 26.2 days Clay Loam Soil – 158 days 48237507 45121731 Supplemental

Supplemental

Anaerobic soil metabolism half-life No Data
Aerobic aquatic metabolism half-life No DataAnaerobic aquatic metabolism halflife 1 (total system) Stable @ 21 °C 45121724 Supplemental

Adsorption - K oc 35.6 (loam soil) 45121717 Acceptable9

Table 5. Amicarbazone (Parent) Environmental Fate Summary

Parameter Value Source (MRID) Study Status

Adsorption– K foc 24.2 (Clay Brazil )

45121719 Supplemental 16.7 (Sandy clay Brazil ) 19.0 (Sandy clay Brazil )

Desorption - K foc 17.2 (Clay Brazil ) 13.9 (Sandy clay Brazil ) 16.4 (Sandy clay Brazil )

Adsorption– K foc 35.9 (silt loam, NE)

45121732 Supplemental 32.0 (silt loam, LA) 37.0 (silt loam, NE) 22.9 (silt loam, WI)

Desorption - K foc 76.7 (silt loam, NE) 95.7 (silt loam, LA) 81.1 (silt loam, NE) 58.2 (silt loam, WI)

Terrestrial Field Dissipation HalfLife 1 29.5 days (NE silty clay loam cropped with pre-emergent corn) 451217-18 Acceptable Major degradation product: Desamino (Max 26% @ 59 days)

24.9 days (WI silt loam soil cropped with pre-emergent corn) 45121727 Acceptable Major degradation product: Desamino (Max 27% @ 61 days)

1 Half-lives were recalculated using PestDF (EFED, 20 14)

Transformation Products

Table 6 summarizes the environmental fate properties of De samino and N-methyl Desamino, while Appendix A provides additional detail on formation of transfo rmation products in the environment, including structures.10

Table 6. Amicarbazone Degradates’ Environmental Fa te Summary

Parameter Value* Source (MRID) Study Status

N-Methyl Desamino

Hydrolysis half-life 1 Stable - pH 4 @ 50 °C Stable - pH 7 @ 50 °C 333 days (SFO) – pH 9 @ 20 °C 13.6 days (SFO) – pH 9 @ 40 °C 0.77 days (SFO) – pH 9 @ 60 °C 48073601 Acceptable

Aerobic soil metabolism halflife 1 @ 20 °C Stable – clay loam soil, sandy loam soil, loamy sand soil, loam soil 48407501 Acceptable

Adsorption – K foc 49.7 (silt loam, NE)

45121733 Supplemental 49.0 (silt loam, LA) 56.4 (silt loam, NE) 34.3 (silt loam, WI)

Desorption – K foc 89.4 (silt loam, NE) 110.4 (silt loam, LA) 101.2 (silt loam, NE) 63.8 (silt loam, WI)
Desamino

Hydrolysis half-life Stable - pH 4 @ 50 °C Stable - pH 7 @ 50 °C Stable - pH 9 @ 50 °C 48237506 Acceptable

Aerobic soil metabolism halflife 1 @ 20 °C 6230 days – clay loam soil 1420 – sandy loam soil Stable – loamy sand soil 758 days – loam soil 48407502 Acceptable

Adsorption – K foc 39.2 (silt loam, NE)

45121801 Supplemental 26.4 (silt loam, LA)
42.3 (silt loam, NE) 27.6 (silt loam, WI)

Desorption – K foc 86.8 (silt loam, NE) 96.7 (silt loam, LA)
89.3 (silt loam, NE) 53.3 (silt loam, WI)11

Table 6. Amicarbazone Degradates’ Environmental Fa te Summary

Parameter Value* Source (MRID) Study Status

N-Methyl Desamino

Hydrolysis half-life 1 Stable - pH 4 @ 50 °C Stable - pH 7 @ 50 °C 333 days (SFO) – pH 9 @ 20 °C 13.6 days (SFO) – pH 9 @ 40 °C 0.77 days (SFO) – pH 9 @ 60 °C 48073601 Acceptable

Aerobic soil metabolism halflife 1 @ 20 °C Stable – clay loam soil, sandy loam soil, loamy sand soil, loam soil 48407501 Acceptable

Adsorption – K foc 49.7 (silt loam, NE)

45121733 Supplemental 49.0 (silt loam, LA) 56.4 (silt loam, NE) 34.3 (silt loam, WI)

Desorption – K foc 89.4 (silt loam, NE) 110.4 (silt loam, LA) 101.2 (silt loam, NE) 63.8 (silt loam, WI)
Decarboxamide Adsorption – K foc 13.4 (silt loam, NE)

48237506 Supplemental 12.3(silt loam, LA) 13.8 (silt loam, NE) 9.4 (silt loam, WI) Desorption – K foc 68.0 (silt loam, NE) 60.2 (silt loam, LA) 81.5 (silt loam, NE) 59.7 (silt loam, WI)

1 Half-lives were recalculated using PestDF (EFED, 20 14)



### RECEPTORS

Tables 7 and 8 provide a summary of the available aquatic and terr estrial toxicity data, respectively, using the most sensitive surrogate sp ecies tested to characterize the potential acute and chronic ecological effects of amicarbazone. In addition, the tables provide information on the available toxicity data for amicarbazone degrad ates.12

Overall, the acute toxicity studies indicate that t echnical grade amicarbazone (amicarbazone TGAI) is practically non-toxic to adult honey bees, slightly toxic to mammals, and slightly toxic to practically non-toxic to birds. However, data fr om chronic toxicity studies show that longerterm exposure to amicarbazone TGAI and the two meta bolites, desamino amicarbazone and Nmethyl desamino amicarbazone, results in adverse ef fects on growth and reproductive parameters in birds. In addition, exposure to the TGAI in mamm alian parents and offspring resulted in reduced growth parameters. No data are available t o characterize the effects of amicarbazone metabolites in mammals or insects; however, the bir d reproduction studies indicate the metabolites are 6 to 38 times less toxic than the p arent compound. No data with passerine birds are available; an acute oral passerine bird study ( Guideline 850.2100) is needed to satisfy EPA guideline requirements.

Tier 2 seedling emergence and vegetative vigor terr estrial plant studies with the amicarbazone formulated product MKH 3586 70 WG show that both mo nocots and dicots are sensitive to amicarbazone, with dicots appearing more sensitive. Studies with the amicarbazone metabolites (Desamino and N-methyl) exhibited some effects to t errestrial plants; however, both are approximately 2-fold less toxic than the parent com pound.

Acute aquatic toxicity studies demonstrate that ami carbazone TGAI is practically non-toxic to freshwater and estuarine/marine fish, slightly toxi c to freshwater invertebrates, and slightly toxic to practically non-toxic to estuarine/marine invert ebrates. Longer-term exposure of aquatic animals to amicarbazone produces adverse effects on growth parameters in freshwater fish and on growth and reproductive parameters in freshwater and estuarine/marine invertebrates. No data are available to characterize the effects of a micarbazone metabolites in aquatic animals but with the parent persistent and stable to hydrolysis , the metabolites are expected to have a minimal impact on aquatic animals in acidic or neut ral surface waters. However, the alkaline hydrolysis metabolite, decarboxamide, may be formed in alkaline surface waters. No toxicity data for the alkaline metabolite, decarboxamide, ar e available; however, because current label language prohibiting applying on coarse-textured so ils (sand, loamy sand and sandy loam soils), or on soils with pH >7.4, such as calcareous soils; data on the effect of the alkaline metabolite to aquatic organisms are not needed at this time. The decarboxamide would be treated as stable in alkaline aquatic systems, if an analysis in alkalin e waters were needed.

