BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Prohydrojasmon (PDJ)

PC Code: 028000

U.S. Environmental Protection Agency 

 Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

(last updated November 25, 2013) 

 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

2 

Table of Contents

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

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

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

A. Application for Pesticide Registration ............................................................................... 6

B. Food Clearances/Tolerances ............................................................................................... 6

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

A. Product Analysis Assessment (40 CFR § 158.2030) .......................................................... 7

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

1. Tier I Toxicology ........................................................................................................................................... 7

2. Tier II and Tier III Toxicity Studies ............................................................................................................ 9

3. Effects on the Endocrine System .................................................................................................................. 9

4. Dose Response Assessment ......................................................................................................................... 10

5. Drinking Water Exposure and Risk Characterization ............................................................................ 10

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

a. Occupational Exposure and Risk Characterization ................................................................................. 10

b. Residential, School and Day Care Exposure and Risk Characterization ............................................... 10

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

a. Food Exposure ............................................................................................................................................. 10

b. Drinking Water Exposure .......................................................................................................................... 10

c. Other Non-occupational Exposure ............................................................................................................ 11

8. Cumulative Effects from Substances with a Common Mechanism of Toxicity ..................................... 11

9. Determination of Safety for United States Population, Infants and Children ....................................... 11

10. Risk Characterization ................................................................................................................................. 11

C. Environmental Assessment ............................................................................................... 12

1. Ecological Hazards ...................................................................................................................................... 12

2. Environmental Fate and Ground Water Data .......................................................................................... 12

3. Ecological Exposure and Risk Characterization ...................................................................................... 12

4. Endangered Species Assessment ................................................................................................................ 13

D. Product Performance Data ............................................................................................... 13

V. RISK MANAGEMENT DECISION ................................................................................. 13

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

B. Regulatory Decision ........................................................................................................... 13
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

3 

C. Environmental Justice ....................................................................................................... 14

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

A. Reporting of Adverse Effects ............................................................................................ 14

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

VII.  APPENDIX A. DATA REQUIREMENTS (40 CFR PART 158-SUBPART U) .......... 15

VIII.  APPENDIX B. REFERENCES ....................................................................................... 20

IX. GLOSSARY OF ACRONYMS AND ABBREVIATIONS ............................................. 21
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

4 

BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM 

Branch Chief 

Linda A. Hollis, M.S. 

Product Chemistry/Human Health Effects/Nontarget Organisms 

Miachel Rexrode, Ph.D., Senior Scientist 

Regulatory Action Leaders 

Gina Burnett, M.S., Regulatory Action Leader 

Leonard Cole, Jr., M.S., Senior Regulatory Specialist 

 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

5 

I. EXECUTIVE SUMMARY 

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

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

all vascular (higher) plants. The highest levels for JA are found in actively growing plant tissues 

such as leaves, flowers, and developing fruit, and thus JA has always been a natural component 

of diets containing plant materials. The jasmonates, of which JA is a member, is a group of plant 

hormones involved in multiple stages of plant development and defense, including the ability to 

stimulate fruit ripening. As a pesticide, PDJ is used to stimulate fruit ripening in apples and 

grapes.

The new active ingredient application for PDJ contains a petition for the exemption from a 

requirement of a tolerance in or on apples and grapes pre-harvest, and two proposed products: 

the manufacturing-use product (MP), Prohydrojasmon Technical (EPA File Symbol 62097-EI) 

and the end-use product (EP), BLUSH (EPA File Symbol 62097-EO), containing 98% and 

5.25% PDJ, respectively. Prohydrojasmon Technical is intended for formulating into EPs, 

including BLUSH, which 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 nontarget 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 was subject to a 15-day comment period as a “new active ingredient.” EPA 

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), draft product labels for the Prohydrojasmon Technical (EPA File 

Symbol 62097-EI) and BLUSH (EPA File Symbol 62097-EO) and the science review 

memorandum for these products (EPA, 2013). The docket identification (ID) number for this 

action is EPA-HQ-OPP-2012-0831. No comments were received in response to this public 

participation comment period. 

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

the registration of Prohydrojasmon Technical (EPA File Symbol 62097-EI) and BLUSH (EPA 

File Symbol 62097-EO), it is in the best interest of the public to issue these registrations and, 

therefore, EPA has registered these products. The basis for this decision can be found in the risk 

assessment for PDJ (EPA, 2013), which is characterized in this BRAD. 

