### Page 1 of 65 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

MEMORANDUM Date 12/09 /201 5 Subject: Registration Review

– Preliminary Problem Formulation for Ecological Risk and

Environmental Fate, Endangered Species, and Drinking Water As sessments for Chlorophacinone

PC Code : 067707

DP Barcode : 426557

To: Christina Motilall, Chemical Review Manager

Neil Anderson, Branch Chief

Risk Management and Implementation Branch 1

Pesticide Re

- evaluation Division ( PRD )

From: Christine Hartless

, Ph.D., Wildlife Biologist

James Lin , Ph.D., Environmental Engineer

Environmental Risk Branch 2

Environmental Fate and Effects Division Office of Pesticide Programs

Through: Melissa Panger, Ph.D., Senior Advisor

Ron Parker, Senior Environmental Engineer Elyssa Arnold, Risk Assessment Process Leader

Brian Anderson

, Branch Chief

Environmental Risk Branch 2

Environmental Fate and Effects Division Office of Pesticide Programs

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

form ulation (attached) for the ecological risk, environmental fate, endangered species

, and drinking water assessment s to be conducted as part of the registration r eview of the rodenticide chlorophacinone

.

The problem formulation draws on information from b oth open literature and studies submitted by the technical registrants in response to data requirements. This document is intended to provide an overview of what is currently known regarding the environmental fate and ecological

effects associated with chlorophacinone and outlines uncertainties regarding attributes of the parent compound and its transformation products . It describes the preliminary ecological risk hypothesis and the processes that will be used during the completion of drinking water and ecological risk assessments in support of registration review

. This document also recommends

### Page 2 of 65



### studies that should be included in a data call

- in (DCI) to address uncertainties surrounding the environmental fate and potential ecolog ical effects of chloropha cinone

.

### Page 3 of 65



# Preliminary Problem Formulation for the Environmental Fate and Ecological Risk , Endangered Species

, a nd Drinking

Water Assessment s in Support of the R eg istration Review of

Chlorophacinone

2

- [2

- (4

- chlorophenyl)

- 2

- phenylacetyl]indan

- 1,3

- dione

(CAS 3691

- 35

- 8 ) (PC Code 067707 )

Environmental Risk Branch II Environmental Fate and Effects Division Christine Hartless, Ph.D., Wildlife Biologist James Lin, Ph.D. Environmental Engineer

Reviewed by: 

### Melissa Panger, Ph.D., Senior Advisor Ron Parker, Senior Environmental Engineer Elyssa Arnold, Risk Assessment Process Leader
Brian Anderson, Branch Chief U. S. Environmental Protection Agency Office of Pesticide Programs 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington, DC 20460

December 9, 2015

### Page 4 of 65 

### Table of Contents

1 EXECUTIVE SUMMARY

................................ ................................ ................................ ................................ .. 5

2 INTRODUCTION

................................ ................................ ................................ ................................ ............ 5

3 USE CHARACTERIZATION

................................ ................................ ................................ .............................. 6

4 CONCLUSIONS FROM PRE VIOUS RISK ASSESSMEN TS

................................ ................................ .................... 9

4.1 E NDANGERED S PECIES A SSESSMENTS

................................ ................................ ................................ ....................... 9

4.2 R EREGISTRATION E LIGIBILITY D ECISION

................................ ................................ ................................ ................... 10

4.3 N EW U SE A SSESSMENTS

................................ ................................ ................................ ................................ ...... 11

4.4 D RINKING WATER ASSESS MENT

................................ ................................ ................................ ............................. 12

5 ENVIRONMENTAL FATE A ND TRANSPORT

................................ ................................ ................................ .. 12

6 RECEPTORS

................................ ................................ ................................ ................................ ................. 15

6.1 T OXICITY S UMMARY

................................ ................................ ................................ ................................ ........... 15

6.2 S ECO NDARY T OXICITY

................................ ................................ ................................ ................................ .......... 17

6.3 I NCIDENT D ATABASE R EVIEW

................................ ................................ ................................ ................................ 20

7 EXPOSURE PATHWAYS OF CONCERN

................................ ................................ ................................ .......... 20

8 ANALYSIS PLAN

................................ ................................ ................................ ................................ ........... 21

8.1 S TRESSORS OF C ONCERN

................................ ................................ ................................ ................................ ...... 21

8.2 M EASURES OF E XPOSURE

................................ ................................ ................................ ................................ ..... 21

8.3 M EASURES OF E FFECT

................................ ................................ ................................ ................................ ......... 30

9 ENDANGERED SPECIES A SSESSMENT

................................ ................................ ................................ .......... 30

10 ENDOCRINE DISRUPTOR SCREENING PROGRAM

................................ ................................ ......................... 30

11 PRELIMINARY IDENTIFI CATION OF DATA GAPS

................................ ................................ ........................... 31

11.1 F ATE

................................ ................................ ................................ ................................ ........................... 31

11.2 E FFECTS

................................ ................................ ................................ ................................ ....................... 31

12 REFERENCES

................................ ................................ ................................ ................................ ............... 35

APPENDIX A: LA BEL USE INFORMATION FOR CHLOROPHACINONE BASED ON BEADS SUMMA RY REPORT

.......... 44

APPENDIX B: SUMMARY OF ECOTOXICITY DATA FOR CHLOROPHACINONE

................................ ......................... 48

APPENDIX C. SCREENI NG LEVEL MODELS TO E VALUATE POTENTIAL IM PORTANCE OF DRINKING WATER AND

INHALATION EXPOSURE PATHWAYS

................................ ................................ ................................ .................... 55

APPENDIX D. WILDLIF E MORTALITY INCIDENT S ATTRIBUTED TO USE OF CHLOROPHACINONE

........................... 58

### Page 5 of 65



# 1 Executive summary

The Environmental Fate and Effects Division (EFED) has completed the preliminary problem formulation for the ecological risk, environmental fate, endangered species, and drinking water assessments to be conducted as part of the registration review of chlorophacinone . The problem

formulation describes the met hods planned to be used during the completion of drinking water and ecological risk assessments in support of registration review and provides an overview of the environmental fate, ecological effects, and potential risks associated with the use of chlorop hacinone as well as uncertainties unique to risk assessment of chlorophacinone

. This

document also identifies additional studies that would be beneficial to the conduct of an ecological risk assessment.

Data needs for ecological effects are:

 Avian acute oral toxicity test (850.2100), one passerine species

 Avian acute oral toxicity test (850.2100), one carnivorous species

 D ata evaluating toxicity and/or bioaccumulation of chloro phacinone in terrestrial

invertebrates Additionally, an Earthworm Subchronic Toxicity Test (850.3100), has been submitted and is currently under review (MRID 47383002) . If this study is determined to be invalid, EFED recommends requesting a new earthworm study. N o additional d ata are needed for

environmental fate assessment at this time.



# 2 Introduction

Chlorophacinone is an indandione anticoagulant rodenticide. Anticoagulants are vitamin

- K antagonists that disrupt normal blood

- clotting mechanisms a nd induce capillary damage. It uncouples oxidative phosphorylation depressing hepat ic synthesis of prothrombin and clotting factors VII, IX and X and, it causes direct damage to capillary permeability. Typically, death is delayed for four to ten or more days after a lethal dose is ingested, and animals may continue to

feed and move about until shortly before death. Death results from hemorrhage, and exposed animals may exhibit behavior that may make them more susceptible to predation (Cox and

Smith

, 1992). This may result in secondary exposure to predatory animals. Chlorophacinone is

me tabolized by vertebrate animals that have eaten bait, but some is sequestered in various body tissues for days or weeks.

The anticoagulant rodenticides registered in the United States have been grouped into "first

generation" (warfarin, chlorophacinone, diphacinone) and "second

- generation" (brodifacoum,

d ifenacoum

, bromadiolone, difethialone) compounds. Although there is overlap in their metabolic and toxicological properties, s econd

- generation anticoagulants tend to be more acutely

toxic than are the fi rst

- generation anticoagulants, and they are retained longer in body tissues. The greater potency and duration of action of long

- acting anticoagulant rodenticides is attributed to their: (i) greater affinity for vitamin K(1)

- 2,3

- epoxide reductase; (ii) abil ity to disrupt the vitamin K(1)

- epoxide cycle at more than one point; (iii) hepatic accumulation; and (iv) unusually long biological half

- lives due to high lipid solubility and enterohepatic circulation (Watt et al. 2005).

### Page 6 of 6 5



### EFED evaluated the most recent ecological risk assessments for chlorophacinone 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. In addition, EFED

co nsidered the latest Agency science policies and risk assessment methodologies. The structure

of chlorophacinone , as well as the chemical names and other identifiers can be found in the chemical identity table in Section 5 of this document.



# 3 Use Characterization

Table 1 summarizes the Section 3 labeled use patterns and bait concentrations for given groups

of target species. Details for individual products are not included; however, this table provides characterization for the expected use pattern s of chlorophacinone. In addition to the Section 3 labels, there are currently nine Section 24C labels for 0.005% chlorophacinone baits target ing :

 California and montane voles, California ground squirrels, chipmunks, black t ailed jackrabbits, and muskrats in California;

 Norway rats, roof rats, Polynesian rats, and house mice in Hawaii;

 voles in Idaho (aerial application);

 Columbian and Richardson’s ground squirrels in Montana;

 mountain beaver in Oregon and Washington; and

 meadow and mountain voles in Washington (aerial application). In addition, there are two Section 24C labels for 0.01% chlorop hacinone bait s targeting California Ground Squirrels , California voles, montane voles, pocket gophers, deer mice, and

house mice in California.

Since there is no national level usage data for this chemical, no Screening Level Usage Analysis (SLUA) is available for chlorophacinone (067707 ). Appendix A lists the maximum use patterns
for the labeled use sites. The table is based on the “EFED Table 1 Report,” which is a part of the Label Use Report Package created by BEAD in support of Registration Review (USEPA, 2015). Prior to the registration review assessment, the label review will be updated.

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### Table 1. Overview of Section 3 Labels for Chloro phacinone

Target Species % a .i. Bait form General Use pattern Use Sites Maximum application rate and re

application interval

House mouse ( Mus

musculus ), Roof rat ( Rattus rattus ), Norway rat ( Rattus norvegicus ), Cotton rat ( Sigmodon hispidus )

, Meadow vole

, ( Microtus

p ennsylvanicus )

, Eastern

harvest mouse ( Reithrodontomys humuli )

, White

- throated woodrat ( Neotoma albigula )

, Golden mouse ( Ochrotomys nuttalli )

, Southern plains woodrat ( Neotoma micropus )

, Polynesian rat ( Rattus

exulans ), and/or Mexican woodrat ( Neotoma mexicana ) 0.005 Bait block, pellet, treated grain, place pack Use indoors and within 100

feet of man

- made structures.

Must use bait station for outdoor above ground use or

when children or no n

- target
mammals or birds can access

the bait. Some labels restrict

use indoors. Some labels permit use in sewers. Some labels permit use in rat burrows. Some labels permit use >100 ft from buildings (for along fence lines, gullies, railroads, etc.) Indoor and

within 100 feet

of man

- made

structures (residential, commercial, agricultural, industrial, public buildings, ships/boats) Refill/replace bait boxes as needed.

House mouse

, Norway rat,

and Roof rat 0.2 Tracking powder Use indoors or in rat burrows

leading indoors. Indoor or in rat burrow leading

indoors. For House mice use at the rate of 1 oz.

powder per 2.5 sq. ft. of runway area. For Norway and Roof rats use at the rate of 2 oz. powder for 2,5 sq. ft. of runway area. Repeat

treatment if burrows ar e reopened. Maintain powder in treated areas for at least 20 days. Repeat treatment when infestation recurs.

Where a continuous source of infestation is present, establish permanent tracking powder stations and replenish the powder as needed.

Pocket gopher ( Geomys spp

. and Thomomys spp.) 0.005 Pellet or treated grain Applied underground to

burrow system by hand or by

mechanical burrow builder Lawns, golf courses, alfalfa fields, rangeland,

orchards and groves, and non

crop areas Maintain a constant s upply of bait for long as

there is gopher activity.

### Page 8 of 65

Vole ( Microtus spp.) H and spot bait , mechanical

g round broadcast Orchards, non

crop areas, nurseries, tree and forestry plantations. Broadcast application

– apply 10 lbs.

product/acre with 2 nd application one month later, if needed. For some labeled sites, max application rate of 20 lbs product/acre/application and 40 lbs product/acre/year.

Black tailed prairie dog ( Cynomys ludovicianus) Place 1/4 cup bait at least 6

inches into burrow Rangeland and adjacent non

crop areas If needed, may make second application

several weeks or months later.

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# 4 Conclusions from Previous Risk Assessments

The Agency has conducted previous ecological risk assessments on chlorophacinone that serve as a basis for this problem formulation. They are briefly summarized below.



## 4.1 Endangered S

pecies Assessments

An endangered species risk assessment for chlorophacinone was completed in 2010 (USEPA 2010). This ecological risk assessment and effec ts determination was specific to Rozol Prairie Dog Bait (EPA Reg. No. 7173

- 286) to address potential product

- specific risks raised in pending litigation, Defenders of Wildlife v. U.S. EPA 1 

### . In this assessment, a “may affect, and likely to adversely affect ” (LAA) determination was made for the following federally listed species: grizzly bear ( Ursus arctos horribilis ), American burying beetle ( Nicrophorus americanus ), Salt Creek tiger beetle ( Cicindela nevadica lincolniana ), California condor ( Gymnogyps californianus ), whooping crane ( Grus americana ), Eskimo curlew ( Numenius borealis ), northern Aplomado falcon ( Falco femoralis septentrionalis ), black

- footed ferret ( Mustela nigripes ), Chiricahua leopard frog ( Rana chiricahuensis ), jaguar ( Panthera onca ), G ulf Coast jaguarundi ( Herpailurus yagouaroundi cacomitli ), Canada lynx ( Lynx Canadensis ), Preble’s meadow jumping mouse ( Zapus hudsonius preblei ), ocelot ( Leopardus pardalis ), Mexican spotted owl ( Strix occidentalis lucida ), piping plover ( Charadrius melod us ), New Mexican ridge

- nosed rattlesnake ( Crotalus willardi obscurus ), Sonora tiger salamander ( Ambystoma tigrinum

stebbinsi ) black

- capped vireo ( Vireo atricapilla ), golden

- cheek warbler ( Dendroica chrysoparia ), and gray wolf ( Canis lupus )

. In addition, th e assessment found the action was expected to result in modification of designated critical habitat for the Salt Creek tiger beetle, whooping crane , Canada lynx, Preble’s meadow jumping mouse, Mexican spotted owl, piping plover, and New Mexican ridge

- nosed rattlesnake because these critical habitats overlap with the use area of Rozol Prairie Dog Bait

.

An endangered species risk assessment was completed in 2011 (USEPA 2011) to address potential risk to the 

### Salt marsh harvest mouse (SMHM) ( Reithrodontomys raviventris ), San Joaquin Kit Fox ( SJKF) ( Vulpes macrotis mutica ), Alameda Whipsnake (AW) ( Masticophis lateralis euryxanthus ), and California Tiger Salamander (CTS) ( Ambystoma californiense ) for which chlorophacinone was alleged to be of concern in a complaint made by the Center for Biological Diversity against United States Environmental Protection Agency on May 30, 2007 (Case No: 07

- 2794

- JCS)

. Based on the best available information, the Agency made a “ May Affect, and Likely to Adversely Affect” dete rmination for the SMHM, SJKF, AW, and CTS from the all uses of chlorophacinone. Additionally, the Agency determined that there was the potential for modification of design ated critical habitat for the AW and CTS from the use of chlorophacinone.

1 Defenders of Wildlife v. U.S. EPA, Case No. 09

- 1199 (D.C. Cir., 2009); Defenders of Wildlife v. Jackson , Case

No. 09

- cv

- 1814 (D.D.C., 2009); NRDC v. U.S. EPA , Case No. 10

- cv

- 1063, (D.D.C., 2010).

### Page 10 of 65



## 4.2 Reregistr

ation Eligibility Decision

The Reregistration Eligibility Decision (RED) for chlorophacinone was published in 1998 as part of the rodenticide cluster (USEPA, 1998b). The RED found that all uses of chlorophacinone except for field rodenticide uses involvi ng baits with chlorophacinone concentrations greater than 0.005% were eligible for reregistration. In addition, the RED found that all rodenticides must incorporate an indicator dye and a bittering agent. Both these measures were intended to help reduce hu man exposure. Other mitigation measures included improved label language regarding placement of bait stations around buildings, submission of information on poisonings, restricted use classification of tracking powders and baits, and the formation of a sta keholder group to investigate safer use technologies.

“Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: a Comparative Approach” (USEPA 2004b) evaluated primary and secondary exposure of chlorophacinone, among other rodenticides, to birds and mammals. This assessment determined that the

gr eatest risk of chlorophacinone use to non

- target animals is via primary and secondary exposure to mammals. Risk associated with primary and secondary exposure to birds, however, was also of concern. These elements provide the general framework for this

a ssessment and are supported through the calculation of RQs in this assessment. The study also specified a number of factors contributing to uncertainty in assessing anticoagulant rodenticides. Those factors that contributed the most uncertainty were: (1) missing data, including acute, chronic, and secondary toxicity as well as data regarding retention of some active ingredients in the liver, blood, and other body tissues; (2) the variable quality and quantity of existing data on metabolism and retention t imes in rodents and non

- target species; (3) specific use information by formulation, including typical amounts applied by use site, seasonally, and annually; distances applied from buildings; amounts used in rural versus urban areas; use by Certified Appli cators versus homeowners and other non

- certified applicators; and other such relevant information; (4) information on the number and species

of birds and non

- target mammals frequenting baited areas and the likelihood of their finding and consuming bait or poisoned primary consumers in the various use areas; (5) methods to determine liver concentration(s) and total body burdens of rodenticide that would

corroborate death or even if such a cause

- effect relationship is appropriate (e.g., the
“threshold of toxi city” concentration); (6) not accounting for the impacts of sub

- lethal effects on reproduction and non

- target mortality (e.g., clotting abnormalities, hemorrhaging, stress factors including environmental stressors, such as adverse weather conditions, food shortages, and predation); (7) not accounting for bioaccumulation of repeated sub

- lethal exposures to bait or poisoned rodents utilized as food by predators and scavengers; and (8) lack of incident reporting. All of the above issues remain as uncertaintie s for this

assessment.

In 2008, EPA released the Risk Mitigation Decision for Ten Rodenticides (RMD) (EPA 2008

, Docket ID EPA

- HQ

- OPP

- 2006

- 0955 ). Chlorophaci n one products were included in the list of ten

rodenticides addressed in this document. The focus of this decision was: 1) T o minimize children’s exposure to rodenticide products used in homes by requiring that all rodenticide bait products marketed to general and residential consumers be

### Page 11 of 65 

### sold only with bait stations, with loose bait (e.g., pellets and me al) as a prohibited bait

form. 2) To reduce wildlife exposures and ecological risks, by requiring sale and distribution limits intended to prevent general consumers from purchasing residential use bait products containing four of the ten rodenticides that po se the greatest risk to wildlife (the second generation anticoagulants

– brodifacoum, bromadiolone, difenacoum, and difethialone). Moreover, bait stations will be required for all outdoor, above

- ground uses of these second generation anticoagulants.

EPA u pdate d its previous risk assessment findings conducted in support of the May 2008 RMD through the application of additional effects and exposure data, use of additional exposure modeling, and quantitative risk assessment techniques for the four rodenticide s subject to the Notice of Intent to Cancel ( NOIC ) (brodifacoum, difethialone, warfarin and bromethalin) and for

two rodenticides that are likely alternatives (i.e., active ingredients included in products with

RMD

- compliant registrations for commensal rod ent control, specifically, chlorophacinone and diphacinone; bromethalin has both compliant and non

- compliant registrations). To support the NOIC, EPA conducted an extensive assessment of the potential for primary and secondary

effects of the rodenticides under evaluation. This work was brought before the Science Advisory Panel (SAP) in 2011 for review ; meeting materials are available under docket number EPA

- HQ

OPP

- 2011

- 0718

.



## 4.3 New Use Assessments

The most recent Section 3 New Use assessment was completed in 2011 for a proposed use of chlorophacinone on California ground squirrels (CGS) (DP Barcode D377940 ). The risk

assessment suggested that chlorophacinone presents a risk to both endangered and non

endangered species of terrestrial animals, including mammals, birds, terrestrial

- phase amphibians, reptiles, and invertebrates

. There was a potential for direct effects to listed terrestrial animals (vertebrates and invertebrates) through consumption of bait or prey that have eaten bait. Consequently, there is a potential concern for indirect effects upon the listed organisms due to decreased prey availability and habitat modification (for individuals that use the CGS burrows). After removal of the CGS, many vacant burrows may be available in the treated area . This could have either a positive or negative effect on listed species residing in or near the treated areas. Risks to aquatic organisms, as well as to aquatic plants, were not expected for this proposed use of chlorophacinone. Toxicity data were not ava ilable for aquatic or terrestrial plants. However, given the mode of action of chlorophacinone, direct toxicity to plants, and thus the risk, is expected to be low. Terrestrial plants that rely on animals for pollination and seed dispersal do have the pote ntial to experience indirect effects through reduction in the animals that perform

those functions.

### Page 12 of 65



### Data gaps were evaluated at the time of the Section 3 assessment for chlorophacinone on CGS

and were assigned a low or high potential to add value to the ecological risk assessment. While still considered data gaps according to 40 CFR Part 158, low potential studies are unlikely to change risk determinations because alternate methods and weights of evidence ( i.e., acute

- to

chronic ratio, scaling factors, or consideration of environmentally relevant concentrations relative to effects thresholds) may possibly be used in the absence of data. High potential studies are needed to better characterize potential risks by eliminating uncertainties for both non

- listed and listed species that cannot be accounted for using alternate methods or weights of evidence

. Studies with a high potential to add value to the risk assessment were :

 Field Testing for Terrestrial Wildlife (850.2500)

 Avian Reproduction Study (850.2300), two species

 Avian Acute Oral Toxicity Test (850.2100), one passerine species.

Studies with a low potential to add value to the risk assessment are:

 Seedling Emergence, Tier II (850.4225 ), ten species

 Vegetative Vigor, Tier II (850.4250) , ten species

 Soil photolysis (835.2410)

 Aqueous photolysis (835.2240)

 Aerobic aquatic metabolism (835.4300)

 Anaerobic aquatic metabolism (835.4400)

 Freshwater Fish Early Life

- Stage Toxicity Test (850.1400)

 Freshwater Invertebrate Life Cycle Toxicity Test (850.1300)

 E stuarine/Marine Fish Acute Toxicity Test (850.1075 )

 Estuarine/Marine Fish Early

- life Stage Toxicity Test (850.1400)

 Aquatic Plant Toxicity Test Using Lemna spp.,Tiers I and II (850.4400)

 Algal Toxicity, Tiers I and II (850.5400), four species Two avian rep roduction studies (850.2300) were submitted to the Agency after the Section 3 New Use assessment was completed, and both have been reviewed. These studies will be

included in the Registration Review risk assessment (MRIDs 48994001 and 48994002 ).



## 4.4 Drinking water assessment

The previous assessments concluded that due to the application amounts and methods of chlorophacinone, the exposure of surface water or ground water is unlikely. No drinking water

assessments have been conducted

.



# 5 Environmental Fate and Transport

Chlorophacinone, 2

- [2

- (4

- chlorophenyl)

- 2

- phenylacetyl]indan

- 1,3

- dione, may be considered moderately persistent (aerobic soil metabolism half

- lives on the order of weeks) and hardly mobile (K
oc 

### = 20,300 L∙kg

- 1 

### ) in the environment. The major rou te of dissipation appears to

aerobic soil metabolism.

The molecule has two chiral centers, one on the 9 carbon of the indanone and the second at the

### Page 13 of 65



### carbon which joins the two phenyl rings ( Figure 1 ). The stereo chemistry at these two chiral

centers is n ot known and no data are available to describe the differential stereochemical properties.

Figure 1

. Structure of chlorophacinone.

Physical and chemical properties of chlorophacinone are summarized in Table 3 . There is no

evide nce that chlorophacinone degrades by hydrolysis at pHs of 7 and 9. At pH 5, chlorophacinone degrades slowly, with a half

- life of 232 d. Previous assessments indicated a rapid degradation of chlorophacinone by photolysis; however, both of these studies (MRI D 42205502 for aqueous photolysis and MRID 42452301 for soil photolysis) used acetone as a solvent to introduce chlorophacinone into the test system. As acetone is a strong photosensitizer, the results of these are likely not related to actual photodegrada tion rates in the environment and

both studies are now classified as invalid. The half

- life values of aerobic metabolic degradation

in soils are 47.2 days and 17.0 days, respectively for sandy clay loam and sandy loam (MRID 43159801)

. Data on aquatic metabolism are not available; therefore, actual persistence in

water/sediment is not known. However, persistence in aquatic systems is often similar to persistence in soil.

Chlorophacinone has two identified minor degradates: o

- phthalic ac id and p

- chlorophenylphenyl

acetic acid ( Table 4. ). Both degradates were found in the hydrolysis study at pH 5 and the aerobic soil metabolism study. A comparison of the structures of these two degradates with those of the parent and other anticoagulant ro denticides suggest that the toxic moiety is no longer present in these degradates.

There were three major degradates, CO 2 

### and two that were not identified. The first unidentified degradate was observed at 11.7% in the pH 5 hydrolysis study, and 0.9% from aerobic soil metabolism study. The second unidentified degradate was material at the origin of the thin

- layer chromatograms at 10.5%. Occurrence at the origin of the chromatogram suggests that material was either very polar, or very immobile. Often this m aterial is composed of a mixture of compounds, so that it may not, in fact be, a single major degradate. Since the structures for these degradates are not known, the nature of their toxicity cannot be assessed.

Chlorophacinone is hardly mobile in the env ironment based on four batch equilibrium studies. Adsorption to soil is significantly correlated with soil organic carbon content with a K
oc 

### of

### Page 14 of 65



### 20,300 L∙kg

- 1 

### based on the regression of the adsorption coefficient, K d 

### , with the soil organic carbon content (R 2 

### = 99.4%) Due to chlorophacinone’s limited immobility in soil, it is

reasonable to conclude it is relatively immobile within bait formulations. Chlorophacinone baits typically retain the parent compound even after exposure to wet weather and moisture (Mer son and Byers 1985). This means that movement in the environment will be minimal while chlorophacinone is still absorbed to the bait or on eroded sediment. A ny material that is transported into water bodies by erosion may remain sorbed onto soil particles and settle to the bottom of the receiving lake or stream bed. Chlorophacinone has a relatively low octanol

- water partition coefficient of 94, and consequently is not expected to bioaccumulate. The vapor pressure is also low ( 3.58 x 10

- 6 

### torr ) , indicating that chlorophacinone is not expected to

volatilize.

Table 3. Physical

- chemical Properties of Chlorophacinone

Study Value and units Source

CAS Number 3691

- 35

- 8

SMILES Code c12ccccc1C(=O)C(C(=O)C(c3ccccc3)(c4cc(Cl)ccc4)) C2(=O) Molecular weight 374.81 calculated Hydrolysis pH 5 : 232 d pH 7 : no evidence of degradation pH 9: no evidence of degradation MRID 42205501

Solubility 3

. 4 3 mg/L @ 25oC MRID 42237401

A erobic Soil Metabolism T 1/2 = 47.2 days; sandy clay loam

T 1/2 = 17.0 days; sandy loam MRID 43159801

Soil Water Partition

Coefficient Sassafras sand: K f = 56 ; 1/n = 1.09 Hesperia loam: K f = 126; 1/n = 1.23 Sequatchie sandy clay loam: K f = 183; 1/n = 1.22 Sharkey clay: K f = 1000; 1/n = 1.14

K
oc = 20,299 L∙kg

- 1 MRID 42666001

MRID 42205503

Vapor pressure 3.58 x 10

- 6 torr MRID 42237401 Henry’s law constant 5. 12 x 10

- 7 atm∙ m 3

∙ mol

- 1 calculated

K
ow 94 .5 MRID 42237401

### Page 15 of 65



### Table 4. Major and minor chlorophacinone degradates and the maximum amounts found in degradation studies. Compound Hydrolysis Aerobic Soil Metabolism

o

- phthalic acid 0.7% @ 30 d 9.8% @70 d

p

- chlorophenylphenyl acetic

acid 0.4% @ 14 d 5.4% @ 14 d

Unknown 1 11.7% @ 14 d (pH 5) 0.9% @ 30 d

Unknown 2

-- 10.5% @ 30 d

CO 2



### -- 64% @ 70 d



# 6 Receptors

6.1 Toxicity Summary

Table 5 provides a summary of the taxonomic groups and the surrogate species tested to characterize the potential acute and chronic ec ological effects of chlorophacinone

. In addition, the table provides a preliminary overview of the potential acute toxicity of chlorophacinone by providing the acute toxicity classifications. No ecotoxicity data are available for any degradates

of chlorop hacinone

.

Chlorophacinone is moderately toxic to birds on an acute oral basis, practically highly toxic to birds on a subacute dietary exposure basis, and very highly toxic to mammals on an acute oral exposure basis. Data on the toxicity of chlorophacinon e to terrestrial plants have not been submitted to the Agency.

Technical grade chlorophacinone is classified as highly toxic to freshwater fish and invertebrates on an acute exposure basis. Acute estuarine/marine fish and invertebrate data as well as c h ronic exposure effect data to chlorophacinone for fish and invertebrates have not been submitted to the Agency. In addition, no acceptable or supplemental toxicity data for aquatic plant studies have been submitted to the Agency.

### Page 16 of 65



### Table 5

. Most Sensitive Test Species Evaluated for Assessing Potential Ecological Effects

of Chlorophacinone

.

Taxonomic Group Study Type Tested Species Toxicity Endpoint Acute Toxicity

Classification /

NOAEC most sensitive endpoint ( s ) MRID and

Classification

Birds 1 Acute oral Northern

bobwhite

Colinus virginianus LD 50 = 258 mg a.i./kg

- bw

Slope = 2.88 Moderately toxic.

Mortalities occurred ≤5 days after gavage, observed 30 days 41513101
(Acceptable)

Dietary Northern

bobwhite LC 50 = 56 mg a.i./kg

- diet

Slope = 1.49 Highly toxic.

Mortalities occurred ≤9 days after test start, observed 30 days 41513102 (Acceptable)

Chronic Mallard duck

Anas platyrhynchos NOAEC = 0.046 mg a.i./kg

diet NOAEC based on

reduction in mean 14

- day survivor weights at 0.096 and 0.96 mg a.i./kg

- diet treatment

levels 489904002 (Acceptable)

Mammals Acute oral

(single dose) Black

- tailed

Prairie Dogs Cynomys

ludovicianus LD 50 = 1.94 mg a.i./kg

- bw Very highly toxic. Single dose,

mortalities occurred 9 to 22 days after dosing 47333601 Supplemental

Acute oral (5

- day

exposure, multiple doses) Laboratory Rat

Rattus norvegicus 5

- day LD 50 = 0.8 mg

a.i./kg

- bw Multiple dose; doses of 0.16 mg a.i./kg

- bw

were administered daily for 5 consecutive days equal the LD 50 dose

. Ashton, et al

. (1986) Supplemental (Qualitative )

Dietary (5

- day exposure) Laboratory Rat LC 50 = 1.14 mg a.i./kg

- diet Slope = 7.19 Mortalities occurred

4

- 9 days after test start, animals observed 9 days. Teeters 1981 (TNM 117) 3 (Supplemental)

Chronic 4 Rabbit Developmental NOAEL = 10 μg/kg

- bw/day Developmental Gavage Exposure (daily from days 7 to 19 of gestation) Endpoint based lack

of sufficient

fetuses/litters at the higher dose levels as high maternal mortality was

observed

. 43570801 (Acceptable)

Terrestrial

invertebrates Acute

contact Honey bee No data

Earthworm

LC 50 > 1000 mg ai/kg

- soil NOAEC (mortality) = 309 mg ai/kg

- soil

NOAEC (weight change) < 95 mg ai/kg

- soil 47383002

Under review

Freshwater

fish 2 Acute Rainbow trout (Oncorhynchus mykiss) 96

- hr LC 50 = 452 μg/L

(416, 494) Slope = 16.3 (9.3, 23.2) highly toxic 42356103 (Acceptable)

Chronic No data

Freshwater

invertebrates Acute Water flea ( Daphnia magna) 48

- hr EC 50 = 640 μg/L

(538, 808) Slope = 5.1 (2.8, 7.4) highly toxic 42356101 (Acceptable)

Chronic No data

### Page 17 of 65



### Table 5

. Most Sensitive Test Species Evaluated for Assessing Potential Ecological Effects

of Chlorophacinone

.

Taxonomic Group Study Type Tested Species Toxicity Endpoint Acute Toxicity

Classification /

NOAEC most sensitive endpoint ( s ) MRID and

Classification

Estuarine/

marine fish Acute and

Chronic No data

Estuarine/

marine

invertebrates Acute and

Chronic No data

Terrestrial plants Seedling

emergence No data

Vegetative vigor No data

Aquatic plants and algae Vascular No data

Non

vascular No data

1 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

2 F reshwater fish are used as surrogates for aquatic

- phase amphibians.

3 T eeters, W.R. (1981) Chlorophacinone technical: Toxicity to Laboratory Rat: Test No. 117. (U.S. Environmental Protection Agency, Pesticides Regulation Div., Agricultural Research Center, Animal Biology Laboratory, unpublished report.)

4 Developmental toxicity study will be use d as to evaluate chronic mammalian toxicity as a two

- generation rat study is not

available.



## 6.2 Secondary Toxicity

Secondary toxicity was evaluated in the laboratory setting by exposing carnivorous birds and

mammals through the dietary route. Test animals were fed chloroph acinone in whole or ground carcasses, which were usually those of rats or mice, or in fortified meat. Most prey animals were fed treated bait, although some were dosed orally. Mortality was included as a measurement endpoint in all studies. Some studies also reported signs of toxicosis ( e.g., bleeding, prolonged

blood

- coagulation time, abnormal behavior, or regurgitation) in surviving test animals. Although exposure scenarios, test species, and the nu mber of test animals varied among the studies, collectively these studies provide useful information to characterize secondary hazards from

short

- term exposure. Though these types of secondary exposure studies provide information on the potential effects f

rom chloro phacinone exposure that may occur under field conditions, it is often not possible to quantify the level of exposure (rodenticide residues in primary consumers or food consumption by secondary consumers) or the sensitivity of the exposed animals to the

rodenticide.

