3-decen-2-one DP Number: 373085

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Human Health Toxicity

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

MEMORANDUM 

DATE: December 20, 2011

SUBJECT: 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.

Decision Numbers: 425383 and 425387

DP Number: 387847

EPA File Symbol Number: 5481-LAI

EPA Petition Number: 9F7670

Chemical Class: Biochemical

PC Code: 068403

CAS Number: 10519-33-2

Active Ingredient Tolerance: Pending

MRID Numbers: 47942601-47942618, 48422301- 48422302, and 484124-02

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

FROM: Colin G. Walsh, M.S., Biologist /s/ 12/20/2011

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

THRU: Angela L. Gonzales, Biologist /s/ 12/20/2011

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

TO: Linda A. Hollis, Chief

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P) 

ACTION REQUESTED

AMVAC Chemical Corporation requests registration of AMV-1018 Technical, a new technical 

grade active ingredient (TGAI) and manufacturing-use product (MP) containing 98.0% of the 

new active ingredient (a.i.), 3-decen-2-one, a chemical occurring naturally in some foods and 
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

2

approved as a direct food additive by the U.S. Food and Drug Administration (FDA) for use as a 

synthetic flavoring agent and adjuvant (21 CFR 172.515). This TGAI/MP product is for 

manufacturing-use only; specifically, for formulation into registered end-use products for use as a 

sprout inhibitor in or on stored potatoes. In support of the proposed product, the applicant has 

submitted a proposed product label, a Confidential Statement of Formula (CSF) dated 

12/08/2009, product chemistry data in MRIDs 47942601-47942608 and 48156401, mammalian 

and human toxicology data and information in MRIDs 47942609-47942616, 47942618, 

48422301-48422302, and 484124-02, and nontarget organism toxicology information in MRID

47942617. A request for registration of a proposed end-use product (EP) containing 3-decen-2-

one (EPA File Symbol No. 5481-LTR) has been submitted concurrently and is discussed in a 

separate memorandum from C. Walsh thru A. Gonzales to L. Hollis dated 12/XX/2011. A 

petition for the exemption of a requirement of a tolerance for residues of the active ingredient on 

stored potatoes has been submitted under Tolerance Petition No. 9F7670 and is discussed in this 

memorandum. EPA is conducting a joint review for these products with Health Canada Pest 

Management Regulatory Agency (PMRA).

RECOMMENDATIONS AND CONCLUSIONS

1. The product chemistry submission is ACCEPTABLE, pending resolution of the 

deficiencies identified below.

MRID 47942601: ACCEPTABLE MRID 47942606: SUPPLEMENTAL

MRID 47942602: ACCEPTABLE MRID 47942607: SUPPLEMENTAL

MRID 47942603: ACCEPTABLE MRID 47942608: ACCEPTABLE

MRID 47942604: ACCEPTABLE MRID 48156401: ACCEPTABLE

MRID 47942605: ACCEPTABLE

a. The applicant must list the flash point in box 9 of the CSF. Refer to the Confidential Appendix 

for further details.

b. The lower certified limit for the a.i. is incorrect on the CSF. Refer to the Confidential 

Appendix for further details.

c. The certified limits for the impurities are incorrect on the CSF based on the 5-batch analysis. 

Refer to the Confidential Appendix for further details.

d. The Chemical Abstract Service (CAS) No. for one the impurities is not listed on the CSF.

Refer to the Confidential Appendix for the identity of the impurity.

e. The applicant must submit one year storage stability (OCSPP Guideline No. 830.6317) and 

corrosion characteristics (OCSPP Guideline No. 830.6320) studies on the TGAI/MP to satisfy 

the data requirements.
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

3

2. The toxicology submission for the active ingredient is SUPPLEMENTAL.

MRID 47942609: ACCEPTABLE MRID 47942616: ACCEPTABLE

MRID 47942610: ACCEPTABLE MRID 47942617: SUPPLEMENTAL

MRID 47942611: ACCEPTABLE MRID 48422318: ACCEPTABLE

MRID 47942612: ACCEPTABLE MRID 48422301: SUPPLEMENTAL

MRID 47942613: ACCEPTABLE MRID 48422302: ACCEPTABLE

MRID 47942614: ACCEPTABLE MRID 48412402: ACCEPTABLE

MRID 47942615: SUPPLEMENTAL

a. The Agency considers the information submitted for the developmental toxicity data 

requirement as UNACCEPTABLE. The data and rationale submitted are insufficient to fulfill 

the data requirement. The developmental toxicity data requirement must be fulfilled with 

developmental toxicity data on 3-decen-2-one or a chemical that is significantly structurallysimilar to 3-decen-2-one. If data on a surrogate chemical is submitted, scientifically-credible 

rationale must also be provided indicating why the data on the surrogate chemical is suitable for 

use to fulfill the developmental toxicity data requirement for the proposed active ingredient.

3. The nontarget organism toxicology submission is ACCEPTABLE. MRID 47942617: ACCEPTABLE

4. The petition for the exemption from the requirement of a tolerance for 3-decen-2-one is 

UNACCEPTABLE. 

a. The applicant has petitioned the Agency that the a.i., 3-decen-2-one, be exempt from the 

requirement of a tolerance under the Federal, Food, Drug, and Cosmetics Act (FFDCA). 

The Agency has determined that there would be dietary risk concerns for the a.i., 3-decen2-one and therefore a blanket tolerance exemption is not supported. Based on the dietary 

risk assessment conducted by the Agency, a numeric tolerance would be better 

suited, however, should the Agency move forward with a numeric tolerance, it is 

proposed to be set at 0.162 ppm with the caveat of one application only of the 

product. It should be noted that an acceptable developmental toxicity data would be 

required to be submitted as confirmatory data. 

b. In support of a tolerance, the applicant must satisfy all applicable residue data 

requirements as indicated in 40 CFR 158.2040. This includes all applicable data 

requirements under the Nature of the Residue and Magnitude of the Residue sections.

NOTES TO RAL:

1. The a.i. is unstable at elevated temperature and in the presence of iron acetate.
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

4

2. The Acute Toxicity data submitted in the applicant’s previous submission places AMV-1018 

Technical in Toxicity Category II for primary eye and dermal irritation, Toxicity Category III

for acute inhalation toxicity, and Toxicity Category IV for acute oral and dermal toxicities.

3. The proposed label Directions for Use will need to change to support the tolerance being set 

at 0.162 ppm for 3-decen-2-one. The potatoes cannot be shipped 24 hours post application 

because the residues will be too high. According to the residue values, the applicant cannot 

ship the potatoes until 8 days after the first application. If multiple applications are performed 

(maximum of four applications per storage season), the applicant must hold the potatoes for 

at least 8 days or longer depending on the residue values determined at shipment.