In the aquatic environment, amicarbazone appears to be particularly toxic to algae, but produces adverse effects on survival and growth in both alga e and vascular plants. The results of a single study assessing the toxicity of the amicarbazone me tabolite Desamino in Selenastrum capricornutum (a freshwater green algae), indicate that Desamino is 16-fold less toxic than the parent compound.

A definitive NOAEC has not been established for chr onic exposure to estuarine/marine invertebrates, which normally results in a presumpt ion of risk for estuarine/marine invertebrates until available data show differently. In the abse nce of such data, EFED is not requiring a mysid chronic toxicity study to establish a definitive NO AEC because the lowest test concentration of 2400 μg a.i./L in the study needs to be 320x more t oxic to result in a chronic LOC exceedance when using the highest 21-day EEC of 7.5 μg a.i./L (EEC used in this calculation was obtained13

from the August 30, 2010 risk assessment for new us e on turf grasses; D384516), which is unlikely.

Table 7. Toxicity Profile for Aquatic Species to A micarbazone and its Degradates

Species (scientific name) Study

Type Test

Material Toxicity

Endpoint* (mg a.i./L) Study

Classification (MRID) Acute

Toxicity Classification

Freshwater Fish Lepomis macrochirus (Bluegill sunfish) Acute TGAI LC 50 >128.5 Supplemental 1 (45121804) Practically

nontoxic

Pimephales promelas (Fathead minnow) Chronic TGAI NOAEC = 7.3 Based on reduced dry weight Acceptable

(45121602) ---

Freshwater Invertebrates

Daphnia magna (Water flea) Acute TGAI EC 50 = 40.8 Acceptable (45121808) Slightly toxic

Chronic TGAI NOAEC = 0.73 Based on reduced dry weight Acceptable

(48071501) --

Estuarine/marine Fish

Cyprinodon variegatus (Sheepshead minnow) Acute TGAI LC 50 >118 Acceptable (45121806) Practically

nontoxic

Chronic TGAI NOAEC = 2.3 No treatment related effects were observed Acceptable

(48237510) --

Estuarine/marine Invertebrates

Mysidopsis bahia (Mysid shrimp) Acute TGAI LC 50 = 109.7 Acceptable (45121810) Practically

nontoxic

Chronic TGAI NOAEC <2.4 Based on reduced female body weight Supplemental 2

(48407503) --

Aquatic Vascular Plants Lemna gibba (Duckweed) Frond

count TGAI EC 50 = 0.21 Acceptable (45121805) -- NOAEC = 0.0406 Aquatic Nonvascular Plants

Growth TGAI EC 50 = 0.017 --14

Table 7. Toxicity Profile for Aquatic Species to A micarbazone and its Degradates

Species (scientific name) Study

Type Test

Material Toxicity

Endpoint* (mg a.i./L) Study

Classification (MRID) Acute

Toxicity Classification
Skeletonema

costatum (Marine diatom) NOAEC = 0.0057 Acceptable (45121818)

Selenastrum capricornutum (Green algae) Growth TGAI EC 50 = 0.084 Acceptable (45121820) -- NOAEC = 0.013

Growth Degradate

of TGAI ( Desamino ) EC 50 >1.35 Acceptable (45121827) -- NOAEC = 1.35

* Animal LC 50 s/ EC 50 s and NOAECs are used as acute and chronic toxicity e ndpoints, respectively; while plant EC 50 s and NOAECs are used as non-listed and listed toxicity e ndpoints, respectively.

1 Mean control fish weight of 0.43 g at test terminat ion was less than the required initial weight range of 0.5 to 5 g.

2 A NOAEC could not be determined for female dry weig ht, the most sensitive endpoint due to significant reductions at all treatment levels.

Table 8. Toxicity Profile for Terrestrial Species t o Amicarbazone and its Degradates.

Species (common name) Test Type Test Material Toxicity Endpoint

(mg a.i./kg-bw or – diet, μg a.i./bee, or lb a.i./A) Study

Classification (MRID) Acute

Toxicity Classification

Upland Game Birds and Waterfowl

Colinus virginianus (Northern bobwhite quail) TGAI LD 50 1965 Supplemental 2 (45121811) Slightly toxic

LC 50 >5690 Acceptable (48237511) Practically

nontoxic

NOAEC 27.1

Reduced no. of viable embryos and % hatchling per eggs set Acceptable

(45121819) --

Degradate of TGAI ( Desamino) NOAEC 1030 No effects seen at highest dose Acceptable

(48237515) --

Degradate of TGAI ( N-Methyl Desamino) NOAEC 413 Reduced hatchling and survivor body weights Acceptable

(48237514) --

Passerine Birds15

Table 8. Toxicity Profile for Terrestrial Species t o Amicarbazone and its Degradates.

Species (common name) Test Type Test Material Toxicity Endpoint

(mg a.i./kg-bw or – diet, μg a.i./bee, or lb a.i./A) Study

Classification (MRID) Acute

Toxicity Classification

No data TGAI LD 50 No data No data No data
Mammals

Rattus norvegicus (Laboratory rat) TGAI LD 50 1087 Acceptable (45121605) Slightly toxic

NOAEC Offspring = 6.4/7.3

mg/kg/day [6.4 mg/kg/day equivalent to 100 mg/kg diet] Acceptable

(45121625) --

Terrestrial Insects

Apis mellifera (Honeybee) TGAI Contact LD 50 >200 Supplemental 3 (45121816) Practically

nontoxic
Oral LD 50 = 24.4 -- Seedling Emergence

Monocot; Onion ( Allium cepa ) Growth TEP EC 25 = 0.1

Acceptable (45121821) -- EC 05 = 0.034 1 [NOAEC = 0.126] Dicot; Sugar beet ( Beta vulgaris ) EC 25 = 0.03
NOAEC = 0.016
Monocot; Wheat ( Triticum astivum )
Growth Deg. of TEP ( N-Methyl Desamino) EC 25 >0.418

Acceptable (48237517) -- NOAEC = 0.00493

Dicot; Sugar beet ( Beta vulgaris ) EC 25 = 0.0866
EC 05 = 0.00465 1 [NOAEC = 0.146]
Monocot; Ryegrass ( Lolium perenne) Growth Deg. of TEP ( Desamino ) EC 25 >0.38 Acceptable (48237516) -- NOAEC = 0.0049 Dicot; Cabbage ( Brassica oleracea) EC 25 = 0.16
NOAEC = 0.061 Vegetative Vigor

Monocot: Onion ( Allium cepa ) Growth TEP EC 25 = 0.026 Acceptable (45121821) -- NOAEC = 0.016 Dicot; Buckwheat EC 25 = 0.003716

Table 8. Toxicity Profile for Terrestrial Species t o Amicarbazone and its Degradates.

Species (common name) Test Type Test Material Toxicity Endpoint

(mg a.i./kg-bw or – diet, μg a.i./bee, or lb a.i./A) Study

Classification (MRID) Acute

Toxicity Classification

( Fagopyrum esculentum ) NOAEC = 0.002

Monocot; Corn ( Zea mays ) Growth Deg. of TEP ( N-Methyl Desamino) EC 25 >0.457 Acceptable (48237518) -- NOAEC = 0.457 Dicot; Sugar beet ( Beta vulgaris ) EC 25 = 0.0251
NOAEC = 0.00532
Monocot; Wheat ( Triticum astivum )
Growth Deg. of TEP ( Desamino ) EC 25 >0.30

Acceptable (48237520) -- NOAEC = 0.019

Dicot; Sugar beet ( Beta vulgaris ) EC 25 = 0.318
EC 05 = 0.122 1 [NOAEC <0.0057]

1 An EC 05 is used when the NOAEC is below the lowest test co ncentration or above the EC 25. 2 A statistically reliable LD 50 value could not be established or established with certainty. 3 The solvent used in the study was not a USEPA reco mmended solvent.