No deaths were recorded in the secondary bird exposure studies that involved birds from ten
different species ( Table 6 ) ; however, many birds exhibit ed signs of chlorophacinone toxicity including instances of external bleeding and internal hematoma, as well as increased blood coagulation time . In secondary mammal exposure studies, 27 (49%) of 55 test mammals died after feeding on rodents fed chloro phacin one. Species affected included mongoose, coyote, European ferret, red fox, and weasel ( Table 7 ).

### Page 18 of 65



### Table 6 . Observed Effects of Chlorophacinone on Birds Consuming Contaminated Carcasses

Secondary species Prey offered to birds No. prey offered daily per bird No. days birds

exposed No. birds

exposed No. birds

dead No. survivors

with signs of chlorophacinone toxicity a Reference

(MRID)

Barn owl Rats fed choice of

0.005% bait or untreated bait for 5 days 1

- 2 10 2 0 0 Mendenhall and

Pank 1980

MRID # 46750931

Black

- billed magpie Rats fed 0.005% bait for

5 days Ad libitum 5 20 0 0 Baroch 1997

MRID# 44631402

American

kestrel Voles fed 0.01% bait

until dead 1 1 every 3 days 21

61 10

10 0

0 10 (eb/ih)

10 (eb/hi) Radvanyi et al.

1988 ( E39765 )

Red

- tailed

hawk Voles fed 10 g 0.0005%

bait daily up to 9 days 2 6 5 0 0 Askham 1988

E73126

Askham and Poch é

1992 Great horned

owl Voles fed 10 g 0.0 05%

bait daily up to 9 days 2 6 1 0 0

Tawny owl Mice fed 0.0075% bait b Ad libitum 10 4 0 (ct)

Riedel et al. 1991 c Eurasian

buzzard Mice fed 0.0075% bait b Ad libitum 7

10

5

- 5

- 5 d

40 4

6

3

3 0

0

0

0 (ct)

(ct) (ct) (ct)

Carrion crow Mice fed 0.0075% bait b Ad libitum 10 4 0 (ct)

Eurasian

buzzard Mice fed 0.0075% bait b 4 7 4 0 0 Anonymous 1978 c

Carrion crow Mice fed 0.0075% bait b 3

- 4 3

5 12

12 0

0 0

0 Sterner 1978 c

White stork Mice fed 0.0075% bait b Ad libitum (treated/untreated) 3

14 3

3 0

0 1 or 2 (ct)

1 or 2 (ct)

a eb = external bleeding; ih = internal hematoma; bl = bleeding (unspecified); ct = increased blood coagulation time; nr = not reported

b baits registered in the U.S. are either 0.005% or 0.01% a.i.

c Cited in US EPA (2004) Potential Risks of Nine Rodentici des to Birds and Nontarget Mammals: a Comparative Approach and Joermann 1998

d the 3 5

- day treatment periods are separated by 3 days when the birds were fed untreated mice

### Page 19 of 65



### Table 7 . Observed Effects of Chlorophacinone on Mammals Consuming Contaminated Carcasses

Secondary species Prey offered to

mammals No. prey offered

daily per

mammal No. days

mammals exposed No.

mammals exposed No.

mammals

dead No. survivors

with signs of chlorophacinone toxicity a Reference

(MRID)

Mongoose Rats fed 0.005% bait

for 5 days 1 1

3

5

6

7

9

10 1

1

2

1

1

1

1 0

1

2

1

1

1

1 nr

no survivors

no survivors

no survivors

no survivors

no survivors

no survivors Pank and Hirata

1976

MRID# 2467

Coyote Ground squirrels fed

15 g of 0.01% bait for 6 days 1 5 7 3 0 Marsh and Howard

1986

MRID# 42760902 European

ferret Rats fed 0.005% bait

for 5 days Ad libitum 5 20 11 nr Ahmed et al. 1996

MRID# 44631401

European

ferret Prairie dogs fed 25 g

of 0.0025% bait daily for 6 days c 4 (1 every other day) 8 6 5 nr Fisher and Timm

1987

European

ferret Voles/mice fed

0.0075% bait c 5 total 4 2 1 d (ct) Bachhuber and

Beck 1988 f Red fox Mice fed 0.0075%

bait c 20 total 4 1 1 e no survivors

European

ferret Muskrats fed 0.0075%

bait c Ad libitum 4

8 2

1 0

1 1 (bl)

no survivors Jobsen 1798 f

European

ferret Voles fed 0.0075%

bait c Ad libitum 3 4 0 (ct) Anonymous 1983 f

Weasel Mice fed 0.005% bait Ad libitum 90 4 3 0 Anonymous 1981 f

a eb = external bleeding; ih = internal hematoma; bl = bleeding (unspecified); ct = increased blood coagulation time; nr = not reported

b ground squirrels were fed no

- choice for 3 days followed by 3 days in which they had a choice of bait or untreated labor atory chow

c baits registered in the U.S. are either 0.005% or 0.01% a.i.

d individual recovered from moribund state after administration of antidote, but assumed ‘dead’ without antidote treatment

e individual was sacrificed but considered ‘dead’ based on coagulation index

f Cited in US EPA (2004) Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: a Comparative Approach and Joerma nn 1998

### Page 20 of 65



## 6.3 Incident Database Review

A th orough review and analysis of available incident reports for all registered anticoagulant rodenticides was completed in 2013 , and a summary of the 18 chloro phacin one wildlife incidents reported with a certainty of possible, probable , or highly probable is included in Appendix C

. This means that, at a minimum, there was supporting evidence ( e.g ., hemorrhaging) and/or residue data to indicate that the wildlife involved in the incident was adversely affected by exposure to an anticoagulant rodenticide and/or a n independent wildlife specialist, based on findings of a necropsy examination and toxicological analysis, identified an anticoagulant rodenticide as the cause of death in the incident report.

The reported avian species include herbivorous geese, granivor ous /insectivorous quail and turkeys, as well as carnivore/scavenger birds that include the barn owl, turkey vulture, bald eagle, and red

- tailed hawk. The reported mammalian species include herbivoro us and granivorous squirrels. Omnivorous mammals such as a raccoon and carnivores including the badger, coyote, and bobcat, were also cited in the reported incidents.

Although most of the reported wildlife incidents involve animals found dead, there are several rodenticide incidents that involve incapacitated animals (most of which died after being found). They demonstrate that animals exposed to rodenticides may be incapacitated in ways that would almost certainly make them more vulnerable to predators and accidental deaths ( e.g., car or window strikes). If an animal dies due to predation or an accident, their death may not necessarily be attributed to a pesticide, even if it is a contributing factor.



# 7 Exposure Pathways of Concern

The environmental fate properties and use patterns of chlorop hacinone indicate that non

- target consumption of bait, consumption of individuals that have consumed bait, and runoff represent potential transport mechanisms of chloro phacinone to aquatic and terrestrial organisms.

Drinking water and inhalation exposur e pathways were screened using the SIP (Screening Imbibition Program) and STIR (Screening Tool for Inhalation Risk) screening methods SIP and

STI R are described in detail at: http://www2.epa.gov/pesticide

- science

- and

- assessing

- pesticide

risks/models

- pesticide

- risk

- assessment#terrestrial

. The drinking water pathway was found to be an exposure pathway of potential concern for acute and chronic risks to mammals as well as chronic risks to birds due to high solubility and high toxicity of chlorophacinone. The inhalation exposure pathway was found not to be an exposure pathway of concern for birds due to the low volatility of chlo rophacinone

. SIP and STIR results are presented in Appendix B

.

### Page 21 of 65



# 8 Analysis Plan

8.1 S tressors of Concern

8.1.1 Ecological Risk

For this registration review, t he stressor of ecological concern for terrestrial and aquatic organisms is parent chlorophacinone

.

Chlorophacinone has two identified minor degradates: o

- phthalic acid and p

- chlorophenylphenyl

acetic acid ( Table 4 ). Both degradates were found in the hydrolysis study at pH 5 and the aerobic soil metabolism study. A comparison of the structures of these t wo degradates with those of the parent and other anticoagulant rodenticides suggest that the toxic moiety is no longer present in these degradates.

There were three major degradates, CO 2 

### and two that were not identified ( Table 4 ). The first unidentified degradate was observed at 11.7% in the pH 5 hydrolysis study, and 0.9% from aerobic soil metabolism study. The second unidentified degradate was material at the origin of

the thin

- layer chromatograms at 10.5%. Occurrence at the orig in of the chromatogram suggests that material was either very polar, or very immobile. Often this material is composed of a mixture of compounds, so that it may not, in fact be, a single major degradate. For the outdoor

uses of chloro phacinone, it is formu lated in pelleted bait or weather

- resistant rodenticide products, it is probable that contact of this degradate with soil and water will be minimal. Furthermore,

b ecause risk is expected to result from direct consumption of bait products or from consumpti on of prey which directly consumed the bait, the formation of degradation products in the soil and water is not a major concern in this assessment. Risk from the unidentified degradates was, therefore, not quantified.

8.1.2 Drinking Water

The previous assess ments concluded that due to the application amounts and application methods of chlorophacinone, surface water or ground water contamination with chlorophacinone is unlikely. No drinking water assessment will be needed.



## 8.2 Measures of Exposure

In this assessment, transport of parent chlorophacinone through runoff to water bodies is considered in deriving quantitative estimates of chlorophacinone. With a vapor pressure of 3.58

x 10

- 6 

### torr and a calculated Henry’s Law constant 5.12 x 10

- 7 

### atm∙m 3 

### ∙mol

- 1 

### , vo latilization and atmospheric transport are very unlikely

For this registration review, it will be assumed that terrestrial animals could be exposed in two different pathways. Animals may directly consume bait (primary consumption), or animals may consume contaminated carcasses either killed or scavenged by the c onsumer (secondary consumption). Both approaches and the expected exposure levels are detailed below. It is

### Page 22 of 65



### important to note that these methods are not typically used in EFED risk assessments.

8.2.1 Estimating Aquatic Exposure

Given that aquatic risks have not been exceeded in previous risk assessments, the exposure

assessment will be conducted at the first tier using the GENEEC model, version 2.0, dated August 1, 2001 and input parameters outlined in Table 8 . G E NEEC is a metamodel of the Tier 2

models PRZM and EXAMS and as such mimics the output of these models. However, GENEEC

is hard

- wired to a single, high exposure scenario which is intended to be protective of aquatic environments for all crops on a nation al basis . If risks are above levels of concern at Tier 1 using GENEEC, more refined modeling at Tier 2 can be conducted which considers crop specific location information and additional fate data such as vapor pressure.

Table 8

. Chlorophacinone Input Values (GENEEC) for Aquatic Exposures

Property Valu e Comment Solubility 3.4 ppm MRID 42237401 Photolysis in Water 0 Assume that chlorophacinone is stable to photolysis. An unacceptable study was used previously. Aerobic Soil Degradation 7 8 d Upper 90% confidence bound on 2 values

Aerobic aquatic metabolism 156 d 2 x aerobic soil metabolism used in absence of

data

K
oc 20,299 l∙kg

- 1 Slope of line regression on K d on OC% Incorporation depth 0 in All labels for broadcast application do not allow for incorporation. Application rate 0.001 lbs a.i./acre Highest labeled application rate appears on the

SLN , CA 890024

, with a broadcast application

rate of 10 lbs product/acre ( 0.001 lbs a.i./acre) and a single reapplication 4 days later. Number of applications 2 Application interval 4 d



### The GENEEC results based on the input values of Table 8 are presented below:

RUN No. 1 FOR chlorophacinone ON rodent * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO

- SPRAY INCORP
ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- 0.010( 0.020) 2 4 20299.0 3.4 GRANUL( 0.0) 0.0 0.0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND

- EFF) (POND) (POND)

------------------------------------- ------------------------------- 78.00 2 0.00 0.00

- 0.00 156.00 156.00

GENERIC EECs (IN NANOGRAMS/LITER (PPTr)) Version 2.0 Aug 1, 2001

--------------------------------------------------------------------
P EAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY

GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 86.31 80.56 56.32 29.97 21.24

### Page 23 of 65



### The estimated environmental concentrations (EECs) are 0.08 6 μg/L, 0.05 6 μg/L, and 0.0 30 μg/L, respectively for the peak concentration, 21

- day average concentration, and 60

- day average concentration. These EECs are in the range of about 0.00 2 5 % of solubility and are orders of magnitude lower tha n the available aquatic toxicity endpoints ; therefore, the likelihood of aquatic impacts from the exposure viewpoint is ins ignificant.

8.2.2 Estimating Primary Terrestrial Exposure

EFED’s exposure assessment for the rodenticides differs from that for most other pesticides . For a rodenticide, the bait itself is the potential food item of concern. Thus, the amount of active ingredient in the formulated bait is used as an estimated environmental concentration ( EEC )

. This information is used to estimate the amount of grain bait th at birds and mammals of various sizes need to consume to obtain a dose expected to be lethal to 50% of the individuals in the population ( i.e. , LD 50 

### dose). Estimates of food

- ingestion rates (g dry matter per day) are

determined from established allometric equations presented in the Wildlife Exposure Factors

Handbook ( US EPA 1993). The concentration of chloro phacinone in grain bait is also used to estimate dietary exposure (mg a

. i

. per kg in bait).



## 8.2.2.1 Expected Chloro phacinone Accumulation through a Single Fe eding on

Bait

Exposure through bait consumption will be calculated using two methodologies. For the first method, chlorophacinone exposure is calculated as mg a.i./kg

- bwt, where kg

- bwt is the kilograms of the consuming individual for three standard weigh t classes of passeriforms and rodents. Exposure (food dry weight consumption) estimates were derived using allometric equations from USEPA (1993). The allometric equations for passeriform birds and rodent mammals were used as these would best approximate t hose individuals with high potential for consuming grain and they would give the most conservative exposure estimates. Food dry weight was converted to wet weight assuming the bait contained 10% water, similar to the assumption

that seeds for wildlife cons umption contain 10% water (USEPA 1993). Formulas for calculation of dose estimates are provided in Table 9 , and chloro phacinone exposure estimates (on a dose basis) are provided in Table 10

.

Table 9

. Formulas for Calculation of Daily Chloro phacinone Intake based on Consumption of

Bait.

Passeriform bird food intake (g, dry weight ): FI (g dry

- wt/day) = 0.398 * Wt(g) 0.850



### Rodent mammal food intake (g, dry weight ): FI (g dry

- wt/day) = 0.621 * Wt(g) 0.564



### Food intake (g, wet weight ): FI (g wet

- wt/d ay) = FI (g dry

- wt/day) / 0.90

Chloro phacinone intake (mg a.i./kg

- bwt/day) = FI (g wet

- wt/day) * mg a.i./kg

- bait / Wt(g)

### Page 24 of 65 

### Where: Wt(g) = weight (in grams) of the bird or mammal consumer

mg a.i./kg

- bait = 50 or 100 depending on chloroph acinone con centration in bait

Table 10

. Expected Daily Chlorophacinone Intake for Default Bird and Mammal Weights based on Consumption of Bait.

Weight (g) Food intake

(g dry

wt/day) Food intake

(g wet

wt/day) Chloro phacinone intake (mg a.i./kg

- bwt/day)

Bait concentration = 50 mg a.i./kg

- bait Bait concentration = 100 mg a.i./kg

- bait

Passeriform

Birds* 20 5.1 5.6 14.1 28.2

100 19.9 22.2 11.1 22.2

1000 141.2 156.9 7.8 15.6

Rodent

Mammals 15 2.9 3.2 10.6 21.2

35 4.6 5.1 7.3 14.6

1000 30.6 34.0 1.7 3.4
*surrogate for reptiles and terrestrial

- phase amphibians



## 8.2.2.2 Expected Chlorophacinone Accumulation through Multiple Feedings

on Bait

Available data on the retention times for chlorophacinone are provided in Table 1 1 . Data on

elimination from blood are available from two studies (half

- life ranges from 0.4 to 11.7 days).

One available liver elimination half

- life is available (35.4 days).

Table 11 . Retention of Chlorophacinone in Blood and Liver

Rodenticide Species Dose (mg a.i./kg) # dos es Blood t 1/2 (days) Liver

retention (days) Reference

(MRID)

Chlorophacinone Mouse 336 μg/mouse 1 11.7 35.4 (t 1/2 ) Vandenbroucke et

al. 2008

Chlorophacinone Rat 4

- 5 1 0.4 NA Belleville 1981 (00155540)



### As indicated previously, chloro phacinone typically causes mortality several days after ingestion, which may allow target animals to consume bait for several days before dying. This can lead to doses that far exceed the lethal dose. A compound that accumulates in body tissues may pose

gr eater risk to primary and secondary consumers, especially if repeated sublethal exposure results in the accumulation of a lethal dose or if additional exposures occur before the lethal dose has taken its effect ( i.e., leading to a dose that is beyond what is sufficient to cause mortality).

