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

TEMPLATE:

[EctoPharma Ltd.]

[4F8313]

EPA has received a pesticide petition ([4F8313]) from [EctoPharma Ltd.], 

[Dunsdale Road, Selkirk, TD7 5EB, United Kingdom] 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 to establish an exemption from the requirement of a tolerance for

biochemical pesticide [1,2-Octanediol].

Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, [EctoPharma Ltd.] 

has submitted the following summary of information, data, and arguments in support of 

their pesticide petition. This summary was prepared by [EctoPharma Ltd.] 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. [EctoPharma Ltd.] Petition Summary

[4F8313]

A. Product Name and Proposed Use Practices
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[Product Name: 1,2-Octanediol Technical (TGAI)

BiodiolTM Bioinsecticide (EP)

Proposed Use Practice: 1,2-Octanediol will be applied to growing crops to 

control insect pests such as aphids, whiteflies and thrips.

Mode of Action: 1,2-octanediol acts to control insect pests by disrupting the 

insect cuticle leading to dehydration and death (MRID No. 493492-01). 

Importantly, this disruption is due to physical interactions rather than a neurotoxic 

mechanism.]

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. [1,2-Octanediol (CAS No. 

1117-86-8). Information regarding the name, identity, chemical composition and 

natural occurrence has been submitted to EPA and can be found in MRID No. 

493492-01. 1,2-octanediol is used commercially in a wide variety of cosmetic 

products (for example, as an emollient in makeup, face wash, contact lens fluid, 

anti-wrinkle creams, skin and hair conditioning products), and as a head lice 

treatment.]

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 1,2-Octanediol would not result 

in residues that are of toxicological concern.]

C. Mammalian Toxicological Profile

[1) Acute Toxicity of 1,2-Octanediol. 

Acute Oral Toxicity – An acute oral toxicity study on rats reported a LD50 of 

greater than 2,000 mg/kg bodyweight (MRID No. 493492-03). Five male and five 

female rats were given a single oral dose of test material as a suspension in 

arachis oil BP at a dose level of 2,000 mg/kg bodyweight and observed for 14 

days. There were no mortalities and animals appeared normal one to two days 

after dosing. All animals showed an expected weight gain. 1,2-Octanediol will be 

identified as Category III for oral toxicity.

Acute Dermal Toxicity - In an acute dermal toxicity study five male and five 

female were dermally exposed to 1,2-Octanediol, moistened with sterile water, to 

an area that was approximately 10% of the total body surface, at a single dose of 

2000 mg/kg bw (MRID No. 493492-04). Test sites were covered with a gauze 

dressing for 24 hours. Animals were then observed for 14 days. There was no 

mortality in any of the animals on study and no signs of systemic toxicity. Two of 

the five females exhibited a slight weight loss during the two week observation 

period and all males gained weight during the observation period. 1,2-Octanediol 

will be identified as Toxicity Category III for the dermal toxicity. 
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Acute Inhalation Toxicity - An acute inhalation study on 1,2-Octanediol 

reported an LC50 for male rats greater than 2.08 mg/L, and an LC50 for female 

rats greater than 5.04 mg/L (MRID No. 493492-05). In this study, 5 male and 5 

female Sprague-Dawley rats were exposed in a nose-only chamber to 5.04 mg/L 

1,2-Octanediol for 4 hours and then monitored for 14 days. The particle mass 

median aerodynamic diameter (MMAD) was 2.43 μm and the geometric standard 

deviation (GSD) was 2.13μm. Two of the 5 males at this high dose died and so 5 

additional males were exposed to 2.08 μm for 4 hours. The MMAD for this lower 

exposure was 2.11 μm, and the GSD was 2.06 μm. None of the male rats died 

at the 2.08 μm exposure concentration. The low toxicity following acute 

inhalation exposure to 1,2-octanediol indicates that 1,2-Octanediol is not 

expected to be particularly toxic by the inhalation route. 1,2-Octanediol will be 

identified as Toxicity Category III for inhalation toxicity. 

Primary Eye Irritation - The eye irritation potential for 1,2-Octanediol was 

assessed in a bovine corneal opacity and permeability assay (MRID No. 493492-

06) and the ingredient was considered to be a severe eye irritant. Further, the 

proposed end use product, BiodiolTM Bioinsecticide, which is a 20% formulation 

of 1,2-Octanediol, was characterized as corrosive to the eye of a rabbit in a 

Primary Eye Irritation study (MRID No. 493493-07). 1,2-Octanediol will be

identified as Category I for eye irritation.

Primary Dermal Irritation – In a primary dermal irritation study, three male or 

female New Zealand White rabbits were dermally exposed to 0.5 g of 

1,2-Octanediol that was moistened with aqua ad injectionem and applied to 

approximately 6 cm2 on the left side of the dorsal area (MRID No. 493492-07). 

The test item was applied first to a gauze patch, which was then applied to the 

skin and held in place with non-irritating tape. Test sites were covered with a 

semi-occlusive dressing for 4 hours. Residual test article was removed with tap 

water from animal 1 after the 4-hour exposure, but test article was not removed 

from animals 2 and 3. Animals were then observed for 9-14 days. Irritation was 

scored based on the severity of erythema and eschar formation, and edema 

formation. In this study, 1,2-Octanediol was mildly or slightly irritating to the skin 

based on slight erythema at 72 hours. 1,2-Octanediol will be identified as 

Toxicity Category IV for skin irritation.

Dermal Sensitization – In a dermal sensitization study with 1,2-Octanediol 

guinea pigs were tested using the method of maximization. 