Exposure Pathways of Concern

The exposure pathways for amicarbazone and its tran sformation products may result in a wide range of potential aquatic and terrestrial exposure scenarios. For this problem formulation, the drinking water and inhalation pathways for birds an d mammals were screened using the SIP (Screening Imbibition Program) and STIR (Screening Tool for Inhalation Risk) screening methods. STIR found the inhalation pathway not like ly to be significant, but the SIP analysis identified exposure through drinking water alone to be a potential pathway of concern for birds and mammals (acute and chronic). This is primarily due to the water solubility of the compound and is a route of exposure that will be further ana lyzed in the forthcoming risk assessment.

Drinking water exposure alone, according to the SIP model, is a potential pathway of concern for birds and mammals on an acute and chronic exposure basis. SIP is a screening (tier I) assessment used to determine whether there is a potential for a pathway of concern, which is intended to be evaluated in further developments of SIP. The follo wing conservative assumptions were used to derive upper bound exposure estimates for drinking water alone: 1) solubility at the solubility limit of amicarbazone, 2) 100% of animal daily wate r needs come from drinking water, 3) the daily water need is equivalent to the daily water i ntake rate, 4) body weight for birds is equivalent to the smallest bird (i.e., 20 g) modele d in T-REX, and 5) body weight for mammals is equivalent to the largest mammal (i.e., 1000 g) modeled in T-REX. The upper bound exposure estimates will be refined further when the next ver sion of SIP is developed.17

Results of the SIP and STIR screening analyses have not been aggregated with all other exposure pathways (dietary, dermal, inhalation, or drinking water). The aggregate value may represent risks of concern for non-target animals beyond our current estimates. The risk characterization section of the future risk assessment will discuss the impact of these multiple routes of exposure on ecological risks and the degree of certainty ass ociated with screening-level risk assessment conclusions. SIP and STIR are described in detail a t http://www.epa.gov/oppefed1/models/terrestrial/inde x.htm and the SIP and STIR model inputs and outputs for amicarbazone are available in Appendices B and C , respectively.



### ANALYSIS PLAN

Ecological Risk Assessment

Stressors of Concern

Parent amicarbazone only will be considered in the risk assessment because: 1) a freshwater green algae study indicates the desamino metabolite is less toxic than parent; 2) four avian reproduction studies indicate the metabolites, desa mino and N-methyl, are less toxic than the parent; 3) seedling emergence and vegetative vigor studies indicate the metabolites, desamino and N-methyl, are less toxic than the parent; and 4 ) labels restricting use on alkaline soils limit the potential formation of the metabolite decarboxa mide, for which toxicity is not known .

Measures of Exposure

In order to estimate risks of amicarbazone exposure to aquatic and terrestrial organisms, all exposure modeling and resulting risk conclusions wi ll be made based on maximum application rates, application methods, and any mitigation meas ures specifically indicated on the label. The models that will be used to predict the estimated e nvironmental concentrations (EECs) of amicarbazone are discussed on OPP’s model website. 2 These models include: SWCC, AgDrift, AgDisp, T-REX, and TerrPlant.

Measure of Effects

Ecological effects data are used as measures of dir ect and indirect effects to biological receptors. Data are typically obtained from registrant-submitt ed studies and from literature studies identified by ECOTOX. The ECOTOX database provides more ecological effects data in an attempt to bridge existing data gaps. ECOTOX is a s ource for locating single chemical toxicity data and potential chemical mixture toxicity data f or aquatic life, terrestrial plants, and wildlife. ECOTOX was created and is maintained by t he U.S. EPA, Office of Research and Development, and the National Health and Environmen tal Effects Research Laboratory's MidContinent Ecology Division.

Integration of Exposure and Effects

2 http://www.epa.gov/opp00001/science/models_pg.htm18

Risk characterization is the integration of exposur e and ecological effects to determine the potential ecological risk from the use of pesticide s and the likelihood of direct and indirect effects to non-target organisms in aquatic and terr estrial habitats. For the assessment of risks, the risk quotient (RQ) method is used to compare exposu re and measured toxicity values. EECs are calculated for acute and chronic concentrations and are compared to acute and chronic toxicity endpoints. The resulting RQs are then compared to t he Agency’s Levels of Concern (LOCs) (USEPA 2004). These criteria will be used to indica te when amicarbazone use, as directed on the label, has the potential to cause adverse direct ef fects to non-target organisms. In addition, any available incident data will be considered (see bel ow) as part of the risk characterization.

Endangered Species Assessments

In November 2013, the EPA, along with the U.S. Fish & Wildlife Service (USFWS), the National Marine Fisheries Service (NMFS) (collectiv ely, the Services), and the U.S. Department of Agriculture (USDA) released a summary of their j oint Interim Approaches for assessing risks to listed species from pesticides. The Interim App roaches were developed jointly by the agencies in response to the National Academy of Sci ences’ (NAS) recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connectio n with their obligations under the Endangered Species Act (ESA) and FIFRA.

The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and Sta te-FIFRA Issues Research and Evaluation Group (SFIREG) meetings, and held a stak eholder workshop in April 2014, allowing additional opportunities for stakeholders to commen t on the Interim Approaches. As part of a phased, iterative process for developing the Interi m Approaches, the agencies will also consider public comments on the Interim Approaches in connec tion with the development of upcoming Registration Review decisions. The details of the joint Interim Approaches are contained in the white paper

“Interim Approaches for National-Level Pesticide E ndangered Species Act Assessments Based on the Recommendations of the Nat ional Academy of Sciences April 2013 Report,” dated November 1, 2013.

Given that the agencies are continuing to develop a nd work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the ecological risk as sessment supporting the proposed interim registration review decision for amicarbazone is no t expected to contain a complete ESA analysis. Once the agencies have fully vetted the s cientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyse s for amicarbazone as part of completing this registration review.19

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerou s studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinog enicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. The se studies include endpoints that may be susceptible to endocrine influence, including effec ts on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental a nd reproductive effects in different taxonomic groups. As part of its reregistration de cision for amicarbazone, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), amicarbazone is subject to the endocrine screening part of the Endo crine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether cer tain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or oth er such endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered appr oach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, a ndrogen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screenin g and are found to have the potential to interact with E, A, or T hormonal systems will proc eed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests a re necessary based on the available data. Tier 2 testing is designed to identify any adverse endocri ne-related effects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test ord ers/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingre dients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was publ ished on June 14, 2013 3 and includes some pesticides scheduled for registration review and ch emicals found in water

. Neither of these lists should be construed as a list of known or likely en docrine disruptors.

For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and th e Tier 1 screening battery, please visit our website. 4

Review of Incident Data

Three incident databases are available: 1) the Ecol ogical Incident Information System v. 2.1.1 (EIIS), maintained by EFED; 2) the Avian Incident M onitoring System (AIMS), maintained by

3 See http://www.regulations.gov/#!documentDetail;D=EPA-H Q-OPPT-2009-0477-0074 for the final second list of chemicals.

4 http://www.epa.gov/endo/20

the American Bird Conservancy; and, 3) the Incident Data System (IDS) maintained by OPP. These databases were searched on 6/1/15.

The Ecological Incident Information System (EIIS) d atabase was queried for incidents related to amicarbazone use. No incidents were reported in th e EIIS database.

A query of the aggregate Incident System (IDS) repo rted no incidents.

The Avian Incident Monitoring System (AIMS), a data base administered by the American Bird Conservancy, was queried for amicarbazone on 6/1/15 and there were no bird incidents reported.



### PRELIMINARY IDENTIFICATION OF DATA GAPS

Environmental Fate

Table 9 identifies the environmental fate studies by MRID that offer data for each Part 158 data requirement, as well as study classifications and w hether or not further data are anticipated to be needed in order to support risk assessment for the amicarbazone registration review.

