BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Prohydrojasmon

(Prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate) 

U.S. Environmental Protection Agency 

 Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

(last updated September 6, 2013) 
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Biopesticides Registration Action Document

TABLE OF CONTENTS

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

II. ACTIVE INGREDIENT OVERVIEW .................................................................................. 6

III. REGULATORY BACKGROUND ........................................................................................ 6

A. Classification.......................................................................................................................... 6

B. Food Clearances and Tolerances ........................................................................................... 6

IV. RISK ASSESSMENT ............................................................................................................. 7

A. Active Ingredient Characterization ........................................................................................ 7

B. Human Health Assessment .................................................................................................... 7

1. Toxicology .......................................................................................................................... 7

2. Dose Response Assessment ................................................................................................ 9

3. Food Quality Protection Act (FQPA) Considerations ........................................................ 9

4. Occupational, Residential, School and Day Care Exposure and Risk Characterization .. 10

5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation ....... 10

6. Cumulative Effects ............................................................................................................ 11

7. Risk Characterization ........................................................................................................ 11

C. ENVIRONMENTAL ASSESSMENT ................................................................................ 11

1. Ecological Hazards ........................................................................................................... 11

2. Environmental Fate and Ground Water Data .................................................................... 11

3. Ecological Exposure and Risk Characterization ............................................................... 11

4. Endangered Species Assessment ...................................................................................... 10

D. EFFICACY DATA............................................................................................................. 12 

V. RISK MANAGEMENT DECISION ................................................................................. 12 

A. Determination of Eligibility for Registration .................................................................. 13 

B. Regulatory Decision ........................................................................................................... 13 

VI. ACTIONS REQUIRED BY REGISTRANTS.................................................................. 14 

A. Determination of Eligibility for Registration .................................................................. 14

B. Reporting of Hypersensitivity Incidents ......................................................................................... 14

VII. APPENDIX A. Data Requirements (40 CFR Part 158) .................................................. 15

VIII. APPENDIX B. Product Specific Information..................................................19
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IX. APPENDIX C. References ................................................................................................... 19 
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM 

Office of Pesticide Programs: 

Biopesticides and Pollution Prevention Division 

Biochemical Pesticides Branch (BPB)

Linda A. Hollis, M.S., Chief 

Miachel Rexrode, Ph.D., Senior Biologist 

Gina Burnett, M.S., Acting Team Leader 

Leonard S. Cole, Jr., M.S., Senior Regulatory Specialist
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I. EXECUTIVE SUMMARY: 

Prohydrojasmon (PDJ) is a synthetically made plant growth regulator that is structurally and 

functionally identical to jasmonic acid (JA), a naturally occurring plant regulator present in all 

vascular (higher) plants. As a pesticidal active ingredient, PDJ stimulates fruit ripening by 

enhancing the red color on apple varieties that have difficulty developing color and red grapes 

that have difficulty developing color. 

The manufacturing-use pesticide product, Prohydrojasmin Technical (EPA File Symbol No. 

62097-EI), is proposed to be registered. This product contains prohydrojasmin propyl-3-oxo-2-

pentylcyclo-pentylacetate at 98%. Prohydrojasmin Technical is intended for formulating the enduse product, Blush, (EPA File Symbol No. 62097-EO) that will be applied pre-harvest, as a foliar 

spray to apples and grapes. 

Data derived from appropriate tests give no indication that PDJ is toxic to humans. No 

unreasonable adverse effects to humans are expected from its use as a fruit ripening agent. 

Furthermore, pesticide products containing PDJ are not likely to pose a risk to the environment, 

including non-target organisms when used according to label instructions. 

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, PDJ 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 PDJ’s lack of toxicity and the determination that PDJ presents low risk of 

any adverse effects to human health and the environment. The notice for this comment period 

includes the draft Biopesticides Registration Action Document (BRAD) and draft product labels 

for the MP, polyhydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate Technical, and EP, 

propyl-3-oxo-2-pentylcyclo-pentylacetate, which contain this new active ingredient. The docket 

identification (ID) number is EPA-HQ-OPP-2012-0831. The Agency believes that based on the 

risk assessment and information submitted in support of the registration of the MP and EP 

containing prohydrojasmon pentylcyclo-pentylacetate, it is in the best interests of the public to 

issue the registration for Prohydrojasmon pentylcyclo-pentylacetate Technical and 

