BIOPESTICIDES REGISTRATION ACTION DOCUMENT

3-decen-2-one PC Code : 068403

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

January 16, 2013
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TABLE OF CONTENTS

I. EXECUTIVE SUMMARY:................................................................................................ 5

II. ACTIVE INGREDIENT OVERVIEW.............................................................................. 7

III. REGULATORY BACKGROUND...................................................................................... 7

A. Classification ........................................................................................................................ 7

B. Food Clearances/Tolerances............................................................................................... 8

IV. RISK ASSESSMENT ......................................................................................................... 9

A. Active Ingredient Characterization.................................................................................... 9

B. Human Health Assessment................................................................................................ 10

1. Toxicology ....................................................................................................................................................10

2. Dose Response Assessment .........................................................................................................................13

3. Food Quality Protection Act (FQPA) Considerations..............................................................................13

4. Occupational, Residential, School and Day Care Exposure and Risk Characterization ......................17

5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation...........................18

6. Cumulative Effects......................................................................................................................................18

7. Risk Characterization .................................................................................................................................19

C. Environmental Assessment ............................................................................................... 19

1. Ecological Hazards......................................................................................................................................19

2. Environmental Fate and Ground Water Data..........................................................................................19

3. Ecological Exposure and Risk Characterization ......................................................................................20

4. Endangered Species Assessment ................................................................................................................20

D. Efficacy Data ..................................................................................................................... 20

V. RISK MANAGEMENT DECISION................................................................................ 21

A. Determination of Eligibility for Registration .................................................................. 21

B. Regulatory Decision........................................................................................................... 21

C. Environmental Justice ....................................................................................................... 21

VI. ACTIONS REQUIRED BY REGISTRANTS................................................................. 22

A. Reporting of Adverse Effects............................................................................................ 22

B. Reporting of Hypersensitivity Incidents.......................................................................... 22
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VII. APPENDIX A. DATA REQUIREMENTS (40 CFR PART 158-SUBPART U).......... 22

VIII. APPENDIX B..................................................................................................................... 27

IX. APPENDIX C.................................................................................................................... 27

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS ............................................. 28
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

Branch Chief

Linda A. Hollis, M.S.

Product Chemistry/Human Health Effects/Nontarget Organisms

Angela L. Gonzales, Biologist

Regulatory Action Leader

Colin G. Walsh, M.S., Biologist
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I. EXECUTIVE SUMMARY:

3-decen-2-one is a new biochemical pesticide active ingredient intended for postharvest use on 

stored potatoes as a sprout inhibitor. 3-decen-2-one is a naturally occurring biochemical 

substance, with a history of unremarkable human exposure. 3-decen-2-one functions as a plant 

growth regulator, affecting plant growth by increasing tuber respiration. Data on file indicate that 

3-decen-2-one interferes with membrane integrity, which results in increased oxidative stress, 

desiccation, and rapid necrosis of the meristems and surrounding sprout tissues. Thus, 3-decen-2-

one inhibits sprouting, with no observed affects on the potato, potato sweetening, or processing 

quality. Based on this information, the Agency considers the mode of action to be non-toxic 

(EPA, 2011).

The Biopesticides and Pollution Prevention Division (BPPD) determined that the data and 

information submitted for product chemistry and Tier I acute toxicity for 3-decen-2-one satisfy 

the current guideline requirements. Based on the primary eye and dermal irritation acute toxicity 

data for 3-decen-2-one, the active ingredient is toxicity category II. A subchronic 90-day oral 

toxicity study (OCSPP 870.3100) on the active ingredient (a.i.) was not conducted. In lieu of the 

study, EPA used a weight-of-the-evidence (WOE) approach to estimate the likelihood of 

potential of toxicity from repeat oral exposure to this substance (EPA, 2013). First, using an 

expert system computer program (DEREK Nexus), EPA identified two potential toxicological 

endpoints for 3-decen-2-one (potential dermal sensitization and in vitro chromosome damage); 

however, follow-up studies did not support these as toxicological endpoints. Second, the 

metabolic pathways of 3-decen-2-one have been characterized and demonstrate that the 

biochemical is metabolized into innocuous compounds that are either excreted or further 

metabolized in the fatty acid pathway or citric acid cycle. Third, 3-decen-2-one occurs naturally 

in some foods and has been used as a food additive without specific reports of adverse effects. 

Finally, U.S. Food and Drug Administration (FDA) has approved the use of 3-decen-2-one as a 

synthetic flavoring agent and adjuvant that may be directly added to food under 21 CFR § 

172.515. Based on this evidence, EPA concluded that 3-decen-2-one has relatively low toxicity

via the repeated oral exposure route. BPPD granted waivers from conducting subchronic 90-day 

dermal (OCSPP 870.3250) and 90-day inhalation (OCSPP 870.3465) studies based on the fact 

that prolonged dermal exposure is not expected because 3-decen-2-one is not purposely applied 

to the skin and repeated inhalation exposure is unlikely due to 3-decen-2-one being applied by a 

thermal fog generator in a closed system. In addition, significant exposure to humans is not 

anticipated for 3-decen-2-one based on its indoor use pattern in a closed system and appropriate 

Personal Protective Equipment (PPE) requirements on the product label. BPPD received data for 

the prenatal developmental data requirement (OCSPP 870.3700), Tier I mutagenicity studies 

[bacterial reverse mutation test (OCSPP 870.5100) and in vitro mammalian cell assay (OCSPP 

870.5300)], and a Tier II mutagenicity study [in vivo mammalian erythrocyte micronucleus test 

assay (OCSPP 870.5395)]. The prenatal developmental toxicity study showed a no-observedadverse-effects-level (NOAEL) of 1,000 mg/kg/day (highest dose tested) for maternal and fetal 

toxicity. EPA’s WOE approach showed that 3-decen-2-one was not a mutagen based on the 

results of the Tier I and Tier II mutagenicity data. Although the data requirements were satisfied 

for the new active ingredient, 3-decen-2-one, BPPD notes that should future intended end-use 

product (EP) applications result in different anticipated exposures to humans, these data 

requirements may need to be readdressed.
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For nontarget organisms and environmental fate data requirements (OCSPP 850.1010 to 

850.4450), the nontarget organism data requirements for 3-decen-2-one were waived based on 

the proposed indoor use pattern. 3-decen-2-one is proposed for use in end-use formulations that 

are applied indoors only as sprout inhibitors on potatoes. The end-use formulations will be 

introduced and dispersed as a vapor through air circulation systems in potato storage warehouse 

facilities and is not expected to be available to nontarget organisms. Based on the indoor use 

pattern, exposure of 3-decen-2-one to nontarget organisms is expected to be minimal.

EPA has not identified any toxic endpoints for nontarget mammals, birds, plants, aquatic, or soil 

organisms. Based on the information provided, EPA has no concerns, at this time, for any 

nontarget organisms exposed to 3-decen-2-one when used in accordance with approved label 

directions. Given that 3-decen-2-one is applied indoors in a closed system, has low toxicity and 

presents little, if any, risk to nontarget organisms, EPA has concluded that it is in the best 

interests of the public to issue the registration for the manufacturing-use product (MP), AMV1018 Technical (EPA File Symbol No. 5481-LAI) and the EP, AMV-1018 EP (EPA File Symbol

No. 5481-LTR), which contain this new active ingredient, 3-decen-2-one.

BPPD has reviewed the data and information in support of the requirements for granting 

registration under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act 

(FIFRA). BPPD has determined that the data and information submitted adequately satisfy 

current data requirements (please refer to 40 CFR Subpart U § 158.2000). 

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for 

the public to participate on major registration decisions before they occur. According to this

policy, EPA provides a public comment period prior to making a registration decision for the 

following types of applications: new active ingredients, first food use, first outdoor use, first 

residential use; and any registration decisions for which the Agency believes there may be 

substantial public interest. 

