Page 1 of 37 OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

December 4 , 2014

PC Code: 035101

MEMORANDUM DP Barcode: 411597

SUBJECT: Preliminary Ecological Risk Assessment for the Registration Review of

Daminozide

FROM: Christine Hartless, Ph.D., Wildlife Biologist

James Lin, Ph.D., Environmental Engineer ERB2/EFED (7507P)

THROUGH: Greg Orri ck, Environmental Scientist

Christina Wendel, Biologist Jean Holmes, DVM, MPH, Risk Assessment Process Leader Brian Anderson, MEM, Branch Chief ERB2/EFED (7507P)

TO: Meg Hathaway , Chemical Review Manager

Kevin Costello , Branch Chief

RMIB2 / PR D (750 8 P)

This memorandum transmits the preliminary ecological risk assessment for the registration

review of the plant growth regulator daminozide . Based on currently registered uses and labeled rates, this preliminary assessment identifies potential risks to n on

- target organisms . This

assessment is focused on species that are not federally listed as threatened or endangered (referred to as “listed”) ; however, some general discussion of taxa of listed species for which “ no effect ” determ i nations are expected is included in this assessment. For taxa where there may be risk, specific determinations for listed species are considered uncertain and are not discussed at
this time and will be considered later in the registration review process.

Risks due to use of daminozide using current labels were considered low for non

- listed species of fish, aquatic

- phase amphibians (that do not have terrestrial

- phases), aquatic invertebrates, aquatic plants, terrestrial invertebrates, monocots (in terrestrial and wetland habitats), and dicots (in terrestrial and wetland habitats)

. Risk due to use of daminozide at currently labeled rates cannot be precluded for listed and non

- listed non

- target birds, reptiles, terrestrial

- phase amphibians and mammals. “No effect” ( NE) determinations were made for listed species of fish, aquatic

- phase amphibians (that do not have terrestrial

- phases), aquatic invertebrates, aquatic plants, terrestrial invertebrates, monocots (in terrestrial and wetland habitats), and dicots (in

terres trial and wetland habitats) that do not rely upon birds, terrestrial

- phase amphibians, reptiles, and/or mammals (for food or shelter).Page 2 of 37



## Preliminary Ecological Risk Assessment for the Registration Review

of Daminozide

CAS Number 1596

- 84

- 5

USEPA PC CODE 035101

Prepared by : Christine Hartless, Ph.D., Wildlife Biologist James Lin, Ph.D., Environmental Engineer

Reviewed by: Greg Orrick

, Environmental Scientist

Christina Wendel , Biologist Jean Holmes, DVM, MPH, Risk Assessment Process Leader

Approved by:

Brian Anderson

, MEM, Branch Chief , Environmental Risk Branch II

Environmental Fate and Effects Division Office of Pesticide Program s U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, D.C. 20460

December 2 , 2014Page 3 of 37 Table of Contents

1 Executive Summary

................................ ................................ ................................ ............ 4

2 Problem Formulation

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

2.1 Target Pests and Mode of Action

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

2.2 Use Characterization

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

2.3 Estimated Use in the United States

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

3 Exposure Analysis

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

3.1 Environmental Fate Summary

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

3.2 Residues of Concern

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

3.3 Aquatic Exposure

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

3.4 Terrestrial Exposure

................................ ................................ .............................. 14

4 Ef fects Analysis

................................ ................................ ................................ ................ 16

4.1 Toxicity of Daminozide

................................ ................................ ........................ 16

4.2 Endocrine Disruptor Screening Program

................................ .............................. 19

5 Risk Characterization

................................ ................................ ................................ ........ 19

5.1 Aquatic Organisms

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

5.2 Terrestrial Organisms

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

5.3 Listed Species

................................ ................................ ................................ ....... 24

5.4 Risk Conclusions

................................ ................................ ................................ .. 25

6 References

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

Appendix A. Summary of All Ecotoxicity Data

................................ ................................ ........... 27

Appendix B. MRID Bibliography for Environmental Fate and Toxicity Studies

....................... 30Page 4 of 37

1 Executive Summary

The purpose of this assessment is to evaluate the potential risks to non

- target organisms from registered uses of daminozide ( ( N

- d imethylamino)succinamic acid ) . This assessment is focused

on non

- listed species and does not consider risks to individual f ederally listed endangered and threatened (listed) species. This assessment is focused on species that are not federally listed as threatened or endangered (referred to as “listed”) ; however, some general discus sion of taxa of listed species for which “ no effect ” determinations are expected is included in this assessment. For taxa where there may be risk, specific determinations for listed species are considered

uncertain and are not discussed in this document. R isks to listed species will be considered later in the registration review process.

Daminozide is a plant growth regulator used to control the development of commercial

container

- grown plants both in greenhouses and outdoors by changing their growth habit ; usually by making the plant smaller in height and thicker (more densely packed)

. It is applied as a foliage spray on ornamentals and is systemically distributed throughout the plant ; there are no currently registered food uses. The maximum single applic ation rate is one gallon of 0.75% daminozide solution for 200 sq feet of plants. This is equivalent to 13.63 lbs a.i./acre for the treated area ( e.g., nursery beds of containerized plants). Multiple applications are allowed for

many uses ; however , an annual maximum total rate is not provided on the label

.

Daminozide is nonvolatile and is not expected to bioaccumulate in fish. Daminozide does not undergo hydrolysis. Aqueous photolysis of daminozide showed a half

- life of 162 days. The compound does not persist in aerobic soil with a half

- life of 9 hour s. It is moderately mobile in

soil ( K OC range of 20 4

- 349 L/kg OC )

. T he compound may move to surface water bodies via spray

drift and runoff of dissolved or sorbed residues. In the aerobic soil metabol ism study, the m ajor degradate wa s CO 2 and the minor degradate was formaldehyde.

Daminozide is practically non

- toxic to b irds and mammals on an acute exposure basis. In a reproduction study with bobwhite quail ( Colinus virginianus )

, there was a reduction in the percent of surviving 14

- day chicks relative to number hatching at 890 mg ai/kg

- diet, resulting in

a no observed adverse effect concentration ( NOAEC ) of 365 mg a.i. /kg

- diet. Available toxicity

data for mammals did not identify a ny reproductive or offspring effects at doses up to 500 mg

a.i. /kg

- bw/day

. Daminozide is practically non

- toxic to honey bees ( Apis mellifera ) on an acute exposure basis. Available data for terrestrial plants indicate that dicotyledonous ( dicots ) species

ar e more sensitive than monocotyledonous ( monocots ) species . No effects to monocots were indicated at rates up to 11.5 lbs a.i./acre. The most sensitive dicot was soybean exposed to daminozide during the vegetative vigor study. The most sensitive parameter w as plant height,

with an IC 25 of 7.71 lbs a.i./acre , a NOAEC < 0.709 lb a.i./acre , and an IC 05 of 0.39 lb a.i./acre. For aquatic animals, daminozide is practically non

- toxic to fish and slightly toxic to invertebrates on an acute exposure basis . No reproduction data are available for fish or invertebrates

. The only aquatic plant species tested ( Pseudokirchneriella subcapitata ) had a NOAEC of 99.8 mg a.i./L. No ecological incidents were reported for daminozide.

Based on the estimated exposure concen trations (EECs) and the toxicity of the parent compound,

c urrently labeled rates of daminozide pose a potential risk to non

- target terrestrial animals,Page 5 of 37

including birds, reptiles, terrestrial

- phase amphibians and mammals. The risk conclusions for

non

- listed species are summarized as follows:

 Indoor Uses

o For all non

- target plant and animal species

, direct adverse effects are not expected for indoor uses ( i.e ., enclosed greenhouse) of daminozide.

 Outdoor Uses

o Mammals : Acute effects are not expected

. Reproductive effects cannot be precluded as predicted exposure levels are higher than laboratory

- tested levels.

o B irds (surrogates for terrestrial

- phase amphibians and reptiles ): O utdoor uses of

daminozide may pose a potential acute and chronic risk to birds feeding on or adjacent to treated plants

. Although daminozide is classified as practically non

toxic on an acute basis , application rates on labels are higher than exposure levels evaluated in the avian toxicity tests ; therefore, acute risk potential cannot be precluded. Chronic LOCs were exceeded for maximum label rates of daminozide.

o Aquatic animals and plants and terrestrial invertebrates and plants (fish are surrogates for aquatic

- phase amphibians) : Direct a dverse effects are not expected.

 EPA ha s not completed effects determinations for most listed species associated with the outdoor registered uses of daminozide. Effect determinations for listed species of birds,

terrestrial

- phase amphibians, reptiles, and mammals as well as other listed species that rely upon birds, terrestrial

- phase amphibians, reptiles, and/or mammals for food or shelter

are incomplete

.

 Based on lack of LOC exceedances from exposure to daminozide assuming currently registered use patterns, a No Effect (NE) determination can be made for listed species of fish, aquatic

- phase amphibians (that do not have terrestrial

- phases), aquatic invertebrates, aquatic plants, terrestrial invertebrates, monocots (in terrestrial and wetland habitats), and dicots (in terrestr ial and wetland habitats) that do not rely upon birds, terrestrial

- phase amphibians, reptiles, and/or mammals for food or shelter.

2 Problem Formulation

Th e problem formulation section of this preliminary ecological risk assessment is based on the prelimin ary problem formulation (PF) for the registration review of damino zide (D P 358996 ; April 23, 2009 ). Modifications have been made to accommodate newly available data and

methods currently approved for use in ecological risk assessments. The purpose of this

assessment is to evaluate the potential risks to non

- target organisms from the registered uses of

daminozide

. This assessment is focused on species that are not federally listed as threatened or endangered ; however, some general discussion of taxa for whic h “ no effect ” determinations are expected is included in this assessment. For taxa where there may be risk for listed species, specific determinations are considered uncertain at this time.

The ecosystems that are potentially at greatest risk are those in close proximity to daminozide

use sites. These include commercial or research greenhouses, shadehouses, and nurseries and the surrounding areas that may receive daminozide via spray drift and/or runoff . Organisms of concern include birds, mammals, reptile s, fish, and terrestrial and aquatic invertebrates, plants,Page 6 of 37

and amphibians.

2.1 T arget Pests and Mode of Action

Daminozide is a plant growth regulator used to control the development of container

- grown plants by changing their growth habit; resulting in a plant appearance that is shorter in height with more densely packed stems and leaves

. Daminozide has been demonstrated to be systemic, moving throughout the plant and any fruits present ( Brewerton et al . 1972; Kvien et al . 1989 ). Generally, plant growth retardants are synthetic compounds, which are used to red uce the shoot length of plants in a desired way without changing developmental patterns or being phytotoxic. Cell elongation is reduced, and the rate of cell division is lowered. In their effect on t he morphological structure of plants, growth retardants such as daminozide are antagonistic to gibberellins (GAs) and auxins, the plant hormones that are primarily responsible for shoot elongation. Specifically, daminozide is a member of the acylcyclohexan edione class of growth retardants, which particularly block 3ß

- hydroxylation, thereby inhibiting the formation of highly active GAs from inactive precursors ( Rademacher

, 2000)

.