RISK ASSESSMENT AND STUDY SUMMARIES

I. Active Ingredient Characterization 

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

stored potatoes as a sprout inhibitor. It is a plant growth regulator known to increase tuber 

respiration rate and seems to interfere with membrane integrity, resulting in increased oxidative 

stress, desiccation, and rapid necrosis of the meristem and surrounding sprout tissues. The 

observed effect is primarily mechanical damage to sprout cell membrane, with no affect on the 

potato, potato sweetening or processing quality. Based on this information, the Agency considers 

the mode of action to be nontoxic.

A. Product Chemistry (MRIDs 47942601-47942608 and 48156401)

With the exception of the deficiencies discussed in the Recommendations and Conclusions 

section above, all product chemistry data requirements have been adequately satisfied. The 

product identity is summarized in Table 1 below. Data submitted to support the product 

chemistry data requirements are summarized in Table 2 below. Physical and chemical properties 

data are summarized in Table 3 below. Refer to the Confidential Appendix of this memorandum 

for further details on the product chemistry data submitted.

TABLE 1. Product Identity for AMV-1018 Technical (40 CFR § 158.2030)

Title Data/Information MRID

Trade Name AMV-1018 Technical 47942601

Chemical Name 3-decen-2-one 47942601

CAS No. 10519-33-2 47942601

Structural Formula O

47942601
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

5

TABLE 1. Product Identity for AMV-1018 Technical (40 CFR § 158.2030)

Title Data/Information MRID

Molecular Formula C10H18O 47942601

Molecular Weight 154.25 47942601

TABLE 2. Product Chemistry Data Requirements for AMV-1018 Technical (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. 47942601

880.1200 Description of starting materials, 

production, and formulation 

process

The description of the starting materials, 

production, and formulation process were 

adequately addressed.

47942602

47942603

880.1400 Discussion of formation of 

impurities

The discussion of formation of impurities was 

adequately addressed. 47942604

830.1700 Preliminary analysis The preliminary analysis of the product was 

acceptable. 47942605

830.1750 Certified limits The certified limits listed on the CSF are 

acceptable pending resolution as indicated in 

the Recommendations and Conclusions.

47942606

830.1800 Enforcement analytical method The enforcement analytical method was 

adequately addressed. 47942605

TABLE 3. Physical and Chemical Properties for AMV-1018 Technical (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
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

6

TABLE 3. Physical and Chemical Properties for AMV-1018 Technical (40 CFR § 158.2030)

OCSPP Guideline Reference No./Property Description of Result MRID

830.6315 Flammability Flash point = 91°C

From Confidential 

Statement of Formula 

(CSF)

830.6317 Storage Stability An unaudited summary of a one year storage 

stability study show the product to be stable 

when stored for 12 months; Unacceptable 

(See Recommendations and Conclusions)

47942607

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

be diluted with petroleum solvents 47942607

830.6320 Corrosion Characteristics Not expected to be corrosive to the container 

material; Unacceptable (See 

Recommendations and Conclusions)

47942607

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

II. Human Health Assessment

A. Toxicology (MRIDs 47942609-47942618, 48422301-48422302, and 484124-02)

The data presented in Table 4, below, are a summary of the toxicity data and information 

submitted to support the registration of the proposed manufacturing-use product AMV-1018 

Technical (EPA File Symbol No. 5481-LAI), which contains 98.0% 3-decen-2-one as its active 

ingredient. At this time, all data requirements have been adequately satisfied.
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

7

Table 4: Mammalian Toxicology Data Requirements for AMV-1018 Technical (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) Test substance is not a dermal sensitizer. - 47942614

90-Day oral toxicity

(870.3100)

5th percentile NOEL = 0.906 mg/kg/day;

NOEL was calculated by plotting the 

cumulative distribution of NOELs for 

structural class II flavoring agents as defined 

by the Joint FAO/WHO Expert Committee on 

Food Additives (JECFA) and fitting a 

lognormal curve to the data. The 5th percentile 

NOEL for the class II flavoring agents was 

used to represent an estimated NOEL for 

unknown chemicals of the structural class 

with a 95% confidence that any unknown 

chemical NOEL would be greater than the 5th

percentile NOEL. 3-decen-2-one is 

considered a structural class II flavoring agent 

with unknown toxicity and is represented by 

the 5th percentile NOEL of 0.906 mg/kg/day. 

In addition, three similar structured

compounds had a NOEL of 6.6 to 6.7 

mg/kg/day (90-day oral one dose studies), 

which indicates that the 5th percentile NOEL 

is conservative.

Adequate rationale 

and data from the 

literature were 

submitted to support 

this data requirement.

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
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

8

Table 4: Mammalian Toxicology Data Requirements for AMV-1018 Technical (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

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 

evacuation of the product. In addition, any 

unlikely inhalation exposure will be mitigated 

on the label by precautionary statements and 

PPE requirements. 

- 47942617; 

48422301

Developmental toxicity

(870.3700)

Information to support data requirement is 

inadequate.

The applicant submitted rationale to satisfy 

the developmental toxicity requirement; 

however, the rationale is considered 

unacceptable l because the information 

submitted were on chemicals that were not 

considered structurally similar enough to 3-

decen-2-one to adequately address the 

developmental toxicity data requirement.

UNACCEPTABLE; 

Adequate rationale 

and data from the 

literature were not 

submitted to support 

this data requirement.

47942617; 

48422301

Mutagenicity

(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

1. Acute Toxicity

All Tier I Human Health Toxicity requirements for Acute Testing were satisfied with studies 

conducted according to OCSPP Harmonized Test Guidelines. All studies contained signed and 

dated Data Confidentiality, Good Laboratory Practice (GLP) Compliance, and Quality Assurance 

statements were provided. A Data Evaluation Record (DER) was written for each submitted 

study (See Memorandum from G. Casciano and C. Walsh thru R. Jones to D. Benmhend dated 

12/07/2010). The results of the Acute Toxicity testing (summarized in Table 4, above) place 
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

9

AMV-1018 Technical in Toxicity Category II for primary eye and dermal irritation, Toxicity 

Category III for acute inhalation toxicity, and Toxicity Category IV for acute oral and dermal 

toxicities.

CLASSIFCATION: These data are ACCEPTABLE; no additional data are required.