For definitions of scientific terms, please refer to http://www.epa.gov/pesticides/glossary/. 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

6 

II. ACTIVE INGREDIENT OVERVIEW 

Common Name: Prohydrojasmon (PDJ) 

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

 cyclopentaneacetic acid, 3-oxo-2-pentyl-, propyl ester 

Trade & Other Names: Prohydrojasmon (PDJ)

CAS Registry Number: 158474-72-7 

OPP Chemical Code: 028000 

Type of Pesticide: Biochemical 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 62097-EI), and BLUSH (EPA File Symbol 62097-EO), containing the new 

biochemical active ingredient, prohydrojasmon (PDJ), propyl-3-oxo-2-pentylcyclo-pentylacetate. 

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 PDJ was 

“biochemical like” and was eligible for a reduced data set. PDJ was classified as “biochemical 

like” due to its non-toxic mode of action and because it is structurally similar 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. 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

7 

IV. RISK ASSESSMENT 

A. Product Analysis Assessment (40 CFR § 158.2030) 

Biochemical pesticide product analysis data requirements include product chemistry and 

composition, analysis and certified limits, and physical and chemical characteristics. Product 

chemistry and composition data include information about the identity of the active ingredient, 

the manufacturing process, and discussion of the potential for formation of unintentional 

ingredients. Analysis and certified limits data include information on analysis of samples and 

certification of limits. Physical and chemical characteristics data describe basic characteristics of 

the registered pesticide products, including color, physical state, odor, stability, miscibility, pH, 

corrosion characteristics, viscosity and density. 

All product chemistry data requirements have been satisfied for the active ingredient, PDJ, and 

the pesticidal products, Prohydrojasmon Technical (EPA File Symbol 62097-EI), and BLUSH 

(EPA File Symbol 62097-EO). Refer to Tables 1 and 2 in Appendix A for a summary of product 

chemistry data. 

B. Human Health Assessment 

1. Tier I Toxicology 

Adequate mammalian toxicology data/information are available to support registration of PDJ. 

All toxicology data requirements for PDJ and the proposed products, Prohydrojasmon Technical 

(EPA File Symbol 62097-EI), and BLUSH (EPA File Symbol 62097-EO) have been satisfied. 

The following is a summary of EPA’s review of the toxicity profile of this biochemical (also 

refer to Tables 3 and 4, in Appendix A of this document): 

Acute Toxicity: Acute toxicity studies on the technical grade active ingredient (TGAI) for PDJ, 

containing 97.98% PDJ, confirm a low toxicity profile. The acute toxicity data show virtual 

nontoxicity for all routes of exposure. Therefore, it can be concluded that any acute dietary risks 

associated with this plant regulator would be negligible. 

1. The acute oral median lethal dose (LD50) in rats was greater than 5,000 milligrams per 

kilogram (mg/kg) bodyweight, demonstrating very low toxicity. There were no observed 

toxicological effects on the test subjects in the acute oral study submitted (MRID No. 47927825). 

PDJ is classified as Toxicity Category IV for acute oral toxicity. 

2. The acute dermal LD50 in rats was greater than 2,000 mg/kg body weight (MRID 

47927826), demonstrating low toxicity. PDJ is classified as Toxicity Category III for acute 

dermal toxicity. 

3. The acute inhalation median lethal concentration (LC50) was greater than 2.8 milligrams per 

liter (mg/L) in rats and showed no significant inhalation toxicity (MRID 47927827). PDJ is 

classified as Toxicity Category IV for acute inhalation toxicity. 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

8 

4. A primary eye irritation study on rabbits indicates that PDJ is minimally irritating to the eye 

(MRID 47927828). PDJ is classified as Toxicity Category IV for primary eye irritation. 

5. A skin irritation study on rabbits indicates that PDJ is not irritating to the skin (MRID 

47927829). PDJ is classified as Toxicity Category IV for primary skin irritation. 

6. Data indicate that PDJ is not a dermal sensitizer (MRID 47927830). 

Mutagenicity: Two mutagenicity studies were performed using the TGAI of PDJ (97.98% PDJ) 

as the test substance: 

1. In the Bacterial Reverse Gene Mutation Test (MRID No. 47927833), the number of mutant 

bacterial colonies that were reverted back to their normal genetic profile (via gene mutation) 

were not significantly increased under PDJ treatment. Therefore, PDJ is considered to be nonmutagenic under the conditions of this assay. 

