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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: [Linda Hollis; (703) 

308-8733] 

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: Email the completed template to: hollis.linda@epa.gov.

TEMPLATE: 

[D-I-1-4, Inc., a division of 1,4Group, Inc.]

[Insert petition number]

 EPA has received a pesticide petition ([insert petition number]) from [D-I-1-4, 

Inc., a division of 1,4Group, Inc.], [PO Box 860, Meridian, ID 83360] requesting, 

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 to establish an exemption from the 

requirement of a tolerance for the biochemical pesticide [1-octanol]

 

Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, [D-I-1-4, Inc., a division of 

1,4Group, Inc.] has submitted the following summary of information, data, and 

arguments in support of their pesticide petition. This summary was prepared by D-I-1-4, 

Inc., a division of 1,4Group, 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. [D-I-1-4, Inc., a division of 1,4Group, Inc.] Petition Summary

 [Insert petition number]

A. Product Name and Proposed Use Practices
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[1-octanol will be applied post-harvest to stored potatoes and other sprouting root and tuber 

crops. It will be applied alone or in combination with the presently registered biochemical sprout 

inhibitor, 1,4-dimethylnaphthalene, by aerosol, through the buildings ventilation ducts. The 

product would be applied to the stored commodity when sprouting is first observed, usually 

several months after the commodity are harvested and are placed in storage.] 

B. Product Identity/Chemistry 

1. Identity of the pesticide and corresponding residues. [Active Ingredient: 1-octanol (CAS 

No. 111-87-5). 

 

 Information regarding the name, identity, chemical composition and natural occurrence 

has been submitted to EPA and can be found in MRID No. 489644-01, and is 

summarized as follows: 

 1-octanol (PC Code 79037) has been previously registered by EPA for use as a tobacco 

sucker control agent (first registered in 1972). Further, 1-octanol has been approved for 

use as an inert ingredient solvent in pesticide formulations and exempted from the 

requirement of a tolerance at 180.920 (tolerance reassessed June 2006). 

 1-octanol has a number of non-pesticidal uses including perfumes, cosmetics, flavoring 

agents and industrial solvents. The ingredient is cleared by the FDA for use as a direct 

food additive per 21 CFR 172.230 in microcapsules for flavoring substances and per 21 

CFR 172.515 as a synthetic flavoring substance and adjuvant. 

 1-octanol has been shown to be a natural constituent of plants and microbes. According 

to the NIH, 1-octanol has been found in green tea, grapefruit, dill, nectarines, apple juice, 

and bitter orange. Its presence has been quantified in certain foods, such as ice cream 

(0.91 ppm), candy (2.8 ppm), baked goods (3.0 ppm), pudding (1.5 ppm), and chewing 

gum (16 to 57 ppm). It has also been identified as a volatile component of fried bacon, 

and has been found in chicken, pork, and beef. 

 Since 1-octanol is present as a natural component of various fruits and vegetables, and is 

present as both a natural constituent found in foods and a constituent produced from 

cooking, it is clearly present in the human diet. Therefore, humans have been exposed to 

naturally occurring 1-octanol for centuries via their diet. The proposed use of 1-octanol 

would not significantly increase the total daily intake of the aliphatic alcohol. 

Mode of Action: 1-octanol has been shown to be an effective plant growth regulator by 

controlling the growth of tobacco plant suckers. As the tobacco plant matures, it 

produces a flower which, if allowed to open, reduces the plant’s ability to increase leaf 

size. The plant’s energy would go towards flower opening rather than to leaf growth. 

Thus, the flowers are removed as soon as the buds begin to open in a process called 

topping. The plant, recognizing that it has lost its reproductive power, attempts to 

propagate by growing auxiliary buds called suckers. If not eliminated, the suckers utilize 

critical nutrients and slow leaf growth. While suckers were previously removed by hand, 

two patents have been issued that describe the application of aliphatic fatty acid alcohols 

to growing tobacco plants to control the growth of the auxiliary buds (suckers). Both 

patents describe the successful use of 1-octanol as a plant growth regulator to control 

sucker growth (5, 6), and there are registered pesticide products in the Registration 
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Division with this active ingredient. 

 As a sprout inhibitor, 1-octanol functions in the same way to inhibit the growth of sprouts 

and peeps on stored potatoes and other post-harvest root and tuber crops.]

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

residue. [NA-Remove] 

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

of the pesticide residue are not needed. [An analytical method for residues is not applicable. 

It is expected that, when used as proposed 1-octanol would not result in residues that are of 

toxicological concern.]

C. Mammalian Toxicological Profile

[1) Acute Toxicity of 1-octanol. 

Acute oral toxicity data is available and reports a LD50 >5,000 mg/kg (Toxicity Category 

IV) for pure 1-octanol and the same for a formulated end-use product with 90% 1-octanol 

(MRID Nos. 489644-03 and 489645-09). 

Acute dermal toxicity data is available and reports a LD50 of >5,000 mg/kg (Toxicity 

Category IV) for pure 1-octanol and the same for a formulated end-use product with 

90% 1-octanol (MRID Nos. 489644-02 and 489645-10). 