2. Subchronic Toxicity

90-day Oral Toxicity

To satisfy the data requirement for 90-day oral toxicity, the applicant submitted rationale stating 

that 3-decen-2-one: 1) occurs naturally in the diet, 2) is approved for use as a direct food additive 

by the U.S. FDA, 3) has a simple chemical structure that is metabolized into innocuous 

components, 4) has sufficient toxicity data available to identify an animal NOAEL for chronic 

oral exposure, and 5) has sufficient toxicology and metabolism data available. 

The applicant cites the natural occurrence of 3-decen-2-one in skipjack tuna, yogurt, edible 

porcini mushrooms, and Iberian ham without report of incident or safety concern (Thomas, 1973; 

Timon et al. 1998; Song et al. 2004; Patrignani et al. 2009). In addition, the Joint FAO/WHO 

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

compounds identified in fruits, juices, spices, vegetables, cocoa, coffee, and tea (JECFA, 2003). 

Its use as a synthetic flavoring agent and adjuvant (21 CFR 172.515) indicates that it may be 

commonly consumed in foods such as baked goods, frozen dairy products, gelatins and puddings, 

candy, and alcoholic and non-alcoholic beverages (Burdock, 2010). The applicant indicated that 

the usual level of 3-decen-2-one addition to baked goods is 9.5 ppm, to candy is 3.5 ppm, and 

non-alcoholic beverages is 2.2 ppm with a maximum addition to these foods of approximately 2x 

the usual addition level. The applicant also indicated that a possible average daily intake (PADI) 

for 3-decen-2-one of 0.029 mg/kg/day derived from assuming that the anticipated average use 

level in each food category was present in all applicable food categories and an average amount 

of food from each category was consumed (Munro and Danielewska-Nikiel, 2006).

JECFA has characterized 3-decen-2-one as belonging to structural class II flavoring agent. 

JECFA has also characterized the metabolic pathways of 3-decen-2-one and determined that 

metabolism of the chemical results in the production of innocuous metabolites. Specifically, 3-

decen-2-one is reduced to its corresponding alcohol, which is subsequently conjugated with 

glucuronic acid and excreted (JEFCA, 2003). In the environment, 3-decen-2-one degrades into 

the compounds 2-decanol and 2-decanone. The Agency agrees with this characterization (see 

Figure 1 below for the metabolic pathways for 3-decen-2-one and similar structured compounds 

as described by JECFA). 
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

10

Figure 1. Metabolic pathways for 3-decen-2-one and similar-structured compounds (JECFA, 

2003)

Munro et al. (1999) determined a 5th percentile NOEL to represent structural class I, II, and III

flavoring agents as outlined by JECFA. To determine a 5th percentile NOEL for each structural 

class, the authors gathered toxicological data for 600 substances that represent industrial 

chemicals, pharmaceuticals, food substances, and environmental and consumer chemicals likely 

to be encountered in commerce. The substances that are represented in this database can be found 

in Munro et al. (1996). The database was intended to be a reference database for evaluating 

flavoring substances. No acute studies were included in the database, only chronic data, which 

included subchronic, chronic, reproductive and teratology data obtained from JECFA 

evaluations, EPA’s Integrated Risk Information System (IRIS), the National Toxicology Program 

(NTP), EPA’s Developmental and Reproductive Toxicity database, the National Institute of 

Environmental Health Sciences (NIEHS), and from published literature. Using this data, the 

authors calculated a 5th percentile NOEL by plotting the cumulative distribution of NOELs for 
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

11

structural class II flavoring agents as defined by the JECFA and fitting a lognormal curve to the 

data. The 5th percentile NOEL for the class II flavoring agents was used to represent an estimated 

NOEL for unknown chemicals of the structural class with a 95% confidence that any unknown 

chemical NOEL would be greater than the 5th percentile NOEL. 3-decen-2-one is considered a 

structural class II flavoring agent with unknown toxicity and is represented by the 5th percentile 

NOEL of 0.906 mg/kg/day. The applicant also noted that three structurally similar compounds, 2-

octen-4-one, 1-octen-3-one, and 1-octen-3-ol showed no clinical, hematological, or 

histopathological effects after 90 day exposure in rats to a single daily dose of 6.6 to 6.7 

mg/kg/day of the test substance (JECFA, 2003). The applicant indicated that the NOEL of 6.6 to 

6.7 mg/kg/day for the three similar structured compounds show that the 5th percentile NOEL of 

0.906 mg/kg/day used for 3-decen-2-one is conservative (see Figure 2 below for 90-day oral 

study compound structures).

As indicated above, 3-decen-2-one degrades into the compounds 2-decanol and 2-decanone. The 

primary degradate, 2-decanol, is considered to be part of structural class I, which has a 5th

percentile NOEL of 2.993 mg/kg/day as defined by Munro et al. (1999). 2-decanol is found in 

variety of foods, including guava, hops, asparagus, and blue cheese (Tressel et al. 1977; 

Nishimura et al. 1989; Gallios and Langlios, 1990; Eri et al., 2000). Furthermore, 2-decanol is 

structurally similar to 1-decanol, which is approved as a food additive and is exempt from the 

requirement of a tolerance under 21 CFR 172.515 and 40 CFR 180.920, respectively. The 

secondary degradate, 2-decanone, is considered to be part of the same structural class II as 3-

decen-2-one, and has the same 5th percentile NOEL of 0.906 mg/kg/day. 2-decanone is also 

found in a variety of foods, including milk, cheeses, leeks, and filberts (Kinlin et al. 1972; 

Schreyen et al., 1976, Gallios and Langlios, 1990; de Frutos et al., 1991; Vasquez-Landaverde et 

al. 2005). Both degradates are considered to be innocuous substances that are metabolized and 

eliminated in the urine and/or bile and of no toxicological concern.

Figure 2. Compound structures for 3-decen-2-one and three similar-structured compounds

O

3-decen-2-one

Structures of compounds on which 90-day oral toxicity studies were performed:

1-octen-3-one 1-octen-3-ol 2-octen-4-one
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

12

The information provided to fulfill the requirement for 90-day oral toxicity is adequate. No DERs 

were written for 90-day oral toxicity. Please refer to MRID 48422301 and the Memorandum 

from G. Casciano and C. Walsh thru R. Jones to D. Benmhend dated 12/07/010 for further 

details regarding rationale submitted by the applicant. 

CLASSIFCATION: The rationale is ACCEPTABLE; additional data and/or information are not 

required.