2. An in vitro Mammalian Cell Chromosome Aberration Test (MRID No. 47927834) tested PDJ 

genotoxicity on Chinese hamster lung cells (CHL/IU) up to the cytotoxic dose level of 80 

micrograms per milliliter [μg/mL], without S9 activation, and up to the limit concentration of 

5000 μg/mL with S9 activation. None of the test substance concentrations induced a significant 

increase in the incidence of cells with chromosomal abnormalities, either in the absence or 

presence of S9 activation and the test substance. Under the conditions of this assay, PDJ is 

considered to be non-mutagenic and does not cause chromosome aberrations. Together, these 

studies are sufficient to confirm that there are no expected dietary or non-occupational risks of 

mutagenicity with regard to food use of PDJ. 

Subchronic Toxicity: In a subchronic oral toxicity study using the TGAI of PDJ (97.98% PDJ) as 

the test substance, no clinically or toxicologically significant effects were found in any treatment 

group (MRID 47927831). Therefore, the no observed adverse effect level (NOAEL) for PDJ has 

been established as the highest test substance dose, 10,000 parts per million (ppm) (equivalent to 

566 mg/kg bw/day for male test animals and 587 mg/kg bw/day for female test animals). A 

lowest observed adverse effect level (LOAEL) was not established, suggesting that the test 

animals could have tolerated a higher dose. In sum, the data submitted to the Agency indicate 

that PDJ has no subchronic dietary risk. 

Developmental Toxicity: In a developmental toxicity study, using the TGAI of PDJ (97.98% 

PDJ) as the test substance (MRID 47927832), there were no treatment-related effects found at 

necropsy in maternal animals nor were there effects on copra lutei, number of implantations, sex 

ratio, fetal body weight, or preimplantation embryonic mortality. The Agency does not consider 

the temporary decrease in body weight or food intake observed in the 500 mg/kg bw/day test 

group to be an adverse effect, as this is likely due to the palatability of the food containing this 

high dose of test substance. Therefore, the Agency establishes the NOAEL for this study as 500 

mg/kg bw/day. A LOAEL was not identified for maternal effects, suggesting that the test animals 

could have tolerated a higher dose. No treatment-related developmental 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 range of the performing 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

9 

laboratories historical control data. Therefore, the Agency does not consider this a treatmentrelated effect. There was also a slight increase in the incidence of a 14th rib, which is a common 

variation in this strain of rat and is therefore not considered an adverse effect. This variation was 

not accompanied by an increased incidence of abnormal embryos, either on external, skeletal, or 

visceral examination, and did not appear at a higher than normal rate. Based on the study results, 

the developmental effects NOAEL for the study is the highest dose tested 500 mg/kg bw/day. A 

LOAEL was not identified for developmental effects, suggesting that the test animals could have 

tolerated a higher dose. In sum, the data submitted to the Agency indicate that PDJ has no 

developmental toxicity risk. 

2. Tier II and Tier III Toxicity Studies 

The biochemical pesticide Human Health Assessment data requirements for Tier II and Tier III 

were not required due to the low toxicity of the active ingredient and the low levels of exposure 

expected from its intended use preharvest in commercial agricultural EP products. 

3. Effects on the Endocrine System 

As required under 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 and 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. 

 

PDJ 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 and 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/. 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

10 

4. Dose Response Assessment 

No toxicological endpoints have been identified for PDJ; therefore, a dose-response assessment 

was not required. 

5. Occupational, Residential, School and Day Care Exposure and Risk 

Characterization 

a. Occupational Exposure and Risk Characterization 

Occupational exposure to PDJ is mitigated when registered products are 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 human exposure to PDJ is highly unlikely in residential, school and day care areas 

when end-use products are used in accordance with EPA-approved labeling. This active 

ingredient is only approved for outdoor commercial agricultural use as a plant growth regulator 

on apples and grapes, preharvest.

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

There is reasonable certainty of no harm to U.S. populations, including infants and children, 

from aggregate exposures to residues of PDJ when used as proposed. This includes all 

anticipated dietary exposures and all other exposures for which there is reliable information. 