Cumulative rodenticide doses for animals consuming bait for six consecutive days were also calculated using formulae in Table 1 2 . This analysis assumed that 100% of the daily diet of the animals is represented by the rodenticide bai t and that they eliminate the chloro phacinone with a

half

- life of 35.4 days based on the single liver half

- life value ( Table 1 1 )

. In the formula, the variable “C” represents the concentration of the pesticide in the bait. The elimination rate

### Page 25 of 65



### constant (k) was calculated using the estimated chloro phacinone half

- life (t 1/2 

### = 35.4 days), and food intake (FI) was calculated according to the allometric equation for each taxonomic group ( Table 9 ). The resulting cumulative body burden concentrations of chloro phacinone are presented in Table 1 3

.

Table 12 . Formulas for Calculation of Chloro phacinone Body Burden based on Consumption of Bait f

or Six Consecutive Days.

Table 13 . Calculated chlorop hacinone body burden in avian and mammalian consumers of bait after six days of exposure
Body weight (g) Bait concentration = 50 mg a.i./kg

- bait Bait concentration = 100 mg a.i./kg

- bait

Passerine Generic Bird Passerine Generic Bird

20 80.6 72.3 161.2 144.6

100 63.3 41.2 126.6 82.4

1000 44.8 18.5 89.6 37.0

Rodent Generic Mammal Rodent Generic Mammal

15 60.5 46.1 121.0 92.2

35 41.8 39.6 83.6 79.2

1000 9.7 21.8 19.4 43.6



## 8.2.2.3 Expected Chlorophacinone Exposure based on Bait Concentration

The second exposure method for primary consumption of bait results in a diet concentration of 50 or 100 mg a.i./kg

- bait (concentrations of chlorophacinone as packaged in bait).

8.2.3 Estimating Secondary Terrestrial Exposure

Secondary exposure analysis (from consumption of contaminated individuals) require s consideration of residues in tissues of target and non

- target organisms that are commonly

consum ed by predators and scavengers

. Moreover, it is important to know how long the residue persists in body tissues. Residue concentrations for non

- target animals fed chlorophacinone were submitted by the registrant and are available in open literature. Design and methodology vary among studies, adding unknown variability to the results and analysis. Pending d evelopment of

additional methods and testing requirements for such studies, these tests provide the best data

available.

The determination of chlorophacinone intake for individuals consuming chlorophacinone poisoned animals or carcasses is calculated in a manner similar to the approach for individuals consuming bait ( Section 3. 3 .1 ). Empirical residue data was used instead of bait concentration of chlorophacinone ( Table 1 4 ). Chlorophacinone body burdens in deceased field and laboratory

studies were determ ined in mammals, after exposure to chlorophacinone bait. Data from severa l

studies were available in which deceased mammals were collected from treated fields and analyzed for residues or in which deceased laboratory animals dosed with chlorophacinone were

### Page 26 of 65



### analyzed for chlorophacinone residues . For all studies, it was assumed the concentrations were reported using wet weights of the mammals . Mea n concentrations ranged from 0.122 to 1.58 mg a.i./kg

- bw , with reported individual values ranging from <LOD to 4. 1 mg a.i./kg

- bw. Field collected data are subject to a number of uncertainties including, but not limited to:

 possible partial decomposition of bodies in field,

 collection may miss carcasses with highest body burdens, and

 collection may miss individuals that were rapidly predated, died off site, or died underground.

B ecause of the lack of data on chloro phacinone residues in birds, amphibians and reptiles, it was assumed the mammal body burden data would be relevant for all the evaluated taxonomic groups. Due to the uncertainties regarding adequate sampling to capture the full distribution of carcass residue values, the maximu m reported individual value, 4.1 mg a.i./kg

- carcass, will be

used for this assessment.

### Page 27 of 65



### Table 14. Chlorophacinone Residue Levels in Mammalian Primary Consumers

Exposure information Carcass species Sample

size mg ai/kg bait Mean w hole

- carcass residue ( mg a.i./kg

- bw) Reference

Field, spot bai t; active burrows treated 2 day interval for 4 applications. Daily carcass searches, first 10 carcasses collected after trt began California ground squirrel 10 100 1.27 + 0.56 (sd) range (0.237

– 2.24) MRID 43922201

Baroch 1996 (Supplemental)

Field, spot bait ; active burrows treated 2 day interval for 4 applications. Daily carcass searches, first 10 carcasses collected after trt began California ground squirrel 10 50 0.52 + 0.31(sd) range (0.244

– 1.29)

Field, bait stations . Daily carcass searches, first 10 carcasses collected after trt began California ground squirrel 10 50 0.57 + 0.27 (sd) range (0.123

– 0.896) MRID 43922202

Baroch 1996 (Supplemental)

Field, spot bait. Daily carcass searches for 15 days after trt began Belding’s ground squirrel 38 100 6 carcasses<LOD=0.025

32 carcasses: 0.159+0.141(sd) range (0.025

– 0.546) Ramey et al. 2007

Primus et al. 2001 (Quantitative)

Field, bait station . Daily carcass searches for 15 days after trt began Belding’s ground squirrel 16 50 0.1 22 range (<LOD, 0. 265 ) Primus et al. 2001 (E 0165) Matschke, 1999 (Quantitative) Microtus sp. vole 3 50 1.58 range(0.26

- 4.1)

Field, bait applied in burrow systems. Radio

collared animals followed for 13 days after application. Collared animals with no movement for 3 days were excavated. Valley pocket gopher 8 50 and 100 0.357 range (<LOD, 1.21) Primus et al. 2001 (E 0165 )

Stewart et al 2000 Quantitative

Field, spot bait; Collected daily 2

- 15 days after first application California ground squirrel 21 50 0.28 range (0.02

– 0.71) MRIDs 45855101

and 46117303

Salmon et al 2002

Goodall et al. 2002 Field, spot bait; Collected daily 2

- 15 days after first application California ground squirrel 16 100 1.41 range (0.30

– 2.72)

### Page 28 of 65



### Table 14. Chlorophacinone Residue Levels in Mammalian Primary Consumers

Exposure information Carcass species Sample

size mg ai/kg bait Mean w hole

- carcass residue ( mg a.i./kg

- bw) Reference

Field, broadcast ; Collected daily 2

- 15 days after first application California ground squirrel 16 50 0.26 range (<LOD, 1.01) (supplemental)

Field, broadcast ; Collected daily 2

- 15 days after first application California ground squirrel 20 100 0.51 range (<LOD

– 1.31)

Field, in

- burrow ; Collected daily 2

- 15 days after first application Black tailed prairie dog s (8) and one

cottontail rabbit 9 50 0.58 range (0.01, 1.25) MRIDs 47333602,

47333603 and

48294401 (supplemental) Field, bait application and collection methods

unknown Black

- tailed prairie dog 8 NA 1.48 range(0.85, 2.24)

Laboratory , 5 days bait consumption Laboratory rat 5 50 0.47 range(0.21

- 0.93) MRID 44631402

Baroch 1997 (supplemental)

Laboratory , 5 days bait consumption Laboratory rat 4 50 0.45 range(0.18

- 0.81) MRID 44631401

Ahmed et al. 1996 (supplemental)

### Page 29 of 65



### Chlorophacinone exposure through carcass consumption is calculated as mg a.i./kg

- bwt, where kg

- bwt is the kilograms of the consuming individual for three weight classes of birds and

mammals. For this ana lysis, bird weight classes of 100, 1000, and 5 000 g individuals and mammal weight classes of 50, 1000, and 3000 g individuals were used to better represent the larger size of carnivores and scavengers relative to the full range of bird and mammal weights.

The measured maximum body burden in the prey w as then used to estimate rodenticide exposure in the secondary consumer using the general food intake allometric equations described in

Section 3.1 above. Secondary consumers were assumed to be mammals weighing 50g, 1000g, or 3000g, or birds weighing 100g, 1000g, or 5000g. For example, American kestrels range from

100

- 150g, red

- tailed hawks range from 900

- 1000g and bald eagles range from 4000

- 5000g (Dunning 1984). Exposure (food dry weight consumption) estimates were derived using generic

bird and mammal a llometric equations (EPA 1993). Food dry weight was converted to wet weight assuming the consumed prey/carcass contained 68% water (USEPA 1993). Formulas for calculation of dose estimates are provided in Table 1 5 , and chloro phacinone exposure estimates (on a dose basis) are provided in Table 1 6

.

Table 15

. Formulas for Calculation of Daily Chloro phacinone Intake for Birds and Mammals based on Consumption of Carcasses

.

B ird food intake (g, dry weight ): FI (g dry

- wt/day ) = 0. 648 * Wt(g) 0. 651



### Mammal food intake (g, dry weight ): FI (g dry

- wt/day) = 0. 235 * Wt(g) 0. 822



### Food intake (g, wet weight ): FI (g wet

- wt/day) = FI (g dry

- wt/day) / 0.32

Chloro phacinone intake (mg a.i./kg

- bwt/day) = FI (g wet

- wt/day) * 4.1 mg a.i./kg

- carcass / Wt(g)

Where: Wt(g) = weight (in grams) of the bird or mammal consumer

Table 16

. Expected Daily Chloro p hacinone Intakes for Carnivorous Bird s and Mammal s based on Consumption of Contaminated Carcasses

Weight (g) Food intake

(g dry

- wt/day) Food intake

(g wet

- wt/day) Chlorophacinone intake (mg a.i./kg

- bwt/day)

Birds * 100 13.0 40.6 1.66

1000 58.2 181.7 0.75

5000 165.8 518.1 0.43

Mammals 50 5.9 18.3 0.51

1000 68.7 214.7 0.88

3000 169.5 529.8 0.72 *surrogate for reptiles and terrestrial

- phase amphibians



### The second exposure method for consumption of contaminated carcasses results i n a carcass concentration of 4.1 mg a.i./kg

- carcass (ma ximum measured concentration of chlorophacinone in carcasses).

### Page 30 of 65



### 8.2.4 Estimating Additional Environmental Exposures

Screening level calculations suggest that the drinking water pathway may be significant in causing acute and chronic effects to terrestrial organisms

. However, screening level calculations

indicate risks d u e to inhalation of chlorophaci n one in vapor phase are low. The drinking water exposure pathway may be further considered at the time of the risk assessment ( Appendix C ).

No monitoring data in surface water, in groundwater or in air were found from the USGS NAWQA program ( http://water.u sgs.gov/nawqa ), the California Department of Pesticide Regulation CDPR ( http://www.cdpr.ca.gov/docs/emon/surfwtr/surfcont.htm ) or from the USEPA STORET program. Water monitoring programs such as these generally monitor for agricultural pesticides and typically

do not include anal ysis for rodenticides such as chloro phacinone. 

### If water monitoring data are identified at the time the risk assessment is conducted, these data will be used for additional exposure characterization.



## 8.3 Measures of Effect

Toxicity data presented in Section 6 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 a ssessment will also 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,

an d wildlife. 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 char acteristics of the affected

communities.



# 9 Endangered Species Assessment

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally threatened and/or endangered (listed) species from regi stered uses of pesticides in registration review . The process for evaluating potential risks to listed species is further described at http://www.epa.gov/oppfead1/endanger/litstat us/riskasses.htm

.



# 10 Endocrine Disruptor Screening Program

Chlorophacinone was not included in the first group or the second group of chemicals issued an order to conduct Tier 1 EDSP testing. For additional information the EDSP program, visit http://www2.epa.gov/endocrine

- disruption

.

### Page 31 of 65



# 11 Preliminary Identification of Data Gaps

11.1 Fate

The environmental fate database for chloro phacinone is not complete ( Table 17 ) . However, data

gap s were not identified as these data are not necessary for risk assessment at this time. Additional fate data would be unlikely to change the risk conclusions for the aquatic risk

assessment for chlorophacinone.

Table 17. Available environmental fate data for chlorophacinone and remaining data

gaps.

158

Guideline (OPPTS) Description MRID Classification Are data

needed for risk

assessment? Comments

835.1240 (163

- 1) Adsorption/Desorption MRID 42666001

MRID 42205503 Acceptable no

Data have not been

submitted to fulfill some guideline s

. D ata gap s were not identified as these data are not necessary for risk

assessment at this time. 835.2120 (161

- 1) Hydrolysis MRID 42205501 Acceptable no

835.2240 (161

- 2) Photodegradation in

water MRID 42205502 Unacceptable no

835.2410 (161

- 3) Photodegradation on

soil MRID 42452301 Unacceptable no

835.4100 (162

- 1) Aerobic soil

metabolism MRID 43159801 Acceptable no

835.4200 (162

- 2) Anaerobic soil

metabolism None NA no

835.4300 (162

- 4) Aerobic Aquatic

Metabolism None NA no

835.4400 (162

- 3) Anaerobic Aquatic

Metabolism None NA no

835.6100 (164

- 1) Terrestrial Field

Dissipation None NA no

850.1730 (165

- 4) Fish Bioconcentration

Factor None NA no



## 11.2 Effects

Tables 1 8 and 19 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.

Inadequate data are available to characterize the differential toxicity among bird species. Data have been submitted to the Agency for the bobwhite quail acute oral gavage study (most

sensitive LD 50 

### = 258 mg a.i./kg

- bwt). However, for diphacinone (also an indandione anticoagulant rodenticide ), large species differences have been documented ( LD 50 

### = 1630 mg a.i./kg

- bw for bobwhite quail (MRID 42245201) and LD 50 

### = 98.6 mg a.i./kg

- bw for American

### Page 32 of 65



### kestrel (Rattner et al ., 2011)). Therefore, EFED requests acute o ral toxicity data be submitted for a passerine species and for a carnivorous species. Toxicity of chlorophacinone to the American kestrel was evaluated by Rattner et al . (2015); however, the study was only carried out for 7 days and no mortality occurred a nd an LD 50 

### could not be estimated. Rattner et al . (2015) concluded

that h istological evidence of hemorrhage was present at all chlorophacinone dose levels and

o vert signs of intoxication, liver chlorophacinone residues, and changes in prothrombin time,

Rus sell’s viper venom time and hematocrit, were generally dose

- dependent. Additional toxicity data on a wider range of species would be beneficial to better understand the natural variation and to improve confidence in the assessment of risk to non

- target sp ecies.

Chlorophacinone exposure to terrestrial invertebrates may occur if individuals feed on the bait, feed on live animals contaminated with chlorophacinone residues, or feed on carcasses with chlorophacinone residues. EFED has reviewed one terrestrial invertebrate study (Burying beetle, Nicrophorus orbicollis , MRID 47383001) and has an earthworm study currently under review (MRID 47383002). If the study is classified as Acceptable, the data need will be considered met. However, EFED would appreciate su bmission of any additional available terrestrial invertebrate toxicity and/or bioaccumulation data for the risk assessment. EFED does not have concerns for

chloro phacinone exposure to insect pollinators such as bees and butterflies, as expected

exposures would b e low. Chloro phacinone is not applied as a spray; therefore, expected exposure on plants, including flowers, would be low. Pollinators would not be expected to feed on live animals or carcasses that may have been contaminated with chloro phacinone. N o terrestrial invertebrate incidents have been reported for chlorophacinone

.

EFED does not recommend requesting terrestrial plant, aquatic plant, chronic fish, or chronic aquatic invertebrate toxicity data at this time as these data would not be expected to change the conclusions of this risk assessment. There remains uncertainty in the level of risk for each of these taxonomic groups given the missing data; however, the expected exposures for the proposed change in use pattern will be relatively low:

 Ter restrial plants

- No data are available to assess of the toxicity of chlorophacinone to terrestrial plants; however, exposure to plants is also expected to be low since there is no spray application and the material is applied as a formulated bait or a tre ated grain. Chlorophacinone binds strongly to organic material (i.e., the formulated bait or grain) and little is expected to be available for runoff or leaching. No plant incidents have been reported for chlorophacinone.

 Aquatic plants

– No data are avail able to assess the toxicity of chlorophacinone to aquatic plants; however, aquatic exposure is also expected to be low since there is no spray application and the material is applied as a formulated bait or a treated grain. Chlorophacinone binds strongly t o organic material (i.e., the formulated bait or grain) and little is expected to be available for runoff or leaching. No aquatic in cidents have been reported for c hlorophacinone.

 Chronic fish and aquatic invertebrates

– No data are available to assess the chronic toxicity of chlorophacinone to fish and aquatic invertebrates; however, aquatic exposure is expected to be low since there is no spray application and the material is applied as a

formul ated bait or a treated grain. Chloro phacinone is highly acute ly toxic to fish and invertebrates, and chronic effects would not be unexpected. However, chloro phacinone binds strongly to organic material (i.e., the formulated bait or grain) and little is expected

### Page 33 of 65



### to be available for runoff or leaching for this propose d use. No aquatic inc idents have been reported for chloro phacinone.

Table 18 . Available ecological effects data for terrestrial organisms exposed to cycloate and remaining data gaps.

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classifications Are data

needed for

risk

assessment? Current Additional Data

Need

850.2100 Avian oral toxicity 41513101 acceptable Yes Data are requested for a vian acute oral with passerine and

acute oral with carnivore 39233 Review pending

850.2200 Avian dietary

toxicity 41513102 Acceptable No

--

41513103 Acceptable

29144 Review pending

29143 Review pending

47323201 Supplemental

850.2300 Avian reproduction 489904001 supplemental No

--

489904002 acceptable

Non

- guideline Avian inhalation (None) (N/A) No Data have not been

submitted to fulfill this guideline. A data gap was

not identified as these data are not necessary for risk

assessment at this time.