Consistent with the policy of making registration actions more transparent, 3-decen-2-one is 

subject to a 15-day comment period as a “new active ingredient.” EPA has established a 

comment period of 15 days on the basis of 3-decen-2-one’s minimal toxicity, the determination 

that 3-decen-2-one presents low risk of any adverse effects to human health and the environment, 

and critical need for this active ingredient. The notice for this comment period includes the draft 

Biopesticides Registration Action Document (BRAD) and draft product labels for the MP, 

AMV-1018 Technical, and EP, AMV-1018 EP, which contain this new active ingredient, 3-

decen-2-one. The docket identification (ID) number is EPA-HQ-OPP-2010-0064. The Agency 

believes that based on the risk assessment and information submitted in support of the 

registration of the MP and EP containing 3-decen-2-one, it is in the best interests of the public to 

issue the registration for AMV-1018 Technical and AMV-1018 EP. The basis for this decision 

can be found in the risk assessment for 3-decen-2-one, which is characterized in this BRAD. 
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II. ACTIVE INGREDIENT OVERVIEW

Common Name: 3-decen-2-one

 Chemical Names: 3-decen-2-one; Heptylidene acetone; Oenanthylidene acetone

Trade & Other Names: AMV-1018 Technical

 CAS Registry Number: 10519-33-2

OPP Chemical Code: 068403

Type of Pesticide: Plant Growth Regulator (Sprout Inhibitor)

III. REGULATORY BACKGROUND

On December 8, 2009, EPA received an application filed by Technology Sciences Group, Inc. 

(TSG) Exponent, 1150 18th Street, NW, Suite 1000, Washington, DC 20036, on behalf of Amvac 

Chemical Corporation (AMVAC), 4695 MacArthur Court, Ste. 1250, Newport Beach, CA 

90660, to register the products, AMV-1018 Technical (EPA File Symbol No. 5481-LAI), AMV1018 EP (EPA File Symbol No. 5481-LTR), AMV-1018 90EC (EPA File Symbol No. 5481-

LTN), and AMV-1018 67.5EC (EPA File Symbol No. 5481-LAO) containing the new 

biochemical active ingredient, 3-decen-2-one. The applicant withdrew AMV-1018 90EC (EPA 

File Symbol No. 5481-LTN) and AMV-1018 67.5EC (EPA File Symbol No. 5481-LAO) from 

consideration by EPA with the letter dated March 2, 2011. A notice of receipt (NOR) of this 

application, allowing for a 30-day comment period, was published in the Federal Register on

March 10, 2010 (75 FR 11175). No comments were received following this publication.

A. Classification

On September 22, 2008, EPA’s Biochemical Classification Committee determined that 3-decen2-one is a biochemical pesticide. The biochemical classification committee indicated that 3-

decen-2-one is a plant growth regulator and the mode of action is to induce a transient increase in 

tuber respiration rate and seemed to interfere with membrane integrity, resulting in increased 

oxidative stress, dessication, and rapid necrosis of meristem and surrounding sprout tissues. The 

observed effect is primarily mechanical damage to sprout cell membranes. Sweetening and 

processing quality of potatoes and the mature tuber were unaffected. 3-decen-2-one is related to 

class of secondary alcohols, ketones, and related esters naturally occurring in foods, flavor 

additives, and fragrances. No safety concerns were identified and the substance is rapidly 

metabolized and excreted from mammals. 3-decen-2-one is approved for use as a synthetic flavor 

under 21 CFR § 172.515.
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B. Food Clearances/Tolerances 

The applicant filed a petition (PP 9F7670) proposing to establish an exemption from the 

requirement of a tolerance for residues of 3-decen-2-one in or on all food commodities. A notice 

of filing (NOF), allowing for a 30-day comment period, was published in the Federal Register on 

March 10, 2010 (75 FR 11171). One comment was received following this publication and is 

described below.

A comment was posted to the NOF docket ID number EPA-HQ-OPP-2010-0065 from Michael J. 

Keim, Keim Aerosol Technologies, on April 21, 2010. Mr. Keim believes that EPA has not been 

adequately informed by the registrants with respect to the use of chemicals for the postharvest 

treatment of stored potatoes and that 3-decen-2-one does pose a risk to humans and the 

environment. Mr. Keim’s states that the primary reason for his claim stems from the registrant’s 

use of the same equipment to apply the proposed product, AMV-1018 EP, as conventional 

products containing Chlorpropham (CIPC). Mr. Keim has concerns with EPA’s evaluation of the 

proposed 3-decen-2-one products and the following year’s (2011) registration review of CIPC 

applications because there is no mention of the significant displacement and degradation of the 

chemicals to the outside atmosphere during the application process. Mr. Keim indicates that he 

believes that half of the applied CIPC to stored potatoes does not deposit on the potatoes and, 

therefore, is expelled to the outside environment. Mr. Keim estimates that approximately 227,500 

pounds of CIPC and over 900,000 pounds of 3-decen-2-one are lost to the outside environment in 

the U.S. each year and believes that this displacement must be evaluated in order to determine 

what testing must be performed to insure no harm comes to humans and the environment. Mr. 

Keim also provided copies of his communications to Canada’s Pesticide Management Regulatory 

Authority (PMRA) during its re-evaluation decision for CIPC in 2007-2009, where he did not 

agree with PMRA’s approval of CIPC. In summary, Mr. Keim indicated that the following data 

must be submitted due to the gross displacement and degradation of the proposed product, AMV1018 EP: 1) product performance data, 2) mammalian toxicity data, 3) nontarget organism data, 

4) post-application exposure data, 5) applicator/user exposure data, 6) spray drift evaluation, 7) 

environmental fate data, and 8) residue chemistry data.

EPA thanks Keim Aerosol Technologies for its comment regarding the NOF for 3-decen-2-one. 

Documents in the docket for the Registration Review of CIPC (docket ID number EPA-HQOPP-2010-0923) prepared by the Agency’s Health Effects Division (HED) and Environmental 

Fate and Effects Division (EFED) have already responded to Mr. Keim’s comments about the 

application equipment used for CIPC products and the potential for exposure based on the 

displacement and degradation of CIPC. Moreover, with respect to 3-decen-2-one, the Agency has 

received and reviewed product chemistry, mammalian toxicity, and nontarget organism data 

and/or information for this new a.i., 3-decen-2-one, as outlined in 40 CFR §§ 158.2030, 

158.2050, and 158.2060 (see infra, Section IV). Based on the risk assessment discussed in the 

subsequent sections, the Agency has concluded that no unreasonable adverse effects to the U.S. 

population in general, and to infants and children in particular, will result from the use of 3-

decen-2-one as a pesticide when label instructions are followed. The data and information 

submitted to the Agency indicate that 3-decen-2-one is of low acute and subchronic toxicity, with 

the exception that it is a primary eye and dermal irritant, is not a developmental toxicant, and is 

not mutagenic. With regard to worker exposure, the thermal fogging application method on the 
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proposed product label used for stored potatoes is an automated system and as such, the Agency 

considers this method a closed-delivery system and does not expect occupational handler 

exposure. The only occupational exposure expected is the handling of the product prior to 

application, which is mitigated by appropriate precautionary statements and PPE requirements 

listed on the label. The Agency has not identified any toxic endpoints for nontarget mammals, 

birds, plants, aquatic, or soil organisms; therefore, EPA has no concerns for any nontarget 

organisms exposed to 3-decen-2-one when used in accordance with approved label directions.

The applicant did submit information that estimated the physical and chemical properties for 3-

decen-2-one by using QSAR modeling based on the Estimation Programs Interface Model (EPI 

SuiteTM 4.0). Using Henry’s Law, which states that the solubility of a gas in a liquid is directly 

proportional to the partial pressure of the gas above the liquid, 3-decen-2-one is estimated to be 

5.4 x 10-4 atm·m3/mol and indicates that the a.i. has a potential for volatility from water or moist 

soil. In soil, the estimated Koc of 165.2 – 860.9 L/kg indicates that the active would have medium 

to low mobility in soil. In water, an estimated log Kow of 3.28 and an estimated bioconcentration 

factor (BCF) of 67.41 L/kg wet-wt indicate that bioaccumulation in aquatic organisms is 

unlikely. In the air, atmospheric oxidation by reaction of hydroxyl radicals is expected to occur 

with estimated half-lives of 1.9 – 2.2 hours. The probability of biodegradation of 3-decen-2-one

was evaluated using EPI SuiteTM 4.0 in the BIOWIN module. Various models in the BIOWIN 

module predicted rapid biodegradation of 3-decen-2-one. Based on a total air volume in potato 

warehouse of 1910 m3 and total applied 3-decen-2-one of 122,475 g calculated by the applicant, 

the maximum air concentration of 3-decen-2-one in warehouse was estimated to be 64.14 mg/L 

of air. With an estimated ventilation rate of 825 m3 of air/min, the air volume in a warehouse will 

be exchanged within 2.5 minutes when the vents to the outdoors are opened. Thus, the 

concentration emitted will be rapidly diluted in the outside air, which further demonstrates 

insignificant exposure to nontarget organisms. In summary, given that 3-decen-2-one is applied 

indoors in a closed system, has low toxicity, and presents little, if any, risk to nontarget 

organisms, the Agency has concluded that products containing this new a.i., 3-decen-2-one, are 

not expected to cause unreasonable adverse effects to humans, including infants and children, and

nontarget organisms.