Moreover, potential non-occupational inhalation and dermal exposure is not likely to pose any 

adverse effects to exposed populations via aggregate and cumulative exposure. 

a. Food Exposure 

Dietary exposure to residues of PDJ is expected to be insignificant. In a worst case scenario, such 

as no degradation of the applied compound, PDJ residues consumed by a 70 kg person are four 

orders of magnitude below the No Observed Adverse Effect Level (NOAEL) that was calculated 

for this compound (EPA, 2013). Furthermore, dietary exposure to residues of PDJ from treated 

fruit is not expected to exist above background levels of naturally occurring JA (EPA, 2013). 

b. Drinking Water Exposure 

Exposure of humans to PDJ in drinking water is unlikely since products are labeled for 

application directly to terrestrial plants and because data demonstrate a soil half-life for this 

chemical from 1.6-2.3 hours, as well as rapid degradation in water (EPA, 2013). Furthermore, 

the expected concentrations in surface water are well below (6 to 7 orders of magnitude) the 

maximum doses used in laboratory testing, where no toxic effects were seen (i.e., Acute Oral 

Toxicity LD50 > 5,000 mg/kg; Developmental Toxicity NOAEL > 500 mg/kg) (EPA, 2013). 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

11 

c. Other Non-occupational Exposure 

Non-occupational exposure is not expected because PDJ is not approved for residential uses. The 

active ingredient is applied directly to commodities and degrades rapidly; data demonstrate a soil 

half-life for this chemical from 1.6-2.3 hours and a half-life in light-irradiated water from 54.0-

57.8 hours. 

7. Cumulative Effects from Substances with a Common Mechanism of Toxicity 

 

The EPA has not found PDJ to share a common mechanism of toxicity with any other 

substances, and PDJ does not appear to produce a toxic metabolite produced by other substances. 

For the purposes of this tolerance action, therefore, the EPA has assumed that PDJ does not have 

a common mechanism of toxicity with other substances. Following from this, the EPA concludes 

that there are no cumulative effects associated with PDJ that need to be considered. For 

information regarding the EPA’s efforts to determine chemicals that have a common mechanism 

of toxicity and to evaluate the cumulative effects of such chemicals, see the EPA’s website at 

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

8. Determination of Safety for United States Population, Infants and Children 

EPA has determined that there are no foreseeable dietary risks to the U.S. population, including 

infants and children, from the use of PDJ as a pesticide (plant growth regulator) on apple and 

grape, when label instructions and good agricultural practices are followed. The available data 

and information indicate that the chemical (1) is of low toxicity and not a developmental 

toxicant, and (2) is structurally similar and functionally identical to jasmonic acid (JA), a 

compound naturally occurring in the human diet. When compared to the amount of JA that is 

likely already consumed in the human diet, dietary exposure from pesticidal use of PDJ is not 

anticipated to significantly increase overall dietary exposure of infants and children. 

Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. 

population, including infants and children, from aggregate exposure to the residues of PDJ when 

it is used as labeled and in accordance with good agricultural practices. Such exposure includes 

all anticipated dietary exposures and all other exposures for which there is reliable information. 

EPA has arrived at this conclusion because the data and information available on PDJ do not 

demonstrate significant toxic potential to mammals, including infants and children. 

9. Risk Characterization 

The Agency has considered human exposure to PDJ in light of the 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 

products containing PDJ when label instructions are followed. In addition, the Agency is 

establishing an exemption from the requirement of a tolerance for residues of the biochemical 

pesticide PDJ in or on apple and grape when used as a plant growth regulator pre-harvest and in 

accordance with label directions and good agricultural practices. 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

12 

C. Environmental Assessment 

1. Ecological Hazards 

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

biochemical pesticide non-target toxicology data requirements have been satisfied. This 

information is summarized in Table 5, in Appendix A of this document. 

2. Environmental Fate and Ground Water Data 

Environmental fate and groundwater data are not required at this time because the results of the 

nontarget organism toxicity assessment (Tier I data requirements) did not trigger these Tier II 

data requirements. 

3. Ecological Exposure and Risk Characterization 

PDJ is not naturally-occurring but is structurally similar to jasmonic acid (JA), which is an 

intermediate in the pathway to plant abscisic acid synthesis. JA can influence growth inhibition, 

senescence, and leaf abscission, and plays 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 (EPA, 2013). 