Table 9. Submitted Environmental Fate Data for Amic arbazone and Data Needs

OCSPP Guideline Data

Requirement Submitted

Studies (MRID) Study

Classifications Are

data needed? Additional Comments

835.2120 Hydrolysis 45121730 48073601* 48237506** Acceptable

Acceptable Acceptable No * N-methyl desamino

degradate ** Desamino degradate 835.2240 Aqueous

photolysis 45121803 Acceptable No
835.2410 Soil photolysis 45121714 Supplemental No 835.4100 Aerobic soil

metabolism 45121731

48237507 48407501* 48407502** Supplemental

Acceptable Acceptable Acceptable No * N-methyl desamino

degradate ** Desamino degradate

835.4200 Anaerobic soil

metabolism 45121720 Unacceptable Yes Will be modeled as stable unless new data are submitted. 835.4300 Aerobic aquatic

metabolism 48237508 Unacceptable Yes Will be modeled as stable unless new data are submitted. 835.4400 Anaerobic

aquatic metabolism 45121724 Supplemental Yes Will be modeled as stable unless new data are submitted.21

Table 9. Submitted Environmental Fate Data for Amic arbazone and Data Needs

OCSPP Guideline Data

Requirement Submitted

Studies (MRID) Study

Classifications Are

data needed? Additional Comments

835.1230 Adsorption/

desorption 45121717

45121719 45121732 45121733* 45121801** 45121802*** Acceptable

Supplemental Supplemental Supplemental Supplemental Supplemental No * N-methyl desamino degradate ** Desamino degradate *** Decarboxamide degradate

835.1410 Volatility –

laboratory No data submitted No Low vapor pressure and Henry’s Law constant indicate volatilization is not likely. 835.6100 Terrestrial field

dissipation 45121718

45121727 Acceptable

Acceptable No
835.7100 Prospective

ground water study 45938501

45938502 46049601 46092401 46145311 46326001 46670902 46675101 In review No

835.6200 Aquatic field

dissipation No data submitted No No aquatic uses

850.1730 Fish

bioconcentration No data submitted No Low log K ow indicates bioconcentration is not likely. 850.6100 Analytical

method in soil 45121728

45121729 (ILV) In review No

850.6100 Analytical

method in water 45121725

45121726 45121715 (ILV) In review No

Ecological Effects

Tables 10 and 11 identify the ecological effects studies, as well a s study classifications, and whether or not further data are anticipated to be n eeded in order to support risk assessment for registration review. The rationale for the addition al data that EFED recommends be requested is presented below.

• Amicarbazone may cause exposure of pollinators visi ting off-site plants that are contaminated by spray drift. A complete set of toxi city data for honey bee adults and22

larvae have not been submitted for amicarbazone and are now needed under EPA’s recent policy on pollinator protection 5 . Thus, the following six Tier I and II honey bee studies, yet to be submitted for amicarbazone, are needed:

o Honeybee larval acute oral toxicity study (followin g OECD 237)

o Honeybee adult 10-day chronic oral (special study)

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

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

o Field trial of residues in pollen and nectar (speci al study, Tier II)

o Semi-field testing for pollinators (special study, Tier II).
Note that it is possible to conduct the larval chro nic 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 s tudy is not needed. For pollinator studies without finalized O ECD 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 amicarbazone will be determined after review of the Tier I studies.

• Acceptable acute avian acute oral toxicity (Guideli ne 850.2100) data for a passerine species exposed to amicarbazone, per the 40 CFR Par t 158 data requirements, are needed. Although the available bobwhite quail study indicat es amicarbazone has low toxicity to upland game bird species, it is uncertain whether p asserines may be more or less sensitive to this chemical as a result of their higher metabo lic rate, smaller size, and differing metabolic pathways. Given the reproductive effects of survivor and hatchling body weights and viable embryos observed in birds, EFED cannot preclude the potential risk to passerines. An avian oral toxicity study is needed for a passerine species.

5 (Guidance for Assessing Pesticide Risks to Bees, 0 6.23.2014; signed by Donald Brady, Director, EFED; http://www2.epa.gov/sites/production/files/2014- 06/documents/pollinator_risk_assessment_guidance_06 _19_14.pdf )23

Table 10. Submitted Aquatic Ecological Effects Dat a for Amicarbazone

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 45121808 Acceptable No --

850.1025 850.1035 Estuarine/Marine

invertebrate acute toxicity 45121809

45121810 Supplemental

Acceptable No --

850.1075 Freshwater fish

acute toxicity 45121804

45121807 Supplemental

Supplemental No --

850.1075 Estuarine/Marine

fish acute toxicity 45121806 Acceptable No --

850.1300 Freshwater

invertebrate life cycle 45121822

48071501 Supplemental

Acceptable No --

850.1350 Estuarine/Marine

invertebrates life cycle 45121601

48407503 Supplemental

Supplemental No A definitive NOAEC was not established; however, EFED is not requiring the data because toxicity needs to be 320x more toxic to result in a LOC exceedance.

850.1400 Estuarine/Marine

fish early-life stage 48237510 Acceptable No --24

Table 10. Submitted Aquatic Ecological Effects Dat a for Amicarbazone

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 45121602 Acceptable No --

850.1500 Fish life cycle (None) (N/A) No No LOC exceedances were observed with aquatic organisms thus a FLC study is not needed.

850.1735 Benthic

invertebrates (acute) No data -- No Not triggered per 40 CFR Part 158 based on chemical characteristics 850.1740 Benthic

invertebrates (chronic) No data -- No

850.4400 Aquatic plant

growth: Vascular plants 45121805 Acceptable No --

850.4500 Aquatic Plant

Growth: Algal 45121812

45121818 45121820 (TGAI) Acceptable

Acceptable Acceptable No

--
45121827 ( Desamino ) Acceptable No

850.4550 Aquatic Plant

Growth: Cyanobacteria 45121825 Acceptable No --25

Table 11. Submitted Terrestrial Ecological Effects Data for Amicarbazone and Data Needs

OCSPP Guideline Data

Requirement Submitted

Studies (MRID) Study

Classifications Are data

needed for assessment? Current Additional

Data Need

850.2100 Avian oral

toxicity 45121811 Supplemental Yes Without data, risk would be presumed for passerine birds, including listed species.

850.2200 Avian dietary

toxicity 45121815

48237511 Acceptable

Acceptable No --

850.2300 Avian

reproduction 45121814

45121819 48237512 48237513 48237514 48237515 Acceptable

Acceptable Acceptable Supplemental Acceptable Acceptable No --

Nonguideline Avian

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

850.3020 Adult honey

bee acute
contact toxicity 45121816 Supplemental No --

SS Adult honey bee acute oral toxicity Supplemental No

850.3030 Honey bee

residue on foliage No data No data No Not triggered. The bee acute contact LD 50 of >200 μg a.i./L is above 11 μg a.i./L, the practically nontoxic toxicity classification for bees.

850.3040 Field testing

for pollinators No data No data Yes Pollinator Tier I, II and III studies with honeybees are necessary to satisfy data requirements. SS Larval honey bee chronic oral toxicity No data No data Yes26

Table 11. Submitted Terrestrial Ecological Effects Data for Amicarbazone and Data Needs

OCSPP Guideline Data

Requirement Submitted

Studies (MRID) Study

Classifications Are data

needed for assessment? Current Additional

Data Need

SS Adult honey bee chronic oral toxicity No data No data Yes Without data, risk would be presumed for pollinators, including listed species.
SS Larval honey

bee acute toxicity No data No data Yes

SS Field testing of residues in pollen and
nectar No data No data Yes

SS Semi-field

testing for pollinators No data No data Yes

850.4100 Tier I or II

seedling
emergence 45121821

45121826 48237516 48237517 Acceptable

Supplemental Acceptable Acceptable No

--

850.4150 Tier I or II

vegetative vigor 45121821

45121826 48237518 48237519 48237520 Acceptable

Supplemental Acceptable Acceptable Acceptable No



### REFERENCES:

USEPA 2010. Section 3 Registration for New Use of A micarbazone on Turf Grasses Grown Nationwide. D384516. August 30, 2010.