EPA determined during the initial review of the petition that the data and/or information 

submitted was insufficient to support the use of the active ingredient, 3-decen-2-one, in or on all 

food commodities. The applicant filed a revised petition (PP 9F7670) proposing to establish an 

exemption from the requirement of a tolerance for residues of 3-decen-2-one in or on stored 

potatoes only. A NOF, allowing for a 30-day comment period, was published in the Federal 

Register on March 14, 2012 (77 FR 15012). No comments were received following this 

publication.

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

3-decen-2-one is a new biochemical pesticide active ingredient intended for postharvest use on 

stored potatoes as a sprout inhibitor. 3-decen-2-one is a naturally occurring biochemical 

substance, with a history of unremarkable human exposure. 3-decen-2-one functions as a plant 
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growth regulator, effecting plant growth by increasing tuber respiration. Data on file indicate that 

3-decen-2-one interferes with membrane integrity, which results in increased oxidative stress, 

desiccation, and rapid necrosis of the meristems and surrounding sprout tissues. Thus, 3-decen-2-

one inhibits sprouting, with no observed affects on the potato, potato sweetening, or processing 

quality. Based on this information, the Agency considers the mode of action to be nontoxic 

(EPA, 2011).

3-decen-2-one has been found to naturally occur in yogurt, skipjack tuna, edible porcini 

mushrooms, and Iberian ham (EPA, 2013). Additionally, in a 2003 report, the Joint FAO/WHO 

Expert Committee on Food Additives (JECFA) indicated that 3-decen-2-one is one in a group of 

compounds that have been identified in fruits, vegetables, spices, cocoa, coffee, and tea (JECFA, 

2003). JECFA also concluded in their report that there is no safety concern at current intake 

levels when the chemical is used as a flavoring agent. The chemical has been approved by FDA 

as a food additive without limitation under 21 CFR § 172.515. According to a report by an 

independent panel of experts retained by the Flavor and Extract Manufacturer’s Association 

(FEMA), 3-decen-2-one is considered safe for its intended use when added at an average 

maximum level of 19 ppm in baked goods, 7.8 ppm in soft candy, 5.8 ppm in frozen dairy 

products, 4.8 ppm in gelatins and puddings, 4.3 ppm in non-alcoholic beverages, and 4.0 ppm in 

alcoholic beverages (EPA, 2013).

Descriptions of the product formulation and production process, formation of impurities, and 

physical and chemical characteristics were examined by BPPD and found to be acceptable in 

meeting current guideline standards.

All product chemistry data requirements for registration of 3-decen-2-one have been satisfied. 

For more information regarding product chemistry data requirements, refer to Tables 3 and 4 in 

Appendix A. 

B. Human Health Assessment

1. Toxicology

For acute toxicity data requirements, toxicity categories are assigned based on the hazard(s) 

identified from studies and/or information on file with the Agency. The active ingredient is 

classified into Toxicity Category I, II, III or IV where Toxicity Category I indicates the highest 

toxicity and Toxicity Category IV indicates the lowest toxicity. 

Adequate mammalian toxicology data/information is available to support registration of 3-decen2-one. All toxicology data requirements for 3-decen-2-one have been satisfied.

a. Acute Toxicity

Acute toxicity testing is required to: 1) determine systemic toxicity from acute exposure via the 

dermal, inhalation, and oral routes; 2) determine irritant effects from exposure to the eyes; and 3) 

determine the potential for skin sensitization (allergic contact dermatitis). 
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Tier I acute toxicity studies submitted and reviewed showed that 3-decen-2-one is moderately 

irritating to the eye and severely irritating to the skin based on the results of primary eye 

irritation and primary dermal irritation studies in rabbits, respectively (toxicity category II). 3-

decen-2-one is a toxicity category III (slightly toxic) compound via the inhalation route of 

exposure, based on LC50 0.52-2.04 mg/L in male rats and > 2.04 mg/L in female rats. 3-decen-2-

one falls in toxicity category IV (not toxic) for acute oral toxicity and acute dermal toxicity. 3-

decen-2-one is not a dermal sensitizer. 

For more information regarding acute toxicity data requirements, refer to Table 5 in Appendix A. 

b. Subchronic Toxicity 

Subchronic data are required to determine a no-observed-effect-level (NOEL) and any toxic 

effects associated with repeated or continuous exposure to a test substance for a period of 90 

days. 

A subchronic 90-day oral toxicity study (OCSPP 870.3100) on the a.i. was not conducted. In lieu 

of the study, EPA used a WOE approach to estimate the likelihood of potential of toxicity from 

repeat oral exposure to this substance. EPA considered the following evidence: (1) lack of 

toxicological endpoints; (2) metabolic pathways, (3) lack of incidents associated with naturally 

occurring levels of 3-decen-2-one in foods, and (4) FDA’s approval of this biochemical as a 

direct food additive. This evidence is further expanded on below.

i. Using an expert system computer program (DEREK Nexus), EPA identified two 

potential toxicological endpoints for 3-decen-2-one (potential dermal sensitization and in 

vitro chromosome damage); however, follow-up studies did not support these as 

toxicological endpoints.

ii. The metabolic pathways of 3-decen-2-one have been characterized and 

demonstrate that the biochemical is metabolized into innocuous compounds that are 

either excreted or further metabolized in the fatty acid pathway or citric acid cycle.

iii. 3-decen-2-one occurs naturally in some foods and has been used as a food 

additive without specific reports of adverse effects.

iv. FDA has approved the use of 3-decen-2-one as a synthetic flavoring agent and 

adjuvant that may be directly added to food under 21 CFR § 172.515.

Based on the above evidence, EPA concluded that 3-decen-2-one has relatively low toxicity via 

the repeated oral exposure route and 90 day oral toxicity data requirement for this a.i. has been 

satisfied.

Waiver requests for the subchronic 90-day dermal toxicity (OCSPP 870.3250) and 90-day 

inhalation toxicity (OCSPP 870.3465) data requirements were granted by BPPD, based on the 3-

decen-2-one’s toxicological and exposure profile, summarized below.

i. Prolonged dermal exposure is not expected because 3-decen-2-one is not 

purposely applied to the skin and do not result in comparable human exposure to the 
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product.

ii. Repeated inhalation exposure is unlikely because 3-decen-2-one is applied by a 

thermal fog generator in a closed system. Personnel are not allowed in the potato storage 

facilities during application and evacuation of the product. In addition, any unlikely 

inhalation exposure will be mitigated on the label by precautionary statements and PPE 

requirements.

For more information regarding the subchronic toxicity data requirements, refer to Table 5 in 

Appendix A. 

 c. Developmental Toxicity and Mutagenicity

The Tier I prenatal developmental toxicity study (OCSPP 870.3700) submitted and reviewed 

showed that the maternal and fetal (developmental) toxicity NOAEL was 1,000 mg/kg/day (the 

highest dose tested). A lower bodyweight gain effect was seen in the highest-dose group (1,000 

mg/kg/day) for maternal rats; however, the bodyweight gain effect is considered to be 

attributable to the palatability of the test substance and not toxicologically significant.

The Tier I mutagenicity studies [bacterial reverse mutation test (OCSPP 870.5100) and in vitro

mammalian cell assay (OCSPP 870.5300)] and Tier II mutagenicity study [in vivo mammalian 

erythrocyte micronucleus test assay (OCSPP 870.5395)] submitted and reviewed showed that 3-

decen-2-one is not mutagenic. Results were negative in the bacterial reverse mutation test. In an 

in vitro mammalian gene mutation assay (mouse lymphoma cell), results were positive without 

metabolic activation and results were equivocal with metabolic activation. These results are 

considered equivocal because it was not clear whether the positive results would translate into an 

in vivo system based on the increased osmotic pressure and marked cytotoxicity noted during the 

experiment. Results of an in vivo mammalian erythrocyte micronucleus test assay were negative 

for the a.i.; therefore, the WOE approach indicates that 3-decen-2-one is not likely to be 

mutagenic.