2.2 U se Characterization

2.2.1 Registered U ses

Historically, daminozide was used on a wide range of crops. Currently, there are no registered food uses for daminozide and it is only registered for use on ornamentals grown in commercial or research greenhouses, shadehouses, and nurseries.

At the present time, t here are two techn ical registrations (EPA Reg. No. 400

- 17 and 62097

- 16), one manufacturing registration (EPA Reg. No. 400

- 79) and three end

- use product (EUP) registrations (EPA Reg. No. 400

- 110, 400

- 478, and 62097

- 17) for daminozide. These registrations are maintained by two different registrants. Table 2.1 summarizes the formulated products currently registered for daminozide as well as uses and application rates and methods.

The label recommended application volume is 1 gallon of spray solution to cover 200 square feet

o f area, providing foliage coverage just to the point of runoff. The maximum label a pplication

rate is 7500 ppm (0.75% solution ) on foliage plant s , which is equivalent to 33.4 grams per gallon

and 13.6 lbs a.i./acre . The application rate e xpressed as lbs a.i./acre was derived as follows:

85% a.i. x 33.4g/gal x gal/200 ft 2 x 43560 ft 2 /acre x lb/453.59g = 13.632 lbs a.i./acre Depending on the targeted plant species, the labeled solution concentration rates range from 1000 ppm to 7500 ppm, resulting in a range of equivalent application rates of 1.8 to 13.6 lbs

a.i./acre of treated plants

. These application rates are reflective of daminozide applied only to the treated plants and does not include roads and non

- production areas in the nursery.

One of the end

- use products (Dazide ® 85 WSG, EPA Reg. No. 62097

- 17) is labeled for use only

in enclosed areas ( e.g., greenhouses). The Dazide ® 85 WSG label includes directions for a foliarPage 7 of 37

spray on ornamentals and for a pre

- plant dip for cuttings. Given this restriction of use only in an enclosed greenhouse , environmental exposures from this EUP to non

- target organisms are unlikely to occur through drift, runoff, or direct contact with treat ed plants.

Two other end

- use products (B

- Nine ® SP and B

- Nine ® WSG, EPA Reg. Nos. 400

- 110 and 400

- 478) are labeled for use in enclosed areas ( e.g., greenhouses ) as well as for use in shadehouses, nurseries, and other production areas. Both of these labels state that use in production areas not

under cover is restricted to containerized ornamentals. Ec ological risk concerns discussed in this

assessment will be with regard to the uses and labels for outdoor application s including, but not limited to, uncover ed production areas, unenclosed nurseries, and shadehouses (B

- Nine ® SP and

B

- Nine ® WSG, EPA Reg. Nos. 400

- 110 and 400

- 478).

Table 2.1 Daminozide Labels and Labeled Uses.

Reg. No.
, Product Name,

% AI Use Maximum single application

rate * Multiple application label language Application

method Restrictions

400

- 110,

B

- Nine ®

- SP, 85% Azaleas (florist)

Bedding/flowering plants Bedding plant plugs Chrysanthemums Foliage plants

Gardenias Hydrangeas

Poinsettias 13.6 lbs

a .i./acre Label states that two

applications at 1⁄2 to 2⁄3 the maximum single label rate may give better control than a single application at the maximum

rate. Minimum time between applications is not specified on

label.

Depending on use, multiple application instructions are provided. Examples of

l anguage are provided in

Footnote #1

. Ground Spray (foliar) Arizona

– use

on bed

- grown

or containerized

ornamentals not permitted on pervious flooring

400

- 478,

B

- Nine ®

WSG,

85% Azaleas (florist)

Bedding/flowering plants Bedding plant plugs Chrysanthemums Foliage plants

Gardenias Hydrangeas

Poinsettias 13.6 lbs

a.i./acre Label states that two

applications at 1⁄2 to 2⁄3 the maximum single label rate may give better control than a single application at the maximum

rate. Minimum time between applications is not specified on

label.

Depending on use, multiple application instructions are provided. Examples of

l anguage are provided in

Footnote #1

. Ground Spray (foliar) Arizona

– use

on bed

- grown

or containerized

ornamentals not permitted on pervious flooringPage 8 of 37

Table 2.1 Daminozide Labels and Labeled Uses.

Reg. No.
, Product Name,

% AI Use Maximum single application

rate * Multiple application label language Application

method Restrictions

62097

- 17,

Dazide ® 85
WSG,

85% Bedding/flowering

plants Bedding plant plugs Chrysanthemums Foliage plants

Gardenias Hydrangeas

Poinsettias 13.6 lbs

a.i./acre Label states that t wo

applications at 1⁄2 to 2⁄3 rate within 48 hours may be more efficacious than a single application of the total application rate.

Depending on use, multiple application instructions are provided. Examples of

l anguage are provided in

Footnote # 2. Ground Spray (foliar) 1) Spray must

be performed

in enclosed area ( e.g ., greenhouse).

2) Arizona

– use on bed

grown or containerized

ornamentals not permitted on pervious flooring *The maximum single application rate for daminozide is 13.6 lbs a.i./acre on the treated (target) plants. Label alternatively recommends applying daminozide at 2⁄3 the maximum rate (9.1 lbs a.i./acre) twice over a 48 hr

interval.

Footnote #1:

- An additio nal application may be made two weeks later, if necessary.

- Repeat applications can be made at 1 to 2 week intervals or as needed.

- Additional applications, if required, may be made at 2 week intervals, stopping one week prior to disbudding.

- Two or more applications may be necessary if new growth begins to stretch or for enhanced coloration.

- Repeat applications may be necessary for optimum plant size.

Footnote #2:

- Repeat applications may be made as new growth continues to elongate.

- Repeat appl ications at 1

- 2 week intervals may be made as required, but the most vigorous seedlings will require the most regular applications.

- Repeat applications may be required if new growth begins.

- Repeat applications can be made as needed.

2.2.2 U nc ertainties S urrounding L abel L anguage

The information provided on the S ection 3 labels is used to parameterize the fate and transport models that estimate exposure concentrations of daminozide in terrestrial and aquatic habitats. Relevant parameters include: maximum single application rate s , number s of applications per year, interval s between applications and application method s . In many cases, these parameter values can be obtained directly fr om the label; however, when the labels are not clear about these parameters, assumptions are made

, u nless there is evidence to the contrary. This section

discusses cases where daminozide labels are unclear and explains the conservative assumptions

that are made in this assessment to compensate for the lack of clearly defined parameters relevant to application of daminozide

.

Maximum single application rate information is clearly labeled; however, t he m aximum annualPage 9 of 37

application rate of daminozide on a given plant is not clearly stated on the labels. For example,

for B

- Nine ® SP use on foliage plants such as ficus , an initial application of 2500 to 7500 ppm solution is permitted, and f ollow

- up applications are permitted if new growth “begins to stretch.”

The l abel does not specify the minimum interval between a pplications

, the maximum number o f applications on a given plant , or the maximum annual application rate

.

Ornamental plants will only stay in nurseries until they are ready to be shipped to wholesalers, retailers, or consumers, thus plants will be constantly moving in and out of a given facility. The current daminozide labels do not specify the maximum number of applications in a calendar year within a nursery

. This maximum environmental exposure to dam inozide is a function of the application rate, the number of times a given plant is treated while in the nursery, and the number of plants that are rotated into the same space in the nursery over the course of a year. Obtaining

t his information would minim ize the uncertainty in exposure frequenc y and duration

.

2.3 E stimated Use in the United States

In 2011, daminozide usage in horticultural nurseries across the United States was reported to be 13,000 lbs active ingredient (EPA Proprietary Data 2012). Additional usage data available for portions of the US are outlined below.

National Agricultural Statistics Service (NASS) conducts periodic summaries of pesticide usage in commercial nurseries and floriculture operations. The six states involved in this survey program are California, Florida, Michigan, Oregon, Pennsylvania, and Texas. In 2006 , a total of 16,300 lbs of daminozide were reported used in the surveyed commercial nurseries floriculture operations; the average and 90 th percentile application ra te for a single application was reported as 3.4 and 7.7 lbs a.i./acre, respectively. In 2009, a total of 10,600 lbs of daminozide were reported used in the surveyed commercial nurseries floriculture operations; the average and 90 th
percentile application r ate for a single application was reported as 1.5 and 4.2 lbs a.i. /acre, respectively (database query at: http://quickstats.nass.usda.gov/ ) (USDA 2007; USDA 2009 )

.

California’s Department of Pesticide Regula tion provides detailed pesticide usage for each registered chemical. Annual r eported us e of daminozide ran ged between a low of 6,570 pounds and a high of 9,635 pounds of active ingredient between 2004 and 2012 ( http://www.cdpr.ca.gov/docs/pur/pur12rep/tables/table5.pdf ) ; however, no temporal trends in total poundage used were identified

.

Daminozide can be used in an enclosed area where environmental exposure is unlikely and in

non

- enclosed areas where environme ntal exposure may occur. California’s Pesticide Information Portal (CA LPIP) provides usage data classified as either indoor or outdoor applications. In 2011, California indoor use ( e.g ., greenhouse) accounted for 5117 lbs a.i. and outdoor use ( e.g ., non

en closed nursery space) accounted for 3285 lbs a.i. , and i n 2012, California indoor use accounted for 4536 lbs a.i. and outdoor use accounted for 3459 lbs a.i. (database query at : http://calpip.cdpr.ca.gov/y ear.cfm ). These data confirm that daminozide is applied in both the indoor and outdoor settings.Page 10 of 37

3 Exposure Analysis

3.1 Environmental Fate Summary

Daminozide is readily soluble in water and is not expected to volatilize from water or soil. It is moderately mobile in soil ( K OC range of 204

- 349 L/kg OC ) and can move to surface water through runoff and spray drift and may leach to groundwater depending on soil conditions

. Daminozide does not undergo hydrolysis , and a queous photolysis of daminozide showed a hal f

life of 162 days. The compound is susceptible to biotic metabolis m with an aerobic soil

metabolism half

- life of 9 hour s. Due to daminozide’s unique and limited use on containerized ornamentals, both t errestrial and aquatic field dissipation study requi rements are waived.