In order to evaluate risk of PDJ to terrestrial species, the Agency used calculated expected 

residues of PDJ in dietary exposure calculations for multiple weight classes of birds and 

mammals using the Terrestrial Residue Exposure Model (T-REX) Version 1.4.1. Expected 

residues were calculated for avian and mammalian food items along with dissipation rates of PDJ 

when applied to foliar surfaces (single or multiple applications) in order to estimate worst case 

scenarios. Calculations showed that PDJ (when applied at 0.009 lbs ai/A) has a low potential for 

toxic impact to birds and mammals that may be feeding in the area of application (risk quotients 

equal to 0.00 for birds and mammals). With this information and PDJ’s non-toxic mode of action 

and biodegradability, the Agency has determined that exposure to PDJ will result in no risk to all 

non-target terrestrial organisms. 

PDJ exposure to aquatic species is also expected to result in no toxicity effects. Estimated 

environmental concentrations (EECs) in aquatic sites from PDJ runoff after application to 

terrestrial crops were estimated using the GENeric Estimated Environmental Concentration 

model (EPA, 2013). 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 halflife in water, and a 1.6 – 2.3 hour half-life in aerobic soil. Risk quotients for fish and aquatic 

invertebrates (0.0001 and 0.00005, respectively) were three and four orders of magnitude below 

the Agency’s levels of concern (LOCs = 0.05 - 1). The Agency has determined that exposure to 

PDJ presents no risk concerns for aquatic species. 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

13 

4. Endangered Species Assessment 

The Agency has not conducted a risk assessment that supports a complete endangered species 

determination. The ecological risk assessment planned during Registration Review will allow the 

Agency to determine whether the uses of PDJ have “no effect” or “may effect” federally listed 

threatened or endangered species (listed species) or their designated critical habitats. 

D. Product Performance Data 

Product performance (efficacy) data must be developed for all pesticides to ensure that the 

products will perform as intended and that unnecessary pesticide exposure to the environment 

will not occur as a result of the use of ineffective products. The Agency reserves the right to 

require, on a case-by- case basis, the submission of efficacy data for any pesticide product 

registered or proposed for registration, but applications to register pesticide products intended to 

control a pest of significance public health importance, as defined in FIFRA section 28(d) and 

section 2(nn), must include such data. For further guidance on the product performance data 

requirement, refer to Pesticide Registration Notice (PR) Notices 96-7, 2002-1 and Explanation of 

Statutory Framework for Risk-Benefit Balancing for Public Health Pesticides 

(http://www.epa.gov/PR _Notices/pr1996-7.pdf) (http://www.ea.gov/PR_Notices/pr2002-1.pdf) 

and (http://www.epa.gov/pesticides/health/risk-benefit.htm). 

PDJ is not intended to be formulated into products to control public health pests as defined in 

FIFRA section 28(d) and section 2(nn), and product performance (efficacy) was not evaluated by 

the Agency. 

V. RISK MANAGEMENT DECISION 

A. Determination of Eligibility for Registration 

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

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

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

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

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

effects on the environment. The four eligibility criteria have been satisfied for PDJ. Products 

containing PDJ are not expected to cause unreasonable adverse effects, and are likely to perform 

as claimed when used according to label instructions. Therefore, the Agency has decided to 

register PDJ as a plant growth regulator on apples and grapes. 

B. Regulatory Decision 

The data submitted fulfill the requirements for the unconditional registration of Prohydrojasmon 

Technical (EPA File Symbol 62097-EI) and BLUSH (EPA File Symbol 62097-EO). For 

product-specific information, please refer to http://www.epa.gov/pesticides/pestlabels. 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

14 

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 products containing the active ingredient PDJ 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. 

VI. ACTIONS REQUIRED BY REGISTRANTS 

EPA evaluated all data submitted in connection with the registration of PDJ as a plant growth 

regulator of use on apples and grapes and determined that these data are sufficient to satisfy 

current registration data requirements. At this time, no additional data must be submitted to EPA 

for these particular products. For new uses and/or changes to existing uses, EPA may require 

additional data. 

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

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

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

below. 

A. Reporting of Adverse Effects 

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

must be submitted to EPA. 

B. Reporting of Hypersensitivity Incidents 

Under the provisions of 40 CFR Part 158.2050(d), all incidents of hypersensitivity (including 

both suspected and confirmed incidents) must be reported to the Agency. 