USEPA 2005. Environmental Fate and Effect Division’ s Risk Assessment for the Section 3 New Active Ingredient Registration for Amicarbazone (CA S Number 129909-90-6). D288631. April 11, 2005.

USEPA, PMRA and CDPR, 2014. Guidance for Assessing Pesticide Risks to Bees. Office of Pesticide Programs, USEPA, Washington D.C. Health C anada Pest Management Regulatory Agency, Ottawa, ON, Canada. California Department of Pesticide Regulation, Sacramento, CA. June 23, 2014.27



### OPPIN BIBLIOGRAPHY:

Environmental Fate
835.2120 Hydrolysis

MRID Citation Reference

45121730 Widmer, S.; Bloomberg, A.; Dement, T. (1998) Hydro lysis of (Triazolinone-3- (carbon 14))MKH 3586 in Aqueous Sterile Buffer Solu tions: Lab Project Number: 107106: M6022402. Unpublished study prepare d by Bayer Corp. 37 p.


### 835.2130 Hydrolysis as a function of pH at 25 C

MRID Citation Reference

48073601 Schick, M. (2010) Hydrolysis of [Carbon 14]N-Methy l Desamino Amicarbazone at pH 4, 7 and 9. Project Number: 1913W, 1913W/1. U npublished study prepared by PTRL West, Inc. 111 p.

48237506 Schick, M. (2010) Hydrolysis of (Carbon 14)Desamin o Amicarbazone at pH 4, 7 and 9. Project Number: 1912W//1912W/1, 1912W/OCR. Unpublished study prepared by PTRL West, Inc. 69 p.


### 835.2240 Photodegradation-water

MRID Citation Reference

45121803 Ripperger, R.; Bloomberg, A.; Puhl, R. (1999) Phot olysis of (Triazolinone-3- (carbon 14))MKH 3586 in Sterile Aqueous Buffer (pH 7) and in Natural Water: Lab Project Number: 107107: M6082401. Unpublished s tudy prepared by Bayer Corp. 77 p.


### 835.2410 Photodegradation-soil

MRID Citation Reference

45121714 Bloomberg, A.; Dement, T.; Helfrich, K. et al. (19 99) Photolysis of (Triazolinone-3-(carbon 14))MKH 3586 on Silt Loam: Lab Project Number: 107108: M6082101. Unpublished study prepared by Bay er Corp. and Springborn Labs. 65 p.28



### 835.4100 Aerobic soil metabolism

MRID Citation Reference

45121720 Marco da Silva, P. (1999) Aerobic Soil Metabolism of MKH 3586-triazolinone3-(carbon 14) on Three Brazilian Soils: Lab Project Number: 109246: M6042102: RF-E12.01/99. Unpublished study prepared by Bioagri Laboratorios Ltda. 65 p.

45121731 Leimkuehler, W.; Billesbach, K. (1998) Aerobic Soi l Metabolism of (triazolinone-5-(carbon 14))MKH 3586: Lab Project N umber: M6042101: 106966. Unpublished study prepared by Bayer Corp. 4 2 p.

48237507 Shepler, K. (2010) Aerobic Soil Metabolism of [Car bon 14] Amicarbazone in Four Soils. Project Number: 1889W/1, 1889W/OCR. Unp ublished study prepared by PTRL West, Inc. 202 p.

48407501 Shepler, K. (2010) Aerobic Soil Metabolism of [Car bon 14]N-Methyl Desamino Amicarbazone in Four Soils. Project Number: 1891W/1 . Unpublished study prepared by PTRL West, Inc. 171 p.

48407502 Shepler, K. (2010) Aerobic Soil Metabolism of [Car bon 14]Desamino Amicarbazone in Four Soils. Project Number: 1890W/1 . Unpublished study prepared by PTRL West, Inc. 188 p.


### 835.4300 Aerobic aquatic metabolism

MRID Citation Reference

45121724 Kelley, I.; Smith, D. (1997) Anaerobic Aquatic Met abolism of (Triazolinone-5- (carbon 14))MKH 3586: Lab Project Number: 107318: M 6042401. Unpublished study prepared by Bayer Corp. 34 p.

48237508 Schick, M. (2010) Aerobic Aquatic Metabolism of [C arbon 14]Amicarbazone in Water/Sediment Systems.. Project Number: 1914W/1, 1 914W/OCR. Unpublished study prepared by PTRL West, Inc. 133 p

. 

### 835.1230 Adsorption/desorption

MRID Citation Reference

45121717 Harbin, A.; Bloomberg, A.; Dement, T. et al. (1999 ) Leaching Potential of Aged (Triazolinone-3-(carbon 14)) MKH 3586 Residues in C oly Loam: Lab Project Number: 107109: M6092101. Unpublished study prepare d by Bayer Corp. 60 p.

45121719 Marco da Silva, P. (1999) Adsorption/Desorption of MKH 3586-triazolinone-3- (carbon 14) on Three Brazilian Soils: Lab Project N umber: RF-E3.01/99: 109209: M6182106. Unpublished study prepared by Bio agri Laboratorios Ltda. 39 p.29

45121732 Hein, W.; Bloomberg, A. (1999) Adsorption/Desorpti on of MKH 3586- triazolinone-3-(carbon 14) in Four Soil Types: Lab Project Number: M6182104: 108714: SLFA--BAC13. Unpublished study prepared by Staatliche Lehr-und Forschungsanstalt fur Landwirtschaft. 78 p.

45121733 Hein, W.; Bloomberg, A. (1999) Adsorption/Desorpti on of 4-Methyl MKH 3594- triazolinone-3-(carbon 14), an MKH 3586 Metabolite, in Four Soil Types: Lab Project Number: 108716: SLFA--BAC12: M6182103. Unpu blished study prepared by Staatliche Lehr-und Forschungsanstalt f ur Landwirtschaft. 72 p.

45121801 Hein, W.; Bloomberg, A. (1999) Adsorption/Desorpti on of MKH 3594- triazolinone-3-(carbon 14), an MKH 3586 Metabolite, in Four Soil Types: Lab Project Number: M6182102: 108715: SLFA-BAC11. Unpub lished study prepared by Staatliche Lehr-und Forschungsanstalt f ur Landwirtschaft. 76 p.

45121802 Hein, W.; Bloomberg, A. (1999) Adsorption/Desorpti on of Decarboxamide MKH 3594, an MKH 3586 Metabolite, in Four Soil Types: L ab Project Number: M6182105: SLFA-BAC14: 108717. Unpublished study pre pared by Staatliche Lehr-und Forschungsanstalt fur Landwirtschaft. 78 p

.



### 835.1230 Adsorption/desorption

MRID Citation Reference

45121717 Harbin, A.; Bloomberg, A.; Dement, T. et al. (1999 ) Leaching Potential of Aged (Triazolinone-3-(carbon 14)) MKH 3586 Residues in C oly Loam: Lab Project Number: 107109: M6092101. Unpublished study prepare d by Bayer Corp. 60 p.


### 835.6100 Terrestrial field dissipation

MRID Citation Reference

45121715 Bauer, M. (1999) Independent Laboratory Validation of the Methods Described in Bayer Reports Nos. 108821 and 107949: Analytical Methods for the Determination of Residues of MKH 3586 and Three Met abolites in Water by High-Performance Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS): Lab Project Number: M6112401: 108829: N 053275A. Unpublished study prepared by Battelle. 66 p.

