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EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION 

COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN 

THE FEDERAL REGISTER 

EPA Biopesticides and Pollution Prevention Division contact: [Gina Burnett, (703) 

605-0513] 

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In 

cases where the outline element does not apply, please insert “NA-Remove” and 

maintain the outline. Please do not change the margins, font, or format in your 

pesticide petition. Simply replace the instructions that appear in green, i.e., “[insert 

company name],” with the information specific to your action.

SUBMISSION: E-mail the completed template to: hollis.linda@epa.gov.

TEMPLATE: 

[Fine Agrochemicals Ltd. c/o SciReg, Inc., 12733 Director’s Loop, Woodbridge, VA 

22192]

[1G7947]

 EPA has received a pesticide petition ([1G7947]) from [Fine Agrochemicals 

Ltd. c/o SciReg, Inc.], [12733 Director’s Loop, Woodbridge, VA 22192] proposing, 

pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 

U.S.C. 346a(d), to amend 40 CFR part 180.

(Options (pick one)

to establish an amendment/expansion of an existing tolerance exemption for the 

(Options (pick one)

biochemical pesticide [Prohydrojasmon (PDJ), propyl-3-oxo-2-pentylcyclopentylacetate ]

Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, [Fine 

Agrochemicals Ltd. c/o SciReg, Inc.] has submitted the following summary of 
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information, data, and arguments in support of their pesticide petition. This summary was 

prepared by [Fine Agrochemicals Ltd. c/o SciReg, Inc.] and EPA has not fully 

evaluated the merits of the pesticide petition. The summary may have been edited by 

EPA if the terminology used was unclear, the summary contained extraneous material, or 

the summary unintentionally made the reader conclude that the findings reflected EPA’s 

position and not the position of the petitioner. 

I. [Fine Agrochemicals Ltd. c/o SciReg, Inc.] Petition Summary

 [1G7947]

A. Product Name and Proposed Use Practices

[FAL 1800, an end-use product containing 5.25% prohydrojasmon, is 

foliarly sprayed onto red apple varieties 7-42 days pre-harvest for fruit color 

enhancement. FAL 1810, an end-use product containing 10% prohydrojasmon, is 

foliarly sprayed onto grape varieties one week before veraison and one week after 

veraison for fruit color enhancement. If additional color development is desired, up 

to two additional applications of FAL 1810 can be applied at 14-28 day spray 

intervals.] 

B. Product Identity/Chemistry 

 1. Identity of the pesticide and corresponding residues. [Prohydrojasmon is the 

synthetic analog of methyl jasmonate, which is a natural derivative of jasmonic acid, 

a naturally-occurring plant hormone. A petition for temporary tolerance exemption 

for grapes accompanies this submission. Residue data are not applicable.]

 2. Magnitude of residues at the time of harvest and method used to determine the 

residue. [No magnitude of residue (MOR) studies have been conducted with 

prohydrojasmon based on the low toxicity of the active ingredient (see Toxicology 

Profile) and its structural similarity to a naturally-occurring plant hormone.] 

 3. A statement of why an analytical method of detecting and measuring the levels 

of the pesticide residue are not needed. [SciReg, Inc. is submitting a petition to 

establish an exemption from the requirement of a tolerance and, therefore, an 

analytical method is not required.] 

C. Mammalian Toxicological Profile

[The full reports that support this petition and which are summarized in this 

section were previously submitted to EPA by Fine Agrochemicals Ltd.

Prohydrojasmon Technical

1. Acute toxicity (oral, dermal, inhalation); OPPTS 870.1100, 870.1200, 870.1300 
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Acute oral toxicity, acute dermal toxicity, and acute inhalation toxicity studies 

using SD rats were conducted with prohydrojasmon technical (PDJ). The acute 

oral LD50 was >5000 mg/kg bodyweight in both male and female rats. The acute 

dermal LD50 of PDJ in male and female rats was >2000 mg/kg bodyweight. The 

acute inhalation LC50 of PDJ was >2.8 mg/L in male and female rats. 

2. Eye and dermal irritation, and skin sensitization; OPPTS 870.2400, 870.2500, 

870.2600 

Primary eye and dermal irritation studies were conducted using Japanese white 

rabbits. Slight eye irritation was observed. No irritation was observed in the 

dermal irritation study. 

A skin sensitization study (Maximization method) was conducted using Hartley 

strain guinea pigs. No skin sensitization was observed. 

3. 90-day subchronic dietary toxicity (rats); OPPTS 870.3100 

A 90-day subchronic dietary toxicity study was conducted using Fischer rats (10 

males and 10 females each per group) by administrating mixed food (technical 

substance; 0, 1000, 3000 and 10000 ppm, corresponding to 0, 56.9, 168 and 566 

mg/kg bodyweight/day for males, and 0, 58.5, 176 and 587 mg/kg 

bodyweight/day for females). 