For more information regarding developmental and mutagenicity data requirements, refer to 

Table 5 in Appendix A. 

d. Tier II/Tier III 

No data were required, except to confirm that 3-decen-2-one is not a mutagen (see section B.1.c 

above) due to the nature of the active ingredient and its intended indoor uses in potential new EP 

products (potato sprout inhibitor).

e. Effects on the Endocrine System

As required under Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(p), EPA has 

developed the Endocrine Disruptor Screening Program (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 
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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 endocrine related effects 

caused by the substance, and establish a dose-response relationship between the dose and the E, 

A, or T effect.

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 nine inert ingredients. 

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors.

3-decen-2-one is not among the group of 58 pesticide active ingredients on the initial list to be

screened under the EDSP. Under FFDCA section 408(p) the Agency must screen all pesticide 

chemicals. Accordingly, EPA anticipates issuing future EDSP test orders/data call-ins for all 

pesticide active ingredients. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

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

2. Dose Response Assessment

Because no toxicological endpoints were identified for this active ingredient, a dose-response 

assessment was not required. 

3. Food Quality Protection Act (FQPA) Considerations

a. Dietary Exposure and Risk Characterization

Human exposure to 3-decen-2-one may occur via dietary exposure to treated potatoes. A 

qualitative risk assessment was conducted for the chemical to assess potential risks (if any) from 

dietary exposure. Although dietary exposure to humans may occur, the Agency has determined 

that there is reasonable certainty of no harm to humans when exposed to residues of the active 

ingredient from pesticidal use when label instructions are followed. This conclusion is based on 

the following: 1) available toxicology data and information indicate that the active ingredient is 

of low acute toxicity (with the exception that it is an eye and skin irritant) and not likely to be a 

developmental toxicant, a mutagen or toxic via repeat oral exposure, 2) humans are already 

exposed to 3-decen-2-one in the diet from foods that naturally contain the chemical and from 

foods to which the chemical has been added as a food additive, 3) metabolism data and 

information on the chemical indicate that it is metabolized into innocuous substances in humans, 

and 4) simplistic exposure analyses suggest that dietary exposure to the chemical as a pesticide is 

likely to be less than dietary exposure to the chemical as a food additive and as a natural 
3-decen-2-one

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constituent in foods and pesticidal use of 3-decen-2-one is not likely to result in a significant 

increase in overall dietary exposure (EPA, 2013). A detailed discussion of how the Agency 

arrived at its conclusion is provided in the subsequent paragraphs.

Residues

Previous residue data submitted by the applicant indicate that residues of 3-decen-2-one persist 

in treated potatoes for up to 61 days post-treatment (after one application), although there is a 

substantial reduction over time (EPA, 2011). In support of the revised petition, a new residue 

study was conducted on stored Ranger Russet potatoes treated with one application of AMV1018 (the end-use product containing 98% 3-decen-2-one; EPA File Symbol No. 5481-LTR) at 

twice the maximum application label rate. Potatoes were analyzed for residues when raw, 

steamed and baked at 1, 3, 5, 7 and 14 days after treatment. The study was terminated after day 

14. Prior to cooking and/or analysis, potatoes were “gently” washed with a vegetable brush. 

Tubers were prepared by quartering each potato, chopping one of the quarters into cubes, mixing 

the cubes for random distribution and then storing at -80oC. The residue data are summarized in 

Table 1 below.

Table 1: 3-Decen-2-one Residues in Raw, Steamed, and Baked Potatoes Treated with 230 mg/kg AMV-1018

(98% 3-decen-2-one)

Days After Treatment Raw (ppm) Steamed (ppm) Baked (ppm)

1 2.224 0.256 0.550

3 1.262 0.255 0.548

7 0.747 0.193 0.347

14 0.459 0.112 0.274

The residue study demonstrated that 3-decen-2-one residues are reduced when potatoes are 

cooked. Residues remained on all forms of potatoes through 14 days, when the study was 

terminated. Based on the results of the previously submitted residue study, residues of 3-decen2-one are likely to persist longer than 14 days, although they decrease over time. It is noted that 

since potatoes were “gently” washed with a vegetable brush prior to residue analysis, some 

residues of the active ingredient were likely washed off. Per the applicant, potatoes were washed 

to simulate normal behavior of consumers who generally wash potatoes prior to cooking and 

eating.

Comparison of Dietary Exposure from Different Sources of 3-Decen-2-One

A simplistic quantitative evaluation of potential dietary exposure to children from consumption 

of pesticide-treated potatoes was conducted and compared to estimated dietary exposure to 3-

decen-2-one as a natural constituent of food and as a food additive. Children (1 to 2 years old) 

were chosen as a representative group to assess exposure due to likely consumption of potatoes 

and potato-products and because children are considered a sensitive subgroup of the population. 

The assessment indicates that overall dietary exposure to the chemical as a naturally-occurring 

component in foods and as a food additive is not likely to substantially increase from exposure 

via consumption by children of potatoes treated with the active ingredient as a pesticide when 

label instructions are followed (EPA, 2013).
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Dietary exposure to 3-decen-2-one as a natural constituent in foods was evaluated by using a 

quantitative estimation of the amount of the chemical likely found in fermented milk (yogurt) 

and calculating the potential exposure to children, aged 1-2 years. The applicant identified two 

scientific articles where information to calculate the naturally occurring amount of 3-decen-2-

one was taken. The active ingredient has been identified by gas chromatography (GC) as a 

volatile constituent in four types of yogurt (Patrignani et al., 2009); however, the amount was not 

quantified. In another study where some volatile constituents of yogurt were analyzed (Ott et al., 

2000), the amount of acetaldehyde present in five different types of yogurt was quantified and 

found to be at an average concentration of 10.82 ppm. Acetaldehyde was also identified in the 

Patrignani study, but not quantified. Because acetaldehyde was the only volatile constituent 

found in both studies, it was used as a surrogate to estimate the amount of 3-decen-2-one found 

in the Patrignani study. The average amount of acetaldehyde in the Ott study was assumed to be 

the same in the Patrignani study. The relationship between the peak areas of 3-decen-2-one and 

acetaldehyde measured using GC was considered to be equivalent to the relationship between the 

average concentration of 3-decen-2-one and acetaldehyde. The amount of the active ingredient 

was then estimated by dividing the 3-decen-2-one peak area by the acetaldehyde peak area for 

each of the four yogurt types in the Patrignani study. For the purposes of this assessment, the 

Agency considers this a reasonable approach for estimation of 3-decen-2-one concentration in 

yogurt. Since the yogurts were analyzed after one day and then after 14 days of storage, instead 

of four concentration estimates, eight estimates of 3-decen-2-one concentrations were calculated. 

These concentrations ranged from 2.15-11.15 ppm with the average of 7.64 ppm. To estimate the 

average amount of yogurt consumed by children per day, EPA’s Exposure Factors Handbook 

(U.S. EPA, 2011) was consulted which indicated that the mean per capita yogurt intake by 

children aged 1-2 years is 12 g/day; the consumer-only intake was not available. The Exposure 

Factors Handbook (EFH) indicates that approximately 8.4% of the age group consumes yogurt. 