90-day Dermal Toxicity

A 90-day dermal toxicity study was not submitted and is it not required at this time for the use of 

3-decen-2-one in the proposed EP. Prolonged repeated exposure via the dermal route is not 

anticipated because the proposed uses are not to involve purposeful application to human skin 

and do not result in comparable human exposure to the product. The proposed use of 3-decen-2-

one by thermal fogging as indicated in the label instructions limit the likelihood of significant 

levels of repeated dermal exposure. Specifically, when 3-decen-2-one is applied to the stored 

potatoes via warehouse air circulation systems, the storage facilities remains closed for 24 hours 

to personnel entry during application. The applicant indicated that the ventilation louvers will be 

opened after the 24 hour thermal fogging application and based on the ventilation rate of 825 

m3/minute, the total estimated maximum air concentration of 3-decen-2-one of 10,175 ppm in the 

warehouse will be evacuated in approximately 2.5 minutes. Although the air will be evacuated 

within 2.5 minutes following the 24 hour thermal fogging application, a restricted-entry interval 

(REI) following thermal fogging must be included on the labels to prevent the possibility of 

exposure to workers. The draft product label for the EP contain instructions for applicator 

Personal Protective Equipment (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.

No DERs were written for 90-day dermal toxicity. Please refer to MRID 47942617 for further 

detail regarding rationale submitted by the applicant. 

CLASSIFCATION: This waiver request is ACCEPTABLE; no additional data and/or 

information are required.

90-day Inhalation Toxicity

A 90-day inhalation toxicity study was not submitted. To satisfy the 90-day inhalation toxicity 

testing requirements, the applicant has submitted data waiver rationale stating: 1) workers do not 

enter the warehouse during the potato treatment process as stated on the current proposed label, 

2) 3-decen-2-one is rapidly released from the ventilation system after each treatment with a 
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

13

maximum of 4 treatments per storage season, 3) 3-decen-2-one released from the storage facility 

vents will be diluted as it disappears in outside air, and 4) repeated inhalation exposure to 

significant levels of AMV-1018 is not expected based on proposed use pattern.

The applicant estimated the mobility and degradation of 3-decen-2-one using the QSAR 

modeling based on the Estimation Programs Interface Model (EPI SuiteTM 4.0). The estimated 

Henry’s Law of 5.4 x 10-4 atm·m3/mol indicates that 3-decen-2-one 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, the estimated log Kow was determined to be

3.28. In the air, atmospheric oxidation by hydroxyl radicals’ reaction 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 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.

Based on the above information, the 90-day inhalation toxicity study is not required for the use of 

3-decen-2-one in thermal fogging because label instructions limit the likelihood of significant 

levels of repeated inhalation exposure. Specifically, when 3-decen-2-one is applied to the stored 

potatoes via warehouse air circulation systems, the storage facilities remains closed for 24 hours 

to personnel entry during application. The applicant indicated that the ventilation louvers will be 

opened after the 24 hour thermal fogging application and based on the ventilation rate of 825 

m3

/minute, the total estimated maximum air concentration of 3-decen-2-one of 10,175 ppm in the 

warehouse will be evacuated in approximately 2.5 minutes. Although the air will be evacuated 

within 2.5 minutes following the 24 hour thermal fogging application, a REI following thermal 

fogging must be included on the labels to prevent the possibility of exposure to workers. In 

addition, appropriate applicator PPE requirements for inhalation must be included on the labels. 

The applicant indicated in the response to deficiencies cover letter dated 03/02/2011 that the 

company, AMVAC, will revise the AMV-1018 Technical (EPA Reg. No. 5481-LAI) and AMV1018 EP (EPA Reg. No. 5481-LTR) product labels according to the Agency’s requirements and 

concerns indicated in the Agency letter dated 12/16/2010. The applicant will submit these revised 

labels upon request by the Agency because it is their understanding that PMRA does not prefer 

revised labels at this time during the application process. The Agency finds the applicant’s 

response acceptable.

No DERs were written for 90-day inhalation toxicity. Please refer to MRID 48422301 and the 

Memorandum from G. Casciano and C. Walsh thru R. Jones to D. Benmhend dated 12/07/2010 

for further details regarding the waiver request rationale. 
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

14

CLASSIFCATION: The waiver request is ACCEPTABLE; additional data and/or information

are not required.

3. Developmental Toxicity and Mutagenicity

To satisfy developmental toxicity testing requirements, the applicant has submitted rationale 

stating that 3-decen-2-one: 1) occurs naturally in the diet, 2) is approved by the U.S. FDA as a 

direct food additive, 3) is metabolized into innocuous compounds, and 4) has sufficient toxicity 

data available to identify an animal NOAEL applicable to developmental effects.

As indicated in the 90-day oral toxicity section in this memorandum, 3-decen-2-one was 

identified as a structural class II flavoring agent by JECFA (2003), with a 5th percentile NOEL of 

0.906 mg/kg/day calculated by Munro et al. (1999). The applicant indicated that the 5th percentile 

NOEL is applicable to developmental toxicity because the database used to calculate this NOEL 

contained subchronic, chronic, reproductive, and teratology (developmental) studies. There were 

three structural class II substances in the Munro et al. (1996) database that had developmental 

data: 1) caffeine, 2) ethylhexyl phthalate, mono-2-, and 3) etretinate. Caffeine had a maternal 

NOEL of 86.6 mg/kg/day and a developmental NOEL of 27.4 mg/kg/day (Collins et al. 1983). 

Ethylhexyl phthalate, mono-2- had a maternal NOEL of 50 mg/kg/day with no developmental 

NOEL determined (Ruddick et al. 1981). Etretinate had no maternal NOEL determined, but the 

developmental NOEL was determined to be 6 mg/kg/day (Agnish et al. 1990). The applicant’s 

rationale that the NOEL is applicable to developmental toxicity is incorrect and unsupported 

since there were no substances used in the database from Munro et al. (1996) that were 

structurally similar enough to 3-decen-2-one; therefore, the 5th percentile NOEL of 0.906 

mg/kg/day cannot be used to satisfy the developmental toxicity requirement.

Munro et al. (1999) also calculated a developmental toxicity 5th percentile NOEL of 3.46 

mg/kg/day determined from a list of 100 substances reported to cause developmental 

abnormalities listed in the National Institute for Occupational Safety and Health (NIOSH) 

Registry of Toxic Effects of Chemical Substances (RTECS, 1987). The authors made this 

developmental toxicity determination based on concerns raised by others commenting on their 

paper that the 5th percentile NOEL of 0.906 mg/kg/day was not sensitive enough for specific 

toxicological endpoints such as developmental effects. This developmental toxicity 5th percentile 

NOEL of 3.46 mg/kg/day determined in Munro et al. (1999) cannot be used to satisfy the 

developmental toxicity data requirement because there is no evidence that any of the substances 

used in the database were structural class II flavoring agents and furthermore, were not 

structurally similar to 3-decen-2-one. The information submitted to fulfill the developmental 

toxicity data requirement is inadequate and the Agency considers this requirement a data gap.
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

15

No DERs were written for the developmental toxicity. Please refer to MRID 48422301 for the 

complete rationale submitted by the applicant and the Memorandum from G. Casciano and C. 