850.3020 Honey bee acute

contact toxicity (None) (N/A) No Data have not been

submitted to fulfill this guideline. A data gap was

not identified as these data are not necessary for risk

assessment at this time. 850.3030 Honey bee residue

on foliage (None) (N/A) No

Non

- guideline,

OECD TG 213 Acute oral toxicity

to adult honey bees (None) (N/A) No

Non

- guideline,

OECD TG 237 Acute oral toxicity

to larval honey

bees (None) (N/A) No

Non

- guideline Chronic oral

toxicity to adult honey bees (None) (N/A) No

Non

- guideline Chronic oral

toxicity to larval honey bees (None) (N/A) No

Non

- guideline Field trial of

residues in pollen

and nectar (None) (N/A) No

Non

- guideline,

OECD Guidance

75 Semi

- field testing

for pollinator (None) (N/A) No

850.3040 Field testing for

pollinator (None) (N/A) No

### Page 34 of 65



### Table 18 . Available ecological effects data for terrestrial organisms exposed to cycloate and remaining data gaps.

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classifications Are data

needed for

risk

assessment? Current Additional Data

Need

850.3100 Earthworm

Subchronic Toxicity Test 47383002 Review pending No Data need may be met pending outcome of review.

850.4100 Seedling

Emergence and Seedling Growth (None) (N/A) No Data have not been

submitted to fulfill this guideline. A data gap was

not identified as these data are not necessary for risk

assessment at this time. 850.4150 Vegetative Vigor (None) (N/A) No



### Table 19 . Available ecological effects data for aquatic organisms exposed to chlorophacinone and remaining data gaps.

OCSPP

Guideline Data Requirement Submitted

Studies (MRID) Study

Classification Are data

needed to

conduct risk

assessment? Current Additional Data Need

850.1010 Freshwater invertebrate

acute toxicity 42356101 Acceptable No

--

850.1025

850.1035

850.1045

850.1055 Saltwater invertebrate

acute toxicity (None) (N/A) No Data have not been submitted to fulfill this guideline. A data gap

was not identified as these data are not necessary for risk assessment at

this time.

850.1075 Freshwater fish acute

toxicity 4235610 2 Acceptable No

--

4235610 3 Acceptable

850.1075 Saltwater fish acute

toxicity (None) (N/A) No Data have not been submitted to fulfill this guideline. A data gap

was not identified as these data are

not necessary for risk assessment at

this time. 850.1300 Freshwater invertebrate

life cycle (None) (N/A) No

850.1350 Saltwater invertebrates

life cycle (None) (N/A) No

850.1400 Freshwater fish

early

- life stage (None) (N/A) No

850.1400 Saltwater fish

early

- life stage (None) (N/A) No

850.1500 Fish life cycle (None) (N/A) No

850.4400 Aquatic plant Toxicity

Test using Lemna spp. (None) (N/A) No

850.4500 Algal toxicity 47323204 Unacceptable No

850.4550 Cyanobacteria (None) (N/A) No

### Page 35 of 65



# 12 References

Open Literature

Cox , P. and R.H. Smith. 1992. Rodenticide ecotoxicology: pre

- lethal effects of anticoagulants on rat behavior. Proc.

Vertebr. Pest Conf. 15:165

- 170.

Crowell, M, C Eason, S Hix, K Broome, A Fairweather, E Moltchanova, J Ross and E Murphy. 2013. First generation anticoagulant rodenticide persistence in large mammals and implications for wildlife management. New Zealand Journal of Zoology, http://dx.doi.org/10.1080/03014223.2012.746234

Dunning

, J. B.

, Jr

. 1984

. Body weights of 686 species of North American birds

. Monograph Number 1

. Western Bird Banding Association , Cave Creek, Arizona, USA

King, R.B. 2002. Predicted and observed maximum prey size

– snake size allometry. Functional Ecology 16: 766

– 772.

Mendenhall, V.M. and L.F. Pank. 1980. Secondary poisoning of owls by anticoagulant rodenticides. Wildl. Soc.

Bull. 8:311

- 315. MRID#s 46750931, 40077202, 00094694

Rattner, BA, KE Horak, SE Warner, DD Day, CU Meteyer, SF Volker, JD Eisemann, JJ Johnson. 2011. Acute toxicity, histopathology, and coagulopathy in American kestrels ( Falco sparverius ) following administration of the rodenticide diphacinone. Environmental Toxicology and Chemistry, Vol. 30, No. 5, pp. 1213

– 1222.

Rattner, B. A., K. E. Horak, R. S. Lazarus , S. L. Schultz, S. Knowles, B. G. Abbo, and S. F. Volker. 2015. Toxicity reference values for chlorophacinone and their application for assessing anticoag ulant rodenticide risk to raptors

. Ecotoxicology. 24:720

– 734

Savarie, P.J. and R.K. LaVoie. 1979. Secondary toxicity hazards of the anticoagulant brodifacoum to American kestrels ( Falco sparverius ). Unpubl. report, Denver Wildlife Research Center. 24 pp. MRID# 80244, 00079312

U.S. Environmental Protection Agency. 1993. Wildlife Exposure Factors Handbook . Office of Research and Development. December. EPA/600/R

- 93/187

U.S. Environmental Protection Agency. 1998a. Guidelines for Ecological Risk Assessmen t . United States Environmental Protection Agency (USEPA). Risk Assessment Forum. Office of Research and Development. Available at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=12460 (Accessed June 19, 2009).

U.S. Environmental Protection Agency

. 199 8b. Reregistration Eligibility Decision (RED): Rodenticide Cluster

. July 1998. EPA 738

- R

- 98

- 007.

U.S. Environmental Protection Agency . 2004a. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs

. US EPA Office of Pestic ide Programs, Environmental Fate and Effects Division.

U.S. Environmental Protection Agency. 2004b. Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: a Comparative Approach. July 2004. US EPA Office of Pesticide Programs, Environment al Fate and

Effects Division.

U.S. Environmental Protection Agency. 2011. Risks of Chlorophacinone Use to the Federally Threatened Alameda Whipsnake ( Masticophis lateralis euryxanthus ), California Tiger Salamander ( Ambystoma californiense ),

Central California Distinct Population Segment, And the Federally Endangered California Tiger Salamander ( Ambystoma californiense ) Sonoma County Distinct Population Segment and Santa Barbara County Distinct Population Segment, Salt Marsh Harvest Mouse ( Reithrodont omys raviventris ), and San Joaquin Kit Fox ( Vulpes

macrotis mutica ). US EPA Office of Pesticide Programs, Environmental Fate and Effects Division. Ju ne 29 , 2011.

### Page 36 of 65



### Environmental Fate Data Submitted To Support Registration

Guideline: 161

- 1 Hydrolysis

------------------------------------------------------------------------------------- MRID: 62177 Lyonnaise Industrielle Pharmaceutique (1978) Residue Studies of Chlorophacinone. (Unpublished study received Jul 25, 1978 under 40868

- 9; submitted by Inters tate Sales, Edgewater, N.J.; CDL: 234579

- AN)

MRID: 129279 Lyonnaise Industrielle Pharmaceutique (1978) Residue Studies of Chlorophacinone. A translation of: Etude de la Remanence de Chlorophacinone. (Unpublished study received Jun 7, 1978 under 7173

- 1 40; submitted by Chempar Chemical Co., Inc., New York, NY; CDL:234130

- A; 234129)

MRID: 42205501 Spare, W. (1992) Hydrolysis of Chlorphacinone: Lab Project Number: 1415. Unpublished study prepared by Agrisearch Inc. 76 p.

Guideline: 161

- 2 Photod egradation

- water

------------------------------------------------------------------------------------- MRID: 155544 Biospherics Inc. (1981) Environmental Fate Studies of Chlorophaci

- none: [Aqueous Photodegradation of Chlorophacinone]: Lipha Re

- port No. 86

- 005. Unpublished study. 16 p.

MRID: 42205502 Spare, W. (1992) Aqueous Photolysis of Chlorphacinone: Lab Project Number: 1417. Unpublished study prepared by Agrisearch Inc. 77 p.

Guideline: 161

- 3 Photodegradation

- soil

--------------------- ---------------------------------------------------------------- MRID: 34510 Chempar Chemical Company, Incorporated (19??) Persistence Study of Chlorophacinone (CPN). A translation of: Etude la Remanence de Chlorophacinene. (Unpublished study including French text received Oct 6,

1976 under 7173

- 140; CDL:234128

- A)

MRID: 74365 Lyonnaise Industrielle Pharmaceutique (1977) Residue Studies of Chlorophacinone. (Unpublished study received Apr 3, 1981 under unknown admin. no.; submitted by Chempar Chemical Co., Inc., New York, N.Y.;

CDL:244794

- A)

MRID: 42452301 Spare, W. (1992) So il Photolysis of Chlorophacinone: Lab Project Number: 1418. Unpublished study prepared by Agrisearch Inc. 98 p.

Guideline: 161

- 4 Photodegradation

- air

------------------------------------------------------------------------------------- MRID: 155 545 Lechevin, J. (1979) Stability in Nature of Chlorophacinone Baits: Lipha Report No. 86

- 006. Unpublished study prepared by Lipha. 3 p.

MRID: 155546 Askham, L.; Singh, S.; Singh, U.; et al. (1984) Bioanalytical Evaluation of Chlorophacinone. Unpublis hed paper presented at the Sixth International Biodeterioration Symposium; Aug 5

- 10, 1984, Washington, DC. 19 p.

Guideline: 162

- 1 Aerobic soil metabolism

------------------------------------------------------------------------------------- MRID: 43159801 Spare, W. (1994) Aerobic Soil Metabolism of Chlorophacinone: Lab Project Number: 1419: 1419R. Unpublished study prepared by Agrisearch Inc. 151 p.

Guideline: 163

- 1 Leach/adsorp/desorption

------------------------------------------------------------------------------------- MRID: 34510 Chempar Chemical Company, Incorporated (19??) Persistence Study of Chlorophacinone (CPN). A translation of: Etude la Remanence de Chlorophacinene. (Unpubli shed study including French text received Oct 6,

1976 under 7173

- 140; CDL:234128

- A)

### Page 37 of 65

MRID: 50807 Chempar Chemical Company, Incorporated (19??) Persistence Study of Chlorophacinone (CPN).

Includes undated method entitled: Method of radiochemical determin ation. (Unpublished study received Dec 30,

1976 under 7173

- 175; CDL:228612

- AR)

MRID: 62177 Lyonnaise Industrielle Pharmaceutique (1978) Residue Studies of Chlorophacinone. (Unpublished study received Jul 25, 1978 under 40868

- 9; submitted by Interstate Sales, Edgewater, N.J.; CDL: 234579

- AN)

MRID: 74365 Lyonnaise Industrielle Pharmaceutique (1977) Residue Studies of Chlorophacinone. (Unpublished study received Apr 3, 1981 under unknown admin. no.; submitted by Chempar Chemical Co., Inc., New York, N .Y.;

CDL:244794

- A)

MRID: 42205503 Spare, W. (1992) Adsorption/Desorption of Chlorphacinone in Four Soil Types: Lab Project Number: 1416. Unpublished study prepared by Agrisearch Inc. 99 p.

MRID: 42666001 Spare, W. (1993) Adsorption/Desorption of Chlorophacinone in Four Soil Types: Amended Final Report: Lab Project Number: 1416. Unpublished study prepared by Agrisearch Inc. 105 p.

MRID: 92018021 Baron, R. (1993) Liphatech Phase 3 Summary of MRID 426660 01 and Related MRIDs 42205503. Chlorophacinone...: Adsorption/ Desorption of Chlorophacinone in Four Soil Types: Project No. 1416 (Amended). Prepared by Agrisearch Inc. 7 p.

Guideline: 164

- 1 Terrestrial field dissipation

------------------------- ------------------------------------------------------------ MRID: 74365 Lyonnaise Industrielle Pharmaceutique (1977) Residue Studies of Chlorophacinone. (Unpublished study received Apr 3, 1981 under unknown admin. no.; submitted by Chempar Chemical Co., Inc., New York, N.Y.;

CDL:244794

- A)

MRID: 128398 Chempar Chemical Co., Inc. (1972) ?Efficacy: Rozol|. (Compilation; unpublished study received Mar 20, 1974; Aug 31, 1972 under 7173

- EX

- 1; CDL:127465

- A)

MRID: 128401 Horsfall, F. (1972) Letter sent to P. Ochs dated Aug 17, 1972: ?Chlorophacinone: Gas chromatograph charts obtained in analyses of sprayed apples|. (Unpublished study received Aug 22, 1972 under

7173

- EX

- 1; prepared by Virginia Polytechnic Institute and State Univ., Dept. of Horticulture, s ubmitted by Chempar Chemical Co., Inc., New York, NY; CDL:127466

- A)

MRID: 129279 Lyonnaise Industrielle Pharmaceutique (1978) Residue Studies of Chlorophacinone. A translation of: Etude de la Remanence de Chlorophacinone. (Unpublished study received J un 7, 1978 under 7173

- 140; submitted by Chempar Chemical Co., Inc., New York, NY; CDL:234130

- A; 234129)



### Ecological Toxicity Data Submitted To Support Registration:

Guideline: 850.2100 Avian Single Dose Oral Toxicity

------------------------------- ------------------------------------------------------ MRID: 29142 Chempar Chemical Company, Incorporated (1980) Fish and Wildlife Studies with Chlorophacinone. Summary of studies 241868

- B through 241868

- F. (Unpublished study received Feb 27, 1980 un

- d er 7173

- 180;

CDL:241868

- A)

MRID: 39233 Beavers, J.B.; Fink, R.; Brown, R.; et al. (1979) Final Report: Acute Oral LD50

-- Bobwhite Quail: Project No. 154

- 109. (Unpublished study received Feb 27, 1980 under 7173

- 180; prepared by Wildlife International, Ltd. in cooperation with Washington Col

- leg e, submitted by Chempar Chemical Co., Inc., New York, N.Y.; CDL:241868

- B)

MRID: 50813 Chempar Chemical Company, Incorporated (1980) Fish and Wildlife Studies with Chlorophacinone: Summary. (Unpublished study re

- ceived Mar 18, 1980 under 7173

- 185; CDL: 242018

- A)

### Page 38 of 65

MRID: 5005716 Grolleau, G.; Paris, G. (1975) Essais d'intoxication du canard col

- vert~Anas platyrhynchos~L_ a l'aide du coumafene et du chlorophacinone_ ?Trials of intoxication of green collared duck,~Anas platyrhynchos~L_ with coumaphene and chlorophacinone_| Annales de Zoologie

-- Ecologie Animales 7(4):553

- 556.

MRID: 41513101 Fletcher, D. ; Pedersen, C. (1989) Chlorophacinone: 30

- Day Acute Oral LD50 Study in Bobwhite Quail: Lab Project No: 87 QD 106. Unpublished study prepared by Bio

- Life Associates, Ltd. 42 p.

MRID: 92018007 Baron, R. (1990) Chempar Phase 3 Summary of MRID 41513101. 30

- Day Acute Oral LD50 in Bobwhite Quail: Chlorophacinone: Study No. BLAL 87 QD 106. Prepared by Bio

- Life Associates. 12 p.

Guideline: 850.2200 A vian Dietary Toxicity

------------------------------------------------------------------------------------- MRID: 2370 Grolleau, G. (1969) Toxicity Tests with Chlorophacinone on Gray Partridge

-- ?~Perdix perdix~(L). (Unpublished study received Jul 24, 197 0 under 7173

- 62; prepared by ?French| National Institute for Agronomic Research, Laboratoire des Petis ?Sic| Vertebres, submitted by Chempar Chemical Co., Inc., New York, N.Y.;

CDL:008006

- P)

MRID: 29142 Chempar Chemical Company, Incorporated (1980) Fish and Wildlife Studies with Chlorophacinone. Summary of studies 241868

- B through 241868

- F. (Unpublished study received Feb 27, 1980 un

- der 7173

- 180;

CDL:241868

- A)

MRID: 29143 Beavers, J.B.; Fink, R.; Brown, R.; et al. (1979) Final Report: 14

- Day Diet ary LCI50^

-- Mallard Duck: Project No. 154

- 102. (Unpub

- lished study received Feb 27, 1980 under 7173

- 180; prepared by Wildlife International, Ltd. in cooperation with Washington College, submitted by Chempar Chemical Co., Inc., New York, N.Y.; CDL:241868

- C)

MRID: 29144 Beavers, J.B.; Fink, R.; Brown, R.; et al. (1979) Final Report: 14

- Day Dietary LCI50^

-- Bobwhite Quail: Project No. 154

- 101. (Un

- published study received Feb 27, 1980 under 7173

- 180; prepared by Wildlife International, Ltd. in cooperati on with Washington College, submitted by Chempar Chemical Co., Inc., New York, N.Y.; CDL:241868

- D)

MRID: 47425 Grolleau, G.; Giban, J. (1969) Toxicity Tests with Chlorophacinone on Gray Partridge

-- Perdix perdix (L.). (France, Institut National de la Re cherche Agronomique, Laboratoire des Petis Vertebres, unpublished study;

CDL:210147

- P)

MRID: 50813 Chempar Chemical Company, Incorporated (1980) Fish and Wildlife Studies with Chlorophacinone: Summary. (Unpublished study re

- ceived Mar 18, 1980 under 7 173

- 185; CDL:242018

- A)

MRID: 41513102 Fletcher, D.; Pedersen, C. (1989) Chlorophacinone: 30

- Day Acute Dietary LC50 Study in Bobwhite Quail: Lab Project No: 87 QC 105. Unpublished study prepared by Bio

- Life Associates, Ltd. 41 p.