45121716 Wujcik, C.; Kelley, I.; Smith, D. (1999) Freezer S tability of MKH 3586 and its Metabolites Desamino MKH 3586, N-Methyl Desamino MK H 3586, and Decarboxamide MKH 3586 in Soil: Lab Project Number: 109468: M6132101. Unpublished study prepared by Bayer Corp. 80 p.

45121718 Bloomberg, A.; Jordan, N.; Wiedmann, J. (1999) Ter restrial Field Dissipation of MKH 3586 in Nebraska Soil, 1996: Lab Project Number : 108920: 010193: 98BAY.REP. Unpublished study prepared by Bayer Rese arch Farm, A &L Great Lakes Lab. and Enviro-Test Labs. 186 p.30

45121723 Kelley, I.; Manske, M. (1997) The Stability of MKH 3586 and its Metabolites MKH 3594 and N-Methyl MKH 3594 in Groundwater Store d under Refrigerated Conditions: Lab Project Number: 107127: M6132401. U npublished study prepared by Bayer Corp. 36 p.

45121727 Bloomberg, A.; Jordan, N.; Wiedmann, J. (1999) Ter restrial Field Dissipation of MKH 3586 in Wisconsin Soil, 1996: Lab Project Numbe r: 010194: 98BAY07.REP: 108733. Unpublished study prepared by AGSTAT, Enviro-Test Labs and Bayer Corp. 197 p.

45121728 Bloomberg, A.; Lam, C.; Nelson, S. et al. (1998) V alidation of the Analytical Method for the Determination of MKH 3586 and Three Metabolites in Wisconsin Soil by High Performance Liquid Chromatog raphy Tandem Mass Spectrometry (LC/MS/MS): Lab Project Number: 98-B-6 7: M6022101: 108733- 1. Unpublished study prepared by Enviro-Test Labs. 112 p.

45121729 Bauer, M. (1999) Independent Method Validation of Bayer Method MKH3586.mth 1 (Bayer Report No. 108733-1): Analytic al Method for the Determination of Residues of MKH 3586 and Three Met abolites in Soil by High Performance Liquid Chromatography Tandem Mass Spect rometry (LC/MS/MS): Lab Project Number: 109105: M6112103: N 053274A. Unpublished study prepared by Battelle. 63 p.


### 860.1900 Field rotational crop

MRID Citation Reference

45121704 Krolski, M.; Bosnak, L. (1999) The Accumulation of (Triazolinone-3-(carbon 14))MKH 3586 Residues in Confined Rotational Crops: Lab Project Number: M6051601: 109220. Unpublished study prepared by Bay er Corp. 202 p. {OPPTS 860.1850}


### 835.7100 Ground water-small prospective

MRID Citation Reference

45121722 Pangilinan, N.; Wujcik, C.; Kelley, I. et al. (199 9) Refrigerator Stability of Decarboxamide 3586, a Metabolite of MKH 3586, in Gr oundwater Addendum to: The Stability of MKH 3586 and its Metabolites M KH 3594 and N-Methyl MKH 3594 in Groundwater Stored under Refrigerated C onditions: Lab Project Number: 107127-1: M6132401. Unpublished study prepa red by Bayer Corp. 35 p.

45121725 Heitkamp, J.; Dyer, D. (1999) Determination of MKH 3586 and Two Degradates (desamino-MKH 3586 and 4-methyl-desamino -MKH 3586) in Water by High-Performance Liquid Chromatography Tan dem Mass Spectrometry (LC-MS/MS): Lab Project Number: 108821 : M6122401: 43042/43043. Unpublished study prepared by Bayer Co rp. 38 p.

45121726 Liemkuehler, W.; Widmer, S.; Billesbach, K. (1999) Analytical Method for the Determination of Decarboxamide MKH 3586 in Groundwa ter by High-31 Performance Liquid Chromatography--Tandem Mass Spec trometry: Lab Project Number: 107949. Unpublished study prepared by Bayer Corp. 28 p.

45938501 Dyer, D.; Helfrich, K. (2000) Amicarbazone (MKH 35 86)--Small-Scale Prospective Ground-Water Monitoring Study; Corn in Minden, Nebraska, 1994: Lab Project Number: TMN-138: 109732. Unpublished st udy prepared by Bayer Corporation, ABC Laboratories and LFR Levine-Fricke , Inc. 72 p.

45938502 Helfrich, K.; Dyer, D. (2000) Amicarbazone (MKH 35 86)--Small-Scale Prospective Ground-Water Monitoring Study; Corn in Shelton, Nebraska, 1994: Lab Project Number: TMN-137: 109731. Unpublished st udy prepared by Bayer Corporation, ABC Laboratories and LFR Levine-Fricke , Inc. 76 p.

46049601 Dyer, D. (2003) Amicarbazane - Small-Scale Prospec tive Ground-Water Monitoring Study, Corn in Minden, Nebraska, 1994: P rogress Report - July 2003. Project Number: M6212402, TMN/138. Unpublishe d study prepared by Bayer Corp. 90 p.

46092401 Dyer, D.; Lewis, T. (2003) Amicarbazone - Small-Sc ale Prospective GroundWater Monitoring Study, Corn in Shelton, Nebraska, 1994: Progress Report - August 2003. Project Number: M6212401, TMN/137, G20 0636. Unpublished study prepared by Bayer Corp., Analytical Bio-Chemi stry Labs., Inc and Levine-Fricke, Inc. 250 p.

46145311 Lewis, T.; Newcombe, A. (2003) Small-Scale Prospec tive Groundwater Study of Amicarbazone (MKH3586) in Hall County, Nebraska: Final Field Phase Report. Project Number: TMN/137, M6212401, 004/1121 3/00. Unpublished study prepared by Levine-Fricke, Inc. and Bayer Cor p. and A & L Great Lakes Laboratories. 247 p.

46326001 Helfrich, K.; Dyer, D. (2004) Amicarbazone (MKH 35 86) -- Small-Scale Prospective Ground-Water Monitoring Study, Shelton, Nebraska, 1994-2000. Project Number: M6212401, 94P/121/I, 42427. Unpubli shed study prepared by Bayer Corp. and Levine-Fricke, Inc. and A & L Great Lakes Laboratories. 433 p.

46670902 Newcombe, A.; Dyer, D. (2005) Amicarbazone (MKH 35 86) - Small-Scale Prospective Groundwater Monitoring Study, Minden, N ebraska, 1994-2004. Project Number: M6212402. Unpublished study prepare d by Bayer Corp. 446 p.

46675101 Newcombe, A.; Dyer, D.; Helfrich, K. (2005) Amicar bazone (MKH 3586) - Small-Scale Prospective Groundwater Monitoring Stud y, Shelton, Nebraska, 1994-2000. Project Number: M6212401. Unpublished st udy prepared by Bayer Cropscience LP. 352 p.



### Eco Effects
850.2100 Avian Single Dose Oral Toxicity

MRID Citation Reference32

45121811 Hancock, G. (1999) MKH 3586 Technical: An Acute Or al LD(50) with Northern Bobwhite: Lab Project Number: 108742: M6711701. Unp ublished study prepared by Bayer Corp. 33 p.


### 850.2200 Avian Dietary Toxicity

MRID Citation Reference

45121815 Hancock, G. (1999) Technical MKH 3586: A Subacute Dietary LC(50) with Mallards: Lab Project Number: 108815: M6720801. Unp ublished study prepared by Bayer Corp. 49 p.

45121823 Bowers, L.; Stoughton, T. (1999) Technical MKH 358 6: A Subacute Dietary LC(50) with Northern Bobwhite: Lab Project Number: M6721701: 109211. Unpublished study prepared by Bayer Corp. 53 p.