Prohydrojasmon pentylcyclo-pentylacetate EP. The basis for this decision can be found in the 

risk assessment for Prohydrojasmon pentylcyclo-pentylacetate, which is characterized in this 

BRAD. 
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II. ACTIVE INGREDIENT OVERVIEW 

Common Name: Prohydrojasmon 

Chemical Names: Prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate 

Trade & Other Names: Prohydrojasmon

CAS Registry Number: 158474-72-7 

OPP Chemical Code: 028000 

Type of Pesticide: Plant growth regulator 

III. REGULATORY BACKGROUND

On June 18, 2012, EPA received an application filed by SciReg, Inc., 12733 Director’s Loop, 

Woodbridge, VA 22192 on behalf of Fine Agrochemicals Ltd., Hill End House, Whittington, 

Worcester WR5 2RQ, United Kingdom, to register the products, Prohydrojasmon Technical 

(EPA File Symbol No. 62097-EI), and Blush EP (EPA File Symbol No. 62097-EO), containing 

the new biochemical active ingredient, Prohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate. A notice of receipt (NOR) of this application, allowing for a 30-day comment 

period, was published in the Federal Register on Wednesday December 16, 2012 (75 FR 11175). 

No comments were received following this publication. 

A. Classification

On September 22, 2008, the Biochemical Classification Committee determined that 

Prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate was “biochemical like” and was 

eligible for a reduced data set. Prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate can be 

classified as “biochemical like” due to its non-toxic mode of action and the compound is 

structurally and functionally identical to jasmonic acid (JA), a naturally occurring plant 

regulator. 

B. Food Clearances/Tolerances 

In the Federal Register of January 9, 2013, (Vol. 78 FR 1798) (FRL-9374-2), EPA issued a 

notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 2F8056) by Fine Agrochemicals Ltd. (the Petitioner), on behalf 

of SciReg, Inc., 12733 Director’s Loop, Woodbridge, VA, 22192. The petition requested that 40 

CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for 

residues of prohydrojasmon (PDJ), propyl-3-oxo-2-pentylcyclo-pentylacetate, in or on red apples 

and grapes. The notice referenced a summary of the petition prepared by the Petitioner, which is 

available in the docket, http://www.regulations.gov. No substantive comments were received in 

response to the notice of filing. 
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IV. RISK ASSESSMENT 

A. Active Ingredient Characterization 

 Prohydrojasmon (PDJ) is a synthetically made plant growth regulator that is structurally and 

functionally identical to jasmonic acid (JA), a naturally occurring plant regulator present in all 

vascular (higher) plants. As a pesticidal active ingredient, PDJ stimulates fruit ripening by 

enhancing the red color on apple varieties that have difficulty developing color and red grapes 

that have difficulty developing color. (EPA, 2013). 

All product chemistry data requirements for registration of prohydrojasmon propyl-3-oxo-2-

pentylcyclo-pentylacetate have been satisfied. 

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 are available to support registration of propyl3-oxo-2-pentylcyclo-pentylacetate. All toxicology data requirements for propyl-3-oxo-2-

pentylcyclo-pentylacetate have been satisfied. 

 a. Acute Toxicity 

For acute dermal toxicity, Prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate Technical 

has been classified in the Toxicological Category of Toxicity III. For acute oral and acute 

inhalation, Prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate Technical has been 

classified in the Toxicological Category of Toxicity IV. Prohydrojasmon propyl-3-oxo-2-

pentylcyclo-pentylacetate is a slight eye irritant (Toxicity Category IV) and is not a skin 

sensitizer or a primary skin irritant (Toxicology Category IV). Assays for mutagenicity, 

chromosomal aberration, developmental toxicity, and subchronic oral did not present any clinical 

or toxicologically significant effects. The toxicology profile for the EP (Blush 5.25% ai) shows 

that this compound is practically non-toxic to mammals with a Toxicity Category IV as noted for 

acute oral and acute inhalation toxicity studies. The acute dermal toxicity study produced an 

LD50 > 2,000 mg/kg bw (Toxicity Category III) and the primary eye irritation study produced 

acute symptoms after the test material was administered; however, they were resolved by day 7 

(Toxicity Category III). The EP is not a skin sensitizer or a primary skin irritant.

 b. Subchronic Toxicity 

Subchronic data is required to determine a no-observed-effect-level (NOEL) and toxic effects (if 

any) associated with repeated or continuous exposure to a test substance for a period of 90 days 

No clinically or toxicologically significant effects were found in any treatment-group. 