Daminozide has an octanol

- water partition coefficient (K OW ) of 0.0309 (log Kow =

- 1.51), and for this reason, the fish bioaccumulation study was not required. Table 3. 1 summarizes the

submitted chemical and environmental fate data for daminozide.

Table 3. 1

. Chemical Properties and Environmental Fate Parameters of Daminozide

.

Parameter Value Source

Selected Physical/Chemical Parameters

Molecular mass (molecular formula) 160. 17 g/mol (C 6 H 12 N 2 O 3 ) (Calculated)

Vapor pressure 1.10 x 10

- 8 torr (2 0 °C) MRID 49385202

Aqueous solubility (20  C) 18,000 mg/L MRID 48395201

Henry’s Law Constant (20°C, pH 7) 1. 32 x10

- 14 atm

- m 3 /mol calculated

Log octanol

- to

- water partition coefficient (log K OW ) (20°C) - 1 .51 (Kow 0.0309 ) http://www.rsc.org/ pdf/general/16dami no.pdf

Dissociation constant (pKa) pK 1 4.19 (amine), pK 2 5.59 (carboxylic acid group) 1993 RED

Persistence

Hydrolysis half

- life (50 o C) No substantial degradation (pH 5 , 7, and 9) MRID 4718 8101

Aqueous photolysis half

- life (25 o C) t1⁄2 = 162 days MRID 47188110

Aerobic soil metabolism half

- life (20 o C) t1⁄2 = 9.5 hours (0.3958 days) MRID 4 6164615

Aerobic aquatic metabolism half

- life Study is w aived Not applicable

Anaerobic aquatic metabolism half

- life Study is w aived Not applicable

Mobility

Freundlich soil

- water partition coefficients (K d ); Freundlich organic carbon

- normalized partition coefficients (K OC ) K d = 1.2 6, 5 .93

, 1.43

, and 3. 2 9 (L/ k g);

K OC = 315

, 349

, 204 and 299 (L/ k goc) MRID 4 6164616

Fish Bioconcentration

Fish bioconcentration factors (steady

- state) Study waived due to low log K OW (

- 1.51) Not applicablePage 11 of 37 3.1.1 Transport and Mobility

Daminozide is not expected to significantly volatilize from soil or water bodies based on its water solubility ( 18,000 mg/L), vapor pressure ( 1.1 x 10

- 8 torr ), and Henry’s Law Constant (1. 32

x 10

- 14 atm

- m 3 /mol). According to the FAO mobility classification, daminozide is “moderately

mobile” in soil with a mean organic carbon adsorption coefficent ( Koc ) of 29 2 L/ k goc (range from 204 to 349).

Daminozide may be sorbed to residues in or dissolved in runof f feeding surface water bodies. The compound may also reach surface water bodies via spray drift.

3.1.2 Degradation

Daminozide does not undergo hydrolysis in water bodies over the range of pH 5 to 9. It degraded in an aqueous photolysis study with the dark

- c ontrol

- adjusted half

- life of 162 days

, indicating that this is not a significant environmental fate pathway

. Daminozide biodegraded rapidly in soil with a half

- life of 9.5 hours (0.3958 days). Aquatic biodegradation studies were

waived.

3.1.3 Field Studies

Terrestrial field dissipation studies are required for terrestrial outdoor uses. Since the use of daminozide on ornamentals in containers is likely to result in minimal offsite transport, EPA granted a waiver for the field studies.

3.1.4 Environmental Degradat es

Based on the aerobic soil metabolism data, sixty

- two percent of daminozide mineralized to CO 2 within 72 hours of application . The other identified degradate was for maldehyde, and it was
present at a maximum of four percent of the applied daminozide

.

3.2 Residues of Concern

Daminozide is considered to be the only residue of concern for this risk assessment.

3.3 Aquatic Exposure

Exposure in surface water from the proposed daminozide uses due to runoff, erosion, and spray

drift w as assessed with the Surface Water Concentration Calculator 1 (SWCC ver 1.106 ). The model input parameters

, based on the general chemical and environmental fate data for

daminozide alone and the model input parameter guidance (USEPA 2009), are listed in Table

3.2.

1 Donald Brady. 2014/04/10. Implementation of the Surface Water Concentration Calculator for use in the Environmental Fate and Effects Division (EFED)Page 12 of 37

Table 3. 2

. SWCC Chemical Input Parameters for Daminozide

. Input Parameter Value Comment Source (MRID)

Molecular Mass (g/mol) 160.17 Product chemistry data (Calculated)

Vapor pressure (torr) 1.10 x 10

- 8 Product chemistry data 48395202

Solubility in Water (mg/L) 18,000 Represents the value at 20 o C 48395201

Organic Carbon Partition Coefficient (K OC ) (L/ k g OC ) 29 2 Represents the mean K OC of f our values (204, 299, 315, and 349) 46164616

Aerobic Soil Metabolism Half

- life (days) 1.1 9 3 times a single half

- life value to account for uncertainty associated with using one value 46164615

Aerobic Aquatic Metabolism Half

- life (days) 2.37 2 times the aerobic soil input value Modeling Input

Guidance (2009)

Anaerobic Aquatic Metabolism Half

- life (days) 0 Assumed stable Modeling Input

Guidance (2009)

Hydrolysis Half

- life (days) (50 o C) 0 Represents stability to hydrolysis 47188101

Aqueous Photolysis Half

- life (days) (25 o C) 162 Dark

- control

- adjusted half

- li fe 47188110

The D azide ® 85 WSG label specifies that spray applications must only be performed in enclosed areas, such as greenhouse s , where spray drift outside the treated area cannot occur. H owever, the B

- Nine ® SP and B

- Nine ® WSG lab els do not have enclosed area requirements.

The maximum application rate is 1 gallon of spray solution containing 0.75% daminozide to

co ver 200 square feet o f area. This will provide foliage coverage just to the point of runoff. As

shown in Section 2.2.1 , this is equivalent to a maximum single application rate on treated plants

of 13.63 lbs a.i./acre. C onsidering the container nursery layout, the t ypical production areas are designed to allow for the orderly, efficient movement of plants into and out of the areas by

workers and to allow easy access for the care of these plants. Yeager and Ingram (2010)

describe the layout of typical production areas for non

- greenhouse nurseries. These areas have plant beds that are 8 feet wide separated by 2

- foot

- wide walkways for placement of tightly

spaced containerized plants

. Equipment access is provided by a narrow road (10 to 20 feet wide) every 100 feet between the plant beds and by a 30

- foot

- wide perimeter road. This layout results in the production area with approximately 50% of the area consisting of plant beds, with the remaining area in service roads and access paths. For the operation as a whole,

this estimate does not account for propagation areas, media preparation and storage areas, service areas (equipment storage and repair facilities, chemical storage areas, offices), employee facilities, and shipping areas. It should be noted that these typical dimensions are

often modified based on local conditions.

As suming the production area is 50% for the plant beds, the maximum application rate used for

estimation of off

- site spray drift and runoff should be adjusted accordingly: Max rate per appli cation per acre: 13.63 lbs a.i./acre x 50% = 6.8 2 lbs a.i./a cre

The labels also state that “two applications at 1⁄2 to 2⁄3 the label rates may give better control than a single ap plication of the total recommended rate ; ” therefore, an application rate of 9.09 lbs a.i./acre before adjusting for plant bed spacing and an application rate of 4.54 lbs a.i./acre after adjusting for plant bed spacing will be used for two applications spac ed 48 hours apart.Page 13 of 37

Consequently, two application scenarios are modeled for estimating aquatic concentrations of

daminozide : (1) a sing le application rate of 6.8 2 lbs a.i./acre , and (2) t wo application rates of

4.54 lbs a.i./acre within 48 hours.

There are six nursery modeling scenarios available in SWCC databas e: California, Florida, Michigan, New Jersey, Oregon, and Tennessee. To determine the potential high exposure situations, the function of “Application Window Batch Analysis” within SWCC wa s set from March 1 to May 31. The first modeling run used March 1 as the first application date and then move on to March 2 as the first application date for the second modeling run. The batch analysis stops at May 31 as the first application date. The m odel input parameters to simulate daminozide application and crop management practices are provided in Table 3.3

.

Table 3. 3

. SWCC Scenario and Input Parameters Describing the Maximum Proposed Daminozide Use Patterns (outdoor applications only)

.

Modeling Scenario App. Rate (lbs a.i./A) + App. per

Year Depth,

cm CAM Input IPSCND

Input Application

Efficiency/ Spray Drift

CA Nursery (1 app.) 6.8 2 1 0 2 1 0.99/0.062

CA Nursery (2 app.) 4.54 2 * 0 2 1 0.99/0.062

FL Nursery (1 app.) 6.8 2 1 0 2 1 0.99/0.062

FL Nursery (2 app.) 4.54 2 * 0 2 1 0.99/0.062

MI Nursery (1 app.) 6.8 2 1 0 2 1 0.99/0.062

MI Nursery (2 app.) 4.54 2 * 0 2 1 0.99/0.062

NJ Nursery (1 app.) 6.8 2 1 0 2 1 0.99/0.062

NJ Nursery (2 app.) 4.54 2 * 0 2 1 0.99/0.062

OR Nursery (1 app.) 6.8 2 1 0 2 1 0.99/0.062

OR Nursery (2 app.) 4.54 2 * 0 2 1 0.99/0.062

TN Nursery (1 app.) 6.8 2 1 0 2 1 0.99/0.062

TN Nursery (2 app.) 4.54 2 * 0 2 1 0.99/0.062

+ The application rate used for calculation of drift and runoff reflects a 50% adjustment for non

- treated areas within the nursery operation.

* A 2

- d interval was modeled between multiple applications.

The SWCC generated highest 1

- in

- 10 year a quatic Estimated E nvironmental C oncentration s (EECs) for the period from March to May are presented in Table 3.4. The highest values are bolded and they are based on Florida and New Jersey n ursery scenarios. For the aquatic exposure assessment, the concentratio n values of 12 3 μg/L, 39.7 μg/L, and 17.3 μg/L, should be used for peak, 21

- day average, and 60

- day average, respectively.Page 14 of 37

Table 3. 4 . 1

- in

- 10

- year Aquatic EECs of Daminozide (outdoor applications only)

Modeling Scenario Peak (μg/L) 21

- day Average (μg/L) 60

- day Average (μg/L)

CA Nursery (1 app.) 42.2 9.02 3.24

CA Nursery (2 app.) 39 10.2 4.1

FL Nursery (1 app.) 123 14.7 5.19

FL Nursery (2 app.) 119 17.3 6.1

MI Nursery (1 app.) 35.2 16.7 7.88

MI Nursery (2 app.) 42.8 23.1 11

NJ Nursery (1 app.) 109 33.8 13.3

NJ Nursery (2 app.) 116 39.7 17.3

OR Nursery (1 app.) 27.5 10.1 3.92

OR Nursery (2 app.) 33.4 13.6 5.26

TN Nursery (1 app.) 80 28.5 10.7

TN Nursery (2 app.) 104 35.9 13.1

3.4 Terrestrial Exposure

3.4.1 Direct Deposition onto F ood I tems for Terrestrial Animals (located on treated field)

To estimate exposure concentrations, the ecological risk assessment considers application at the

maximum rate to fields that have vulnerable soils. This assessment will focus on daminozide only. For this assessment, the Terrestrial Residue Exposure ( T

- REX ) model (version 1.5.2) is used to assess risks to terrestrial vertebrates ( i.e.