MRID: 92018008 Baron, R. (1990) Chempar Phase 3 Summary of MRID 41513102. 30

- Day Acute Dietary LC50 Study in Bobwhite Quail: Chlorophacinone: Study No. BLAL 87 QC 105. Prepared by Bio

- Life Associates. 14 p.

MRID: 92018009 Baron, R. (1990) Chempar Phase 3 Summary of MRID 41513103. 30

- Day Acute Dietary LC50 Study in Mallard Ducklings: Chlorophacinone: Study No. BLAL 87DC103. Prepared by Bio

- Life Associates. 13 p.

Guideline: 850.2300 Avian reproduction test

----------------------------------------------------- -------------------------------- MRID: 48994001 Stafford, J. (2012) Reproductive Toxicity Test with the Northern Bobwhite (Colinus virginianus): Chlorophacinone. Project Number: 14007/4101. Unpublished study prepared by Smithers Viscient. 388p.

MRID: 48994002 Stafford, J. (2012) Reproductive Toxicity Test with the Mallard (Anas platyrhynchos): Chlorophacinone. Project Number: 14007/4102. Unpublished study prepared by Smithers Viscient. 348p.

### Page 39 of 65

Guideline: 850.2400 Wild mammal acute toxicity

--- ---------------------------------------------------------------------------------- MRID: 2467 Pank, L.F.; Hirata, D.N. (1976) Primary and Secondary Toxicity of Anticoagulant Rodenticides: Job Completion Report: Work Unit DF

- 103.7. (Unpublished study rece ived on unknown date under unknown admin. no.; prepared by U.S. Fish and Wildlife Service, Denver Wildlife Research Center, Wildlife Damage Research Station, submitted by Velsicol Chemical Corp., Chicago, Ill.; CDL: 230307

- B)

MRID: 69557 Virginia Polyte chnic Institute and State University (1971) (Effectiveness Data with Regard to Chlorophacinone). (Compilation; unpublished study received Jul 9, 1973 under 7173

- 140; submitted by Chempar Chemical Co., Inc., New York, N.Y.; CDL:008321

- A)

MRID: 100061 Chempar Chemical Co., Inc. (1974) (Efficacy of Various Rodenticides). (Compilation; unpublished study received Jan 22, 1975 under 7173

- 140; CDL:235182

- A)

MRID: 92018001 Baron, R. (1990) Chempar Phase 3 Summary of MRID 00162324. Ground Squirrel

- Coyote Secondary Toxicity Studies with Chlorophacinone and Bromadiolone, Residue Levels in Ground Squirrel Tissues from Davis, CA, and Residue Method Validation, Chlorophacinone Tissues: LiphaTech Report Nos. 86

- 032, 1410, and 1400a. Prepared by Univ. of CA. 11 p

.

MRID: 47333601 Yoder, C. (2008) Acute Oral Toxicity (LD50) of Chlorophacinone in Black

- Tailed Prairie Dogs (Cynomys ludovicianus): Final Report. Project Number: QA/1446. Unpublished study prepared by US Dept. of Agriculture, APHIS, WS. 86 p.

Guide line: 850.2500 Field testing for terrestrial wildlife

------------------------------------------------------------------------------------- MRID: 50803 Horsfall, F., Jr.; Libke, K.G.; Osborne, J.C. (1972) Toxicity Studies under Simulated Orchard Conditions. (Unpublished study including letters dated Nov 15, 1972 and Nov 20, 1972 from K.G. Libke and J.C. Osborne to Frank Horsfall, Jr., received Dec 30, 19 76 under 7173

- 175; prepared by Virginia Polytechnic Institute and State Univ., submitted by Chempar Chemical Co., Inc., New York, N.Y.; CDL:228612

- AN)

MRID: 69567 Virginia Polytechnic Institute and State University (1972) (Toxicity Data Regarding

Chloro phacinone and Opossums). (Compilation; unpublished study received Jul 9, 1973 under 7173

- 140; prepared by Dept. of Veterinary Science, Research Div., submitted by Chempar Chemical Co., Inc., New York, N.Y.;

CDL:008321

- AF)

MRID: 42124101 Baron, R. (1991 ) LiphaTech Phase 3 Summary of MRID 40751402: Secondary Hazard Evaluation of Chlorophacinone in Raptors and Chlorophacinone Residue Levels in Hawk, Owl, and Vole Tissues from Pullman, Washington: Study 1407: Field Study No. 88

- 1. Revised. Unpublished stud y prepared by Agrisearch, Inc. 7 p.

MRID: 44631401 Ahmed, S.; Baroch, J.; Carlet, L. et al. (1996) Secondary Hazard Study Using Chlorophacinone

Killed Laboratory Rats Fed to Domestic Ferrets (Mustela putorius furo): Lab Project Number: 96004. Unpublis hed study prepared by Genesis labs., Inc. 84 p.

MRID: 44631402 Baroch, J. (1997) Secondary Hazard Study Using Chlorophacinone

- Killed Laboratory Rats Fed

to Black

- Billed Magpies (Pica pica): Lab Project Number: 96019. Unpublished study prepared by Gene sis labs., Inc. 77 p.

MRID: 45855101 Salmon, T.; Whisson, D.; Gorenzel, W. (2001) Field Efficacy Studies Comparing 0.005% and 0.01% Diphacinone and Chlorophacinone Baits for Controlling California Ground Squirrels (Spermophilus beecheyi): Final Report: Lab Project Number: 00

- 0471: 29: 30. Unpublished study prepared by University of California, Davis. 131 p.

MRID: 48373006 Ingenloff, K.; Soniat, M. (2011) Exposure of Rozol Prairie Dog Bait to Northern Bobwhite Quail. Project Number: 10009. Unpubli shed study prepared by Genesis Laboratories, Inc. 36 p.

### Page 40 of 65

MRID: 92018010 Baron, R. (1990) Chempar Phase 3 Summary of MRID 40751402. Secondary Hazard Evaluation of Chlorophacinone in Raptors and Chlorophacinone Residue Levels in Hawk, Owl, and Vole Tissues from Pullman, Washington: Field Study No. 88

- 1. Prepared by Agrisearch Inc. 7 p.

MRID: 45855101 Salmon, T.; Whisson, D.; Gorenzel, W. (2001) Field Efficacy Studies Comparing 0.005% and 0.01% Diphacinone and Chlorophacinone Baits for Controlling Califo rnia Ground Squirrels (Spermophilus beecheyi): Final Report: Lab Project Number: 00

- 0471: 29: 30. Unpublished study prepared by University of California, Davis. 131 p.

MRID: 45855102 VerCauteren, K.; Pipas, M.; Bourassa, J. (2002) A Camera and Hook Sy stem for Viewing and Retrieving Rodent Carcasses From Burrows: (Diphacinone and Chlorophacinone Baits): Lab Project Number: QA

879. Unpublished study prepared by National Wildlife Research Center. 29 p. (OPPTS 850.2500)

MRID: 46117301 Salmon, T.; Whi sson, D.; Gorenzel, W. (2001) Field Efficacy Studies Comparing 0.005% and 0.01% Diphacinone and Chlorophacinone Baits for Controlling California Ground Squirrels (Spermophilus beecheyi). Unpublished study prepared by University of California, Davis. 61 p

.

MRID: 46117302 VerCauteren, K.; Pipas, M.; Bourassa, J. (2002) A Camera and Hook System for Viewing and Retrieving Rodent Carcasses from Burrows. Unpublished study prepared by U.S. Dept. of Agriculture, APHIS, ADC. 22 p.

MRID: 46117303 Goodall, M.; Primus, T.; Johnston, J. (2002) Determination of Cholorphacinone (sic) and Diphacinone Residues in California Ground Squirrels and Non

- Target Animals. Unpublished study prepared by U.S. Dept. of Agriculture, APHIS, ADC. 19 p.

Guideline: 72

- 1 Acute Toxicity to Freshwater Fish

------------------------------------------------------------------------------------- MRID: 29142 Chempar Chemical Company, Incorporated (1980) Fish and Wildlife Studies with Chlorophacinone. Summary of studies 241868

- B throu gh 241868

- F. (Unpublished study received Feb 27, 1980 un

- der 7173

- 180;

CDL:241868

- A)

MRID: 29146 Sleight, B.H., III (1973) Acute Toxicity of Rozol to Bluegill (Lepomis macrochirus) and Rainbow Trout (Salmo gairdneri). (Unpublished study received Feb 27, 1980 under 7173

- 180; prepared by EG&G Bionomics, submitted by Chempar Chemical Co., Inc., New York, N.Y.; CDL:241868

- F)

MRID: 47427 Ludermann, ? (1971) Report on Toxicity of Chlorophacinone in Carp and Trout. (Unpublished study received Jul 26, 1 972 under 7173

- EX

- 43; prepared by Institut fur Wasser Boden Und Lufthygiene des Bundesgesundheitsamtes I, Germany, submitted by Chempar Chemical Co., Inc., New York, N.Y.; CDL:210147

- R)

MRID: 50802 Sleight, B.H., III (1973) Acute Toxicity of Rozol to B luegill (?~Lepomis macrochirus~) and Rainbow Trout (~Salmo gaird~

- ?~neri~). (Unpublished study received Dec 30, 1976 under 7173

- 175; prepared by Bionomics, Inc., submitted by Chempar Chemical Co., Inc., New York, N.Y.; CDL:228612

- AM)

MRID: 50813 Chem

par Chemical Company, Incorporated (1980) Fish and Wildlife Studies with Chlorophacinone: Summary. (Unpublished study re

- ceived Mar 18, 1980 under 7173

- 185; CDL:242018

- A)

MRID: 78596 Ludermann, ? (19??) Report on Toxicity of Chlorophacinone in Carp an d Trout. (Unpublished study received Jun 27, 1974 under 7173

- EX

- 6; prepared by Institut fur Wasser, Boden und Lufthygiene des Bundesgesundheitsamtes I

-- Berlin, Germany, submitted by Chempar Chemical Co., Inc., New York, N.Y.;

CDL:223685

- U)

MRID: 42356 102 Machado, M. (1992) Chlorophacinone

-- Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus) under Flow

- through Conditions: Final Report: Lab Project Number: 92

- 1

- 4079: 11219.0891.6104. 105. Unpublished study prepared by Springborn Labs, Inc. 60 p.

### Page 41 of 65

MRID: 42356103 Machado, M. (1992) Chlorophacinone

-- Acute Toxicity to Rainbow Trout (oncorhynchus mykiss)

under Flow

- through Conditions: Final Report: Lab Project Number: 91

- 12

- 4025: 11219.0891. 6103.108. Unpublished study prepared by Springborn Labs, In c. 58 p.

MRID: 92018002 Baron, R. (1990) Chempar Phase 3 Summary of MRID 00029146. Chlorophacinone (LM

- 91) (2

- ((4

- Chlorophenyl) Phenyl Acetyl) lH

- indane

- 1,3(2H)

- Dione) or (2

- ((p

- Chlorophenyl) Phenyl Acetyl)

- 1,3

- indanedione)..(CAS#3691

- 35

- 8)..Acute Tox icity of Rozol to Bluegill (Lepomis macrochirus) and Rainbow Trout (Salmo gairdneri). Prepared by EG&G Bionomics. 10 p.

MRID: 92018003 Baron, R. (1990) Chempar Phase 3 Summary of MRID 00029146. Chlorophenyl(LM

- 91) (2

- ((4

- Chlorophenyl) Phenyl Acetyl) 1H

- indane

- 1,3(2H)

- dione) or (2

- ((p

- Chlorophenyl) Phenyl Acetyl)

- 1,3

- indan

dione)..(CAS #3691

- 35

- 8)..Acute Toxicity of Rozol to Bluegill (Lepomis macrochirus) and Rainbow Trout (Salmo gairdneri). Prepared by EG&G Bionomics. 10 p.

MRID: 92018017 Baron, R . (1992) LiphaTech Phase 3 Summary of MRID 42356102: Chlorophacinone

- Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus) under Flow

- through Conditions: Report # 92

- 1

- 4079; SLI #

11219

- 0891

- 6104

- 105. Unpublished study prepared by Springborn Laborato ries, Inc. 9 p.

MRID: 92018018 Baron, R. (1992) LiphaTech Inc. Phase 3 Summary of MRID 42356103. Chlorophacinone

- Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss) under Flow

- through Conditions: Report # 91

- 12

- 4025; SLI Study # 11219

- 0891

- 6103.108. Prepared by Springborn Laboratories, Inc. 9 p.

Guideline: 72

- 2 Acute Toxicity to Freshwater Invertebrates

------------------------------------------------------------------------------------- MRID: 42356101 Putt, A. (1992) Chlorophacinone

-- Acute Toxicity to Daphnids (Daphnia magna) under Flow

through Conditions: Final Report: Lab Project Number: 91

- 11

- 3998: 11219.0891.6105.115: 010190/FIFRA 72

- 2 DM. Unpublished study prepared by Springborn Labs, Inc. 64 p.

MRID: 92018004 Baron, R. (1990) Chempar Phase 3 Summary of MRID 00019142. Chlorophacinone @

- ((4

- Chlorophenyl) Phenyl Acetyl)1H

- indane

- 1,3(2H)

- dione) or (2

- ((p

- Chlorophenyl) Phenyl Acetyl)

- 1,3

- indanedione).... (CAS #3691

- 35

- 8)..Acute Toxicity of Chlorop hacinone to the Water Flea (Daphnia magna). Prepared by EG&G Bionomics. 9 p.

MRID: 92018019 Baron, R. (1992) LiphaTech Inc. Phase 3 Summary of MRID 42356101. Chlorophacinone

- Acute Toxicity to Daphnids (Daphnia magna) under Flow

- through Conditions: Re port #91

- 11

- 3998; SLI # 11219

- 0891

- 6105.115. Prepared by Springborn Laboratories, Inc. 8 p.

Guideline: 96

- 11 Rodenticides in orchards

------------------------------------------------------------------------------------- MRID: 46227401 Schmit, T. (2004) Field Efficacy of Rozol Pellets for Controlling Montane Voles (Microtus montanus) and Other Microtus spp. in Orchards of the Pacific Northwest: Final Report. Project Number: 02143. Unpublished study prepared by Qualls Agricultural Laboratories, I nc. and Liphatech, Inc. 321 p.

Guideline: 96

- 12 Rodenticides on farms and rangelands

------------------------------------------------------------------------------------- MRID: 41649301 Poche, R. (1990) California Ground Squirrel Field Efficacy St udy Using Wilco Ground Squirrel Bait: Lab Project Number: WD

- 90

- 1. Unpublished study prepared by Genesis Laboratories. 78 p.

MRID: 45377804 Mach, J. (2001) Field Efficacy of Rozol Pocket Gopher Bait (0.005% chlorophacinone) for the Plains Gopher (Geomy s bursarius): Final Report: Lab Project Number: 00007. Unpublished study prepared by LiphaTech, Inc. 201 p.

MRID: 45855101 Salmon, T.; Whisson, D.; Gorenzel, W. (2001) Field Efficacy Studies Comparing 0.005% and 0.01% Diphacinone and Chlorophacinone B aits for Controlling California Ground Squirrels (Spermophilus beecheyi): Final Report: Lab Project Number: 00

- 0471: 29: 30. Unpublished study prepared by University of California, Davis. 131 p.

### Page 42 of 65

MRID: 45855102 VerCauteren, K.; Pipas, M.; Bourassa, J. (2002) A Camera and Hook System for Viewing and Retrieving Rodent Carcasses From Burrows: (Diphacinone and Chlorophacinone Baits): Lab Project Number: QA

879. Unpublished study prepared by National Wildlife Research Center. 29 p. (OPPTS 850.2500)

MRID : 46117301 Salmon, T.; Whisson, D.; Gorenzel, W. (2001) Field Efficacy Studies Comparing 0.005% and 0.01% Diphacinone and Chlorophacinone Baits for Controlling California Ground Squirrels (Spermophilus beecheyi). Unpublished study prepared by University of California, Davis. 61 p.

MRID: 46117302 VerCauteren, K.; Pipas, M.; Bourassa, J. (2002) A Camera and Hook System for Viewing and Retrieving Rodent Carcasses from Burrows. Unpublished study prepared by U.S. Dept. of Agriculture, APHIS, ADC. 22 p.

MRID: 46117303 Goodall, M.; Primus, T.; Johnston, J. (2002) Determination of Cholorphacinone (sic) and Diphacinone Residues in California Ground Squirrels and Non

- Target Animals. Unpublished study prepared by U.S. Dept. of Agriculture, APHIS, ADC. 19 p.