 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

15 

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

TABLE 1. Product Chemistry Data Requirements for PDJa (40 CFR § 158.2030) 

OCSPP Guideline No. Study Results 

830.1550 

to 

830.1670 

Product identity; 

Manufacturing process; 

Discussion of formation of 

unintentional ingredients 

The product identity and composition was adequately 

addressed. 

830.1700 Analysis of samples Analysis of samples was adequately addressed. 

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

830.1800 Analytical method The Analytical method is acceptable. 

a

MRIDs 479278-01 thru -17 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

16 

TABLE 2. Physical and Chemical Properties for PDJ a,b (40 CFR § 158.2030)

OCSPP Guideline 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 

Method based on Notification 

No. 71 of the Ministry of 

Agriculture, Forestry, and 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

17 

TABLE 2. Physical and Chemical Properties for PDJ a,b (40 CFR § 158.2030)

OCSPP Guideline No./Property Description of Result Methods 

water. 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 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 

b

 Prohydrojasmon Technical (EPA File Symbol 62097-EI) requirements satisfied with technical grade active 

ingredient (TGAI) data; BLUSH (EPA File Symbol 62097-EO) requirements satisfied with EP specific data. 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

18 

Table 3. Human Health Toxicity Data for Prohydrojasmon Technical (EPA File Symbol 62097-EI) (40 

CFR § 158.2050) 

OCSPP Guideline No. 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 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

19 

Table 4. Human Health Toxicity Data for BLUSH (EPA File Symbol 62097-EO) (40 CFR § 158.2050)

OCSPP Guideline No. 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 

TABLE 5. Non-Target Organism Toxicity Data for Prohydrojasmon Technical (EPA File Symbol 62097-

EI) (40 CFR § 158.2060) 

OCSPP Guideline No. 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 

Growth 

ER50 > 1,140 g ai/ha 

(> 456 g ai/A) 

48869004 Acceptable 

850.3020 

Acute Contact Honeybees 

LD50 = 0.129 ug ai/bee (0.116 

– 0.148 ug ai/bee) 

48869002 Acceptable 

850.4150 

Terrestrial Plant Vegetative Vigora

ER50 > 1,140 g ai/ha 

(> 456 g ai/A) 

48869005 Acceptable 

a

Performed on the EP, BLUSH (62097-EO) 

 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

20 

VIII. Appendix B. References 

EPA (2013) Environmental Protection Agency (EPA) Risk Assessment: 

Request for new registration for prohydrojasmon technical and product registration 

Section 3 for BLUSH 5.25% ai with tolerance exemption. May 12, 2013. 

 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

21 

IX. GLOSSARY OF ACRONYMS AND ABBREVIATIONS 

a.i. active ingredient 

BPPD Biopesticides and Pollution Prevention Division 

BRAD Biopesticide Registration Action Document 

bw body weight 

CBI Confidential Business Information 

CFR Code of Federal Regulations 

cm3 cubic centimeter 

CSF Confidential Statement of Formula 

°C degrees Celsius 

EC50 median effective concentration. A statistically derived single concentration in 

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

animals when administrated by the route indicated (inhalation). It is expressed 

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

EDSP Endocrine Disruptor Screening Program 

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee 

EP end-use product 

EPA Environmental Protection Agency (the “Agency”) 

FDA Food and Drug Administration 

FFDCA Federal Food, Drug, and Cosmetic Act 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FQPA Food Quality Protection Act 

FR Federal Register 

g gram 

ha hectare 

kg kilogram 

Kow octanol-water partition coefficient 

L liter 

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

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

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

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

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

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

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

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

MRID No. Master Record Identification Number 

mg milligram 

mPa millipascal 

mL milliliter 

MP manufacturing-use product 

N/A not applicable 

NE “No Effect” 

NIOSH National Institute for Occupational Safety and Health 
Prohydrojasmon (PDJ)

PC Code 028000

Biopesticides Registration Action Document

22 

nm nanometer 

NOEL no-observed-effect-level 

NOF notice of filing 

NOR notice of receipt 

OPP Office of Pesticide Programs 

OCSPP Office of Chemical Safety and Pollution Prevention 

pa pascal 

PPE personal protective equipment 

PR Notice Pesticide Registration Notice 

 TGAI technical grade of the active ingredient 

 ug microgram 

 USDA United States Department of Agriculture 

 UV ultra-violet