In the 10000 ppm dose group, body weight gain suppression and relative adrenal 

gland e weight increase were observed in males and females; Hb concentration 

decreased; MCH decreased; total protein decreased; A/G ratio increased; 

relative liver weight increased; and relative kidney weight increased in males. In 

the 1000 ppm dose groups, food intake decreased; total cholesterol increased; 

and serum chlorine decreased in males. In females, platelet number decreased; 

nitrogen as urea in urine increased; and relative liver weight increased. 

The No Observed Adverse Effect Level (NOAEL) in this study is considered to 

be 1000 ppm (male: 56.9 mg/kg bodyweight/day; female: 58.5 mg/kg 

bodyweight/day). 

4. Developmental toxicity (rat); OPPTS 870.3700 

A developmental toxicity study was conducted using SD rats (24 females each 

per group) via gavage administration (technical substance; 0, 30, 120 and 500 

mg/kg bodyweight/day) during days 6-15 of gestation. 

In the 500 mg/kg dose group, body weight gain and food intake decreases were 

observed, and body weight gain was suppressed in the 120 mg/kg dose group. 

For fetuses, excessive rib growth was observed with higher frequency in the 500 

mg/kg dose group, but skeletal malformations were not observed. Malformation 

increases were not observed at 1000 mg/kg dose group in a preliminary study. 
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Therefore, frequency of increase of excessive rib growth is not considered to be a 

teratogenic effect of prohydrojasmon. 

The NOAEL in this study is considered to be 80 mg/kg bodyweight/day for dams 

and 300 mg/kg bodyweight/day for fetuses. No teratogenicity was observed. 

5. Genotoxicity; OPPTS 870.5100, 870.5300 

An Ames bacterial reverse mutation test and a chromosome aberration test 

using Chinese hamster lung cells were conducted. Both studies were negative. 

(Table 1) Prohydrojasmon is not considered to be genotoxic. 

Table 1. Summary of results 

Test Subject Dose levels Result

in vitro 

Reverse 

mutation test 

(±S9) 

S. typhimurium strains 

TA98, TA100, TA1535, 

TA1537 

E. coli strain WP2uvrA

(-S9) TA100, 

TA1535, TA1537: 

2.44, 4.88, 9.77, 

19.5, 39.1, 78.1 

μg/plate 

(+S9) TA100, 

TA1535, TA1537: 

9.77, 19.5, 39.1, 

78.1, 156, 313, 625 

μg/plate 

(-S9) TA98, 

WP2uvrA: 2.44, 

4.88, 9.77, 19.5, 

39.1, 78.1, 156 

μg/plate 

(+S9) TA100, 

TA1535, TA1537: 

39.1, 78.1, 156, 

313, 625, 1250, 

2500 μg/plate 

Negative

Chromosome 

aberration 

test (±S9) 

Chinese hamster lung 

cells (CHL/IU) 

(-S9): 10, 20, 40, 

80 μg/ml 

(+S9): 1250, 2500, 

5000 μg/ml

Negative

Note: ±S9 = with and without metabolic activation. 

FAL 1800 (BLUSH)

1. Acute toxicity (oral/dermal/inhalation); OPPTS 870.1100, 870.1200, 870.1300 

Acute oral toxicity, acute dermal toxicity, and acute inhalation toxicity studies 

using SD rats were conducted with FAL 1800 containing 5.25% PDJ. The acute 

oral LD50 was >5000 mg/kg bodyweight in both male and female rats. The acute 

dermal LD50 of FAL 1800 in male and female rats was >2000 mg/kg bodyweight. 

The acute inhalation LC50 of FAL 1800 was >5.0 mg/L in male and female rats. 
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2. Eye and dermal irritation, and skin sensitization; OPPTS 870.2400, 870.2500, 

870.2600 

Primary eye and dermal irritation studies were conducted using Japanese white 

rabbits. In the eye study, the maximum of the weighted mean score according to 

the Draize grading method was 52.0 in the non eye-washed group. Classification 

of irritation effects based on this value and according to the Kay and Calandra 

method revealed that the degree of irritation of the test substance was "severely 

irritating." However, in both the non eye-washed group and the eye-washed 

group, similar acute symptoms were observed after administration, but were 

resolved by day 7 after administration. In view of these results, it was concluded 

that FAL 1800 produces reversible intense irritation in the eyes of rabbits under 

the conditions of this study. 

No irritation was observed in the skin. 