Walsh thru R. Jones to D. Benmhend dated 12/07/2010 for further details regarding the initial 

rationale submitted by the applicant. 

CLASSIFCATION: The information submitted to support the data requirement is

UNACCEPTABLE; A developmental toxicity study or a more robust rationale supported by 

data on structurally similar compound are required at this time.

The applicant submitted a Tier II in vivo mammalian erythrocyte micronucleus test guideline 

study (OCSPP Guideline No: 870.5395) under MRID 48412402 due to the equivocal results 

found in the mouse lymphoma assay under MRID 47942615. See the EPA Memorandum from 

G. Casciano and C. Walsh thru R. Jones to D. Benmhend dated 12/07/2010 for further details on 

the equivocal results of the mouse lymphoma assay. 

The test substance for the study was AMV-1018 Technical (EPA File Symbol No. 5481-LAI), 

containing 98.0% 3-decen-2-one. The test substance was prepared with cottonseed oil and the 

volume administered intraperitoneal to the 5 male and 5 female mice was 10 mL/kg bw. A range 

finding study was performed prior to the experiment to determine the maximum tolerable dose 

(MTD). The MTD was determined to be 50 %/kg bw, which is equivalent to an application of 10 

mL/kg bw of 5% v/v test item solution. The three dose levels used in the experiment were 1 

MTD, 0.5 MTD, and 0.2 MTD, which is equivalent to 50 %/kg bw, 25 %/kg bw, and 10 %/kg 

bw, respectively. The animals treated with a dose of 0.2 MTD showed no signs of systemic 

toxicity after treatment, whereas the animals at 1 MTD and 0.5 MTD showed signs of toxicity 

including reduction of spontaneous activity, prone position, clonic convulsion, ataxia, constricted 

abdomen, piloerection, half eyelid closure, diarrhea, cramps, and loss of weight. Peripheral blood 

samples were taken at 44 and 68 hours after a single application of the test item solution for 

micronuclei analysis. All mean values of micronuclei were within range or decreased compared 

to the corresponding negative control in all dose groups. The positive control used

Cyclophosphamide (40 mg/kg bw), which showed significant increase in micronucleus frequency

and was used to validate the assay. A nonparametric Mann-Whitney Test was performed and 

showed no statistically significant increase (p<0.05) of micronuclei cells in any dose group. The 

study authors concluded that the test item material, AMV-1018 Technical, is non-mutagenic with 

respect to clastogenicity and aneugenicity based on the test item material showing no signs of 

induction of structural or numerical chromosomal damage in the immature erythrocytes of the 

mice. The Agency is in agreement with the study authors conclusions.

No DERs were written for the in vivo mammalian erythrocyte micronucleus test guideline study. 

Please refer to MRID 48412402 for further detail regarding the study. 

CLASSIFCATION: These data are ACCEPTABLE; no additional data are required.
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

16

4. Effects on Endocrine System

EPA is required under the Federal Food, Drug, and Cosmetics Act (FFDCA), as amended by the 

Food Quality Protection Act (FQPA), to develop a screening program to determine whether 

certain substances (including all pesticide active and other ingredients) “may have an effect in 

humans that is similar to an effect produced by a naturally-occurring estrogen, or other such 

endocrine effects as the Administrator may designate.” Following the recommendations of its 

Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined 

that there was scientific basis for including, as part of the program, the androgen and thyroid

hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC’s 

recommendation that the program include evaluations of potential effects in wildlife. For 

pesticide chemicals, the Agency will use FIFRA and, to the extent that effects in wildlife may 

help determine whether a substance may have an effect in humans, FFDCA authority to require 

the wildlife evaluations. As the science develops and resources allow, screening of additional 

hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

The Agency is not requiring information on the endocrine effects of 3-decen-2-one at this time. 

The Agency has considered, among other relevant factors, available information concerning 

whether the active ingredient may have an effect on humans similar to an effect produced by 

naturally-occurring estrogen or other endocrine effects. Based on the low potential exposure 

level associated with the proposed use, the Agency expects no incremental adverse effects to the 

endocrine or immune systems.

B. Dose Response Assessment

No toxicological endpoints have been identified thus far; therefore, a dose response assessment is 

not required at this time. 

C. Food Quality Protection Act (FQPA) Considerations

1. Dietary Exposure and Risk Characterization

The most likely human exposure to 3-decen-2-one will occur via dietary exposure (consumption) 

to treated potatoes. A residue study was performed on stored potatoes treated with AMV-1018 at 

the 98% a.i. concentration at the maximum application label rate of 0.75 mmol (0.116 g of 

product per kg of potatoes). The residues were measured in the outer 5 mm layer of the potato 

(including the peel) for 3-decen-2-one and its two primary degradates, 2-decanol and 2-decanone,

from days 1-61 after application. The residue data is listed in Table 5 below. It should be noted 

that the residue studies were not ideal and did not mimic true field use. The absence of true data 

has contributed to the decision that a blanket tolerance exemption cannot be supported. 
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

17

Table 5: Residue Data in the Outer 5 mm Layer in Potatoes Treated with 0.75 mmol/kg of AMV-1018 (98% a.i.)

Days After Treatment 2-decanone (ppm) 2-decanol (ppm) 3-decen-2-one (ppm)

1 0.819 3.448 5.089

8 0.170 2.694 1.065

16 0.088 2.313 0.675

24 0.091 1.347 0.444

32 0.052 1.762 0.333

61 0.020 1.065 0.152

The residue study showed maximum residue levels in the outer 5 mm layer of the potatoes at day 

1 of 5.089, 3.448, and 0.819 ppm for 3-decen-2-one, 2-decanol, and 2-decanone, respectively. 

The maximum residue levels at day 8 were 1.065, 2.694, and 0.170 ppm. The corresponding 

calculated residue values in the whole potato with peel at day 1 are 0.774, 0.697, and 0.166 ppm

and at day 8 are 0.162, 0.545, and 0.034 ppm for 3-decen-2-one, 2-decanol, and 2-decanone, 

respectively. These calculated residue values were calculated based on the potato weight divided 

by the total residues in each potato section on a per gram basis (see MRID 48422301, pages 426-

429 for further details on how the residue values were calculated).