It is anticipated that the consumer-only intake is considerably higher (for perspective, a 3.5 oz 

container of yogurt weighs approximately 100 g). With regard to this assessment, the per capita 

intake is the average yogurt consumed per person in a population of both individuals who ate 

yogurt during a specified time and those who did not and the consumer-only intake is the average 

yogurt consumed per person in a population composed only of people who ate yogurt during a 

specified period. Using the average estimated concentration of 3-decen-2-one in yogurt and the 

average amount of yogurt consumed by children per day, an estimate of dietary exposure was 

calculated. The concentration of the active ingredient (ppm, or μg/g) is multiplied by the grams 

of yogurt consumed per day; the resulting number is then adjusted for inclusion of body weight 

(the average body weight of a child aged 1-2 years is 11.4 kg (U.S. EPA, 2011)). Assuming 

consumption of 12 g yogurt/day, the dietary exposure for children is as follows: 

7.64 μg 3-decen-2-one/g yogurt × 12 g yogurt consumed/day = 91.68 μg 3-decen-2-

one/day;

91.68 μg/day ÷ 11.4 kg bodyweight = 8.04 μg 3-decen-2-one/kg body weight/day

Thus, the estimated exposure to 3-decen-2-one of a child consuming 12 g of yogurt per day is 

8.04 μg/kg bw/day. To account for the lack of consumer-only intake data and to use a more 

conservative approach, an estimate of 50 g yogurt (which is approximately half of a 3.5 oz 

container of yogurt) consumed per day was employed. Using this consumption amount and the 
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same calculation presented above, the estimated exposure of a child consuming 50 g of yogurt 

per day is 33.5 μg/kg bw/day. Based on these data, the amount of the chemical consumed by 

children aged 1-2 years is estimated to range from 8.04-33.5 μg/kg bw/day

 

Dietary exposure to 3-decen-2-one as a food additive was also evaluated using the same 

methodology and calculations presented above and the levels of the chemical added to food as 

described by Oser and Ford (1978). According to this report, the chemical is considered safe for 

its intended use when added to baked goods at an average maximum of 19 ppm and to 

nonalcoholic beverages at an average maximum of 4.3 ppm. According to the EFH, the average 

daily per capita intake of bread (includes breads, rolls, muffins, bagels, biscuits, cornbread and 

tortillas) for children aged 1-2 years is 2 g/kg bw/day. The average per capita intake of non-citrus 

juices and nectars and citrus juices is 132 g/day and 49 g/day, respectively. The juice intake 

values were chosen as reasonable representations for nonalcoholic beverages that children may 

ingest. Because the amounts of 3-decen-2-one added to food are considered maximum amounts, 

two calculations for each food group were performed to create a range of dietary exposure 

estimates. The first estimate is based on exposure to the maximum amount of the chemical added 

to the specific food group and the second estimate is based on the maximum amount of the 

chemical divided in half. The division is considered a reasonable estimate for levels of 3-decen2-one that may be generally added to food and is useful in creating a range of possible dietary 

exposures. For example, for baked goods, the maximum amount of the chemical added can be 19 

ppm; to estimate dietary exposures, concentrations of 19 ppm and 9.5 ppm were used in the 

calculations. Assessments similar to those discussed regarding dietary exposure to 3-decen-2-one 

in yogurt suggest a range of dietary exposures of 19.0-38.0 μg/kg bw/day in baked goods and 

9.24-49.8 μg/kg bw/day (24.9-49.8 μg/kg bw/day in non-citrus juices and nectars and 9.2 - 18.5 

μg/kg bw/day in citrus juices) in nonalcoholic beverages. 

Dietary exposure to 3-decen-2-one from use as a pesticide was evaluated by using the residue 

data presented in Table 2 and similar calculations to those discussed above. Residues in the 

amount of 0.550 ppm 3-decen-2-one were identified in potatoes that were baked one day after 

treatment with double the application rate on the label. The residue value for baked potatoes was 

selected since children are not likely to eat raw potatoes. The label indicates that 4 applications 

of the pesticide can be made in 7-day increments. A conservative estimate of potential residues 

after four pesticide applications was conducted by using the residue value for baked potatoes at 

day 1 and multiplying that value by four. The estimate is conservative because it is assumed that 

four applications of the pesticide will be made all at one time and potatoes will be consumed at 

day 1 after treatment when in reality, the pesticide will not be applied all in one interval and 

residue data indicate that levels of 3-decen-2-one decline in potatoes over time. According to the 

EFH, the average consumer-only intake of white potatoes by children aged 1-2 years is 1.86 g/kg 

bw/day (uncooked weight). Using the type of calculations discussed above, the estimated dietary 

exposure to children from exposure to 3-decen-2-one as a pesticide is 4.1 μg/kg bw/day. The 

estimated dietary exposures for children aged 1-2 years as calculated and discussed above are 

summarized in Table 2 below.
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Table 2: Estimated Dietary Exposures to 3-decen-2-one for Children Aged 1-2 Years 

Source of 3-decen-2-one Estimated Dietary Exposure (μg/kg bw/day)

Naturally-occurring constituent of yogurt 8.0 - 33.5

Food additive in baked goods 19.0 – 38.0

Food additive in nonalcoholic beverages:

Non-citrus juices and nectars

Citrus juices

24.9 – 49.8 (non-citrus)

9.24 -18.5 (citrus)

Pesticide residues on baked potatoes 4.1

The information presented above suggests that dietary exposure to residues of 3-decen-2-one 

used as a pesticide is likely to be less than dietary exposure to the chemical as a naturally

occurring constituent in food and/or as a food additive. Further, when compared to the amount of

the chemical that is likely already consumed in the human diet, pesticidal use is not anticipated 

to significantly increase overall human dietary exposure to 3-decen-2-one as a food additive and 

a natural constituent in food (EPA, 2013). 

 b. Drinking Water Exposure and Risk Characterization

Based on the proposed use pattern of the active ingredient as a potato sprout inhibitor used in 

indoor settings, residues in drinking water are not anticipated if products are used according to 

label instructions. Products containing the active ingredient will be used in indoor commercial 

settings only; therefore, 3-decen-2-one residues in drinking water are highly unlikely. In the 

unlikely event that exposure via drinking water does occur, the health risk would be expected to 

be minimal based on the low acute oral toxicity of 3-decen-2-one.

c. Acute and Chronic Dietary Risks for Sensitive Subpopulations Particularly 

Infants and Children

The Agency has determined that there are no foreseeable dietary risks to sensitive 

subpopulations, including infants and children, from the use of 3-decen-2-one as a pesticide on 

stored potatoes when label instructions are followed. The available data and information indicate 

that the chemical: 1) is of low toxicity and is not a developmental toxicant; 2) naturally occurs in 

the human diet; 3) has been approved for use in foods as a food additive by the FDA; and 4) is 

metabolized into innocuous substances. Additionally, basic exposure analyses that were 

specifically conducted for children aged 1-2 years suggest that dietary exposure from ingestion 

of the chemical as a pesticide is likely to be less that dietary exposure from ingestion of the 

chemical as a food additive and/or as a constituent that naturally occurs in foods. When 

compared to the amount of 3-decen-2-one that is likely already consumed in the human diet, 

dietary exposure from pesticidal use is not anticipated to significantly increase overall dietary 

exposure of infants and children. 

4. Occupational, Residential, School and Day Care Exposure and Risk Characterization

a. Occupational Exposure and Risk Characterization

An occupational exposure assessment was not conducted for 3-decen-2-one, and is not required.
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Significant occupational exposure is not expected when 3-decen-2-one is used according to label 

instructions. Products containing this active ingredient are intended for indoor use as a sprout 

inhibitor on stored potatoes. The application method is a thermal fog generator in a closed 

system. The end-use product is fogged into the storage area by way of the ventilation ducts and 

re-circulated through the air by the ventilation system for 24 hours. After the re-circulation is 

complete, the ventilation louvers will be opened and the air in the storage area will be evacuated 

to the outside. The only occupational exposure expected is the handling of the product prior to 

application, which is mitigated by appropriate precautionary statements and PPE requirements 

listed on the label. This will include instructions for applicator PPE, which includes: coveralls 

worn over long sleeve shirt and long pants, socks, chemical resistant footwear, chemical-resistant 

gloves, face shield or shielded safety glasses, and appropriate PPE for potential exposure via the 

inhalation route. Additionally, no relevant toxicological endpoints have been identified. Based on 

the data and information available to the Agency, anticipated exposure is not likely to result in

unreasonable risk to humans.

b. Residential, School and Day Care Exposure and Risk Characterization

Exposure to 3-decen-2-one will be minimal in residential, school, and day care areas, as the enduse product containing this active ingredient is intended for use as a sprout inhibitor on stored 

potatoes in a closed system.

5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation

There is reasonable certainty that no harm to the U.S. population will result from aggregate 

exposure to 3-decen-2-one. This includes all exposures for which there is reliable information.

Based on the use pattern of the chemical as a sprout inhibitor on stored potatoes in a closed

system and appropriate personal PPE requirements on the label, significant exposure via the 

dermal and inhalation routes is not anticipated when label instructions are followed. Dietary 

(oral) exposure has been identified as the only likely route of exposure. Exposure is not 

anticipated in drinking water based on the use pattern and the pesticide is not to be used in 

residential settings. The chemical’s highly specific mode of action as a sprout inhibitor, its low 

toxicity (with the exception that 3-decen-2-one is an eye and skin irritant) further support the 

EPA’s conclusion. In consideration of the above information, the Agency has determined the risk 

from aggregate exposure (via oral, dermal, and inhalation exposures) is negligible.