A skin sensitization study (Buehler method) was conducted using Hartley strain 

guinea pigs. No skin sensitization was observed. 

FAL 1810

1. Acute toxicity (oral/dermal/inhalation); OPPTS 870.1100, 870.1200, 870.1300 

The acute oral LD50 is estimated to be >500 mg/kg bodyweight and <5.000 mg/kg 

bodyweight. 

The acute dermal LD50 of FAL 1810 is estimated to be >2000 mg/kg bodyweight 

and <5.000 mg/kg bodyweight. 

The acute inhalation LC50 of FAL 1810 is estimated to be >0.5 mg/L and <2 

mg/kg bodyweight. 

2. Eye and dermal irritation, and skin sensitization; OPPTS 870.2400, 870.2500, 

870.2600 

The primary eye and dermal irritation potentials of FAL 1810 are estimated to 

place the product into Toxicity III. 

FAL 1810 is not believed to be a skin sensitizer.] 

D. Aggregate Exposure

 1. Dietary exposure. [The potential for non-occupational, dietary, and nondietary exposure to prohydrojasmon by the general population, including infants 

and children, is likely through ingestion of treated fruit.]
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 i. Food. [Dietary exposure to prohydrojasmon should not be of concern due 

to its low toxicity shown across the entire toxicological profile (see above).]

 ii. Drinking water. [Prohydrojasmon does not pose a risk to drinking water, as 

agricultural practice prohibits direct application of the end-use products directly to 

water. Further, based on the environmental fate studies submitted to support the 

Experimental Use Permit, prohydrojasmon rapidly degrades in the environment.]

 2. Non-dietary exposure. [Non-dietary exposure to prohydrojasmon will be 

much more likely through handling by formulators and applicators, but in light of 

the subject chemical’s toxicological profile, should be of little concern. There are no 

non-pesticidal uses of prohydrojasmon. There are no residential, indoor, school or 

day care uses proposed for this active ingredient. The proposed use pattern is for 

agricultural food crops (apples and grapes). Therefore, there is no potential for nonoccupational exposure to the general population.]

E. Cumulative Effects

 [Section 408(b)(2) of the FFDCA requires that, when considering whether to 

establish an exemption from a tolerance, the Agency consider available information 

concerning the cumulative effects of the particular ingredient’s residues and other 

substances that have a common mechanism of toxicity. These considerations include 

the possible cumulative effects of such residues on infants and children. There is the 

possibility that the human population may be cumulatively exposed to other plant 

hormones; however, based on the ubiquitous nature of these hormones, it is unlikely 

that detrimental effects to the human population will occur through their use.]

F. Safety Determination

 1. U.S. population. [With respect to the potential for harmful effects of 

prohydrojasmon to the U.S. population, the toxicity and exposure data are sufficient 

to adequately address potential exposure to prohydrojasmon. There is reasonable 

certainty that no harm will result to the U.S. population, including infants and 

children, from aggregate exposure to residues of prohydrojasmon as a result of 

preharvest uses, as toxicity and exposure is expected to be minimal. This includes all 

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

information. This chemical will be applied as a plant growth regulator to apples and 

grapes.]

 2. Infants and children. [It is believed that the potential exposure of infants 

and children to residues of prohydrojasmon through its use to enhance the color of 

red apple and grape varieties is no greater than that of the general population. 

Available information does not suggest that infants and children are more 

susceptible to the effects of prohydrojasmon than are adults.] 

G. Effects on the Immune and Endocrine Systems 
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 [No specific studies have been conducted with prohydrojasmon to determine 

whether it may have an effect in humans that is similar to an effect produced by a 

naturally-occurring estrogen or other endocrine-affecting substance. However, it is 

not likely that prohydrojasmon would have estrogen or endocrine effects since it is 

structurally similar to a naturally-occurring plant hormone, it has demonstrated 

low mammalian toxicity, and there is no evidence that prohydrojasmon affects the 

immune system, functions in a manner similar to any known hormone, or that it 

acts as an endocrine disruptor.] 

H. Existing Tolerances

 [There is an existing U.S. tolerance exemption for prohydrojasmon on apples 

(40 CFR 180.1299).]

I. International Tolerances

 [Codex Maximum Residue Level. No maximum residue levels (MRLs) have 

been established for prohydrojasmon by the Codex Alimentarius Commission 

(CODEX). 

The European Union (EU) has assigned a default MRL for prohydrojasmon of 0.01 

mg/kg according to Article 18(1)(b) Reg. 396/2005. 

The Japanese Ministry of Agriculture, Farming and Fisheries (JMAFF) has 

assigned an MRL for prohydrojasmon of 0.05 ppm in apples and grapes.]