Acute inhalation limit dose testing for an end-use product with 90% 1-octanol resulted in 

an LC50 of >5.10 mg/L (MRID No. 489645-11). 1-octanol has also been evaluated for 

developmental toxicity in pregnant rats which were exposed via the inhalation route. 1-

octanol demonstrated low mammalian toxicity when administered to pregnant rats daily 

via the respiratory route for eighteen days (MRID No. 489644-02). 

Primary eye irritation data is available and reports 1-octanol is irritating to eyes (Toxicity 

Category III) for pure 1-octanol and the same for a formulated end-use product with 90% 

1-octanol (MRID Nos. 489644-02 and 489645-12). 

Primary skin irritation data is available and reports 1-octanol is slightly irritating to eyes 

(Toxicity Category IV) for pure 1-octanol and moderately irritation for a formulated enduse product with 90% 1-octanol (MRID Nos. 489644-02 and 489645-13). 

Dermal sensitization data is available and reports 1-octanol is not a skin sensitizer 

(Toxicity Category IV) for pure 1-octanol, but a contact sensitizer in a formulated enduse product with 90% 1-octanol (MRID Nos. 489644-02 and 489645-14). 

2) Subchronic Toxicity, Teratogenicity and Genotoxicity of 1-octanol. 

Subchronic Toxicity 

1-octanol was administered daily to mice via oral gavage for one month at a dose of 180 

mg/kg/day. No treatment-related adverse effects were reported by the scientists in their 

publication (MRID No. 489644-02). 
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A ninety day dermal toxicity study was conducted in rats with a blend of 57 percent 

decanol and 43 percent octanol. Doses applied daily to the skin were 0, 100, 300, or 

1000 mg/kg. While all three doses of the blend caused dermal irritation, which was 

observed as erythema, edema, and some exfoliation, body weight loss and hematological 

changes were observed only in the high dose animals. A systemic NOEL was set at 1000 

mg/kg/day based on clinical chemistry, hematology, and organ weights. Other than 

dermal irritation, histopathologic examination showed that the thirteen week exposure did 

not cause target organ toxicity, confirming the relatively low systemic toxicity of 1-

octanol (MRID No. 437012-01). 

Developmental Toxicity 

Pregnant rats received daily oral doses of 1-octanoic acid, the oxidized form of 1-octanol, 

on gestation days six through fifteen. The doses were 0, 1125, or 1500 mg/kg/day. 

While the highest dose caused significant maternal toxicity and maternal mortality, 

confirming that the Maximum Tolerated Dose was administered, there was no 

developmental toxicity in the exposed pups. Therefore, 1-octanoic acid did not 

demonstrate developmental toxicity (MRID No. 489644-02). 

In a second developmental toxicity study, a blend of two aliphatic alcohols containing 41 

percent 1-octanol and 55 percent n-decanol was administered by oral gavage to pregnant 

rats from gestation day six through sixteen. The doses administered were 0, 125, 375, or 

1000 mg/kg/day. While the high dose caused significant maternal toxicity, it did not 

cause developmental toxicity in the offspring (MRID No. 426093-01). 

In a third developmental toxicity study, several aliphatic alcohols were individually 

administered to groups of pregnant rats via the inhalation route. The animals were 

exposed to the maximally attainable vapor concentration which, for 1-octanol, was 65 

ppm (350 mg/m3

), seven hours per day, from gestation day one to gestation day nineteen. 

The maximally generated vapor concentration did not cause maternal toxicity, nor did it 

cause developmental toxicity (MRID No. 489644-02). 

Mutagenicity 

1-octanol was evaluated for mutagenic activity in the Ames Test, along with sixty-two 

other food flavoring ingredients. Five strains of Salmonella typhimurium were exposed 

to 1-octanol in the presence and absence of a metabolic activating system. The same 

laboratory evaluated these sixty three food ingredients in the Unscheduled DNA 

Synthesis Assay and the Mouse Lymphoma Test. 1-octanol did not demonstrate 

mutagenic activity in any of the three assays (MRID No. 489644-02). 

In a second Ames Test, five strains of Salmonella typhimurium were exposed to six doses 

of a blend of 55 percent decanol and 41 percent 1-octanol. The test, consisting of two 

independent trials, was conducted in the presence and absence of a metabolic activating 

system, using doses up to 500 ug per plate. The 1-octanol/n-decanol blend did not 

demonstrate mutagenic activity (MRID No. 42372-02). 

The 55 percent n-decanol/41 percent 1-octanol blend was evaluated in a mouse 

lymphoma assay in the presence and absence of a metabolic activating system. Two 

independent assays were conducted, using doses sufficiently high to cause severe 

cytotoxicity. The alcohol blend did not demonstrate mutagenic activity in this assay 

(MRID No. 423720-03). 
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A mouse micronucleus assay was conducted with the 55 percent n-decanol/41 percent 1-

octanol blend. Bone marrow cells were harvested 24 and 48 hours after treatment with 

three daily doses of 500, 1000, or 2000 mg/kg/day. Treatment with the blend did not 

induce the formation of micronuclei and thus the blend did not express mutagenic activity 

in this test. Although a high dose of 2000 mg/kg/day was administered, the blend did not 

cause signs of toxicity in any of the animals, again demonstrating the relatively low 

systemic toxicity of the alcohol blend, and thus 1-octanol (MRID No. 423720-01). 