To evaluate acute and chronic dietary exposure based on the calculated residues of 3-decen-2-one

when used as a pesticide on stored potatoes, the Agency conducted a Dietary Exposure 

Evaluation Model (DEEM) analysis. DEEM is used by the Agency to provide probabilistic 

assessments of dietary pesticide exposure. The Agency used the maximum residue measured at 

day 1 of 0.774 ppm and at day 8 of 0.162 ppm from a single application of 3-decen-2-one and a 

NOEL of 0.906 mg/kg/day in the DEEM analysis. The results of the DEEM analysis to calculate 

the dietary exposure to human populations using the submitted residue values and are listed in 

Tables 6 and 7 below.

To express risk, the Agency calculated a Margin of Exposure (MOE) for each population 

subgroup by dividing the point of departure (e.g. NOEL) by the exposure (estimated in DEEM).

If the MOE is greater than the Agency’s Level of Concern (LOC) of 1000 (to account for 

uncertainty factors of 100X and the FQPA safety factor of 10X), the dietary risk of 3-decen-2-

one on humans when used as a pesticide on stored potatoes is expected to be negligible. The 

uncertainty factor (UF) that is generally used is 100, which represents 10X uncertainty factor for 

interspecies (extrapolation from animal data to humans) and 10X uncertainty factor for 

intraspecies (variability of humans). 

The MOE is represented by the equation below:

Point of Departure (e.g. NOEL)

MOE = --------------------------------------

Exposure
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

18

The Agency conducted this risk assessment because pesticidal residues were found after 

treatment on stored potatoes, which is a widely consumed commodity. The MOEs for all human 

population subgroups using the day 1 calculated residue value of 0.774 ppm for 3-decen-2-one

are listed in Tables 6 and 7 below.

Table 6: DEEM Acute Analysis for 3-decen-2-one at day 1 of 0.774 ppm

Population Subgroups

(age in years)

Estimated Dietary Exposure 

(mg/kg/day)

Margin of Exposure

(Level of Concern < 1000)

U.S. Population 0.001049 864

All infants (< 1) 0.000000 N/A

Children (1-2) 0.000000 N/A

Children (3-5) 0.000000 N/A

Children (6-12) 0.000000 N/A

Youth (13-19) 0.000757 1196

Adults (20-49) 0.000999 908

Adults (50+) 0.001262 720

Females (13-49) 0.000802 1132

Table 7: DEEM Chronic Analysis for 3-decen-2-one at day 1 of 0.774 ppm

Population Subgroups

(age in years)

Estimated Dietary Exposure 

(mg/kg/day)

Margin of Exposure

(Level of Concern < 1000)

U.S. Population 0.000126 7190

U.S. Population (spring season) 0.000136 6662

U.S. Population (summer season) 0.000133 6812

U.S. Population (autumn season) 0.000104 8712

U.S. Population (winter season) 0.000132 6864

Northwest region 0.000115 7878

Midwest region 0.000138 6565

Southern region 0.000112 8089

Western region 0.000144 6292

Hispanics 0.000170 5329

Non-hispanics whites 0.000126 7190

Non-hispanic blacks 0.000093 9742

Non-hispanic/Non-white/Non-black 0.000107 8467

All infants (< 1) 0.000019 47684

Nursing infants 0.000004 226500

Non-nursing infants 0.000024 37750

Children (1-6) 0.000160 5663

Children (7-12) 0.000106 8547

Females (13-19) not pregnant or nursing 0.000093 9742

Females (20+) not pregnant or nursing 0.000117 7744

Females (13-50) 0.000112 8089

Females (13+) pregnant/not nursing 0.000097 9340

Females (13+) nursing 0.000119 7613

Males (13-19) 0.000133 6812

Males (20+) 0.000140 6471

Seniors (55+) 0.000144 6292

Children (1-2) 0.000166 5458
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

19

Table 7: DEEM Chronic Analysis for 3-decen-2-one at day 1 of 0.774 ppm

Population Subgroups

(age in years)

Estimated Dietary Exposure 

(mg/kg/day)

Margin of Exposure

(Level of Concern < 1000)

Children (3-5) 0.000171 5298

Children (6-12) 0.000107 8467

Youth (13-19) 0.000113 8018

Adults (20-49) 0.000117 7744

Adults (50+) 0.000147 6163

Females (13-49) 0.000104 8712

For the acute dietary risk of 3-decen-2-one when used as a pesticide on stored potatoes, MOEs 

were calculated for five human population subgroups: 720 (adults 50+ yrs), 864 (U.S. population 

in general), 908 (adults 20-49), 1132 (females 13-49), and 1196 (youths 13-19). All other 

population subgroups did not have measurable exposures; therefore, MOEs were not applicable. 

For the chronic dietary risk of 3-decen-2-one, MOEs were calculated for all human population 

subgroups as listed in Table 7 above. The MOEs ranged from 5298 (children 3-5 years) to

226500 (nursing infants). The acute dietary risk has three subpopulations that are below the 

Agency’s LOC of 1000: adults 50+ years, the U.S. population in general, and adults 20-49. The 

chronic dietary risk has MOEs of all subpopulations over 1000. Based on the acute dietary risk 

analysis which resulted in MOEs that are lower than 1000 for three subpopulations and MOEs 

just above the Agency’s LOC for two other populations, the Agency cannot make a safety finding

at a residue level of 0.774 ppm. The proposed label language indicating that potatoes may be 

shipped one day post-application must be revised as there are dietary risk concerns regarding 

consumption of treated potatoes one-day post application. 

Due to the acute dietary risk concern at day 1, the Agency performed another DEEM analysis 

using the day 8 calculated residue value of 0.162 ppm from one application of 3-decen-2-one. 

The MOEs for all human population subgroups using the day 8 calculated residue value of 0.162 

ppm for 3-decen-2-one are listed in Tables 8 and 9 below.