, mammals, birds, terrestrial

- phase amphibians and reptiles) consuming food directly from the treated field.

The T

- REX model is used to generate upper

- b ound concentrations of daminozide on food items ( i.e. , grass, broadleaf plants, seeds and arthropods) located on the treated field. The relevant single maximum application rate for estimate of daminozide spray residues on plant materials or insects on or near the treated plants is 13. 63 lbs a.i./acre. The adjustment for untreated pathways in the nursery is not made when considering exposure to terrestrial wildlife on or adjacent to the treated plants. The resulting conc entrations on the treated plants from a single maximum label

rate application and two closely spaced applications (48

- hr interval) at 2⁄3 the maximum single

rate are provided in Table s 3. 5 and 3.6 for birds (surrogate for terrestrial

- phase amphibians and

rep tiles) and mammals , respectively . These values are used to represent dietary

- based exposures

and were converte d to dose

- based exposures using food ingestion rates for mammals and birds. Daminozide is systemic in plants and magnitude of residue data suitable for calculating a foliar dissipation half

- life are not available ; the refore, f or multiple applications of daminozide , the default foliar dissipation half

- life of 35 days will be used for terrestrial assessments

.Page 15 of 37

Ta ble 3. 5 On

- Field Upper

- bound Ken a ga Nomogram EECs for Dietary

- and Dose

- based Exposures of Birds (surrogate for terrestrial

- phase amphibians and reptiles) to
Daminozide (outdoor uses only)

Application Rate (Interval days) Dietary Category Avian Dosed

- based EECs (mg/kg

- bwt) Avian Dietary

b ased EECs (mg/kg

- diet) 20 g 100 g 1000 g

13.63 lb a.i./acre

(single application at the

maximum rate ) Short Grass 3742 2134 955 3286

Tall Grass 1715 978 438 1506

Broadleaf plants 2105 1200 537 1848

Fruits/pods 234 133 60 205

Arthropods 1466 836 374 1287

Seeds 52 30 13 205

9.09 lb a.i./acre

(two applications at 2⁄3

the maximum rate 48 hours apart) Short Grass 4873 2779 1244 4278

Tall Grass 2233 1274 570 1961

Broadleaf plants 2741 1563 700 2407

Fruits/pods 305 174 78 267

Arthropods 1909 1088 487 1676

Seeds 68 39 17 267

Table 3. 6 On

- Field Upper

- bound Ken a ga Nomogram EECs for Dietary

- and Dose

- based Exposures of Mammals to Daminozide (outdoor uses only)

Application Rate (Interval days) Dietary Category Mammalian Dosed

- based EECs (mg/kg

- bwt) Mammalian Dietary

- based

EECs (mg/kg

- diet) 15 g 35 g 1000 g

13.63 lb a.i./acre

(single application at the

maximum rate ) Short Grass 3133 2165 502 3286

Tall Grass 1436 992 230 1506

Broadleaf plants 1762 1218 282 1848

Fruits/pods 196 135 31 205

Arthropods 1227 848 197 1287

Seeds 4 4 30 7.0 205

9.09 lb a.i./acre

(two applications at 2⁄3 the

maximum rate 48 hours apart) Short Grass 4079 2819 654 4278

Tall Grass 1870 1292 300 1961

Broadleaf plants 2295 1586 368 2407

Fruits/pods 255 176 41 267

Arthropods 1598 1104 256 1676

Seeds 57 39 9.1 267Page 16 of 37 3.4.2 Drift and runoff to non

- target terrestrial plants.

The s pray drift and runoff exposure concentrations as calculated by TerrPlant 1.2.2 are provided

in Table 3.7

. T hese figures represent point estimates of off

- field exposure based on the maximum single application rate of 6.8 2 lbs ai/acre. The application rate of 6.8 2 lbs a.i./acre accounts for targeted application on nursery plants and not on pathways in the nursery (see

Section 3.3 ).

Table 3. 7 EECs for daminozide exposure to off

- field non

- target plants (outdoor uses only)

Exposure Description Equation # EEC (lbs a

. i

. /acre)

Runoff to dry areas (A/I)*R 0.34

Runoff to semi

- aquatic areas (A/I)*R*10 3.4 1

Spray drift A*D 0.068

Total for dry areas ((A/I)*R)+(A*D) 0.408

Total for semi

- aquatic areas ((A/I)*R*10)+(A*D) 3.476

# A= application rate (=6.8 2 lbs ai/acre)

I = incorporation depth (=1 inch, default) R = runoff fraction (=0.05, for solubility >100mg/L) D = drift fraction (=0.01, for ground spray)

4 E ffects Analysis

This section summarizes the available toxicity data for daminozide. Additional details on the

daminozide ecotoxicity studies are provided in Appendix A

. The endpoints used for deriving risk quotient ( RQ ) value s are provided in Tables 4.1 and 4.2

. Toxicity data were obtained from registrant

- submitted studies and the scientific literature. A search o f the publically available ecotoxicity data cataloged in EPAs ECOTOX database ( http://cfpub.epa.gov/ecotox/ ) did not identify any studies with endpoints more sensitive tha n those submitted to the Agency within t he categories of mortality, growth, and reproduction for animals and plants.

In addition, the Ecological Incident Information System ( EIIS )

, the Avian Incident Monitoring System ( AIMS ) and aggregate incident databases were searched for incident reports on April 30, 2014. No ecological incidents were reported in any of the evaluated databases.

4.1 Toxicity of Daminozide

For aquatic animals, daminozide is classified as practically non

- toxic to fish and slightly toxic to invertebrates on an acute exposure b asis ( Table 4.1 ) . No reproduction data are available for fish or invertebrates. The only aquatic plant species tested, a green algae

, had a NOAEC of 99.8 mg

a.i./L.

Daminozide is practically non

- toxic to birds and mammals on an acute exposure basis ( Tabl ePage 17 of 37

4.2 ) . In a reproduction study with bobwhite quail , there was a 5% reduction in the percent of surviving 14

- day chicks relative to number hatching at 890 mg a

. i

. /kg

- diet, resulting in a no observed adverse effect concentration (NOAEC) of 365 mg a.i./kg

- di et. Available toxicity data

for mammals did not identify any reproductive or offspring effects at doses up to 500 mg a.i. /kg

bw/day ( Daminozide (Alar). Draft Risk Assessment to Support Registration Review ; DPbarcode : D 411596 ).

Daminozide is pract ically non

- toxic to adult honey bees on an acute exposure basis ; data are not available to assess the toxicity to adult bees through ingestion of residues in pollen/nectar nor are data available on the toxicity of the compound to larval bees.

Available da ta for terrestrial plants indicate that dicotyledonous (dicots) species are more sensitive than monocotyledonous (monocots) species. No effects to monocots were indicated at rates up to 11.5 lbs a.i./acre. The most sensitive dicot exposed to daminozide dur ing the vegetative vigor study was soybean . Twenty

- five percent plant height reductions (IC 25 ) were predicted at 7.71 lbs a.i./acre and significant reductions (p<0.05) were detected at all test concentrations (NOAEC < 0.709 lb a.i./acre). A 5% reduction in plant height (IC 05 ) was predicted at 0.39 lb a.i./acre

.

Table 4.1

. Measurement E ndpoints for Aquatic Organisms Exposed to Daminozide

Assessment Endpoint Species Toxicity Value * Reference and Study

Classification Comments

Freshwater fish** Rainbow trout Salmo gairdneri 96

- hr LC 50 = 149.3

mg a.i./L MRID 00097046 Acceptable PF identified a different

study; MRID 00097046 was subsequently identified as having a

lower LC 50 . Fish were lethargic and swam erratically at test concentration of 180 mg

a.i./L

Freshwater invertebrates Waterflea Daphnia magna 48

- hr EC 50 > 100

mg a

. i

. /L MRID 47188103 Acceptable PF identified a different

study; MRID 47188103 was recently submitted to the Agency. No mortality

or sub

- lethal effects were reported.

Estuarine/marine fish

and invertebrates No data No data No data

Vascular aquatic plant No data No data No data

Non

- vascular aquatic plant Green a lga

Pseudokirchneriella subcapitata 72

- hr I C 50 >99.8

mg a

. i./L

NOAEC = 99.8 mg

a

. i./L MRID 471881 06 Supplemental No growth reductions or

phytotoxic effects

observed

* For animals, LC /EC 50 values are used to evaluate acute exposures and NOAEC values are used for chronic

exposures. Only acute data are available for th is aquatic toxicity assessment.

** Freshwater fish represent surrogates for aquatic

- phase amphibians.Page 18 of 37

TABLE 4.2

. Measurement E ndpoints for Terrestrial Organisms Exposed to Daminozide

Taxonomic

group Study type and

Species Toxicity Value * Reference and Study

Classification Comments

Birds ** Acute Oral

–

Mallard duck (

Anas platyrhynchos ) LD 50 > 4640 mg

a.i./kg

- bw MRID 00009703

Supplemental No mortality

Sub

- acute Dietary

– Bobwhite quail ( Colinus virginianus) LC 50 > 10,000 mg

a.i./kg

- diet MRID 2030700

Acceptable No mortality

Avian Reproduction

- Bobwhite quail NOAEC = 365 mg

ai/kg

- diet MRID 48791803

Acceptable Most sensitive endpoint:

p ercent of surviving 14

- day chicks relative to number hatching reduced at 890 mg a

. i

. /kg

- diet

Terrestrial

mammals Acute Oral

–

Laboratory Rat LD 50 >5000 mg

a.i./kg

- bw MRID 46164609

Acceptable No mortality.

2

- generation

– Laboratory Rat Reproductive :

NOAEL ≥   mg a.i. /kg

- bw /day MRID 40233901 No reproductive or offspring effects observed. ( DPbarcode: D 411596)

Terrestrial

insects Acute Contact

–

Honey bee ( Apis mellifera ) LD 50 > 205 μg ai/bee MRID 00018842 Acceptable PF identified a different

toxicity value; the correct value from the study is reported here.