6. Cumulative Effects

Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available information 

concerning the cumulative effects of 3-decen-2-one residues and other substances that have a 

common mechanism of toxicity. Unlike other pesticides for which EPA has followed a 

cumulative risk approach based on a common mechanism of toxicity, the Agency has not made a 

common mechanism of toxicity finding for 3-decen-2-one and any other substances and 3-decen2-one does not appear to produce a toxic metabolite produced by other substances. The active 

ingredient is a biopesticide that has a nontoxic mode of action. For information regarding EPA’s 

efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the 

cumulative effects of such chemicals, see the policy statements released by the Agency’s Office 
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of Pesticide Programs concerning common mechanism determinations and procedures for 

cumulating effects from substances found to have a common mechanism on EPA’s website at 

http://www.epa.gov/pesticides/cumulative/.

7. Risk Characterization

EPA has considered human exposure to 3-decen-2-one in light of the relevant safety factors in 

FQPA and FIFRA and has determined that no unreasonable adverse effects to the U.S. 

population in general, and to infants and children in particular, will result from the use of 3-

decen-2-one as a pesticide when label instructions are followed.

C. Environmental Assessment

1. Ecological Hazards

The nontarget organism data requirements for 3-decen-2-one are waived based on the proposed 

indoor use pattern. 3-decen-2-one is proposed for use in end-use formulations that are applied in 

indoors only as sprout inhibitors on potatoes. The end-use formulations will be introduced and 

dispersed as a vapor through air circulation systems in potato storage warehouse facilities and is 

not expected to be available to nontarget organisms. Based on the indoor use pattern, exposure of 

3-decen-2-one to nontarget organisms is expected to be minimal. All nontarget toxicology data 

requirements for 3-decen-2-one have been satisfied.

For more information regarding nontarget organism toxicity data requirements, refer to Table 6

in Appendix A. 

2. Environmental Fate and Ground Water Data 

The need for environmental fate and groundwater data is not required based on the proposed 

indoor use pattern of 3-decen-2-one and the information submitted for the nontarget organism 

toxicology data requirements, which did not trigger additional Tier I studies. The applicant did 

submit information that estimated the physical and chemical properties for 3-decen-2-one by 

using QSAR modeling based on the Estimation Programs Interface Model (EPI SuiteTM 4.0). 

Using Henry’s Law, which states that the solubility of a gas in a liquid is directly proportional to 

the partial pressure of the gas above the liquid, 3-decen-2-one is estimated to be 5.4 x 10-4

atm·m3/mol and indicates that the a.i. has a potential for volatility from water or moist soil. In 

soil, the estimated Koc of 165.2 – 860.9 L/kg indicates that the a.i. would have medium to low 

mobility in soil. In water, an estimated log Kow of 3.28 and an estimated BCF of 67.41 L/kg wetwt indicate that bioaccumulation in aquatic organisms is unlikely. In the air, atmospheric 

oxidation by reaction of hydroxyl radicals is expected to occur with estimated half-lives of 1.9 –

2.2 hours. The probability of biodegradation of 3-decen-2-one was evaluated using EPI SuiteTM 

4.0 in the BIOWIN module. Various models in the BIOWIN module predicted rapid 

biodegradation of 3-decen-2-one. Based on a total air volume in potato warehouse of 1,910 m3

and total applied 3-decen-2-one of 122,475 g calculated by the applicant, the maximum air 

concentration of 3-decen-2-one in warehouse was estimated to be 64.14 mg/L of air. With an 

estimated ventilation rate of 825 m3 of air/min, the air volume in a warehouse will be exchanged 
3-decen-2-one

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within 2.5 minutes when the vents to the outdoors are opened. Thus, the concentration emitted 

will be rapidly diluted in the outside air, which further demonstrates insignificant exposure to 

nontarget organisms.

3. Ecological Exposure and Risk Characterization

Significant exposure and risk to nontarget organisms is not expected because of the proposed 

indoor use pattern as a sprout inhibitor on potatoes for 3-decen-2-one. The end-use formulations 

will be introduced and dispersed as a vapor through air circulation systems in potato storage 

warehouse facilities and are not expected to be available to nontarget organisms. In addition, the 

estimated ventilation rate of 825 m3 of air/min in the potato storage warehouse facilities will 

exchange the air volume in the warehouse within 2.5 minutes when the vents to the outdoors are 

opened; therefore, the concentration emitted will be rapidly diluted in the outside air.

4. Endangered Species Assessment

Tier I studies were not submitted for 3-decen-2-one, but are not required. Based on its use pattern 

and use instructions as a sprout inhibitor on stored potatoes intended for use in indoor, enclosed 

potato storage facilities, exposure to nontarget organisms is not expected. Based on its use 

pattern and use instructions, EPA has determined 3-decen-2-one will have “No Effect” on any 

currently listed threatened or endangered species or any designated critical habitat.

D. Efficacy Data

Product performance data must be developed for all pesticides to ensure that pesticide products 

will perform as intended and that unnecessary pesticide exposure to the environment will not 

occur as a result of the use of ineffective products. The Agency reserves the right to require on a 

case-by-case basis, submission of efficacy data for any pesticide product registered or proposed 

for registration that are intended to be used to control a pest of significance public health 

importance and a public health pest as defined in FIFRA section 28(d) and section 2(nn). For 

further guidance on product performance requirement, refer to Pesticide Registration Notice (PR) 

Notices 96-7, 2002-1 and Explanation of Statutory Framework for Risk-Benefit Balancing for 

Public Health Pesticides (http://www.epa.gov/PR _Notices/pr1996-7.pdf) 

(http://www.ea.gov/PR_Notices/pr2002-1.pdf) and (http://www.epa.gov/pesticides/health/riskbenefit.htm).

The EPs submitted with this new active ingredient did not list pests of significance public health 

importance or a public health pest as defined in FIFRA section 28(d) and section 2(nn). 

Therefore, product performance (efficacy) was not evaluated. 
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V. RISK MANAGEMENT DECISION

A. Determination of Eligibility for Registration 

Section 3(c)(5) of FIFRA provides for the registration of a new active ingredient if it is 

determined that: (A) its composition warrants proposed claims; (B) its labeling and other 

materials comply with the requirements of FIFRA; (C) it will perform its intended function 

without unreasonable adverse effects on the environment; and (D) when used in accordance with 

widespread and commonly recognized practice, it will not generally cause unreasonable adverse 

effects on the environment. 

The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied by 

the science assessments supporting products containing the technical grade active ingredient, 3-

decen-2-one. Such products are not expected to cause unreasonable adverse effects. Therefore, 3-

decen-2-one as a technical grade active ingredient is eligible for registration for the labeled uses. 

B. Regulatory Decision

The data submitted fulfill the registration requirements of 3-decen-2-one for use as a potato 

sprout inhibitor. Refer to Appendix B for product-specific information.

Conditional/Unconditional Registration

All data requirements are fulfilled, and EPA determined that an unconditional registration of 3-

decen-2-one is appropriate.

Consistent with the policy of making registration actions more transparent, 3-decen-2-one is 

subject to a 15-day comment period as a “new active ingredient.” EPA has established a 

comment period of 15 days on the basis of 3-decen-2-one’s minimal toxicity, the determination 

that 3-decen-2-one presents low risk of any adverse effects to human health and the environment, 

and critical need for this active ingredient. The notice for this comment period includes the draft 

Biopesticides Registration Action Document (BRAD) and draft product labels for the MP, 

AMV-1018 Technical, and EP, AMV-1018 EP, which contain this new active ingredient, 3-

decen-2-one. The docket identification (ID) number is EPA-HQ-OPP-2010-0064. The Agency 

believes that based on the risk assessment and information submitted in support of the 

registration of the MP and EP containing 3-decen-2-one, it is in the best interests of the public to 

issue the registration for AMV-1018 Technical and AMV-1018 EP. The basis for this decision 

can be found in the risk assessment for 3-decen-2-one, which is characterized in this BRAD. 

C. Environmental Justice

EPA seeks to achieve environmental justice—the fair treatment and meaningful involvement of 

all people regardless of race, color, national origin, or income—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. At this time, 

EPA does not believe that use of 3-decen-2-one pesticide products will cause harm or a 

disproportionate impact on at-risk communities. For additional information regarding 
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environmental justice issues, please visit EPA’s website at

http://www.epa.gov/compliance/environmentaljustice/index.html.