Therefore, EPA establishes the NOAEL as the highest dose, 1,000 ppm (566 mg/kg bw/day for 

males and 587 mg/kg bw/day for females). A LOAEL was not established suggesting that the 

test animals could have tolerated a higher dose (protocol calls for a high test level of at least 

1,000 mg/kg). 
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. 

 c. Developmental Toxicity 

No treatment-related effects were found at necropsy in maternal animals nor were there effects 

on copra lutei, number of implantations, sex ratio, fetal body weight, or pre-implantation 

embryonic mortality. EPA does not consider the transient decrease in body weight or food 

intake as adverse and establishes the NOAEL for the study as 500 mg/kg bw/day. A LOAEL 

was not identified. No treatment-related effects were found on external examination of the 

fetuses. Visceral examination showed a slight increase in the incidence of thymic remnants; 

however, the increase was within the historical background of the performing laboratory. 

Therefore, EPA does not consider this a treatment-related effect. There was also a slight increase 

in the incidence of a 14th rib but this was not accompanied by an increased incidence of abnormal 

embryos either on external, skeletal, or visceral examination. Additionally, no increase in the 

incidence of litters with this effect was found. This effect is a common variation in this strain of 

rat and is therefore not considered an adverse effect. Based on the study results, the NOAEL for 

the study is the high-dose 500 mg/kg bw/day. A LOAEL was not identified. EPA has calculated 

the possibility of dietary exposure and concludes that in a worst case scenario (no degradation) 

the PDJ residues consumed by a 70 kg man are four orders of magnitude below NOAEL that was 

calculated for this compound in the Developmental Toxicity Test (OCSPP 870.3700) (EPA, 

2013). 

d. Mutagenicity

No data, except to confirm that prohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate is not a mutagen were required due to the nature of the active ingredient 

(structural and functional identity of the naturally occurring JA) and its intended use in 

the new EP product (ripening agent). 

 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 

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.
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Prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate 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

The most likely dietary route of exposure of humans to prohydrojasmon propyl-3-oxo-2-

pentylcyclo-pentylacetate is via exposure to treated fruit or foliage (e.g. apples and grapes). 

Table 7.0 shows possible prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate residues on 

various matrices after one maximum application of 0.009 lbs ai/A (200 ppm ai/A). The dietarybased estimated environmental concentrations range from 0.77 to 0.06 ppm on the day of 

application and decline to 0.0 by Day 2. This compound is relatively unstable in the environment 

with an aerobic soil half-life of 1.6 – 2.3 hours, and upon consumption breaks down in the 

stomach within 0.8 days. 

EPA has calculated the possibility of risk to humans through dietary exposure by using a worst 

case scenario of maximum application and no degradation. These calculations show that the 

prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate residues consumed by a 70 kg person 

are about seven orders of magnitude below Developmental Toxicity values (NOAEL > 500 

mg/kg) and about eight orders of magnitude below the Acute Oral toxicity value (LD50 > 5,000 

mg/kg), suggesting no dietary or sublethal risk. 

 

 b. Drinking Water Exposure and Risk Characterization 

No significant exposure via drinking water is expected when prohydrojasmon propyl-3-oxo-2-

pentylcyclo-pentylacetate is used in accordance with EPA-approved product labeling. The end 

product is not to be applied directly to water or to areas where surface water is present. In the 

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

be minimal, based on low acute oral toxicity of prohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate. 

EPA estimated environmental concentrations (EECs) to an aquatic site from prohydrojasmon 

propyl-3-oxo-2-pentylcyclo-pentylacetate runoff (spray to apple trees) using the GENeric 

Estimated Environmental Concentration model (GENEEC; EPA, 2001). The model assumed 2 

maximum applications of end product at 0.009 lbs ai/A (4g ai/A) at 7 day intervals, a 10.7 day 

aquatic half-life, a 57.8 hours photodegradation half-life in water, and a 1.6 – 2.3 hour half-life in 
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aerobic soil. The peak aquatic EEC was calculated at about 0.00048 ppm with a decline to 

0.000024 ppm after 21 days. No acute or subacute endpoints were identified through mammalian 

testing and the expected concentrations in surface water are well below (6 to 7 orders of 

magnitude) the maximum doses used in laboratory testing (e.g. Acute Oral Toxicity LD50 > 

5,000 mg/kg; Developmental Toxicity NOAEL > 500 mg/kg). 