Terrestrial plants Seedling emergence

- M onocot IC 25 >11.5 lb a.i./acre

NOAEC =11.5 lb

a.i./acre MRID 48791804

Acceptable No effects on survival or

growth for monocot ( onion, Allium cepa ;

ryegrass, Lolium perenne ; wheat, Triticum aestivum ; and corn, Zea mays ) and dicot (sugarbeet, Beta vulgaris ; oilseed rape, Brassica napus ; cabbage,

Brassica oleracea ; soybean, Glycine max ; lettuce, Lactuca sativa ; and tomato, Lycopersicon

esculentum ) Seedling emergence

- Dicot IC 25 >11.3 lb a.i./acre

NOAEC =11.3 lb

a.i./acre

Vegetative vigor

- Monocot IC 25 >11.5 lb a.i./acre

NOAEC =11.5 lb

a.i./acre MRID 48791805

Acceptable No effects on survival or

growth for o nion,

ryegrass
, wheat, and corn. Vegetative vigor

- Dicot ( most
sensitive

- soybean ) IC 25 = 7.71 lb a

. i

. /acre

NOAEC <0.709 lb

a

. i

. /acre (lowest concentration)

IC 05 = 0.39 lb

a

. i

. /acre For dicots, soybean height most sensitive parameter. Significant reductions at

all test concentrations.

* For birds and mammals, LC 50 and LD 50 values are used to evaluate acute exposures and NOAEC and NOAEL

values are used for reproduction studies

. For terrestrial plants, IC 25 values are used to evaluate non

- listed species, and NOAEC values are used to evaluate listed species.

* * Birds are considered surrogates for terrestrial

- phase amphibians and reptiles.Page 19 of 37

4.2 Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxici ty, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturati on, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of the Preliminary Problem Formulation for Registration Review (DP

Barcode 34 2370 ), EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by

FF DCA section 408(p), daminozide is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required

determinations . Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse end ocrine

- related effects caused by the substance, and

establish a dose

- response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 ( http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 ) and includes some pesticides scheduled for registration review and chemicals found in water

. Neither

of thes e lists should be construed as a list of known or likely endocrine disruptors.

Daminozide is not on the first or the second list of chemicals identified for EDSP screening

. Further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery is available at http://www.epa.gov/endo/

.

5 Risk Characterization

For this preliminary assessment of daminozide , the deterministic RQ method was used to provide

a metric of potential risks. The RQ is a comparison of exposure estimates to toxicity endpoints ( i.e. , RQ = EEC/toxicity endpoint) . The resulting RQs are compared to the Agency’s risk levelsPage 20 of 37

of concern (LOC), which are the Agency’s interpretive policy such that when acute or chronic

risk LOCs are exceeded, the need for regulatory action may be considered. The LOCs are used to indicate when the use of a pesticide, as directed on the label, has the potential to cause adverse

effects to non

- target organisms. For acute and chronic risks to animals, the LOCs are 0.5 and 1.0, respectively

, and for plants, the LOC is 1.0. For each tax on , RQs are generated and risks are

discussed. This discussion includes consideration of additional data and lines of evidence such as environmental monitoring and ecological incident data

5.1 Aquatic Organisms

For fish, an RQ was generated using the most conservative EEC derived from SWCC ( i.e., FL nursery with one application per year had peak EEC = 123 μg a.i./L ) and the most conservat ive acute endpoint for fish ( Table 5.1 ). For outdoor uses of daminozide, the acute RQ for fish does

not exceed the LOC for non

- listed species ( i.e., 0.5) or the LOC for listed species ( i.e ., 0.05)

. Since the endpoints from the invertebrate and aquatic plant studies were non

- definitive (EC 50 >
101000 μg a.i./L and IC 50 >98000 μg a.i./L ), respectively), RQs were not calculated. Acute risks

to invertebrates and non

- vascular plants are presumed low as the EEC was approximately 1000 times less than the high est test concentrations.

Table 5.1. Daminozide RQs for acute exposures to aquatic organisms (outdoor uses only)

Taxa EEC (μg a.i./L) Endpoint (μg a.i./L) RQ

F ish

123* 1493 00 <0.001
Aquatic

invertebrates > 101000 **

Aquatic

non

- vascular plants > 98000 ***

*Highest modeled aquatic concentration of daminozide (FL nursery with one application per year at a rate of 6.82 lbs a.i./acre, accounting for non

- treated walkways in the nursery ) ** An RQ was not calculated; however, the highest EEC is approximately 1000 times less than the highest test concentration in the acute daphnid study. *** An RQ was not calculated; however, the highest EEC is approximately 1000 times less than the highest test concentration in the green algae study.Page 21 of 37

Although an RQ was not calculated for determining chronic risk to fish (due to a lack of toxicity data), effects to growth and reproduction are not expected because the chronic toxicity of

daminozide would have to be at least 86 00 times greater than the acute toxi city (LC 50 = 149300

μg a.i./L ) in order to equal or exceed the chronic LOC of 1.0 2

. Similarly f or aquatic

invertebrates

, effects to growth and reproduction are not expected as the chronic toxicity would

have to be at least 2500 times greater than the highest tested acute concentration in daphnids (100,000 μg a.i./L with no lethal or sublethal effects observed) in order to equal or exceed the

chronic LOC of 1.0 3

. It is unlikely that daminozide would be orders of magnitude more toxic to

fish or aquatic i nvertebrates on a chronic exposure basis than on an acute exposure basis because this pattern has not been observed in other taxa ( i.e.

, birds and mammals). In addition, observed

acute

- to

- chronic ratios ( ACR ) of 8600 and 250 0 are unlikely given that median and 90 th
percentile aquatic ACRs calculated from the available toxicity d ata in the EFED toxicity database were 8.3 and 79.5, respectively (Raimondo et al

. 2007). Therefore, the likelihood that

runoff and drift from use of daminozide will result effects on survival, growth

, and reproduction

of non

- listed aquatic organisms via long

- term exposure is considered low

.

Although only one aquatic plant species ( Pseudokirchneriella subcapitata ) was tested

, the highest test concentration can be used to characteriz e low thresholds of effect as no effects were observed at any test concentration . The NOAEC for non

- vascular aquatic plants is 98 mg a.i./L

. The high

- end estimate of exposure, i.e., 123 μg a.i./L, is 800 times lower than the NOAEC for

non

- vascular aquatic plants . This indicates , with some uncertainty since only one non

- vascular plant species was tested, that adverse effects to other species of non

- vascular aquatic plants are unlikely. In addition, g iven the large differential betwe en the NOAEC for non

- vascular plants and the EEC, it is reasonable to presume that effects to vascular aquatic plants are also unlikely.

5.2 Terrestrial Organisms

5 .2.1. Birds, Amphibians and Reptiles

As birds are considered surrogates for terrestrial

- phase amphibians and reptiles, conclusions

related to risks to birds also applied to risks to terrestrial

- phase amphibians and reptiles. Although daminozide is classified as practically non

- toxic to birds on an acute oral exposu re basis (LD 50 > 4640 mg a.i. /kg

- bw with no mortalities ) and sub

- acute dietary basis (LC 50 > 10,000

mg a

. i

. /kg

- diet with no mortalities ) , and the reproductive endpoint (NOAEC = 365 mg a.i. /kg

diet , based on ratio of number of 14

- day

- old chicks to hatched ch icks ) suggests low toxicity, risk cannot be precluded due to potential high exposures from high application rates.

Since definitive toxicity endpoints were not determined in the acute and sub

- acute studies for birds and no mortality was observed in these studies, RQs were not calculated. T he highest

2 Using a 60

- day aquatic EEC of 17.3 μg a.i/L, a fish chronic NOAEC of 17.3 μg a.i/L or less would be ne cessary to exceed the chronic LOC (1.0). The resulting Acute

- to

- Chronic Ratio (ACR) would be calculated as 149300/17.3 = 8630. Therefore, the chronic NOAEC would need to be at least 8600 times lower that the LC 50 for the chronic LOC

to be exceeded.

3 Using a 21

- day aquatic EEC of 39.7 μg a.i/L, an aquatic invertebrate chronic NOAEC of 39.7 μg a.i/L or less would be necessary to exceed the chronic LOC (1.0). The resulting ACR would be calculated as 101000/39.7 = 2540. Therefore, the chronic NOAEC would need to be at least 2500 times lower that the highest test concentration

in the acute test for the chronic LOC to be exceeded.Page 22 of 37

concentration tested for the acute oral study (4640 mg a.i./kg

- bw ) is less than the environmentally relevant exposure concentration ( the highest ratio of exposure to toxicity is 1.55, for small birds consuming short grass ) . The highest concentration tested for the sub

- acute dietary study (10,000 mg a.i./kg

- diet) is greater than the environmentally relevant exposure concentration ( the highest ra tio of exposure to toxicity is 0.33 for birds consuming short grass)

.

Table 5. 2 presents chronic RQs based on dietary exposures. Exposure estimates represent single application of daminozide at the maximum labeled use rate and two applications 48 hours apart

at 2⁄3 the maximum labeled rate ( Table 3.5 ). Exposure estimates a nd RQs were calculated using

T

- REX 1.5.2

. As indicated in these tables

, daminozide application at the maximum labeled rates results in chronic LOC exceedances for consumers of short grass, tall grass, broadleaf plants, and arthropods feeding at the treated sites

.

Table 5.2 Upper

- bound Ken a ga Nomogram RQs for Chronic Dietary

- Exposures of Birds

to Daminozide (outdoor uses only)

Application Rate (Interval days) Dietary Category Avian Chronic Dietary based RQ s (mg/kg

- diet) *

13.63 lb a.i./acre

(single application at
the maximum rate ) Short Grass 9.00

Tall Grass 4.13 Broadleaf plants 5.06 Fruits/pods /seeds 0.56 Arthropods 3.53

9.09 lb a.i./acre

(two applications at 2⁄3

the maximum rate 48 hours apart) Short Grass 11.72

Tall Grass 5.37 Broadleaf plants 6.59 Fruits/pods /seeds 0.73
Arthropods 4.59

* Bolded RQs indicate an exceedance of the Chronic LOC (>1.0).

There is uncertainty in the risks to birds for several reasons:

 There was no mortality in the acute oral or dietary bird studies, but the highest evaluated

exposures were less than the maximum pr edicted environmental exposures; therefore, risks cannot be precluded.

 None of the target plant species listed on the labels are grasses; however, drift of daminozide to adjacent orn amental grasses or grassy weeds may occur. Exposure to short and tall grasses cannot be precluded.

 It is expected that commercial nurseries and floriculture operations would work to minimize the occurrence of birds and other taxa within the growing areas in order to minimize any damage by birds and other animals that may occur. However, the presence of birds, including beneficial pollinators, feeding or moving through the treated plants cannot be precluded.