Table 8: DEEM Acute Analysis for 3-decen-2-one at day 8 of 0.162 ppm

Population Subgroups

(age in years)

Estimated Dietary Exposure 

(mg/kg/day)

Margin of Exposure

(Level of Concern < 1000)

U.S. Population 0.000219 4137

All infants (< 1) 0.000000 N/A

Children (1-2) 0.000000 N/A

Children (3-5) 0.000000 N/A

Children (6-12) 0.000000 N/A

Youth (13-19) 0.000158 5734

Adults (20-49) 0.000209 4335

Adults (50+) 0.000264 3432

Females (13-49) 0.000168 5393
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

20

Table 9: DEEM Chronic Analysis for 3-decen-2-one at day 8 of 0.162 ppm

Population Subgroups

(age in years)

Estimated Dietary Exposure 

(mg/kg/day)

Margin of Exposure

(Level of Concern < 1000)

U.S. Population 0.000026 34846

U.S. Population (spring season) 0.000028 32357

U.S. Population (summer season) 0.000028 32357

U.S. Population (autumn season) 0.000022 41182

U.S. Population (winter season) 0.000028 32357

Northwest region 0.000024 37750

Midwest region 0.000029 31241

Southern region 0.000023 39391

Western region 0.000030 30200

Hispanics 0.000036 25167

Non-hispanics whites 0.000026 34846

Non-hispanic blacks 0.000020 45300

Non-hispanic/Non-white/Non-black 0.000022 41182

All infants (< 1) 0.000004 226500

Nursing infants 0.000001 906000

Non-nursing infants 0.000005 181200

Children (1-6) 0.000033 27455

Children (7-12) 0.000022 41182

Females (13-19) not pregnant or nursing 0.000019 47684

Females (20+) not pregnant or nursing 0.000024 37750

Females (13-50) 0.000023 39391

Females (13+) pregnant/not nursing 0.000020 45300

Females (13+) nursing 0.000025 36240

Males (13-19) 0.000028 32357

Males (20+) 0.000029 31241

Seniors (55+) 0.000030 30200

Children (1-2) 0.000035 25886

Children (3-5) 0.000036 25167

Children (6-12) 0.000022 41182

Youth (13-19) 0.000024 37750

Adults (20-49) 0.000024 37750

Adults (50+) 0.000031 29226

Females (13-49) 0.000022 41182

For the acute dietary risk of 3-decen-2-one when used as a pesticide on stored potatoes, MOEs 

were calculated for five human population subgroups: 3432 (adults 50+ yrs), 4137 (U.S. 

population in general), 4335 (adults 20-49), 5393 (females 13-49), and 5734 (youths 13-19). All 

other population subgroups did not have measurable exposures; therefore, MOEs were not 

applicable. For the chronic dietary risk of 3-decen-2-one, MOEs were calculated for all human 

population subgroups as listed in Table 9 above. The MOEs ranged from 25167 (children 3-5 

years) to 906000 (nursing infants). As indicated in Tables 8 and 9 above, the MOEs for both 

acute and chronic dietary risk are significantly greater than 1000 (with all chronic MOEs being at 

least an order-of-magnitude greater), which indicates that there are no foreseeable dietary risks to 

humans and sensitive subpopulations, including infants and children, from the use of 3-decen-2-

one as a pesticide on stored potatoes at the day 8 calculated residue value of 0.162 ppm. 
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

21

The proposed label submitted with the application indicates a maximum reapplication of the 

product of four times per storage season. The applicant also indicated the preference for 7-day 

application intervals. Using the day 8 calculated residue value for 3-decen-2-one of 0.162 ppm, 

the Agency multiplied this value by four, which equals 0.648 ppm, and performed a DEEM 

analysis to determine if there are still no foreseeable dietary risks to humans and sensitive 

subpopulations, including infants and children. The MOEs for all human population subgroups 

using the day 8 calculated residue value of 0.648 ppm (day 8 residue data times four applications)

for 3-decen-2-one are listed in Tables 10 and 11 below.

Table 10: DEEM Acute Analysis for 3-decen-2-one at day 8 (times four applications) of 0.648 ppm

Population Subgroups

(age in years)

Estimated Dietary Exposure 

(mg/kg/day)

Margin of Exposure

(Level of Concern < 1000)

U.S. Population 0.000878 1032

All infants (< 1) 0.000000 N/A

Children (1-2) 0.000000 N/A

Children (3-5) 0.000000 N/A

Children (6-12) 0.000000 N/A

Youth (13-19) 0.000634 1429

Adults (20-49) 0.000836 1084

Adults (50+) 0.001056 858

Females (13-49) 0.000671 1350

Table 11: DEEM Chronic Analysis for 3-decen-2-one at day 8 (times four applications) of 0.648 ppm

Population Subgroups

(age in years)

Estimated Dietary Exposure 

(mg/kg/day)

Margin of Exposure

(Level of Concern < 1000)

U.S. Population 0.000105 8629

U.S. Population (spring season) 0.000114 7947

U.S. Population (summer season) 0.000111 8162

U.S. Population (autumn season) 0.000087 10414

U.S. Population (winter season) 0.000110 8236

Northwest region 0.000096 9438

Midwest region 0.000116 7810

Southern region 0.000094 9638

Western region 0.000120 7550

Hispanics 0.000142 6380

Non-hispanics whites 0.000106 8547

Non-hispanic blacks 0.000078 11615

Non-hispanic/Non-white/Non-black 0.000089 10180

All infants (< 1) 0.000016 56625

Nursing infants 0.000003 302000

Non-nursing infants 0.000020 45300

Children (1-6) 0.000134 6761

Children (7-12) 0.000089 10180

Females (13-19) not pregnant or nursing 0.000078 11615

Females (20+) not pregnant or nursing 0.000098 9245

Females (13-50) 0.000094 9638

Females (13+) pregnant/not nursing 0.000081 11185
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

Type of Review: Product Chemistry, Human Health Toxicity, Nontarget Organisms

22

Table 11: DEEM Chronic Analysis for 3-decen-2-one at day 8 (times four applications) of 0.648 ppm

Population Subgroups

(age in years)

Estimated Dietary Exposure 

(mg/kg/day)

Margin of Exposure

(Level of Concern < 1000)

Females (13+) nursing 0.000100 9060

Males (13-19) 0.000111 8162

Males (20+) 0.000117 7744

Seniors (55+) 0.000120 7550

Children (1-2) 0.000139 6518

Children (3-5) 0.000143 6336

Children (6-12) 0.000090 10067

Youth (13-19) 0.000095 9537

Adults (20-49) 0.000098 9245

Adults (50+) 0.000123 7366

Females (13-49) 0.000087 10414

For the acute dietary risk of 3-decen-2-one when used as a pesticide on stored potatoes, MOEs 

were calculated for five human population subgroups: 858 (adults 50+ yrs), 1032 (U.S. 

population in general), 1084 (adults 20-49), 1350 (females 13-49), and 1429 (youths 13-19). All 

other population subgroups did not have measurable exposures; therefore, MOEs were not 

applicable. For the chronic dietary risk of 3-decen-2-one, MOEs were calculated for all human 

population subgroups as listed in Table 11 above. The MOEs ranged from 6336 (children 3-5 

years) to 302000 (nursing infants). The acute dietary risk analysis resulted in and MOE for one 

subpopulation, adults 50+ years, that is below the Agency’s LOC of 1000. The other acute 

subpopulations that had measurable exposures had MOEs from 1032 to 1429. The chronic 

dietary risk analysis resulted in MOEs for all subpopulations over 1000. Because the acute 

dietary risk analysis resulted in one MOE less than 1000 for one subpopulation (adults 50+ 

years), and MOEs just slightly greater than 1000 for four other subpopulations, the Agency 

cannot make a safety finding at the day 8 residue of 0.162 ppm with application intervals and

four applications (the number of applications per storage season as allowed by the proposed 

label).