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

and Children

FFDCA section 408 provides that the Agency shall apply an additional tenfold margin of 

exposure (safety) for infants and children in the case of threshold effects to account for pre- and 

post-natal toxicity and the completeness of the database unless the Agency determines that a 

different margin of exposure (safety) will be safe for infants and children. Margins of exposure 

(safety) are often referred to as uncertainty (safety) factors. In this instance, based on all the 

available information, the Agency has concluded that there is reasonable certainty that no harm 

to infants and children or adults will result from the use of Prohydrojasmon propyl-3-oxo-2-

pentylcyclo-pentylacetate when label instructions are followed. 

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

 a. Occupational Exposure and Risk Characterization 

Occupational exposure to prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate is mitigated 

as long as the end-use product is used in accordance with EPA-approved labeling. Occupational 

exposures are not included under the Federal Food, Drug, and Cosmetic Act (FFDCA) in the 

assessment of aggregated exposures for the purpose of establishing tolerances and exemptions 

from tolerance. 

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

Significant exposure of prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate to humans is 

highly unlikely to occur in residential, school and day care areas when the end use product is 

used in accordance with EPA-approved labeling. The product is only intended for commercial 

use as a plant growth regulator on apples and grapes.

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 residues of prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate. This included 

all exposures for which there is reliable information. The Agency arrived at this conclusion 

based on lack of toxicity and rapid break-down of the compound upon consumption and into soil. 

The risk from aggregate exposure via oral, dermal, and inhalation are a compilation of three lowrisk exposure scenarios (oral, dermal, and inhalation) and are negligible. Since there are no 

threshold effects of concern for this compound, and no known toxic endpoints, the provision 

requiring an additional margin of safety does not apply. 
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6. Cumulative Effects

Residues of prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate will not reach levels that 

are of toxicological concern if the compound is used as proposed. Because of its lack of toxicity 

and low level of exposure, cumulative effects with other substances that share a common 

mechanism of toxicity are not expected. 

7. Risk Characterization 

The Agency considered human exposure to prohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate in light of relevant safety factors in FQPA and FIFRA. A determination has been 

made 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 prohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate when used in accordance with EPA-approved labeling. 

C. ENVIRONMENTAL ASSESSMENT 

1. Ecological Hazards 

Adequate non-target toxicology data/information are available to support registration of 

prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate. All non-target toxicology data 

requirements for prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate have been satisfied. 

2. Environmental Fate and Ground Water Data 

The need for environmental fate and groundwater data was not triggered because results of the 

acute toxicity studies did not trigger any additional Tier I studies. 

3. Ecological Exposure and Risk Characterization

Prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate is not naturally-occurring but is 

structurally and functionally identical to jasmonic acid (JA) which is an intermediate in the 

pathway to plant abscisic acid synthesis and can influence growth inhibition, senescence, leaf 

abscission, as well as, a role in wound response and systemic resistance. When plants are 

attacked by insects there is a release of JA, which inhibits the insect’s ability to digest protein. 

In order to evaluate the risk of prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate 

exposure to terrestrial species, the Agency has estimated RQ values using the Terrestrial Residue 

Exposure Model (T-REX) Version 1.4.1. A terrestrial risk assessment includes calculated 

expected residues, as well as, numerous calculations of dietary exposure for multiple weight 

class animals (Appendix B). Expected residues were calculated for avian and mammalian food 

items along with dissipation rate of a chemical applied to foliar surfaces (single or multiple 

applications) in order to estimate worst case acute RQs relative to weight class for various sized 

birds and mammals. These calculations showed upper bound Kenega values and that exposure to 

prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate (0.009 lbs ai/A) has a low potential 

for toxic impact to birds (RQ = 0.00) and mammals (RQ= 0.00) that may be feeding in the area 

of application as noted in Appendix B. The unique characteristics of this product, 

prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate, and the non-toxic mode of action, 

biodegradability and low potential for exposure will result in no risk to all non-target terrestrial 
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organisms. 

Prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate exposure to aquatic species should 

result in no toxicity effects. Estimated environmental concentrations (EECs) in aquatic sites from 

prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate runoff after application to terrestrial 

crops were estimated using the GENeric Estimated Environmental Concentration model 

(GENEEC; EPA, 2001). The model assumed 2 maximum applications of end product at 0.009 

lbs ai/A (4g ai/A) at 7 day intervals, a 10.7 day aquatic half-life, a 57.8 hours photodegradation 

half-life in water, and a 1.6 – 2.3 hour half-life in aerobic soil. The peak aquatic EEC was 

calculated at a peak of about 0.00048 ppm which declined to 0.000024 ppm after 21 days (Table 

8.0). Since the LC50 values for fish and aquatic invertebrates is 3.3 mg/L and 9.54 mg/L this 

would result in Risk Quotients (RQs) of 0.0001 and 0.00005, respectively, which are about three 

and four orders of magnitude below the Agency’s levels of concern (LOCs = 0.05 - 1), 

suggesting no risk concerns for aquatic species. 

4. Endangered Species Assessment 

The Agency’s Individual Effects Chance Model Version 1.1 was used to estimate to the chance 

of risk to endangered/threatened avian and aquatic species from exposure to prohydrojasmon 

propyl-3-oxo-2-pentylcyclo-pentylacetate. These values (avian risk at 1 in 294,000 and aquatic 

risk at 1 in 418,000,000) suggest that prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate 

should not cause toxic risk to endangered/threatened species. In evaluating risk to aquatic 

endangered species the calculated RQs are about two and three orders of magnitude below the 

aquatic endangered species LOC = 0.05 resulting in no effect (NE) to aquatic endangered 

species. The calculated RQ values for terrestrial species are 0.00 resulting in a no effect (NE) to 

endangered/threatened terrestrial organisms. 

D. PRODUCT PERFORMANCE DATA (EFFICACY) 

Submission of product performance data (OPPTS 810.3000) is listed as a requirement for all 

pesticide products. Customarily, the Agency requires efficacy data to be submitted for review 

only in connection with the registration of products directly pertaining to the mitigation of 

disease bearing human health organisms and certain designated quarantine pests, i.e., ticks, 

mosquitoes, fleas, Mediterranean fruit flies, gypsy moths, Japanese beetles, etc. For a list of 

organisms considered by the Agency as “public health pests”, please refer to Pesticide 

Registration Notice 2002-1 (http://www.epa.gov/PR_Notices/pr2002-1.pdf). 

V. Risk Management Decision

A. Determination of Eligibility for Registration

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

determined that (A) its composition is such as to warrant the proposed claims for it; (B) its 

labeling and other materials required to be submitted comply with the requirements of FIFRA; 

(C) it will perform its intended function without unreasonable adverse effects on the 
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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 active ingredient. Such products are not 

expected to cause unreasonable adverse effects, and are likely to provide protection as claimed 

when used according to label instructions. Therefore, prohydrojasmon propyl-3-oxo-2-

pentylcyclo-pentylacetate is eligible for registration for the labeled uses. 

B. Regulatory Decision 

The data submitted fulfill the registration requirements of prohydrojasmon propyl-3-oxo-2-

pentylcyclo-pentylacetate for use as a ripening agent. Refer to Appendix B for product-specific 

information. 

1. Conditional/Unconditional Registration

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

prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate is appropriate.

Consistent with the policy of making registration actions more transparent, prohydrojasmon 

propyl-3-oxo-2-pentylcyclo-pentylacetate 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 

prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate minimal toxicity, the determination 

that prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate 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, Prohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate Technical, and EP, Blush, Prohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate, which contain this new active ingredient, prohydrojasmon propyl-3-oxo-2-

pentylcyclo-pentylacetate. The docket identification (ID) number is EPA-HQ-OPP-2012-0831. 