 There is uncertainty associated with the magnitud e of exposure resulting fr om applications to ornamentals as labels do not define the maximum number of applications per year. EFED assessed risk assuming that only one or two applications would be used in a given location in the ornamental plant nursery. H owever, the labels state that repeat applications on the same plants may be necessary. Therefore, exposures to birds may bePage 23 of 37

higher than presented.

 Individual ornamental and floriculture specimens are likely to move through the nursery

to wholesalers and r etailers at rates faster than one cycle per year. Even if individual plants are only treated one time while in the nursery, daminozide exposure to birds may be relatively continuous throughout the year as the mature plant stocks move out of the nursery and new plants stocks move in and are treated. Under this scenario, daminozide exposure could be continuous for birds who visit the nursery grounds throughout the year and risks to those birds may be higher than the risks to birds only exposed to one or two

a pplications annually.

5.2.2 Mammals

Although daminozide is classified as practically non

- toxic to mammals on an acute oral exposure basis (LD 50 >5000 mg a.i./kg

- bw with no mortalities ) and no reproductive or offspring effects

were observed in the 2

- gen r eproduction study ( NOAEC = 500 mg a.i./kg

- bw/day) , risk cannot be precluded due to potential high exposures from high application rates.

Since definitive toxicity endpoints were not determined in the acute toxicity study for rats and no mortality was observed in these studies, RQs were not calculated. The highest concentration tested for the acute oral study (5000 mg a.i./kg

- bw ) is greater than the highest exposure concentration from Table 3.6 ( i.e

., the highest ratio of exposure to toxicity is 0.37 fo r small

mammals consuming short grass ). Since estimated exposure is less than the highest tested acute toxicity level and no effects were observed in the toxicity study, acute risk to mammals from currently labeled use rates of daminozide is low.

As with the acute oral exposure , RQs were not calcu lated for evaluation of chronic risks as a definitive NOAEC was not determined in the reproduction study. Based on dietary intake estimates, the highest ratio of exposure to high test concentration was 0.43 (cons umption of short grass). Using dose

- based intake estimates, the highest ratio of exposure to high test concentration was 3.71 (small mammals consuming short grass). Since potential exposure is higher than the highest tested dose, chronic risk to mammals ea ting on treated sites cannot be precluded.

There is uncertainty in the risks to mammals for several reasons:

 None of the target plant species listed on the labels are grasses; however, drift of daminozide to adjacent ornamental grasses or grassy weeds ma y occur. Exposure to short and tall grasses cannot be precluded.

 It is expected that commercial nurseries and floriculture operations would work to minimize the occurrence of mammals and other taxa within the growing areas in order to minimize any damage that may occur. However, the presence of mammals feeding or moving through the treated plants cannot be precluded.

 There is uncertainty associated with the magnitude of exposure resulting from applications to ornamentals as labels do not define the maximum number of applications per year. EFED assessed risk assuming that only one or two applications would be used

in a given location in the ornamental plant nursery. However, the labels state that repeat applications on the same plants may be necessary. Therefore, exposures to mammals may be higher than presented.Page 24 of 37

 Individual ornamental and floriculture specimens are like ly to move through the nursery to wholesalers and retailers at rates faster than one cycle per year. Even if individual plants are only treated one time while in the nursery, daminozide exposure to mammals may be relatively continuous throughout the year a s the mature plant stocks move out of the nursery and new plants stocks move in and are treated. Under this scenario, daminozide exposure could be continuous for mammals who visit the nursery grounds throughout the year and risks to those mammals may be hi gher than the risks to mammals only exposed to one or two applications annually

.

5 .2.3. Terrestrial I nvertebrates

Daminozide is classified as practically non

- toxic to adult honeybees on an acute contact exposure basis, and with LD 50 > 205 μg ai/bee . RQ values were not calculated because no definitive toxicity endpoints were available for honeybees; however, due to low toxicity the potential for adverse effects form contact exposure to daminozide residues on plants is expected

to be low. Studies repo rted in EPAs ECOTOX database did not identify any terrestrial invertebrate species with a greater sensitivity to daminozide.

5.2.4. Plants

T he measurement endpoint ( I C 25 ) for non

- listed dicot plants is 7.71 lb a.i./A, based on effects to vegetative vigor (reduction in soybean plant height)

. For listed dicot plants, the measurement endpoint (IC 05 ) is 0.35 lbs a.i. / acre as the NOAEC was not defined (less than the lowest test concentration)

. No effects to monocots were indicated at rates up to 11.5 lbs a.i./ acre

. Using TerrPlant 1.2.2 ( Table 5. 2 ), all calculated RQs were less than the LOC (1.0); therefore, off

- field

drift risks to non

- target plants is presumed to be low.

Table 5. 2 RQ values for plants in dry and semi

- aquatic areas exposed to daminozide through runoff and/or spray drift* (outdoor uses only)

Plant Type Listed Status Dry Semi

- Aquatic Spray Drift

Monocot non

- listed <0.1 0.30 <0.1

Monocot listed <0.1 0.30 <0.1

Dicot non

- listed <0.1 0.31 <0.1

Dicot listed <0.1 0.31 0.17

*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.

5.3 Listed Species

Although EPA has not completed effects determinations for most listed species associated with the registered uses of daminozide, t his analysis indicates that direct effects to fish, aquatic invertebrates, aquatic plants , terrestrial invertebrates, monocot plants (in terrestrial and wetland habitats) , and dicot plants (in terrestrial and wetland habitats) are unlikely

. Risk cannot be precluded for birds, terrest rial

- phase amphibians, reptiles, and mammals. Indirect effects may occur to listed animals and plants that rely upon birds, terrestrial

- phase amp hibians, reptiles,

and/or mammals for food or shelter.Page 25 of 37

“ No Effect (NE)” determinations can be made for listed species of fish, aquatic

- phase amphibians (that do not have terrestrial

- phases), aquatic invertebrates, aquatic plants

, terrestrial insects, monocot plants (in terrestrial and wetland habitats)

, and dicot plants (in terrestrial and wetland habitats) that do not rely upon birds, terrestr ial

- phase amphibians, reptiles, and /or

mammals for food and shelter. For all other species, the effect determinations are uncertain.

5.4 Risk Conclusions

Based on the estimated environmental exposure levels coupled with acute and reproductive toxicity estimates, c urrently labeled rates of daminozide pose a potential risk to non

- target terrestrial animals, including birds, reptiles, terrestrial

- phase amphibians and mammals. The risk

conclusions are summarized as follows:

 Direct adverse effects are not expected for aquatic animals, aquatic plants, and terrestrial plants exposed to daminozide following spray drift and runoff.

 Direct adverse effects are not expected for terrestrial invertebrates exposed to daminozide

on the treated plants or off

- site drift.

 For birds (and terrestrial

- phase amphibians and reptiles, for which birds are considered surrogates), risk due to outdoor uses of daminozide cannot be precluded

.

 For mammal s, chronic risk due to outdoor daminozide exposures cann ot be precluded

. Acute risk to mammals is low.

 “ No Effect (NE)” determinations can be made for listed species of fish, aquatic

- phase amphibians (that do not have terrestrial

- phases), aquatic invertebrates, aquatic plants

, terrestrial invertebrates, monocots (in terrestrial and wetland habitats) , and dicots (in terrestrial and wetland habitats) that do not rely upon birds, terrestrial

- phase amphibians, reptiles, and/or mammals (for food or shelter).

 Effect determinations for listed species of birds, terrestrial

- phase amphibians, reptiles,

and mammals are uncertain. Effects determinations for any listed species that relies on birds, terrestrial

- phase amphibians, reptiles, and/or mammals (for food or shelter) are uncertain.Page 26 of 37

6 References

Brewerton, H.V., M.M. Gibbs and R.M. Davison. 1972. Dimas (‘alar’) residues in apples and Chinese gooseberries (

Actinidia chinensis Planch), New Zealand Journal of Agricultural Research, 15:2, 388

- 394.

Kvien, C.S., R.A. DePalma, A.R. Raczynski, and L.M. Hellmann. 1989. Effect of Soil and Foliar Daminozide Applications on Residue Levels in Peanut. J ournal of Agricultural and Food

Chem istry 37: 200

- 203.

Rademacher W. 2000. Growth retardants: effects on gi bberellin biosynthesis and other metabolic pathways. Annual Review of Plant Physiology and Plant Molecular Biology 51:501

- 531.

Raimondo, S., B.J. Montague and M.G. Barron. 2007. Determinants of variability in acute to chronic ratios for aquatic inverteb rates and fish. Environ. Toxicol. Chem. 26:2019

- 2023.

USDA. 2007. Agricultural Chemical Usage 2006 Nursery and Floriculture Summary. December 2007. U.S. Department of Agriculture, National Agricultural Statistics Service. Ag Ch 1 (07).

USDA. 2009. Sta tistical Methodology: Nursery and Floriculture Chemical Use Survey (NFCUS), 2009. Online at: http://www.nass.usda.gov/Surveys/Guide_to_NASS_Surveys/Chemical_Use/ChemUseNurseryF loricultureStatisticalMethodology.pdf

USEPA. 2009. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides. Version 2.1. U.S. Environmental Protection Agency, Office of Pesticide Programs, Environmental Fate and Effects Division, Oct. 22, 2009 . Online at: http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm

Yeager, T.H. and D. L. Ingram. 2010. Layout and Design Considerations for a Wholesale Container Nursery. CIR558, Environmental Horticulture Department, Florida Cooperative Extension Service, Institute of Food and Agricultural Sciences, University of

Florida.Page 27 of 37

Appendix A

. Summary of All Ecotoxicity Data

Table A1

. Daminozide Toxicity Data for Freshwater Fish

Species Toxicity Value Reference and Study Classification Comments

Rainbow trout Salmo gairdneri 96

- hr LC 50 = 149.3 mg a.i./L MRID 00009706

MRID 00096322 Acceptable Fish were lethargic and

swam erratically at test concentration of 180 mg

a.i./L

Rainbow trout 96

- hr LC 50 > 100 μg a.i./L MRID 00009732

MRID 00140204 Supplemental One mortality at 17.8 μg

a.i./L and 31.6 8 μg a.i./L.

Rainbow trout 96

- hr LC 50 > 5 mg a.i./L MRID 00024631 Supplemental End

- use product (B

- Nine)

with 5% daminozide was

used. No mortalities were

recorded.

Rainbow trout NA MRID 00009730

Invalid Polyethylene liners used in

all test vessels.

Bluegill sunfish Lepomis macrochirus 96

- hr LC 50 = 448 mg a.i./L MRID 00009704

MRID 00143056 Acceptable Moribund fish became dark

and lethargic, then lost equilibrium and died.