Based on the DEEM analysis data and calculated MOEs as indicated in Tables 6-11 above, the 

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

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

stored potatoes at the day 8 calculated residue value of 0.162 ppm. In addition, all estimated 

acute and chronic dietary exposure at the 0.162 ppm as indicated in Tables 8 and 9 above are 

significantly less (by at least two order-of-magnitudes) than the calculated PADI of 0.029 

mg/kg/day for 3-decen-2-one as a food additive. 

 

2. Drinking Water Exposure and Risk Characterization

Significant exposure via drinking water 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 
3-decen-2-one DP Number: 387847

PC Code: 068403 EPA File Symbol No.: 5481-LAI

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sprout inhibitor on stored potatoes and are not to be applied directly to water or to areas where 

surface water is present.

3. Acute and Chronic Dietary Risks for Sensitive Subpopulations Particularly Infants 

and Children

For the acute dietary risk of 3-decen-2-one when used as a pesticide on stored potatoes, MOEs 

were not calculated for any infant or children subpopulation because there were no measurable 

exposures. All acute dietary exposures as estimated by DEEM were 0.000000 mg/kg/day as 

indicated in Tables 6, 8, and 10 above; therefore, a dietary risk assessment was not necessary. 

For the chronic dietary risk of 3-decen-2-one, MOEs were calculated for all infant and children 

subpopulations as indicated in Tables 7, 9, and 11 above. The MOEs ranged from 25167 

(children 3-5 years) to 906000 (nursing infants) for the day 8, one application calculated residue 

value of 0.162 ppm. The MOEs for chronic dietary risk to infants and children are significantly 

greater than the Agency’s LOC of 1000 (by at least an order-of-magnitude), which indicates that 

there are no foreseeable chronic dietary risks to sensitive human subpopulations, including 

infants and children, from the use of 3-decen-2-one as a pesticide on stored potatoes at the 

calculated residue value of 0.162 ppm.

Based on the DEEM analysis data and calculated MOEs as indicated in Tables 6-11 above, acute 

or chronic dietary risks to sensitive subpopulations, including infants and children, from the use 

of 3-decen-2-one as a pesticide on stored potatoes at the day 8, one application calculated residue 

value of 0.162 ppm seem negligible. The FQPA safety factor of 10X is being applied to the use 

of 3-decen-2-one to be protective of developmental toxicity as the information submitted for the 

data requirement is considered unacceptable. In addition, all estimated acute and chronic dietary 

exposure at the 0.162 ppm as indicated in Tables 8 and 9 above are significantly less (by at least 

two order-of-magnitudes) than the calculated PADI of 0.029 mg/kg/day for 3-decen-2-one as a 

food additive. 

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

1. Occupational Exposure and Risk Characterization

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 
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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. The applicant indicated that the ventilation louvers will be opened after the 24 

hour thermal fogging application and based on the ventilation rate, the total estimated maximum 

air concentration of 3-decen-2-one in the warehouse will be evacuated in approximately 2.5 

minutes. Although the air will be evacuated within 2.5 minutes following the 24 hour thermal 

fogging application, a REI following thermal fogging must be included on the labels to prevent 

the possibility of exposure to workers.

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

Exposure to 3-decen-2-one is not expected 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. 

E. 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. 

The Agency arrived at this conclusion based on the pesticide’s highly specific mode of action as 

a sprout inhibitor and the low toxicity to mammalian systems, except for it being an eye and skin 

irritant. Based on the proposed use pattern that the product will be a sprout inhibitor on stored 

potatoes in a closed system, there will be insignificant dermal and inhalation exposure during 

application. Based on the above information, the risk from aggregate exposure (via oral, dermal,

and inhalation exposures) is negligible.

F. Cumulative Effects

EPA has considered the potential for cumulative effects of 3-decen-2-one and other substances in 

relation to a common mechanism of toxicity. However, because of its low toxicity to mammalian 

system, except for it being an eye and skin irritant, and its nontoxic mode of action, the Agency 

does not expect any cumulative or incremental effects from exposure to residues of 3-decen-2-

one when applied/used as directed on the label and in accordance with good agricultural 

practices.

G. Risk Characterization

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

FQPA and FIFRA. A determination has been made that no unreasonable adverse effects to the 
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U.S. population in general, and to infants and children in particular, will result from the use of 3-

decen-2-one when the residue levels of 3-decen-2-one are at or below 0.162 ppm.

III. Environmental Assessment

A. Nontarget Organism Toxicology (MRID 47942617)

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 used 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. In addition, the end-use 

formulations do not contain any impurities or inert ingredients that are of toxicological concern 

to nontarget organisms. The information presented in Table 12 below is a summary of nontarget 

organism information submitted to support the proposed TGAI/MP, AMV-1018 Technical.

Table 12: Nontarget Organism Toxicity Data Requirements for AMV-1018 Technical (40 CFR § 158.2060)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

Avian acute oral toxicity

(850.2100)

Adequate information to support data 

requirement: 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)

Adequate information to support data 

requirement: 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)

Adequate information to support data 

requirement: 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
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Table 12: Nontarget Organism Toxicity Data Requirements for AMV-1018 Technical (40 CFR § 158.2060)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

Fish acute toxicity, freshwater

(850.1075)

Adequate information to support data 

requirement: 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)

Adequate information to support data 

requirement: 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)

Adequate information to support data 

requirement: 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

B. Environmental Fate and Groundwater 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). The 

estimated Henry’s Law of 5.4 x 10-4 atm·m3

/mol indicates that 3-decen-2-one 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 hydroxyl radicals’ reaction 

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 
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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 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.

C. 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 is 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.

D. 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.

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C. Walsh, Biologist, FT, PY-S: 12/20/2011