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

the registration of the MP and EP containing prohydrojasmon propyl-3-oxo-2-pentylcyclopentylacetate, it is in the best interests of the public to issue the registration for Prohydrojasmon 

propyl-3-oxo-2-pentylcyclo-pentylacetate Technical and Blush, Prohydrojasmon propyl-3-oxo-2-

pentylcyclo-pentylacetate EP. The basis for this decision can be found in the risk assessment for 

prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate, 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 prohydrojasmon propyl-3-oxo-2-pentylcyclo-pentylacetate 

pesticide products will cause harm or a disproportionate impact on at-risk communities. For 

additional information regarding environmental justice issues, please visit EPA’s website at 

http://www.epa.gov/compliance/environmentaljustice/index.html. 
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VI. ACTIONS REQUIRED BY REGISTRANTS

The Agency evaluated all of the data submitted in connection with the initial registration of 

active ingredient and determined that these data are sufficient to satisfy current registration data 

requirements. No additional data are required to be submitted to the Agency at this time. For 

new uses and/or changes to existing uses, additional data may be required. 

Not withstanding the information stated in the previous paragraph, it should be clearly 

understood that certain, specific, data are required to be reported to the Agency 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 

Reports of all incidents of adverse effects to the environment must be submitted to the Agency 

under the provisions stated in FIFRA, Section 6(a)(2). 

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). 
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VII. Appendix A. Data Requirements (40 CFR Part 158-Subpart U) 

*NOTE: MRID numbers listed in the following tables are representative of supporting data 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. 

TABLE 1. Product Chemistry Data Requirements forBLUSH (EP) and Prohydrojasmon Tech. 

 (40 CFR § 158.2030) 

OPPTS Guideline No. Study Results (below are example results) 

830.1550 

to 

830.1670 

Product identity; 

Manufacturing process; 

Discussion of formation of 

unintentional ingredients 

The product identity and composition were adequately 

addressed. Confidential Business Information (CBI).

830.1700 Analysis of samples The analysis of samples data were adequately addressed. 

Confidential Business Information (CBI). 

830.1750 Certification of limits The certified limits have been adequately addressed. 

Confidential Business Information (CBI). 

830.1800 Analytical method The Analytical method is acceptable. Confidential 

Business Information (CBI). 
Active Ingredient Page 16 of 19 

Biopesticides Registration Action Document

TABLE 3.0. Physical and Chemical Properties for BLUSH (EP) and Prohydrojasmon Techa

Guideline Reference No./Property Description of Result Methods 

830.6302 Color EP: Clear with very slight yellow 

coloring. 

TGAI: Light yellow and clear. 

Visual observation at room 

temperature 

830.6303 Physical State EP: Clear, homogeneous mobile 

liquid. 

TGAI: Oily liquid. 

Visual observation at room 

temperature 

830.6304 Odor EP: Sweet, fruity, solvent-like. 

TGAI: No odor. 

830.6313 Stability Not required for EP. 

TGAI: Stable at room temperature 

and at 54°C for 14 days. Stable in 

contact with iron, zinc, aluminum, 

and their acetates at room 

temperature and at 54°C for 14 

days. 

Degrades at 342°C and above. 

OCSPP 830.6313 

OECD No. 113, 1981 

830.6314 Oxidation/Reduction: 

Chemical Incompatibility 

Not applicable, the product does 

not contain an oxidizing or 

reducing agent. 

830.6315 Flammability EP: flashpoint = 33.0°C. 

EP: flashpoint = 33.5°C. 

Not required for TGAI. 

Tag closed cup 

Setaflash closed cup 

830.6316 Explodability Not applicable, the product is not 

potentially explosive and has no 

explosive characteristics. 

830.6317 Storage Stability EP: stable at room temperature for 

36 months. 

Not required for TGAI. 

Stored in polyethylene containers 

in the dark at room temperature, 

and analyzed for active ingredient 

content after 22 and 36 months. 

830.6319 Miscibility Not applicable, the product is not 

an emulsifiable liquid and is not to 

be diluted with petroleum solvents. 

830.6320 Corrosion Characteristics EP: no change in appearance of 

containers after 36 months of 

storage at room temperature in the 

dark. 

Not required for TGAI. 

Stored in polyethylene containers 

in the dark at room temperature, 

and appearance of the container 

was examined after 22 and 36 

months. 

830.6321 Dielectric Breakdown Voltage Not applicable, the product is not 

for use around electrical 

equipment. 