MRID: 46227401 Schmit, T. (2004) Field Efficacy of Rozol Pellets for Controlling Montane Voles (Microtus montanus) and Other Microtus spp. in Orchards of the Pacific Northwest: Final Report. Project Number: 02143. Unpublished study prepared by Qualls A gricultural Laboratories, Inc. and Liphatech, Inc. 321 p.

MRID: 46993801 Borchert, J. (2006) Field Efficacy of Kaput Pocket Gopher Bait (0.005% Diphacinone) for Controlling Black

- Tailed prairie Dogs (Cynomys ludovicianus) in Colorado. Project Number: N 05006. Unpublished study prepared by Genesis Laboratories, Inc. 16 p.

MRID: 47116901 Arjo, W.; Shwiff, S.; Kirkpatrick, K. (2007) Efficacy and Economics of an Integrated Pest Management Program for Mountain Beaver Control: Final Report. Project Number : QA/1313. Unpublished study prepared by USDA APHIS National Wildlife Research Center and Olympia Field Station. 91 p.

MRID: 47267701 Lee, C.; Hygnstrom, S. (2007) Field Efficacy and Hazards of Rozol Bait for Controlling Black

Tailed Prairie Dogs (Cyno mys ludovicianus). Project Number: 06076. Unpublished study prepared by Kansas State University

- State Agr. Sta. and University of Nebraska. 300 p.

MRID: 47333602 Lee, C.; Hygnstrom, S. (2007) Field Efficacy and Hazards of Rozol Bait for Controlling Black

Tailed Prairie Dogs (Cynomys ludovicianus). Project Number: 06076. Unpublished study prepared by Kansas State University and University of Nebraska. 300 p.

MRID: 48046801 Forgacs, T. (2009) Field Efficacy of Rozol Bait for Control of California Ground Squirrels (Spermophilus beechii). Project Number: 09038. Unpublished study prepared by Liphatech, Inc. 179 p.

MRID: 49668101 Brunlinger, M. (2014) Field Efficacy of Rozol Bait for Control of California Ground Squirrels (Spermophilus beecheyi). Project Number: 13003. Unpublished study prepared by Liphatech, Inc. 250p.

Guideline: 171

- 4A3 Nature of the Residue in Livestock

------------------------------------------------------------------------------------- MRID: 42760903 Spare, W. (1986 ) Chlorophacinone Residue Levels in Ground Squirrels from Davis, California: Lab Project Number: 1413. Unpublished study prepared by Agrisearch Inc. 23 p.

Guideline: 850.5400 Algal toxicity, Tiers 1 and II

----------------------------------------- -------------------------------------------- MRID: 47323204 Peither, A. (2003) Toxicity of Chlorophacinone to Scenedesmus subspicatus in a 72

- hour Algal Growth Inhibition Test. Project Number: 844814. Unpublished study prepared by RCC Ltd. 63 p.

Guideline: 860.1300 Nature of the residue

- plants, livestock

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

### Page 43 of 65

MRID: 47333603 Primus, T. (2007) Determination of Chlorophacinone Residues in Prairie Dog Whole Body and Liver Tissues: Final Report. Project Number: 70/C/SS, QA/1405. Unpublished study prepared by US Dept. of Agriculture, APHIS, WS. 58 p.

### Page 44 of 65



# Appendix A: Label Use Inf ormation for chloro phacinone based on BEADs summary report

Use Single Max

Applicati on Rate Max

Application Rate per

Year Min

Application

Retreatment

Interval (days) Max # of

Applications

Per Year (or Crop Cycle) Application

Methods

A gricultural C rops / S oils (U nspecified ) 0.0000252

lb / burrow

NS 4 2 GBT

A gricultural F allow / I dleland /

C onservation Reserve 0.001lb / ac AB, GB

0.0000252

lb / burrow

GBT

A gricultural /F arm S tructures
/ B uildings and Equipment 0.00000219

lb/bait station

NS

NS 0.0001 lb/ placement

4.4 lb / ac

A gricultural U ncultivated

A reas 0.0005 lb / ac 0.001 lb / ac 1 AB

0.001 lb /ac 0.002 lb / ac 1 GB

0.0001 lb / placement

NS NS GBT

0.0005 lb / ac GST

Alfalfa 0.0000126

lb/ burrow GBT

0.0004 lb / ac

0.0002 lb /

bait station GBT (granular)

0.00001688

lb / burrow 3 GBT (wettable powder) 0.0004 lb / ac

NS A nimal B urrows , H arborages

or D ens Of P lague R eservoir

Hosts 0.0001 lb /

burrow or / placement

GBT

Artichoke 0.00000055

lb / plant or

0.00000625 lb / plant 3 21

Barley 0.0002 lb /

bait station NS NS GBT (granular)

0.00000099

lb / burrow 2 2 GST (granular)

C hristmas Tree P lantations 0.0005 lb / ac 0.001 1 NS AB

0.001 lb / ac 0.002 1 GB

### Page 45 of 65 0.0005 lb / ac

NS NS GST

Commercial/Institutional/ Industrial Premises/Equip. (Indoor) 4.4 lb / ac, or

0.0001 lb / placement, or

0.00000219

lb / bait

station

GBT Commercial/Institutional/ Industrial Premises/Equip. (Outdoor)

0.0001 lb /

placement Commercial Transportation Facilities (All or Unspecified)

Commercial Transportation Vehicles (All or Unspecified)

F encerows / H edgerows

Food P rocessing P lant

P remises (N on

- Food Contact )

F orest P lanting (R eforestation

P rograms ) (T ree F arms , T ree P lantations

, etc .) 0.0005 lb /ac 0.001 lb /ac 1 AB

0.001 lb /ac 0.002 lb /ac 1 GB

0.005 lb /ac NS NS GST

Forest T rees (A ll or

U nspecified ) 0.001 lb / ac 4 2 AB

0.002 lb /ac 1

NS GB

0.005 lb / ac NS NS GST

G olf C ourse T urf 0.005 lb / ac 0.001 lb /ac 1

0.0004 lb / ac

NS NS GBT

0.00001688

lb / burrow 3 GBT (wettable powder)

H ousehold / D omestic

D wellings I ndoor P remises 4.4 lb / ac

NS GBT

H ousehold / D omestic

D wellings Outdoor P remises 0.0001 lb / placement

N onagricultural R ight

- of

- Way

/ F encerows / H edgerows 0.001 lb / ac

4 2 AB

0.0000252 lb

/ burrow GBT

0.001 lb /ac GB

N onagricultural U ncultivated

A reas / S oils 0.0004 lb / ac NS NS GBT

0.00000099

lb / burrow 2 2 GST (granular)

0.00001688

lb / burrow 3 NS GBT (wettable powder)

N ursery S tock 0.001 lb /ac 4 2 AB

0.002 lb /ac 1 NS GB

0.0005 lb /ac

NS NS GST

0.0000252 lb

/ burrow 4 2 GBT (granular)

Oats 0.0002 lb /

bait station NS NS

### Page 46 of 65 0.00000099

lb / burrow 2 2 GST (granular)

O rchards (U nspecified ) 0.001 lb / ac NS 4 2 AB

0.001 lb / ac 0.002 lb / ac 1

NS GB

0.0005 lb / ac

NS NS GST

0.0004 lb / ac GBT

GBT (wettable powder)

O rnamental Herbaceous

Plants 0.0005 lb / ac 0.001 lb / ac 1 GST

O rnamental L awns and T urf 0.004 lb / ac NS NS GBT

GBT (wettable powder)

O rnamental Woods Shrubs

and Vines 0.0005 lb / ac 0.001 lb / ac 1 GST

P astures 0.00000099

lb / burrow

NS 2 2 GST (granular)

0.0002 lb /

bait station NS NS GBT (granular)

P ublic B uildings / S tructures (V ert. P est C ontrol ) 0.0001 lb / placement GBT

R angeland 0.001 lb / ac 4

2 AB

GB

0.00000099

lb / burrow 2 GST (granular)

0.0000252 lb

/ burrow 4 GBT

0.0004 lb /ac

NS NS 0.0004 lb /ac GBT (wettable powder)

R ecreational A reas 0.001 lb / ac

4 2 AB

GB

0.0000252 lb

/ burrow

GBT R efuse / S olid W aste S ites (Indoor ) 0.0001 lb /

placement NS NS R efuse / S olid W aste S ites (O utdoor )

R ight

- of

- Way (R ailroad )

Wheat 0.0002 lb /

bait station(s) GBT (granular)

0.00000099

lb / burrow 2 2 GST (granular)
Note: AB=Aerial Broadcast, GB=Ground Broadcast, GBT=Ground Bait Treatment, GST=Ground Spot treatment, NS=Not Specified. When formulation type is not specified, it is Bait/Solid.

There are several use sites being identified as NDC (no dosage conversion). They are as follows: agric ultural/farm structure/buildings and equipment, commercial/institution/industrial premises/equipment

### Page 47 of 65

(indoor or outdoor), commercial transportation vehicles (all or unspecified), food processing plant premises (nonfood contact), household/domestic dwelling (indoor or outdoor) premises, public buildings/structure (vert. pest control), refuse/solid waste site (indoor or outdoor)

### Page 48 of 65



# Appendix B : Summary of Ecotoxicity Data for Chlorophacinone

Table B

- 1. Freshwater Fish Acute Toxicity of Chlorophacinone
Species 1,2 % a.i. 96

- hourLC 50 (mg a.i./L) Toxicity

Category MRID No. Study Classification

Bluegill sunfish, ( Lepomis macrochirus ) 100 0.710 Highly toxic 43256102* (Machado, 1992) Acceptable (flow

through, 10 fish/level)
Rainbow trout, ( Onchorhynchus mykiss ) 100 0.450 Highly toxic 43256103** (Machado, 1992) Acceptable (flow

through, 10 fish/level)

*In previous assessments this study was cited as MRID 43249501 ; the correct MRID is 43256102. ** In previous assessments this study was cited as MRID 43249502; the correct MRID is 43256103.



### Table B

- 2 . Freshwater Invertebrate Acute Toxicity of Chlorophacinone
Species % diquat

cation 48

- hourEC 50

(mg /L) Toxicity

Category MRID No.

Author, Year Study Classification

Water flea ( Daphnia magna ) 100 0.64 Highly toxic 42356101 (Putt, 1992) Acceptable (flow

through)

### Page 49 of 65



### Table B

- 3: Avi an Acute Toxicity to Chlorophacinone

Species % A.I. Toxicity Endpoint Toxicity

Classification MRID Status

Acute Single Oral Dose

Bobwhite quail ( Colinus virginianus ) 100 L D 50 = 258 mg /kg

bw 1 Moderately

toxic 41513101 (Fletcher

and Pederson, 1989) Acceptable

Bobwhite quail ( Colinus virginianus ) Tech. L D 50 = 495 mg /kg

bw 2 Not classified,

study not

reviewed 39233 (Beavers et

al., 1979) Study not yet

reviewed by EPA; endpoints as reported by study

author.

Acute Dietary

Bobwhite quail 100 LC 50 = 56 mg /kg

diet 3 Highly toxic 41513102 (Fletcher and Pederson, 1989) Acceptable

Mallard duck ( Anas platyrhynchos ) 100 LC 50 = 172 mg a.i./kg

- diet 4 Highly toxic 41513103 (Fletcher and Pederson, 1989) Acceptable

Bobwhite quail Tech. LC 50 = 242 mg a.i./kg

- diet 5 Not classified,

study not

reviewed 29144 (Beavers et

al., 1979) Study not yet

reviewed by EPA; endpoints as reported by study

author.

Mallard duck Tech LC 50 = 426 mg a.i./kg

- diet 5 Not classified,

study not

reviewed 29143 (Beavers et

al., 1979) Study not yet

reviewed by EPA; endpoints as reported by study

author.

Japanese quail 

### ( Coturnix c. 

### japonica ) 0.25% oil

concentrate LC 50 = 60 mg

a.i./kg

- diet 4 Highly toxic 47323201 (Reidel et al, 1990) Supplemental (non

GLP study, raw data not submitted)

1 Birds were dosed on day 0 and followed for 30 days after dosing. All mortalities occurred within 5 days of the

start of the test.

2 Birds were dosed on day 0 and followed for 14 days after dosing. All mortalities occurred within 10 days of the

start of the test.

3 Birds were fed treated diet for 5 days and untreated diet for the following 25 days. All mortalities occurred within

nine days of the start of the test.

4 Birds were fed treated diet for 5 days and untreated diet for the following 3 days. Total observation time was 8 days after start of test.

5 Birds were fed treated diet for 5 days and untreated diet for the following nine d ays. Birds were observed for a total of 14 days.

### Page 50 of 65



### Table B

- 4: Avi an Sub

- Chronic Toxicity to Chlorophacinone

Species % A.I. Toxicity Endpoint s Affected Endpoints MRID and Status

Japanese quail 0.25% oil

concentrate NOAEC = 1 mg

a.i./kg

- die t
LOAEC = 2 mg a.i./kg

- diet - Adult mortality at all test levels

greater than 1 mg a.i./kg

- diet.

- Increased relative liver mass and prothombin time at 4 mg a.i./kg

- diet and greater for females.

- Increased liver mass, relative liver mass and prothombin time at 8 mg a.i./kg

- diet and greater for males.

- Progeny appear unaffected. 47323201 (Reidel et al, 1990)

Supplemental (non

guideline, non

- GLP study, raw data not submitted)



### Table B

- 5: Avi an Reproductive Toxicity to Chlorophacinone

Species % A.I. Toxicity Endpoint s Affected Endpoints MRID and Status

Bobwhite quail 99.7% NOAEC < 0.982 mg a.i./kg

- diet

LOAEC = 0.982 mg a.i./kg

- diet Reduced eggshell thickness at 0.982

and 2.9 mg a.i./kg

- diet . Reduced

n umber of eggs hatched as a percentage of live embryos at 2.9 and

9.04 mg a.i./kg

- diet. Reduced number of hatchling survivors as a percentage of eggs hatched at 9.04 mg a.i./kg

diet. One treatment

- related adult mortality at 9.04 mg a.i./kg

- diet. 489904001

Supplemental (definitive NOAEC not established)

Mallard duck 98.4% NOAEC = 0.046 mg a.i./kg

- diet

LOAEC = 0.096 mg a.i./kg

- diet Reduction in mean 14

- day survivor

weights at 0.096 and 0.96 mg a.i./kg

diet concentrations. Reductions in number of hatchlings of eggs set, 14

- day hatchling survival of eggs set, hatchling survival of number hatched, and hatchling weight at the 0.96 mg a.i./kg

- diet concentration.

Nine of 16 adult females died (treatment

- related) at the 0.96 mg

a .i./kg

- diet concentration. 489904002

Acceptable

### Page 51 of 65

Table B

- 6 : Mammalian Acute Toxicity to Chlorophacinone

Test Type % A.I. Toxicity Endpoint Toxicity

Classification MRID Status

Acute oral (gavage) single dose

Laboratory rat

Rattus norvegicus 100% LD 50 = 3.15 mg a.i./kg

- bw (male)

LD 50 = 10.95 mg a.i./kg

- bw (female)

LD 50 = 6.26 mg a.i./kg

- bw (combined) Very highly

toxic 41875301 Acceptable a (Single dose, mortalities occurred 4 to 9 days after dosing)

Black

- tailed Prairie Dogs ( Cynomys

ludovicianus ) 99.4% LD 50 : 1.94 mg ai/kg bw 95% C.I.: (1.46, 5.77)

Slope = 3.45 Very highly

toxic 47333601 Supplemental (Single dose, mortalities occurred 9 to 22 days after dosing) (sufficient raw data not included)

Pine vole ( Microtus

subterraneus ) NA LD 50 : 14.2 95% C.I.: (11.4, 17.6) Slope = 0.81 Highly toxic Byers (1978) Supplemental ( qualitative)

Acute oral (gavage) multiple dose

Norway Rat (wild type)

Rattus norvegicus 5

- day cumulative dose

LD 50 = 0.8 mg a.i./kg

- bw

Doses were administered daily for 5 days, the 5

- day LD 50 = 0.8 mg a.i./kg

- bw is equivalent to 5 days of administration of 0.16 mg a.i./kg

- bw/day Very highly

toxic Ashton, et al.

(1987) Qualitative (no

controls, length of

observation not stated, time of

mortalities and

additional raw data not provided)

Laboratory

Rat 5

- day cumulative dose

LD 50 = 0.95 mg a.i./kg

- bw

Doses were administered daily for 5 days, the 5

- day LD 50 = 0.95 mg a.i./kg

- bw is equivalent to 5 days of administration of 0.19 mg a.i./kg

- bw/day Very highly

toxic Ashton, et al.

(1987) Qualitative (no

controls, length of

observation not stated, time of

mortalities and

additional raw data not provided)

Laboratory mouse ( Mus

musculus ) 5

- day cumulative dose

LD 50 = 5.95 mg a.i./kg

- bw

Doses were administered daily for 5 days, the 5

- day LD 50 = 5.95 mg a.i./kg

- bw is equivalent to 5 days of administration of 1.19 mg a.i./kg

- bw/day Very highly

toxic Ashton, et al.