VI. ACTIONS REQUIRED BY REGISTRANTS

EPA evaluated all data submitted in connection with the registration of the 3-decen-2-one

pesticide products and determined that these data are sufficient to satisfy current registration data 

requirements. At this time, no additional data must be submitted to EPA for these particular 

products. For new uses and/or changes to existing uses, EPA may require additional data. 

Notwithstanding the information stated in the previous paragraph, it should be clearly understood 

that certain specific data are required to be reported to EPA as a requirement for maintaining the 

Federal registration for a pesticide product. A brief summary of these types of data are listed 

below. 

A. Reporting of Adverse Effects

Pursuant to FIFRA section 6(a)(2), reports of all incidents of adverse effects to the environment 

must be submitted to EPA.

B. Reporting of Hypersensitivity Incidents

Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) 

must be reported to the Agency under the provisions of 40 CFR Part 158.2050(d).

VII. APPENDIX A. DATA REQUIREMENTS (40 CFR PART 158-SUBPART U)

*NOTE: Master Record Identification (MRID) numbers listed in the following tables are 

representative of supporting data/information for the original registration of the product 

containing this active ingredient. Subsequent to this registration, there may be additional MRIDs 

that support registration of other products containing this active ingredient. 
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TABLE 3. Product Chemistry Data Requirements for 3-decen-2-one (40 CFR § 158.2030)

OCSPP Guideline Reference No./Study Description of Result MRID

880.1100 Product identity and composition The product identity and composition were 

adequately addressed. Confidential Business 

Information (CBI).

47942601

880.1200 Description of starting materials, 

production, and formulation 

process

The description of the starting materials, 

production, and formulation process were 

adequately addressed. CBI.

47942602

47942603

880.1400 Discussion of formation of 

impurities

The discussion of formation of impurities was 

adequately addressed. CBI. 47942604

830.1700 Preliminary analysis The preliminary analysis of the product was 

acceptable. CBI. 47942605

830.1750 Certified limits The certified limits listed on the CSF are 

acceptable. 47942606

830.1800 Enforcement analytical method The enforcement analytical method was 

adequately addressed. CBI. 47942605
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TABLE 4. Physical and Chemical Properties for 3-decen-2-one (40 CFR § 158.2030)

OCSPP Guideline Reference No./Property Description of Result MRID

830.6302 Color Colorless to pale yellow 47942607

830.6303 Physical State Clear liquid 47942607

830.6304 Odor Pleasant 47942607

830.6313 Stability to normal and elevated 

temperatures, metals and metal 

ions

The stability of the active ingredient of the 

test substance untreated and in presence of 

metals and metal ions (iron powder, iron 

acetate, aluminum powder, and aluminum 

acetate) stored for 1, 2, 7 and 14 days was 

determined at ambient (21 - 23°C) and 

elevated temperature (54°C). A significant 

decrease in the concentration of the active 

ingredient was observed at elevated 

temperatures for all treatments and with the 

samples treated with iron acetate at ambient 

temperature after 7 days.

47942607

830.6315 Flammability Flash point = 91°C

From Confidential 

Statement of Formula 

(CSF)

830.6317 Storage Stability Not required for TGAI. MP is stable during 

one year storage stability study. 48970301

830.6319 Miscibility N/A, not an emulsifiable liquid and is not to 

be diluted with petroleum solvents 47942607

830.6320 Corrosion Characteristics Not required for TGAI. MP showed no signs 

of corrosion (cracking, pitting, or 

discoloration) during one year storage 

stability study.

48970301

830.7000 pH 4.33 of 1% w/w suspension in water at 23°C 47942607

830.7050 UV/Visible light absorption pH λmax (nm) ε (L/mol*cm)

Neutral 229.0 14408.1

Acidic 229.0 16464.7

Alkaline 229.0 9330.6

47942607

830.7100 Viscosity 2.211 mm2

/s at 25°C 48156401

830.7200 Melting Range N/A, not a solid 47942607

830.7220 Boiling Range 224.0°C 47942607

830.7300 Density/Relative Density/Bulk 

Density 0.845 g/mL at 20°C 47942607

830.7520 Particle size, fiber length, and 

diameter distribution N/A, not insoluble in water and not a fiber 47942607

830.7550 Partition Coefficient (n-Octanol/ 

830.7560 Water)

830.7570

Log Pow = 3.45 47942607

830.7840 Water Solubility 0.140 g/L at 24°C 47942607

830.7950 Vapor Pressure 430 Pa at 25°C 47942608
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Table 5: Mammalian Toxicology Data Requirements for 3-decen-2-one (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

Acute oral toxicity (rat)

(870.1100)

LD50 > 5,000 mg/kg body weight in female 

rats Toxicity Category IV 47942609

Acute dermal toxicity (rat)

(870.1200)

LD50 > 5,000 mg/kg body weight in male and 

female rats Toxicity Category IV 47942610

Acute inhalation toxicity (rat)

(870.1300)

LC50 0.52-2.04 mg/L in male rats and > 2.04 

mg/L in female rats Toxicity Category III 47942611

Primary eye irritation (rabbit)

(870.2400)

One hour after test substance instillation, all 

three treated eyes exhibited corneal opacity 

and conjunctivitis, and two treated eyes 

exhibited iritis. Severity decreased over time, 

with all animals free of ocular irritation by 

Day 10. Test substance is classified as 

moderately irritating to the eye.

Toxicity Category II 47942612

Primary dermal irritation (rabbit)

(870.2500)

Animals exhibited severe irritation (severe 

erythema and moderate edema) through 72 

hours post patch removal. Irritation was no 

longer observed by Day 14. Test substance is 

classified as severely irritating to the skin. 

Toxicity Category II 47942613

Dermal sensitization (guinea pig)

(870.2600) Not a dermal sensitizer. - 47942614

90-Day oral toxicity

(870.3100)

A subchronic 90-day oral toxicity study 

(OCSPP 870.3100) on the active ingredient 

(a.i.) was not conducted. In lieu of the study, 

EPA used a WOE approach to estimate the 

likelihood of potential of toxicity from repeat 

oral exposure to this substance. First, using an 

expert system computer program (DEREK 

Nexus), EPA identified two potential 

toxicological endpoints for 3-decen-2-one 

(potential dermal sensitization and in vitro 

chromosome damage); however, follow-up 

studies did not support these as toxicological 

endpoints. Second, the metabolic pathways of 

3-decen-2-one have been characterized and 

demonstrate that the biochemical is 

metabolized into innocuous compounds that 

are either excreted or further metabolized in 

the fatty acid pathway or citric acid cycle. 

Third, 3-decen-2-one occurs naturally in some 

foods and has been used as a food additive 

without specific reports of adverse effects. 

Finally, FDA has approved the use of 3-

decen-2-one as a synthetic flavoring agent and 

adjuvant that may be directly added to food 

under 21 CFR § 172.515. Based on this 

evidence, EPA concluded that 3-decen-2-one 

has relatively low toxicity via the repeated 

oral exposure route.

- 47942617

48422301

90-Day dermal toxicity

(870.3250)

Not required. Proposed uses not to involve 

purposeful application to human skin and do 

not result in comparable human exposure to 

the product.

- 47942617

90-Day inhalation toxicity

(870.3465)

Not required. Repeated inhalation exposure is 

unlikely due to product being applied by a 

thermal fog generator in a closed system. 

Personnel are not allowed in the potato 

storage facilities during application and 

- 47942617; 

48422301
3-decen-2-one

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Biopesticides Registration Action Document

Table 5: Mammalian Toxicology Data Requirements for 3-decen-2-one (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

evacuation of the product. In addition, any

unlikely inhalation exposure will be mitigated 

on the label by precautionary statements and 

PPE requirements. 

Developmental toxicity

(870.3700)

Maternal and fetal NOAEL = 1,000 

mg/kg/day (the highest dose tested).

A lower bodyweight gain effect was seen in 

the highest-dose group (1,000 mg/kg/day) for 

maternal rats; however, the bodyweight gain 

effect is considered to be attributable to the 

palatability of the test substance and not 

toxicologically significant.

- 48970303

Mutagenicity – Tier I

(870.5100, 5300 and 5375)

Mutagenicity – Tier II

(870.5395)

Test substance is negative in bacterial reverse 

mutation assay with and without metabolic 

activation.