830.7000 pH EP: 6.1 

TGAI: Not applicable, the product 

is not dispersible in water. 

Method based on Notification No. 

71 of the Ministry of Agriculture, 

Forestry, and Fisheries (February 

3, 1960) 

830.7100 Viscosity EP: at 20°C, mean viscosity ranges 

from 23.9 mPa at a spindle speed 

of 3.0 rpm to 23.5 mPa at a spindle 

speed of 25.0 rpm. At 40°C, mean 

viscosity ranges from 8.9 mPa at a 

spindle speed of 8.0 rpm to 9.1 

mPa at a spindle speed of 60.0 

rpm. 

Not required for TGAI. 

Brookfield DVII+Pro Viscometer 

using a ULA adapter and spindle 

830.7200 Melting Range Not applicable, the EP and TGAI 
Active Ingredient Page 17 of 19 

Biopesticides Registration Action Document

TABLE 3.0. Physical and Chemical Properties for BLUSH (EP) and Prohydrojasmon Techa

Guideline Reference No./Property Description of Result Methods 

are liquids. 

830.7220 Boiling Range Not required for EP. 

TGAI: 318°C. 

Differential thermal analysis 

(OECD No. 103, 1995) 

830.7300 Density/Relative Density/Bulk 

Density 

EP: specific gravity = 0.955 at 

20°C. 

TGAI: 0.974 g/cm3 at 25°C. 

Hydrometer method (JIS K0061) 

Pycnometer (OECD No. 109, 

1995) 

830.7370 Dissociation Constant in Water Not required for EP. 

TGAI: indeterminate. Conductometric method (OECD 

No. 112, 1981) 

830.7550 Partition Coefficient Not required for EP. 

TGAI: Not applicable, the product 

is partially/completely soluble in 

water. 

830.7840 Water Solubility Not required for EP. 

TGAI: 60.2 mg/L at 25°C. Flask method (OECD No. 105) 

830.7950 Vapor Pressure Not required for EP. 

TGAI: 0.0167±0.00017 Pa at 

25°C. 

0.324±0.0221 Pa at 50°Cb. 

Gas saturation method (OECD No. 

104, 1995) 

aData from MRIDs 47927804-10, 47927812-17, 47927843 

Table 4.0. Toxicological Data for FAL 1800 5.25%ai

Data Requirement LD50 MRIDs Study Conclusion 

Acute Oral Toxicity 

OCSPP 870.1100 

LD50 >5000 mg/kg 

IV 

47927818, 

47927819 

Acceptable 

Acute Dermal Toxicity 

OCSPP 870.1200 

LD50 >2000 mg/kg 

III 

47927818, 

47927820 

Acceptable 

Acute Inhalation Toxicity 

OCSPP 870.1300 

LC50 > 5.0 mg/L 

IV 

47927818, 

47927821

Acceptable 

Primary Eye Irritation 

OCSPP 870.2400 

Acute symptoms 

were observed after 

test material was 

administered, but 

resolved by day 7. 

BLUSH produces 

reversible intense 

eye irritation 

 III 

47927818, 

47927822 

Acceptable 

Primary Dermal Irritation 

OCSPP 870.2500 

No skin irritation. 

 IV 

47927818, 

47927823 

Acceptable 

Dermal Sensitization 

OCSPP 870.2600 

Not a dermal 

sensitizer 

47927818, 

47927824 

Acceptable 
Active Ingredient Page 18 of 19 

Biopesticides Registration Action Document

Table 5.0. Toxicological Data for Prohydrojasmon Technical (PDJ) 

Guideline # 

Test

Results/Toxicity 

Category 

MRIDs Study Conclusion 

Acute Oral Toxicity 

OCSPP 870.1100 

LD50 > 5000 mg/kg 

IV 

47927818, 

47927825 

Acceptable 

Acute Dermal Toxicity 

OCSPP 870.1200 

LD50 > 2000 mg/kg 

III 

47927818, 

47927826 

Acceptable 

Acute Inhalation Toxicity 

OCSPP 870.1300 

LC50 > 5.0 mg/L 

IV 

47927818, 

47927827

Acceptable 

Primary Eye Irritation 

OCSPP 870.2400 

 slight eye irritation 

IV 

47927818, 

47927828 

Acceptable 

Primary Dermal Irritation 

OCSPP 870.2500 

No skin irritation. 