Bluegill sunfish 96

- hr LC 50 > 562 μg a.i./L MRID 00009733 Supplemental No mortalities.

Bluegill sunfish 96

- hr LC 50 > 5 mg a.i./L MRID 00024630 Supplemental End

- use product (B

- Nine)

with 5% daminozide was

used. No mortalities were

recorded.

Bluegill sunfish NA MRID 00009730

Invalid Polyethylene liners used in

all test vessels.

Common carp Cyprinus carpio LC 50 >100 mg a.i./L MRID 47188104 Acceptable No mortality or sublethal

effects at any test

concentration.

Table A2

. Daminozide Toxicity Data for Freshwater Invertebrates

Species Toxicity Value Reference and Study

Classification Comments

Waterflea Daphnia magna 48

- hr EC 50 > 100 mg a.i./L MRID 47188103 Acceptable No mortality or sub

- lethal effects were reported.

Waterflea 48

- hr EC 50 > 100 mg a.i./L

96

- hr EC 50 = 71 mg a.i./L MRID 42429002 Supplemental Due to length of test, daphnids were fed Selenastrum capricornutum.

Waterflea NA MRID 00009576

Invalid Precipitate observed at all

test levels.Page 28 of 37

Table A3

. Daminozide Toxicity Data for Non

- vascular Aquatic Plants

Species Toxicity Value Reference and Study Classification Comments

Green a lga Pseudokirchneriella subcapitata 72

- hr EC 50 >99.8 mg a

. i./L MRID 471881 06 Supplemental No growth reductions or phytotoxic effects

observed

TABLE A4

. Daminozide Toxicity Data for Acute Oral Exposure to Birds

Species Toxicity Value Reference and Study

Classification Comments

Mallard duck Anas platyrhynchos LD 50 > 2250 mg a.i./kg

- bw MRID 42429001 Acceptable No mortality

Mallard duck LD 50 > 464 0 mg a.i./kg

- bw MRID 00009703 Supplemental No mortality, 14

- day old

birds were used.

Japanese quail Coturnix coturnix japonica LD 50 : >2250 mg a.i./kg

- bw MRID 47188105 Acceptable No mortality or sublethal

effects

TABLE A5

. Daminozide Toxicity Data for Dietary Exposure to Birds

Species Toxicity Value Reference and Study

Classification Comments

Bobwhite quail Colinus virginianus LD 50 > 464 0 mg a.i./kg

- diet MRID 00009416 Supplemental No mortality,

B obwhite quail LC 50 > 10,000 mg a.i./kg

- diet MRID 00009705 Acceptable No mortality, reduced

weight gain at 10,000 mg a.i./kg

- diet

Mallard duck LC 50 > 10,000 mg a.i./kg

- diet MRID 00009575 Acceptable No mortality or sublethal

effects.

TABLE A6

. Daminozide Chronic Toxicity Data for Exposure to Birds (Reproduction)

Species Toxicity Value Reference and Study

Classification Comments

Bobwhite quail NOAEC = 365 mg ai/kg

- diet MRID 48791803 Acceptable Most sensitive endpoint:

percent of surviving 14

- day chicks relative to number hatching reduced

at 890 mg a.i./kg

- diet

Mallard duck NOAEC = 890 mg ai/kg

- diet MRID 48791802 Acceptable No growth or reproductive

effects.Page 29 of 37

TABLE A7. Daminozide Toxicity Data for Contact Exposure to Honey Bees

Species Toxicity Value Reference and Study

Classification Comments

Honey bee Apis mellifera LD 50 > 205 μ g ai/bee MRID 00018842 Acceptable Mortalities not reported.

TABLE A8. Daminozide Toxicity Data for Terrestrial Plants

Study type and Plant

classification Toxicity Value Reference and Study

Classification Comments

Seedling emergence

- M onocot IC 25 >11.5 lb a.i./acre

NOAEC =11.5 lb a.i./acre MRID 48791804 Acceptable No effects on survival or growth for

monocot ( onion, Allium cepa ;

ryegrass, Lolium perenne ; wheat,

Triticum aestivum ; and corn, Zea

mays ) and dicot (sugarbeet, Beta vulgaris ; oilseed rape, Brassica

napus ; cabbage, Brassica oleracea ; soybean, Glycine max ; lettuce,

Lactuca sativa ; and tomato, Lycopersicon esculentum ) Seedling emergence

- Dicot IC 25 >11.3 lb a.i./acre

NOAEC =11.3 lb a.i./acre

Vegetative vigor

- Monocot IC 25 >11.5 lb a.i./acre

NOAEC =11.5 lb a.i./acre MRID 48791805 Acceptable No effects on survival or growth for

o nion, ryegrass
, wheat, and corn.

Vegetative vigor

- Dicot ( most sensitive

soybean ) IC 25 = 7.71 lb a

. i

. /acre

NOAEC <0.709 lb

a

. i

. /acre (lowest concentration)

IC 05 = 0.39 lb a

. i

. /acre For dicots, soybean height most sensitive parameter. Significant

reductions at all test concentrations.Page 30 of 37

Appendix B. MRID Bibliography for Environmental Fate and Toxicity Studies

850.1010 Aquatic invertebrate acute toxicity, test, freshwater daphnids

MRID Citation Reference

47188103 Manson, P.; Scholey, A. (2005) Daminozide Technical: Acute Toxicity to

Daphnia magna: Final Report. Project Number: 2242/039, 2242/039/D2149. Unpublished study prepared by Covance Laboratories, Ltd. 33 p.

42429002 Lintott, D. (1992) Alar Technical: Acute Toxicity to the Water Flea, Daphnia

magna, under Flow

- through Test Conditions: Lab Project N umber: J9202003B. Unpublished study prepared by Toxikon Environmental Sciences. 24 p.

850.1075 Fish acute toxicity test, freshwater and marine

MRID Citation Reference

3059 Weir, R.J. (1966) Final Report: Acute Toxicity in Aqueous Exposure to

Bluegill Sunfish: Project No. 798

- 100. (Unpublished study received Dec 14,

1966 under 400

- EX

- 27; prepared by Hazleton Lab

- oratories, Inc., submitted by Uniroyal Chemical, Bethany, Conn. ; CDL:123429

- B)

76405 Weir, R.J.; Rathbun, F. (1966) Final Report: Acute Toxicity in Aqueous

Exposure to Bluegill Sunfish: Project No. 798

- 100. (Unpublished study received Apr 10, 1967 under 400

- 82; prepared by Hazleton Laboratories, Inc., submitted by U niroyal Chemical, Bethany, Conn.; CDL:090718

- G)

112368 Weir, R.; Rathbun, F. (1966) Acute Toxicity in Aqueous Exposure to Bluegill

Sunfish: ?Alar 85 and Other Compounds|: Project No. 798

- 100. Final rept. (Unpublished study received May 29, 1967 under 7F0 614; prepared by Hazleton Laboratories, Inc., submitted by Uniroyal Chemical, Bethany, CT;

CDL:092906

- C)

140204 Weir, R.; Hopkins, M. (1966) Acute Aqueous Exposure: Rainbow Trout: Alar

85 and F461

- 75W: Project No. 798

- 100. Final rept. (Unpublished study received Dec 3, 1969 under 400

- 90; prepared by Hazleton Laboratories, Inc., submitted by Uniroyal Chemical, Bethany, CT; CDL:003277

- E)

143056 Sleight, B. (1972) Acute Toxicity of Alar to Bluegill (Lepomis ma

- crochirus).

Unpublished Bioassay study prepared by Bionomics, Inc. 7 p.Page 31 of 37

47188104 Manson, P.; Scholey, A. (2005) Daminozide Technical: Acute Toxicity to

Cyprinus carpio: Final Report. Proj ect Number: 2242/038, 2242/038/D2149. Unpublished study prepared by Covance Laboratories, Ltd. 34 p.

9704 Sleight, B.H., III (1972) Bioassay Report Submitted to Uniroyal Chemical,

Naugatuck, Connecticut: Acute Toxicity of Alar(R) to Bluegill (Lepomis

macr ochirus). (Unpublished study received Aug 25, 1977 under 400

- 79; prepared by Bionomics, Inc., submitted by Uniroyal Chemical, Bethany, Conn.; CDL:096322

- B)

9706 Kuc, W.J. (1977) Acute Toxicity of Alar Technical, Lot BL 8190 to the

Rainbow Trout,~?Salmo g airdneri~Richardson: UCES Project No. 11506

- 29

- 04. (Unpublished study received Aug 25, 1977 under 400

- 79; prepared by Union Carbide Corp., submitted by Uniroyal Chemical, Bethany, Conn.;

CDL:096322

- D)

9730 Mastri, C. (1970) Report to Uniroyal Chemical, D ivision of Uniroyal, Inc.:

Four

- Day Fish Toxicity Study on Alar

- 85: IBT No. A8585. (Unpublished study received Sep 15, 1970 under unknown admin. no.; prepared by Industrial

Bio

- Test Laboratories, Inc., submitted by Uniroyal Chemical, Bethany, Conn.;

CDL: 1 32143

- A)

9732 Weir, R.J. (1966) Final Report: Acute Aqueous Exposure

-- Rainbow Trout:

Project No. 798

- 100. (Unpublished study received Nov 30, 1966 under unknown admin. no.; prepared by Hazleton Labora

- tories, Inc. for United States Rubber Co., submitted by Uniroyal Chemical, Bethany, Conn.;

CDL:104900

- A)

9733 Weir, R.J. (1966) Final Report: Acute Toxicity in Aqueous Exposure to

Bluegill Sunfish: Project No. 798

- 100. (Unpublished study received Nov. 16, 1966 under unknown admin. no.; prepared by Hazleto n Laboratories, Inc. for United States Rubber Co., sub

- mitted by Uniroyal Chemical, Bethany, Conn.;

CDL:104902

- A)

24630 McCann, J.A. (1971) ?B

- Nine: Toxicity to Bluegill|: Test No. 320. (U.S.

Agricultural Research Service, Pesticides Regulation Div., Animal Biology Laboratory, unpublished report.)

24631 McCann, J.A. (1971) ?B

- Nine: Toxicity to Rainbow Trout|: Test No. 332

.

(U.S. Agricultural Research Service, Pesticides Regu

- lation Div., Animal Biology Laboratory, unpublished report.)