Test substance positive in 24-hr exposure 

without metabolic activation and equivocal 

results with metabolic activation in an in vitro

mammalian gene mutation assay (mouse 

lymphoma cell). Mouse lymphoma results are 

considered equivocal because it is not clear 

whether the positive results would translate 

into an in vivo system based on the increased 

osmotic pressure and marked cytotoxicity 

noted during the experiment.

Test substance is considered non-mutagenic 

based on in vivo mammalian erythrocyte 

micronucleus test assay results.

-

47942616

47942615

48412402

Table 6: Nontarget Organism Toxicity Data Requirements for 3-decen-2-one (40 CFR § 158.2060)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

Avian acute oral toxicity

(850.2100)

Not required. Significant exposure to birds is 

not expected due to the proposed indoor use 

only as a sprout inhibitor on potatoes. In 

addition, 3-decen-2-one is applied and 

released as a vapor and is not expected to be 

available to birds via the oral route.

Significant exposure 

not expected 47942617

Avian dietary toxicity

(850.2200)

Not required. Significant exposure to birds is 

not expected due to the proposed indoor use 

only as a sprout inhibitor on potatoes. In 

addition, 3-decen-2-one is applied and 

released as a vapor and is not expected to be 

available to birds via the oral route.

Significant exposure 

not expected 47942617

Aquatic invertebrate acute toxicity, 

freshwater

(850.1010)

Not required. Significant exposure to aquatic 

invertebrates is not expected due to the 

proposed indoor use only as a sprout inhibitor 

on potatoes. In addition, 3-decen-2-one is 

applied and released as a vapor and is not 

expected to enter surface water in amounts 

sufficient to impact aquatic life.

Significant exposure 

not expected 47942617
3-decen-2-one

Page 27 of 30

Biopesticides Registration Action Document

Table 6: Nontarget Organism Toxicity Data Requirements for 3-decen-2-one (40 CFR § 158.2060)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

Fish acute toxicity, freshwater

(850.1075)

Not required. Significant exposure to fish is 

not expected due to the proposed indoor use 

only as a sprout inhibitor on potatoes. In 

addition, 3-decen-2-one is applied and 

released as a vapor and is not expected to 

enter surface water in amounts sufficient to 

impact aquatic life.

Significant exposure 

not expected 47942617

Terrestrial plant toxicity, Seedling 

emergence/Vegetative vigor 

(850.4100 and 850.4150)

Not required. Significant exposure to 

terrestrial plants is not expected due to the 

proposed indoor use only as a sprout inhibitor 

on potatoes. In addition, 3-decen-2-one is 

applied and released as a vapor during winter 

months when terrestrial plants are generally 

dormant and when seedlings are not 

emerging.

Significant exposure 

not expected 47942617

Nontarget insect testing

(880.4350)

Not required. Significant exposure to insects 

is not expected due to the proposed indoor use 

only as a sprout inhibitor on potatoes. In 

addition, 3-decen-2-one is applied and 

released as a vapor during winter months 

when nontarget insects are generally dormant.

Significant exposure 

not expected 47942617

VIII. APPENDIX B.

For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels.

IX. APPENDIX C.

REFERENCES

JECFA. 2003. Joint FAO/WHO Expert Committee on Food Additives. WHO Food Additives 

Series 50. Secondary alcohols, ketones and related esters. International Programme on Chemical 

Safety.

Munro, I. and B. Danielewska-Nikiel. 2006. Comparison of estimated daily intakes of flavoring 

substances with no-observed effect levels. Food and Chemical Toxicology. Vol. 44: 758-809.

Patrignani, F., P. Burns, D. Serrazanetti, G. Vinderola, J. Reinheimer, R. Lanciotti, and M.E. 

Guerzoni. 2009. Suitability of high pressure-homogenized milk for production of probiotic 

fermented milk containing Lactobacillus acidophilus. J. Dairy Research. Vol. 76: 74-82.

Oser B.L. and R.A. Ford. 1978. Recent progress in the consideration of flavoring ingredients 

under the Food Additives Amendment. 11. GRAS Substances. Food Technology. Vol. 32 (2): 

60-70.
3-decen-2-one

Page 28 of 30

Biopesticides Registration Action Document

Ott A., A. Hugi, M. Baumgartner and A. Chaintreau. 2000. Sensory investigation of yogurt 

flavor perception: mutual influence of volatiles and acidity. J. Agric. Food Chem. Vol. 48: 441-

450.

U.S. EPA. 2011. Exposure Factors Handbook 2011 Edition (Final) (EPA/600/R-09/052F). U.S. 

Environmental Protection Agency, Washington, DC. 

REVIEWS AND OTHER REFERENCES

EPA. 2010. Memorandum from Gina M. Casciano and Colin G. Walsh thru Russell S. Jones to 

Driss Benmhend. Revised Hazard Assessment for Tier I Human Health Toxicity in Support of 

the Registration of AMV-1018 Technical, Containing 3-decen-2-one as its Active Ingredient

(Amends EPA Memorandum from G. Casciano and C. Walsh through R. Jones to D. Benmhend 

dated June 16, 2010). U.S. Environmental Protection Agency Office of Pesticide Programs. 

December 7, 2010.

EPA. 2011. Memorandum from Colin G. Walsh thru Angela L. Gonzales to Linda A. Hollis. 

Joint Science Review with Health Canada Pest Management Regulatory Agency (PMRA) in 

Support of the Registration of AMV-1018 Technical (EPA File Symbol No. 5481-LAI), a 

Manufacturing-Use Product (MP), Containing 98.0% of 3-decen-2-one as its Active Ingredient 

and Tolerance Exemption Petition Review in Support of 3-decen-2-one. U.S. Environmental 

Protection Agency Office of Pesticide Programs. December 20, 2011.

EPA. 2013. Memorandum from Angela L. Gonzales thru Felecia A. Fort to Colin G. Walsh. 

Joint Science Review with Health Canada Pest Management Regulatory Agency (PMRA) in 

Support of the Registration of AMV-1018 Technical Containing 98.0% of 3-Decen-2-One as its 

Active Ingredient. U.S. Environmental Protection Agency Office of Pesticide Programs. January 

3, 2013.

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

a.i. active ingredient

AMVAC Amvac Chemical Corporation

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticide Registration Action Document

bw body weight

CBI Confidential Business Information

CFR Code of Federal Regulations

CIPC Chlorpropham

cm3 cubic centimeter

CSF Confidential Statement of Formula

°C degrees Celsius

EC50 median effective concentration. A statistically derived single concentration in 

environmental medium that can be expected to cause an effect in 50% of the test 

animals when administrated by the route indicated (inhalation). It is expressed 
3-decen-2-one

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Biopesticides Registration Action Document

as a concentration in air or water (e.g. mg/L).

EDSP Endocrine Disruptor Screening Program

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee

EFH Exposure Factors Handbook

EP end-use product

EPA Environmental Protection Agency (the “Agency”)

FDA Food and Drug Administration

FEMA Flavor and Extract Manufacturer’s Association

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

g gram

ha hectare

JECFA Joint FAO/WHO Expert Committee on Food Additives

kg kilogram

Kow octanol-water partition coefficient

L liter

LC50 median lethal concentration. A statistically derived single concentration in air or 

water that can be expected to cause death in 50% of the test animals when 

administrated by the route indicated (inhalation and environment). It is 

expressed as a concentration in air or water (e.g. mg/L).

LD50 median lethal dose. A statistically derived single dose that can be expected 

to cause death in 50% of the test animals when administered by the route 

indicated (oral and dermal). It is expressed as a weight of 

substance per unit weight of animal (e.g., mg/kg).

MRID No. Master Record Identification Number

mg milligram

mPa millipascal

mL milliliter

MP manufacturing-use product

N/A not applicable

NE “No Effect”

NIOSH National Institute for Occupational Safety and Health

nm nanometer

NOAEL no-observed-adverse-effect-level

NOEL no-observed-effect-level

NOF notice of filing

NOR notice of receipt

OPP Office of Pesticide Programs

OCSPP Office of Chemical Safety and Pollution Prevention

pa pascal

PADI possible average daily intake

PMRA Canada’s Pesticide Management Regulatory Authority

PPE personal protective equipment

PR Notice Pesticide Registration Notice
3-decen-2-one

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Biopesticides Registration Action Document

 TGAI technical grade of the active ingredient

 TSG Technology Sciences Group, Inc.

 ug microgram

 USDA United States Department of Agriculture

 UV ultra-violet

 WOE weight of the evidence