IV 

47927818, 

47927829 

Acceptable 

Dermal Sensitization 

OCSPP 870.2600 

Not a dermal sensitizer 47927818, 

47927830 

Acceptable 

90-day Oral Toxicity-Rat 

OCSPP 870.3100 

NOEL= 1,000 ppm 

(56.6-58.7 mg/kg/day) 

47927831 Acceptable 

90-day Inhalation Toxicity 

OCSPP 870.3465 

Waiver Request 48869007 Acceptable 

90-day dermal toxicity 

OCSPP 870.3250 

Waiver Request 48869006 Acceptable 

Prenatal Developmental 

Toxicity Study - Rat 

OCSPP 870.3700 

Maternal NOEL > 500 

mg/kg/day 

Developmental NOEL > 

500 mg/kg/day 

47927832 Acceptable 

Bacterial Reverse 

Mutation Test 

OCSPP 870.5100 

There was no evidence of 

induced mutant colonies 

over background 

47927833 Acceptable 

In Vitro Mammalian 

Chromosome Aberration 

Tests 

OCSPP 870.5375 

There was no evidence of 

cells with chromosomal 

abnormalities 

47927834 Acceptable 

Classification: Acceptable; no additional data are required. 

TABLE 4. Non-Target Organism Toxicity Requirements for prohydrojasmon propyl-3-

oxo-2-pentylcyclo-pentylacetate (40 CFR § 158.2060)

Guideline # 

Test 

Results/Toxicology 

Category 

MRID Study 

Conclusion 

850.1010 

Acute Toxicity Test, Daphnids 

EC50 = 9.54 mg/L. 

Moderately toxic 

47927838 Acceptable 

850.1075 

Acute Toxicity Freshwater Fish 

Cyprinus carpio 

96 hr LC50 = 3.3 mg/L. 

Moderately toxic 

47927837 Acceptable 

850.2100 

Avian Acute Oral Toxicity 

Bobwhite (Colinus virginianus) 

LD50 >2000 mg/kg 

Practically non-toxic 

47927835 Acceptable 

850.2200 

Avian Dietary Toxicity 

Japanese quail (Colinus 

virginianus) 

LC50 >5000 ppm 

Practically non-toxic 

47927836 Acceptable 

Honey bee Acute Oral Toxicity LC50 > 100 ug ai/bee 47927838 Acceptable 

850.4100 

Seedling Emergence and Seedling 

ER50 > 1,140 g ai/ha 

(> 456 g ai/A) 

48869004 Acceptable 
Active Ingredient Page 19 of 19 

Biopesticides Registration Action Document

Guideline # 

Test 

Results/Toxicology 

Category 

MRID Study 

Conclusion 

Growth 

850.3020 

Acute Contact Honeybees 

LD50 = 0.129 ug ai/bee 

(0.116 – 0.148 ug ai/bee) 

48869002 Acceptable 

Ecotoxicity Data for FAL 1800 4.25 % ai (PDJ)

850.4150 

Terrestrial Plant Vegetative Vigor 

ER50 > 1,140 g ai/ha 

(> 456 g ai/A) 

48869005 Acceptable 

VIII. Appendix B. 

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

IX. Appendix C. 

REFERENCES

1. Parker, R.D., R.D. Jones and H.P. Nelson., 1995. GENEEC: A Screening Model for 

Pesticide Environmental Exposure Assessment, in Proceedings of the International 

Exposure Symposium on Water Quality Modeling; American Society of Agricultural 

Engineers, pp. 485-490; Orlando, Florida. 

2. U.S. EPA. 1998. Guidance for Ecological Risk Assessment. Risk Assessment Forum. 

EPA/630/R-95/002F, April 1998. 

3. U.S.EPA 2008. Terrestrial Residue Exposure Model (T-REX) Version 1.4.1. 

EFED/OPP/USEPA. 

4. U.S.EPA 2004. Individual Effects Chance Model Version 1.1. EFED/OPP/USEPA. 

5. U.S. EPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of 

Pesticide Programs. Office of Prevention, Pesticides, and Toxic Substances. Office of 

Pesticide Programs. Washington, D.C. January 23, 2004.