(1987) Qualitative (no

controls, length of

observation not stated, time of

mortalities and

additional raw data not provided)

Acute Dietary

Laboratory

Rat Tech. LC 50 = 1.14 (1.02

- 1.36) mg a.i./kg

- diet Slope = 13.2 Very highly

toxic Teeters 1981

(TNM 66)* Supplemental,

Observed 14 days,

mortalities 5

- 8 days

### Page 52 of 65

Table B

- 6 : Mammalian Acute Toxicity to Chlorophacinone

Laboratory

Rat Tech. LC 50 = 1.14 (0.98

- 1.35) mg a.i./kg

- diet Slope = 7.2 Very highly

toxic Teeters 1981

(TNM 117)* Supplemental

Observed 14 days, mortalities days 4

- 12 Laboratory

Rat Tech. LC 50 = 1.26 (1.11

- 1.47) mg a.i./kg

- diet Slope = 9.9 Very highly

toxic Teeters 1981

(TNM 120)* Supplemental

Observed 14 days, mortalities days 4

- 8

Laboratory

Rat Tech. LC 50 = 1.26 (0.97

- 1.64) mg a.i./kg

- diet Slope not estimated, binomial

method Very highly

toxic Teeters 1981

(TNM 74)* Supplemental

Observed 14 days, mortalities days 5

- 12

a As classified by OPP Health Effects Division (HED)

*Teeters, W.R.(1981) Chlorophacinone technical: Toxicity to Laboratory Rat. (U.S. Environmental Protection Agency, Pesticides Regulation Div., Agricultural Research Center, Animal Biology Laboratory, unpu blished report.)

### Page 53 of 65



### Table B

- 7 : Mammalian Developmental and Maternal Toxicity to Chlorophacinone

Test Type % A.I. NOAEL ( μ g/kg

bw/day ) LOAEL

( μ g/kg

bw/day ) Affected Endpoints MRID (Status)

Developmental (New Zealand white rabbit) 101 Maternal

NOAEL = 5

Develop

NOAEL = 10 Maternal

LOAEL = 10

Develop

LOAEL = 25 Dose administered by oral gavage

daily from gestation days 7 to 19,

inclusive.

Maternal NOAEL based on increased prothrombin and activated partial thromboplastin times in the preliminary range

- finding study at gestation day 20.

Developmental NOAEL based on lack

of sufficient fetuses/litters at the higher dose levels as high mortality was observed ( 13/16 rabbits at 25 μg/kg/day and 16/16 rabbits at 75 μg/kg/day) in definitive t est. In addition external bleeding and internal hemorrhage were observed in the 25 μg/kg/day and 75 μg/kg/day dose

groups. 43570801 (Acceptable a )

Developmental (Laboratory rat) 101 Maternal

NOAEL = 5 0

Develop

NOAEL<12.5 Maternal

LOAEL = 10 0

Develop

LOAEL ≤12.5 Dose administered by oral ga vage

daily from gestation days 6 to 15

, inclusive.

Maternal NOAEL based on dam mortality.

Developmental NOAEL based on increased incidences of hydroureter,

distended ureter and total ureter anomaly in the fetuses. 43349501

(Acceptable a )

a As classified by OPP Health Effects Division (HED)

### Page 54 of 65



### Table B

- 8 : Toxicity to Chlorophacinone to Non

- target Terrestrial Invertebrates

Species % A.I. Toxicity Endpoint s MRID Status

Burying

beetle Nicrophorus

orbicollis 100 Number of beetle young emerging and total biomass of young was reduced in beetle trt group laying eggs in carcasses fed 50 mg a.i./kg

- bait for 5

- 10 days compared when to control. 47383001 Supplemental (non

- guideline)

Earthworm

( Eisenia foetida ) 99.77 LC 50 > 1000 mg ai/kg

- soil

NOAEC (mortality) = 309 mg ai/kg

- soil

NOAEC (weight change) < 95 mg ai/kg

- soil 47383002 Study not yet reviewed by EPA; endpoints as reported by study

author.

### Page 55 of 65



# Appendix C . Screening Level Models to Evaluate Potential Importance of Drinking Water and Inhalation Exposure Pathways

### Page 56 of 65



### SIP ( Screening Imbibition Program, v1.0) Inputs and Conclusions
Table 1. Inputs

Parameter Value

Chemical name chlorophacinone

Solubility (in water at 25 o C; mg/L) 3.4

Mammalian LD 50 (mg/kg

- bw) 6.26

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

Mammalian NOAEL (mg/kg

- bw) 0.01

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

Avian LD 50 (mg/kg

- bw) 258

Avian test species northern bobwhite quail
Body weight (g) of "other" avian species

Mineau scaling factor 1.15

Mallard NOAEC (mg/kg

- diet) 0.046
Bobwhite quail NOAEC (mg/kg

- diet) 0

NOAEC (mg/kg

- diet) for other bird species 0
Body weight (g) of other avian species

NOAEC (mg/kg

- diet) for 2nd other bird species 0
Body weight (g) of 2nd other avian species

Table 2. Mammalian Results

Parameter Acute Chronic

Upper bound exposure (mg/kg

- bw) 0.5848 0.5848
Adjusted toxicity value (mg/kg

- bw) 4.8149 0.0077

Ratio of exposure to toxicity 0.1215 76.0309

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) 2.7540 2.7540
Adjusted toxicity value (mg/kg

- bw) 185.8708 0.0023
Ratio of exposure to acute toxicity 0.0148 1206.7420

Conclusion* Drinking water exposure alone is NOT 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. Therefore, when aggregated with other routes ( i.e ., diet, inhalation, dermal), pesticide exposure through drinking water may contribute to a total exposure that has potential for effects to non

- target animals.

### Page 57 of 65

Welcome to the EFED Screening Tool for Inhal ation Risk

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

significance of the inhalation exposure route to birds and mammals in a risk assessment. Input

Application and Chemical Information

Enter Chemical Name chlorophacinone

Enter Chemical Use rodenticide Is the Application a Spray? (enter y or n) n If Spray What Type (enter ground or air) ground Enter Chemical Molecular Weight (g/mole) 374.81 Enter Chemical Vapor Pressure (mmHg) 3.58E

- 06 Enter Application Rate (lb a.i./acre) 0.001

Toxicity Properties

Bird

Enter Lowest Bird Oral LD 50 (mg/kg bw) 258 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178

Mammal

Enter Lowest Rat Oral LD 50 (mg/kg bw) 6.26

Enter Lowest Rat Inhalation LC 50 (mg/L) 0.007 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 ) 7.22E

- 02

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 9.08E

- 03 Adjusted Inhalation LD 50 1.61E+00

Ratio of Vapor Dose to Adjusted Inhalation LD 50 5.64E

- 03 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) not applicable Ratio of Droplet Inhalation Dose to Adjusted Inhalation

LD 50 not applicable not applicable

Results Mammalian (0.015 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 7.22E

- 02

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 1.14E

- 02

Adjusted Inhalation LD 50 4.17E

- 01

Ratio of Vapor Dose to Adjusted Inhalation LD 50 2.74E

- 02 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) not applicable Ratio of Droplet Inhalation Dose to Adjusted Inhalation

LD 50 not applicable not applicable

### Page 58 of 65



# Appendix D . Wildlife Mortality I ncidents Attributed to Use of
Chloro phacinone

The table below is based on the Summary Table that was included in Docket ID EPA

- HQ

- OPP

2011

- 0718 (“ Risks of Non

- Compliant Rodenticides to Nontarget Wildlife

- Appendix D

- Wildlife Mortality Incidents”; Document ID EPA

- HQ

- OPP

- 2011

- 0718

- 0010) . The table was updated to include additional incidents and additional information on previously reported

incide nts that was available to the Agency as of 2013. Any additional incidents reported to the Agency after 2013 for chlorophacinone have not been added to the table below.

### Page 59 of 65

INCIDENT

NUMBER YEAR LEGALITY CERTAINTY A STATE LAND

USE GENERIC

SPECIES (Number) COMMENTS

B000179

- 001 1981 Registered

use Highly probable WA Field Quail (1) This incident was reported in an article entitled, “Effects of Pelletized Anticoagulant Rodenticides on California Quail,” in the Journal of Wildlife Diseases, 1985, pp391

– 395. A moribund emaciated California quail was

found in an orchard. The rodenticide chlorophacinone was found in the crop, and the gizzard contained a pink mass of paraffin that was selectively accumulated from the paraffinized pellets. [NOT IN EIIS]

I003351

- 033 1995 N/R Highly probable CA N/R Bobcat (1) A bobcat was found dead the day after it was observed feeding on a barn owl in the

Golden Gate National Recreation Area on February 14, 1995. The owl and bobcat

carcasses were to the California Dept. of Fish and Game for analysis. A rodent carcass was found in the crop of the owl. Chlorophacinone was detected in the liver of the bobcat at 0.4 ppm.

I006306

- 005 1994 N/R Highly probable NY Residential Squirrel (1) A gray squirrel was found dead in Albany County, NY in August, 1993. A subsequent necropsy showed both brodifacoum (0.53 ppm) and chlorophacinone (0.62 ppm) to be present

in the liver and brodifacoum in the

stomach contents. There were inter

- and

intram uscular hemorrhages and free hemorrhage or bloody fluid in the body cavity.

### Page 60 of 65

INCIDENT

NUMBER YEAR LEGALITY CERTAINTY A STATE LAND

USE GENERIC

SPECIES (Number) COMMENTS

I006306

- 007 1993 N/R Highly probable NY Residential Squirrel (1) A dead male gray squirrel was submitted on August 13, 1993, in Albany County, NY to the Wildlife Pathology Unit to

determine cause of death. Gross pathology findings indicated that the squirrel died from anticoagulant rodenticides. Brodifacoum 0.53 ppm and chlorophacinone 0.62 ppm were detected in the squirrel's liver.

I009111

- 001 1999 N/R Highly probable NY Urban Squirrel (1) A grey squirrel was found dead in

Manhattan and arrived at the Wildlife Pathology Unit the same day. A hemorrhage was present in the musculature overlying both scapulae. The right lung was hemorrhagic. The stomach contained ground nutmeats and analysis of the liver detected chlorophacinone residues at 0.47 ppm.

I009118

- 001 1999 N/R Probable NY Urban Squirrel (1) An adult male gray squirrel was found dead, head

- first in the split of a tree stump in Central Park, on February 14, 1999. A bacterial infection with pus was present over the skull, and several large tan necrotic areas were present in the liver. An analysis of the liver showed the presence of chlorophacinone at 0.29 ppm. In the opinion of the technical investigator, the squirr el may have died from the infection alone, but the pale

musculature indicates blood loss had

occurred from the anti

- coagulant.

### Page 61 of 65

INCIDENT

NUMBER YEAR LEGALITY CERTAINTY A STATE LAND

USE GENERIC

SPECIES (Number) COMMENTS

I012972

- 001 2002 N/R Probable KS Field Turkey (2) Two wild turkeys were found dead approximately 100 yards from a prairie dog town that has been baited with poisoned grain two and a half to three weeks prior to submission. The suspected poison was Rozol® pocket gopher poison. The landowner that found th e turkeys contacted the Kansas Department of Wildlife and Parks. Necropsy showed dilated vessels in the crop area and diffuse hemorrhage around the crop. Pebbles and green feed material are present in the ventriculus. The gastrointestinal tract contains blue green grain in the crop. An analysis of the livers detected chlorophacinone residues of 0.69 and 0.40 ppm.

I013810

- 013 1999 N/R Probable NY Urban Hawk (1) This incident was part of the Contaminant Exposure and Effects

– Terrestrial Vertebrates (CEE

- TV) Database, Version 3.3, October 2002 report. A red

- tailed hawk was found in Manhattan. Necropsy results showed 0.18 ppm chlorophacinone

residues in the liver

.

I019311

- 001 2008 N/R Highly probable KS N/R Badger (1) Use of the product Rozol Pocket Bait

Burrow Builder Formula with active ingredient chlorophacinone caused mortality of a badger in Kansas. A necropsy by the National Fish and

Wildlife Forensics Lab determined that anticoagulant poisoning was the cause of death. Chlorophacinone was measured at 320 ppb in the stomach and 2 ppm in the liver. Route of exposure was listed as "unknown" because no prairie dog

remains were found inside the bad ger, but being a strict carnivo r e , it almost certainly

### Page 62 of 65

INCIDENT

NUMBER YEAR LEGALITY CERTAINTY A STATE LAND

USE GENERIC

SPECIES (Number) COMMENTS

was affected through secondary poisoning.

I019968

- 001 2008 N/R Highly probable CA Field Geese (70), vulture (2), Barn owl (1), bobcat (1) In 2008, Department of Fish and Game

Office of Spill Prevention and Response staff in Santa Cruz responded to an

incident near a lettuce field near Morro Cojo Slough involving several dead Canada geese. A dditional geese were

found dead at the site for several weeks after the initial incident report. The total

number of de ad geese was estimated to be 70. In addition, two turkey vultures, a

red

- tailed hawk, a barn owl, and a bobcat were found dead in the vicinity. The

geese
, predators and scavengers showed signs of anticoagulant toxicity. All but

one of the animals tested positive for chlorophacinone.

I020607

- 001 2009 N/R Highly

Probable KS Field Badger (1) A dead badger was found on a private property. The liver was tested and chlorophacinone residues of 4.4 ppm (with a detectable limit of 0.25 ppm) were

detected. It was determined the badger died from secondary poisoning, most likely resulting from use of chlorophacinone to control prairie dogs in

the area.

I020996

- 001 2009 N/R Possible KS Field Wild Turkey (45) Forty

- five wild turkeys were found dead

in and near the small town of Russell Springs, KS. Analyses of 6 of the turkey found phosphene gas in the crop contents, indicating poisoning by zinc phosphide. However, chlorophacinone was also detected in the crop contents of one of the turkeys, indicating that it ma y have also contributed to causing the mortality of

some of the birds.

### Page 63 of 65

INCIDENT

NUMBER YEAR LEGALITY CERTAINTY A STATE LAND

USE GENERIC

SPECIES (Number) COMMENTS

I020996

- 003 2009 N/R Possible KS Park Raccoon (1) The Department of Wildlife and Parks received numerous reports of dead raccoon at a city park. The raccoon was

delivered to the Southeastern Cooperative Wildlife Disease Study College of Veterinary Medicine (SCWDS) for postmortem analysis. The intestines of the raccoon were distended with bloody contents. Several areas of hemorrhage were present under the skin and on the

surface of many organs. Brodifacoum, chlorophacinone, and bromadiolone

residues were detected in the liver although no residue amounts were provided in the report.

I022986

- 001 2011 N/R Possible NY Urban Red

- tailed hawk (1) A dead immature red

- tailed hawk was

found in Fort Tryon Park in Manhattan, NY. A clotted hemorrhage was observed in the left optical area of the left side of

the head. There was 1

- 2 ml of clotted hemorrhage found in the ceolomec cavity. Toxicology analy sis of liver tissue found brodifacoum at 0.149 ppm. Low

concentrations of three other anticoagulant rodenticides were also detected 0.024 ppm difethialone, 0.018 ppm bromadialone, and 0.004 ppm chlorophacinone.)

I023324

- 002 2006 Registered

use Highly pr obable NE Field Bald eagle (1) On December 6, 2006 a dead bald eagle was found in Red Willow County, NE by a Nebraska Conservation Officer (CFO). A pesticide applicator told the CFO that

he had followed label instructions when applying Rozol to control prairie dogs.

An internal examination noted hemorrhaging in muscle tissues and in the clavicular air sac. Chlorophacinone was

### Page 64 of 65

INCIDENT

NUMBER YEAR LEGALITY CERTAINTY A STATE LAND

USE GENERIC

SPECIES (Number) COMMENTS

detected in the liver sample at 0.30 ppm.

I023352

- 001 2011 N/R Highly probable NE Field Bald eagle (1) The carcass of a bald eagle from Buffalo County, NE was received by the USFWS on March 31, 2011. Chlorophacinone was detected at 0.4 ppm in the liver sample. Hemorrhaging was present in the

subcutaneous tissue.

I02 4146

- 009 1997 N/R Highly probable CA N/R Coyote (1) On September 12, 1997 a coyote was

recovered from the Santa Monica

Mountains National Recreation Area in Los Angeles County, CA. The carcass was sent to the Department of Fish and

Game Pesticide Investigations Unit for necropsy and tissue analysis to try and

determine the cause of death. Lab results detected residues of chlorophacinone in (blood sample 0.04 ppm), (intestinal sample 0.24 ppm), (liver sample 1.2 ppm). Large hematomas involving mos t of the musculature were present on all four limbs. It is highly probable that the loss of this coyote was due to exposure to chlorophacinone, but unable to determine if exposure was primary or secondary.

I024152

- 004 2006 N/R Highly

Probable CA N/R Coyote (1) In 2006 in Santa Cruz County, CA a laboratory staff reported that a coyote

liver was submitted to the Pesticide Investigations Unit in order to analyze for anticoagulant residues. The liver contained four anticoagulants; chlorophacinone (1.13 ppb), coumatetralyl (0.10 ppb), diphacinone (1.50 ppb) and warfarin (0.060 ppb). It is highly likely that mortality was caused by exposure to anticoagulants.

### Page 65 of 65

INCIDENT

NUMBER YEAR LEGALITY CERTAINTY A STATE LAND

USE GENERIC

SPECIES (Number) COMMENTS

A: Certainty describes the level of certainty that exposure to the given pesticide was the caus e or a significant contributing factor of the effects

observed in the incident.