45139603 Bowers, L.; Stoughton, T. (1999) Technical MKH 358 6: A Subacute Dietary LC 50 with Northern Bobwhite: Lab Project Number: M672 1701: 109211. Unpublished study prepared by Bayer Corporation. 53 p.

48237511 Hubbard, P.; Martin, K.; Beavers, J. (2009) Amicar bazone (MKH 3586): A Dietary LC50 Study with the Northern Bobwhite. Project Numb er: 443/126, 443/126/OCR. Unpublished study prepared by Wildlife International Ltd. 77 p.


### 850.2300 Avian Reproduction

MRID Citation Reference

45121814 Martin, K.; Beavers, J.; Jaber, M. et al. (1999) M KH 3586 Technical: A Reproduction Study with the Mallard (Anas platyrhyn chos): Lab Project Number: 109202: 149-178. Unpublished study prepared by Wild life International, Ltd. 184 p.

45121819 Gallagher, S.; Martin, K.; Jaber, M. et al. (1999) MKH 3586 Technical: A Reproduction Study with the Northern Bobwhite (Coli nus virginianus): Lab Project Number: 109203: 149-177. Unpublished study prepared by Wildlife International, Ltd. 180 p.

45139601 Gallagher, S.; Martin, K.; Beavers, J. et al. (199 9) MKH 3586 Technical: A Reproduction Study with the Northern Bobwhite (Coli nus virginianus): Lab Project Number: 149-177: 109203: 149/072498/QR.WC/S UB. Unpublished study prepared by Wildlife International, Ltd. 180 p.

48237512 Temple, D.; Martin, K.; Beavers, J.; et al. (2010) Desamino Amicarbazone: A Reproduction Study with the Mallard: Final Report. Project Number: 443/125, 443/125/OCR. Unpublished study prepared by Wildlife International Ltd. 197 p.

48237513 Temple, D.; Martin, K.; Beavers, J.; et al. (2010) N-Methyl Desamino Amicarbazone: A Reproduction Study with the Mallard : Final Report. Project Number: 443/121, 443/121/OCR. Unpublished study pre pared by Wildlife International Ltd. 198 p.33

48237514 Temple, D.; Martin, K.; Beavers, J.; et al. (2010) N-Methyl Desamino Amicarbazone: A Reproduction Study with the Norther n Bobwhite: Final Report. Project Number: 443/120, 443/120/OCR. Unpublished s tudy prepared by Wildlife International Ltd. 208 p.

48237515 Temple, D.; Martin, K.; Beavers, J. ; et al. (2010 ) Desamino Amicarbazone: A Reproduction Study with the Northern Bobwhite: Fina l Report. Project Number: 443/124, 443/124/OCR. Unpublished study prepared by Wildlife International Ltd. 205 p.


### 850.1075 Acute Toxicity to Freshwater Fish

MRID Citation Reference

45121804 Bowers, L.; Lam, C. (1999) Acute Toxicity of MKH 3 586 Technical to the Bluegill (Lepomis macrochirus) Under Static Conditions: Lab Project Number: 108803: M6810301. Unpublished study prepared by Bayer Corp. 31 p.

45121807 Bowers, L.; Franks, J. (1997) Acute Toxicity of MK H 3586 Technical to the Rainbow Trout (Oncorhynchus mykiss) Under Static Co nditions: Lab Project Number: 107803: M6812201. Unpublished study prepare d by Bayer Corp. 28 p.

45121806 Bowers, L.; Franks, J. (1997) Acute Toxicity of MK H 3586 Technical to the Sheepshead Minnow (Cyprinodon variegatus) Under Sta tic Conditions: Lab Project Number: 107744: M6832801. Unpublished study prepared by Bayer Corp. 29 p.


### 850.1010 Acute Toxicity to Freshwater Inverte brates

MRID Citation Reference

45121808 Bowers, L. (1998) Acute Toxicity of MKH 3586 Techn ical to the Waterflea (Daphnia magna) Under Static Conditions: Lab Projec t Number: M6820701: 107912. Unpublished study prepared by Bayer Corp. 2 8 p.



### 850.1025 & 850.1035 Acute Toxicity to Estuari ne/Marine Invertebrates

MRID Citation Reference

45121809 Palmer, S.; Krueger, H. (1998) MKH 3586 Technical: A 96-Hour Shell Deposition Test with the Eastern Oyster (Crassostrea virginica ): Lab Project Number: 149- 108: 108113. Unpublished study prepared by Wildlife International Ltd. 44 p.34

45121810 Palmer, S.; Krueger, H. (1998) MKH 3586 Technical: A 96-Hour Flow-Through Acute Toxicity Test with the Saltwater Mysid (Mysid opsis bahia): Lab Project Number: 149A-107: 108107. Unpublished study prepare d by Wildlife International Ltd. 44 p.


### 850.1300 Aquatic Invertebrate Life Cycle Stu dy

MRI D Citation Reference

45121822 Hall, A.; Lam, C. (1999) Chronic Toxicity of MKH 3 586 Technical to the Waterflea (Daphnia magna) Under Static Renewal Conditions: La b Project Number: M6840701: 108454. Unpublished study prepared by Bay er Corp. 50 p.

48071501 Minderhout, T.; Kendall, T.; Krueger, H. (2010) Am icarbazone (MKH 3586): A Flow-Through Life-Cycle Toxicity Test with the Clad oceran (Daphnia magna). Project Number: 443A/141. Unpublished study prepare d by Wildlife International, Ltd. 81 p.


### 850.1350 Mysid Chronic Toxicity test

MRID Citation Reference

45121601 Drottar, K.; Krueger, H. (1998) MKH Technical: A F low-Through Life-Cycle Toxicity Test with Saltwater Mysid (Mysidopsis bahi a): Lab Project Number: 149A-109: 108109. Unpublished study prepared by Wil dlife International Ltd. 58 p.

48407503 Drottar, K.; Krueger, H. (2011) MKH 3586 Technical : A Flow-Through Life-Cycle Toxicity Test with the Saltwater Mysid (Mysidopsis bahia). Project Number: 443A/146. Unpublished study prepared by Wildlife In ternational, Ltd. 80 p.


### 850.1400 Fish early-life stage toxicity test

MRID Citation Reference

48237510 Minderhout, T.; Kendall, T.; Krueger, H. (2010) AM ICARBAZONE (MKH 3586): An Early Life-Stage Toxicity Test with the Sheephea d Minnow (Cyprinodon variegatus). Project Number: 443A/142A, 443A/142A/O CR. Unpublished study prepared by Wildlife International Ltd. 90 p.

45121602 Drottar, K.; Krueger, H. (1999) MKH 3586 Technical : An Early Life-Stage Toxicity Test with Fathead Minnow (Pimephales promelas): Lab Project Number: 149A115: 108949. Unpublished study prepared by Wildlife International Ltd. 76 p.


### 850.4100 Seedling emergence35

MRID Citation Reference

45121821 Bowers, L. (2000) Tier 2 Seedling Emergence and Ve getative Vigor Nontarget Phytotoxicity Study Using MKH 3586 70WG Formulation : Lab Project Number: 109249: M6201601: M6201602. Unpublished study prepa red by Bayer Corp. 155 p.

45121826 Bowers, L.; Lam, C.; Dollinger, M. (2000) Tier 2 S eedling Emergence and Vegetative Vigor Nontarget Phytotoxicity Study Usin g MKH 3594 (a Metabolite of MKH 3586): Lab Project Number: 109480. Unpublished study prepared by Bayer Corp. 83 p.

45139602 Bowers, L. (2000) Tier 2 Seedling Emergence and Ve getative Vigor Nontarget Phytotoxicity Study Using MKH 3586 70WG Formulation : Lab Project Number: M6201601: M6201602: 109249. Unpublished study prepa red by Bayer Corporation. 155 p.