The results of toxicity testing on 1-octanol and its long history of safe human exposure from 

natural occurrence in foods, and from use in perfumes, as a flavoring agent and as a direct food 

additive show there is no risk to human health from 1-octanol. Both dietary and non-dietary 

exposures would not be expected to pose any quantifiable risk due to a lack of residues of 

toxicological concern.]

D. Aggregate Exposure

 1. Dietary exposure.

 i. Food. [Dietary exposure from use of 1-octanol, as proposed, is minimal. The intended 

use of 1-octanol is indoor application to post-harvest crops. 1-octanol is not considered 

persistent based on its characteristics, properties or known degradation pathways. 

 Acute toxicity studies have shown that 1-octanol is not toxic during acute, subchronic, 

and teratology studies. Further, 1-octanol is not mutagenic as demonstrated in multiple studies 

The results of toxicity testing on 1-octanol and its long history of safe human exposure from 

natural occurrence in foods, and from use in perfumes, as a flavoring agent and as a direct food 

additive show there is no risk to human health from 1-octanol. Dietary exposures would not be 

expected to pose any quantifiable risk due to a lack of residues of toxicological concern.] 

ii. Drinking water. [Similarly, exposure to humans from residues of 1-octanol in 

consumed drinking water would be unlikely. Potential exposure to surface water would 

be negligible and exposure to drinking water (well or ground water) would be impossible 

to measure. The intended use of 1-octanol is indoor application to post-harvest crops. 

The ingredient is not applied directly to water. 

 Acute toxicity studies have shown that 1-octanol is not toxic during acute, 

subchronic and chronic studies. Further, 1-octanol is not mutagenic as demonstrated in 

multiple studies. The results of toxicity testing on 1-octanol and its long history of safe 

human exposure from natural occurrence in foods, and from use in perfumes, as a 

flavoring agent and as a direct food additive show there is no risk to human health from 

1-octanol. Drinking water exposures would not be expected to pose any quantifiable risk 

due to a lack of residues of toxicological concern.] 

 2. Non-dietary exposure. [The potential for non-dietary exposure to the general 

population, including infants and children, is unlikely as the proposed use sites are indoor 

and agricultural. The intended use of 1-octanol is application to post-harvest crops. 1-

octanol is not considered persistent based on its characteristics, properties or known 

degradation pathways. 

Acute toxicity studies have shown that 1-octanol is not toxic during acute, subchronic and 
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chronic studies. Further, 1-octanol is not mutagenic as demonstrated in multiple studies. 

The results of toxicity testing on 1-octanol and its long history of safe human exposure 

from natural occurrence in foods, and from use in perfumes, as a flavoring agent and as a 

direct food additive show there is no risk to human health from 1-octanol. Non-dietary 

exposures would not be expected to pose any quantifiable risk due to a lack of residues of 

toxicological concern.] 

E. Cumulative Effects

[It is not expected that, when used as proposed, 1-octanol would result in residues that are 

of toxicological concern. The intended use of 1-octanol is application to post harvest 

crops. 1-octanol is not considered persistent based on its characteristics, properties or 

known degradation pathways. 

Acute toxicity studies have shown that 1-octanol is not toxic during acute, subchronic and 

chronic studies. Further, 1-octanol is not mutagenic as demonstrated in multiple studies. 

The results of toxicity testing on 1-octanol and its long history of safe human exposure 

from natural occurrence in foods, and from use in perfumes, as a flavoring agent and as a 

direct food additive show there is no risk to human health from 1-octanol.] 

F. Safety Determination

1. U.S. population. [The results of toxicity testing on 1-octanol and its long history of 

safe human exposure from natural occurrence in foods, and from use in perfumes, as a 

flavoring agent and as a direct food additive show there is no risk to human health from 

1-octanol. The intended use of 1-octanol is application to post-harvest crops. There is a 

reasonable certainty of no harm to the general US population from exposure to this active 

ingredient.]

2. Infants and children. [As mentioned above, it is not expected that, when used as 

proposed, 1-octanol would result in residues that are of toxicological concern. There is a 

reasonable certainty of no harm for infants and children from exposure to 1-octanol from 

the proposed uses.] 

G. Effects on the Immune and Endocrine Systems 

[To date there is no evidence to suggest that 1-octanol functions in a manner similar to 

any known hormone, or that it acts as an endocrine disrupter.]

H. Existing Tolerances

 [There is an exemption from the requirement of a tolerance for 1-octanol when used as a 

solvent inert ingredient in pesticide formulations applied to food at 40 CFR 180.920 (tolerance 

reassessed June 2006).]

I. International Tolerances
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 [A Codex Alimentarium Commission Maximum Residue Level (MRL) is not established 

for 1-octanol.]