29174 Weir, R.J.; Rathbun, F.; Hopkins, M. (1967) ?Acute Toxicity in Aqueous

Exposure to Bluegill Sunfish and Rainbow Trout|: Project No. 798

- 100. Final rept. (Unpublished study received Dec 12, 1967 under 400

- 49; prepared by Hazleton Laboratories, Inc., sub

- mitted by Uniroyal Chemical, Bethany, Conn.; CDL:009021

- G)Page 32 of 37

850.2100 Avian acute oral toxicity test

MRID Citation Reference

9416 Weir, R.J. (1966) Final Report: Acute Dietary Toxicity

-- Bobwhite Quail:

Project No. 798

- 100. (Unpublished study received Dec 15, 1966 under 7F0552; prepared by Hazleton Laboratories, Inc., sub

- mitted by United States Rubber Co., Naugatuck, Conn.; CDL : 090684

- J)

9703 Beavers, J.B. (1977) Final Report: Acute Oral LD50

-- Mallard Duck: Project

No. 117

- 121. (Unpublished study received Aug 25, 1977 under 400

- 79; prepared by Wildlife International, Ltd., submit

- ted by Uniroyal Chemical, Bethany, Conn.; CDL:096322

- A)

424290 01 Campbell, S.; Lynn, S. (1992) Alar Technical: An Acute Oral Toxicity Study

with the Mallard: Lab Project Number: 117

- 165. Unpublished study prepared by Wildlife International, Ltd. 18 p.

47188105 Gallagher, S.; Beavers, J. (2006) Daminozide Technical: An Acute Oral

Toxicity Study with the Japanese Quail. Project Number: 429/104. Unpublished study prepared by Wildlife International, Ltd. 31 p.

48791801 Hubbard, P.; Beavers, J. (2011) Daminozide: An Acute Oral Toxicity Study

with the Zebra Finch (Taenio pygia guttata). Project Number: 616/106. Unpublished study prepared by Wildlife International, Ltd. 70p.

850.2200 Avian Dietary Toxicity

MRID Citation Reference

9575 Fink, R. (1974) Final Report: Eight

- Day Dietary LCI50^

-- Mallard Ducks:

Project No. 117

- 104. (Unpublished study received Oct 13, 1976 under 6F1752; prepared by Truslow Farms, Inc., submitted by Uniroyal Chemical, Bethany, Conn.; CDL:095567

- A)

9705 Beavers, J.B. (1977) Final Report: Eight

- Day Dietary LC50

-- Bobwhite Quail:

Project No. 117

- 126. (Unpublished study received Aug 25, 1977 under 400

- 79; prepared by Wildlife International, Ltd., submitted by Uniroyal Chemical, Bethany, Conn.; CDL:096322

- C)Page 33 of 37

850.2300 Avian reproduction test

MRID Citation Reference

48791802 Frey, L.; Martin, K.; Beavers, J. et al. (2012) Daminozide: A Reproduction

Study with the Mallard: Final Report. Project Number: 616/105. Unpublished study prepared by Wildlife International, Ltd. 197p.

48791803 Frey, L.; Martin, K.; Beavers, J. et al. (2012) Daminozide: A Reproduction

Study with the Northern Bobwhite: Final Report. Project Number: 616/104. Unpublished study prepared by Wildlife International, Ltd. 203p.

850.3 020 Honey bee acute contact

MRID Citation Reference

00018842 Atkins, E.L., Jr. J Anderson, L.D.J Greywood, E.A. {1969) Effect of

Pesticides on Apiculture: Project No. 14991 Research Report CF

- 7501. {Unpublished study re ceived May 8, 1971 under 1F1174; prepared by Univ. of

California

-- Riverside, Dept. of Entomology, submitted by Ciba Agrochemical co., Summit, N.J., CDL:090973

- B)

850.4225 Seedling emergence, Tier II

MRID Citation Reference

48791804 Sindermann, A.; Porch, J.; Krueger, H. et al. (2012) Daminozide Formulation:

A Toxicity Test to Determine the Effects (Tier II) on Seedling Emergence of Ten Species of Plants: Final Report. Project Number: 616/107. Unpublished study prepared by Wildlife International, Ltd. 122p.

850.4250 Vege tative vigor, Tier II

MRID Citation Reference

48791805 Sindermann, A.; Porch, J.; Krueger, H. et al. (2012) Daminozide Formulation:

A Toxicity Test to Determine the Effects (Tier II) on Vegetative Vigor of Ten Species of Plants: Final Report. Project Number: 616/108. Unpublished study prepared by Wildlife International, Ltd. 157p.

850.5400 Algal toxicity, Tiers 1 and II

MRID Citation ReferencePage 34 of 37

47188106 Manson, P.; Scholey, A. (2006) Daminozide Technical: Inhibition of Growth

to the Alga Pseudokirchneriella subcapitata: Final Report. Project Number: 2242/049, 2242/049/D2149. Unpublished study prepared by Covance Laboratories, Ltd. 42 p.

161

- 1 Hydrolysis

MRID Citation Reference

9707 Kucharczyk, N.; Smith, A.; Stone, G. (1971) Environmental Fate Studies on

Alar^(R)I: Status Report on PR 70

- 15: Work on Suc

- cinic acid, 2,2

- Dimethylhydrazide (Alar

- 85, Kylar

- 85, Kylar). (Unpublished study received Sep 27, 1971 under 400

- 79; submitted by U niroyal Chemical, Bethany, Conn.;

CDL:120366

- A)

126786 Stone, G. (1983) Daminozide Status Report: Draft. (Unpublished study

received Apr 14, 1983 under 400

- 79; submitted by Uniroyal Chemical, Bethany, CT; CDL:249926

- A)

128352 Uniroyal Chemical (1983) D aminozide Residue and Hydrolysis Studies:

?Apples and Other Crops|. (Compilation; unpublished study re

- ceived May 3,

1983 under 400

- 79; CDL:250161

- A)

138265 Uniroyal Chemical (1983) Summary Report: ?UDMH|. (Compilation;

unpublished study received Apr 17 , 1984 under 400

- 117; CDL: 253012

- A)

147749 Lengen, M. (1985) Addendum to: Hydroysis of Daminozide... and Daminozide

Photolysis in Water and on Soil

-- Interim Report: Pro

- ject No. 84244/84246. Unpublished study prepared by Uniroyal Chemical. 59 p.

154942 Lengen, M.; Abdel

- Kader, H.; Peterson, G. (1984) Hydrolysis of Daminozide:

Project No. 84244. Unpublished study prepared by Uniroyal Chemical. 21 p.

47188101 Knowles, R. (2005) Determination of Hydrolysis as a Function of pH for

Daminozide: Final Report. Project Number: J15268, FOR/04/055. Unpublished study prepared by GC Laboratories, Ltd. 14 p.

161

- 2 Photodegradation

- water

MRID Citation Reference

147749 Lengen, M. (1985) Addendum to: Hydroysis of Daminozide... and Daminozide

Photolysis in Water and on Soil

-- Interim Report: Pro

- ject No. 84244/84246. Unpublished study prepared by Uniroyal Chemical. 59 p.

154943 Lengen, M.; Dzialo, D. (1984) Daminozide Ph otolysis in Water and on Soil:

Project No. 84246. Unpublished study prepared by Uniroyal Chemical. 21 p.Page 35 of 37

47188110 Brice, A.; Scholey, A. (2006) Carbon 14 Daminozide: Photodegradation in

Sterile, Aqueous Solution: Final Report. Project Number: 2242/044/D2 149, 2242/044. Unpublished study prepared by Covance Laboratories, Ltd. 54 p.

161

- 3 Photodegradation

- soil

MRID Citation Reference

147749 Lengen, M. (1985) Addendum to: Hydroysis of Daminozide... and Daminozide

Photolysis in Water and on Soil

-- Interim Report: Pro

- ject No. 84244/84246. Unpublished study prepared by Uniroyal Chemical. 59 p.

42457301 Batorewicz, W. (1992) UV

- Visible Spectra of Daminozide, N

- Dimethylamino

Succinimide and 1,1 Dimethylhydrazine: Lab Project Number: 92160. Unpublished study prepared by Uniroyal Chemical Co., Inc. 20 p.

162

- 1 Aerobic soil metabolism

MRID Citation Referen ce

9707 Kucharczyk, N.; Smith, A.; Stone, G. (1971) Environmental Fate Studies on

Alar^(R)I: Status Report on PR 70

- 15: Work on Suc

- cinic acid, 2,2

- Dimethylhydrazide (Alar

- 85, Kylar

- 85, Kylar). (Unpublished study received Sep 27, 1971 under 400

- 79; submitted by U niroyal Chemical, Bethany, Conn.;

CDL:120366

- A)

9708 Dannals, L.E.; Puhl, R.J.; Kucharczyk, N. (1972) Environmental Fate Studies

on Alar^(R)I: Second Status Report on PR 70

- 15: Work on Succinic acid, 2,2

- dimethylhydrazide (Alar

- 85, Kylar

- 85, Kylar). (Unp ublished study received Apr 20, 1972 under 400

- 79; submitted by Uniroyal Chemical, Bethany, Conn.;

CDL:120367

- A)

160675 Dzialo, D.; Harned, W. (1986) Daminozide Aerobic and Anaerobic Soil

Metabolism Studies: Project No. 8501

- 2, 8561. Unpublished study pr epared by Uniroyal Chemical. 35 p.

42687201 Yu, W.; Kobryn, K. (1993) Daminozide Aerobic Soil Metabolism: Lab Project

Number: 92123. Unpublished study prepared by Uniroyal. 53 p.

43005601 Yu, W. (1993) Characterization of Volatiles from Daminozide Aero bic Soil

Metabolism: Lab Project Number: 9398. Unpublished study prepared by Uniroyal Chemical Co., Inc. 47 p.

46164615 Goodyear, A. (1995) (Carbon 14)

- Daminozide Soil Metabolism and

Degradation: Final Report. Project Number: 1137/2/1015, 1137/2, 5239/24. Unpublished study prepared by Corning Hazleton (Europe), A & L Great Lakes Laboratories, and Eurolabs Ltd. 94 p.Page 36 of 37

162

- 2 Anaerobic soil metabolism

MRID Citation Reference

160675 Dzialo, D.; Harned, W. (1986) Daminozide Aerobic and Anaerobic Soil

Metabolism Studies: Project No. 8501

- 2, 8561. Unpublished study prepared by Uniroyal Chemical. 35 p.

163

- 1 Leach/adsorp/desorption

MRID Citation Reference

9707 Kucharczyk, N.; Smith, A.; Stone, G. (1971) Environmental Fate Studies on

Alar^(R)I: Status Report on PR 70

- 15: Work on Suc

- cinic acid, 2,2

- Dimethylhydrazide (Alar

- 85, Kylar

- 85, Kylar). (Unpublished study received Sep 27, 1971 under 400

- 79; submitted by U niroyal Chemical, Bethany, Conn.;

CDL:120366

- A)

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