48237516 Porch, J.; Krueger, H.; Kendall, T. (2010) Desamin o Amicarbazone: A Toxicity Test to Determine the Effects of the Test Substance on Seeding Emergence of Ten Species of Plants: Final Report. Project Number : 443/127, 443/127/OCR. Unpublished study prepared by Wildlife Internationa l Ltd. 109 p.

48237517 Porch, J.; Krueger, H.; Kendall, T. (2010) N-Methy l Desamino Amicarbazone: A Toxicity Test to Determine the Effects of the Test Substance on Seedling Emergence of Ten Species of Plants: Final Report. P roject Number: 443/128, 443/128/OCR. Unpublished study prepared by Wildlife International Ltd. 107 p.


### 850.4150 Vegetative vigor

MRID Citation Reference

45121821 Bowers, L. (2000) Tier 2 Seedling Emergence and Ve getative Vigor Nontarget Phytotoxicity Study Using MKH 3586 70WG Formulation : Lab Project Number: 109249: M6201601: M6201602. Unpublished study prepa red by Bayer Corp. 155 p.

45121826 Bowers, L.; Lam, C.; Dollinger, M. (2000) Tier 2 S eedling Emergence and Vegetative Vigor Nontarget Phytotoxicity Study Usin g MKH 3594 (a Metabolite of MKH 3586): Lab Project Number: 109480. Unpublish ed study prepared by Bayer Corp. 83 p.

45139602 Bowers, L. (2000) Tier 2 Seedling Emergence and Ve getative Vigor Nontarget Phytotoxicity Study Using MKH 3586 70WG Formulation : Lab Project Number: M6201601: M6201602: 109249. Unpublished study prepa red by Bayer Corporation. 155 p.

48237518 Porch, J.; Krueger, H.; Kendall, T. (2010) N-Methy l Desamino Amicarbazone: A Toxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants: Final Report. Proje ct Number: 443/131, 443/131/OCR. Unpublished study prepared by Wildlife International Ltd. 156 p.

48237519 Porch, J.; Krueger, H.; Kendall, T. (2010) Amicarb azone 70 WDG (Amicarbazone DF): A Toxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Sugarbeet and Toma to: Final Report. Project36 Number: 443/129, 443/129/OCR. Unpublished study pre pared by Wildlife International Ltd. 68 p.

48237520 Porch, J.; Krueger, H.; Kendall, T. (2010) Desamin o Amicarbazone: A Toxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants: Final Report. Project Number: 44 3/130, 443/130/OCR. Unpublished study prepared by Wildlife Internationa l Ltd. 156 p.


### 850.4400 Aquatic plant toxicity test using Le mna spp.

MRID Citation Reference

45121805 Bowers, L.; Lam, C. (1999) Toxicity of MKH 3586 Te chnical to Lemna gibba G3: Lab Project Number: 108940: M6883701. Unpublished s tudy prepared by Bayer Corp. 34 p.



### 850.4500 Algal Toxicity

MRID Cita tion Reference

45121812 Bowers, L.; Lam, C. (1999) Toxicity of MKH 3586 Te chnical to the Freshwater Diatom Navicula pelliculosa: Lab Project Number: M6 883401: 109133. Unpublished study prepared by Bayer Corp. 39 p.

45121818 Lam, C.; Bowers, L. (1999) Toxicity of MKH 3586 Te chnical to the Marine Diatom Skeletonema costatum: Lab Project Number: 10 9125: M6883601. Unpublished study prepared by Bayer Corp. 35 p.

45121820 Hancock, G.; Lam, C. (1999) Toxicity of MKH 3586 T echnical to the Green Alga Selenastrum capricornutum: Lab Project Number: 1092 48: M6883501. Unpublished study prepared by Bayer Corp. 34 p.

45121827 Hall, A.; Lam, C. (2000) Toxicity of Desamino MKH 3594 a Metabolite of MKH 3586, to the Green Alga Selenastrum capricornutum: Lab Project Number: 108934: 98-B-202. Unpublished study prepared by Bay er Corp. 30 p.



### 850.4550 Cyanobacteria Toxicity

MRID Citation Reference

45121825 Hall, A.; Lam, C. (1999) Toxicity of MKH 3586 Tech nical to the Bluegreen Alga Anabaena flos-aquae: Lab Project Number: 108935: M6 883801. Unpublished study prepared by Bayer Corp. 37 p.


### 850.3020 Honey bee acute contact

MRID Citation Reference37

45121816 Schmitzer, S. (1998) Laboratory Testing for Toxici ty (Acute Contact and Oral LD(50)) of MKH 3586 on Honey Bees (Apis mellifera L .) (Hymenoptera, Apidae): Lab Project Number: 109350. Unpublished st udy prepared by Institute for Biological Analysis and Consulting IBACON GmbH. 28 p.38



### Appendix A. Amicarbazone Transformation Products39



### Appendix B. SIP analysis inputs and results

Table 1. Inputs Parameter Value Chemical name amicarbazone Solubility (in water at 25 o C; mg/L) 4,600

Mammalian LD 50 (mg/kg-bw) 1087 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg-bw) 6.4 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg-bw) 1965 Avian test species northern bobwhite quail Body weight (g) of "other" avian species Mineau scaling factor 1.15

Mallard NOAEC (mg/kg-diet) 27.1 Bobwhite quail NOAEC (mg/kg-diet) 27.1 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) 791.2000 791.2000 Adjusted toxicity value (mg/kg-bw) 836.0775 4.9226 Ratio of exposure to toxicity 0.9463 160.7272

Conclusion* Exposure through drinking water alone is a potential concern for mammals Exposure through drinking water alone is a potential concern for mammals

Table 3. Avian Results Parameter Acute Chronic Upper bound exposure (mg/kg-bw) 3726.0000 3726.0000 Adjusted toxicity value (mg/kg-bw) 1415.6440 1.3445 Ratio of exposure to acute toxicity 2.6320 2771.2895

Conclusion* Exposure through drinking water alone is a potential concern for birds Exposure through drinking water alone is a potential concern for birds

*Conclusion is for drinking water exposure alone. This does not combine all routes of exposure. Ther efore, when aggregated with other routes ( i.e ., diet, inhalation, dermal), pesticide exposure th rough drinking water may contribute to a total exposure that has potential f or effects to non-target animals.40



### Appendix C. STIR analysis results

Input Application and Chemical Information
Enter Chemical Name Amicarbazone Enter Chemical Use Corn, Turf, Conifers Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) ground Enter Chemical Molecular Weight (g/mole) 241 Enter Chemical Vapor Pressure (mmHg) 2.20E-08 Enter Application Rate (lb a.i./acre) 0.45 Toxicity Properties
Bird Enter Lowest Bird Oral LD 50 (mg/kg bw) 1965 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178 Mammal Enter Lowest Rat Oral LD 50 (mg/kg bw) 1087 Enter Lowest Rat Inhalation LC 50 (mg/L) 2.242 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35

O utput Results Avian (0.020 kg ) Maximum Vapor Concentration in Air at Saturation (m g/m 3 ) 2.85E-04 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 3.59E-05 Adjusted Inhalation LD 50 2.26E+01

Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.59E-06 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg ) 4.76E-02

Ratio of Droplet Inhalation Dose to Adjusted Inhala tion LD 50 2.10E-03 Exposure not Likely Significant

Results Mammalian (0.015 kg ) Maximum Vapor Concentration in Air at Saturation (m g/m 3 ) 2.85E-04 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 4.51E-05 Adjusted Inhalation LD 50 1.33E+02

Ratio of Vapor Dose to Adjusted Inhalation LD 50 3.38E-07 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg ) 5.98E-02

Ratio of Droplet Inhalation Dose to Adjusted Inhala tion LD 50 4.48E-04 Exposure not Likely Significant