Mercapobenzothiazole (>98% purity) was used as the positive control substance 

for the reliability check in October 2013 (6 months earlier). Ten animals were in 

the test group, 5 were in the negative control group and 6 were in the dose range 

finding study. All animals in the test and control groups survived throughout the 

test period. There was no evidence of sensitization in either group and the 

percentage of sensitized animals was 0%. The sensitization rate after application 

of the positive control substance was 100%. 1,2-Octanediol is not a contact 

dermal sensitizer.

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

Subchronic Toxicity
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Two repeated dose studies have shown minimal toxicity following oral exposure 

to 1,2-octanediol. 

In the first study, groups of male and female Wistar rats were exposed by gavage 

to 0, 50, 300 or 1,000 mg/kg 1,2-octanediol daily for 28 days (MRID No. 493492-

12). There were no test article-related effects on mortality, clinical signs, 

functional observational battery, food consumption, body weight, hematology or 

clinical biochemistry. An increase in mean absolute and relative liver and kidney 

weights was reported in rats treated with 1000 mg/kg/day. Histopathologic 

changes were seen in the stomach of rats treated with 300 and 1000 mg/kg/day. 

These effects were indicative of portal of entry irritation by the test item on the 

pars non glandularis of the stomach. The no observed adverse effect level 

(NOAEL) was identified as 300 mg/kg/day based on the consideration that the 

findings noted in the stomach were local effects due to irritation by 1,2 

octanediol. 

In the second study, groups of male and female rats were exposed by gavage to 

0, 50, 150 or 300 mg/kg 1,2-octanediol daily for 90 days (MRID No. 493492-13). 

Treatment-related findings identified in the trachea and lungs were determined to 

be due to accidental inhalation of the test item (basophilic foreign material) by 

regurgitation. These effects in the lungs and trachea represent a local artifact of 

the gavage dosing and were not considered a systemic test item effect. The 1,2-

octanediol NOAEL was the high dose tested, 300 mg/kg/day. 

Rationales for no further testing have been submitted for the conditionally 

required 90-day Dermal and 90-day Inhalation data requirements based on the 

facts that 1) 1,2-Octanediol is demonstrated to be of low dermal and inhalation 

toxicity; 2) significant repeated dermal or inhalation exposure is not expected 

form the intended use patters; 3) metabolism of 1,2-Octanediol is expected to 

follow the same pathways for both oral and dermal exposure; 4) 28-day and 90-

day rat studies of repeat oral exposure to 1,2-Octanediol resulted in minimal 

adverse effects; 5) systemic levels of 1,2-Octanediol in oral studies are expected 

to be higher following oral rather than dermal or inhalation exposure; and 6) a 90-

day inhalation study conducted on a compound that is structurally similar to 1,2-

Octanediol reported no test article related adverse effects at 2.2 mg/L (MRID No. 

493492-20).

Developmental Toxicity

In a developmental toxicity study 1,2-Octanediol was administered to groups of 

24 female Wistar rats/dose by gavage at dose levels of 0, 150, 300 or 

1000 mg/kg bw/day from Days 5 through 19 of gestation (MRID No. 493492-14). 

Daily administration of the test item did not result in any mortality, clinical signs of 

toxicity or gross necropsy findings in the dams at any dose level. Overall, no 

maternal toxicity was observed except of lower gravid uterine weights at 300 and 

1000 mg/kg bw/day correlating with lower mean fetus weights at 

1000 mg/kg/day.

Under the conditions of this study, the maternal NOAEL of the test item, 

1,2-octanediol, was 150 mg/kg bw/day based on the occurrence of lower gravid 

uterine weights at the LOAEL of 300 mg/kg bw/day and at 1000 mg/kg bw/day. 

The NOAEL for developmental toxicity was 300 mg/kg bw/day based on the 
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occurrence of lower fetus weights at the LOAEL of 1000 mg/kg bw/day 

correlating with an increased incidence of a 14th accessory rib. On the basis of 

the results of this study, the test item 1,2-octanediol was considered to have no 

teratogenic potential in Wistar rats up to a dose level of 1000 mg/kg bw/day.

Mutagenicity

1,2-Octanediol was evaluated for mutagenic activity in the “Ames Test” (MRID 

No. 493492-09). Four strains of Salmonella typhimurium and one of Escherichia 

coli were exposed to 1,2-Octanediol in the presence and absence of a metabolic 

activating system. The test material was considered to be non-mutagenic under 

the conditions of the test.

1,2-Octanediol was evaluated in an in vitro chromosome aberration test using 

mammalian culture cells (MRID No. 493492-10). The study was designed to 

examine a clastogenic potential of the test material in the chromosome 

aberration test system using Chinese Hamster lung cell (CHL0IU). Study results 

demonstrated that 1,2-Octanediol did not show the chromosome aberrations 

without and with metabolic activation system under the conditions of the study.

Finally, 1,2-Octanediol was evaluated in a gene mutation assay in Chinese 

hamster V79 cells in vitro (MRID No. 493492-11). The assay was performed in 

two independent experiments, using two parallel cultures each. The first 

experiment was performed with and without liver microsomal activation and a 

treatment period of 4 hours. The second experiment was performed with a 

treatment time of 4 hours with and 24 hours without metabolic activation. No 

substantial and reproducible dose depend increase of the mutation frequency 

was observed in both experiments, this it was stated that under the experimental 

conditions the test material did not induce gene mutations. 

The results of toxicity testing on 1,2-Octanediol and its long history of safe human 

exposure from cosmetic and personal care product uses show there is no risk to human 

health from 1,2-Octanediol. 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. [The intended use of 1,2-Octanediol is application to food crops, so there 

is a potential for dietary exposure. Acute toxicity studies have shown that 1,2-

Octanediol is not toxic during acute or subchronic testing. Further, 1,2-

Octanediol is not mutagenic as demonstrated in multiple studies. 

The results of toxicity testing on 1,2-Octanediol and its long history of safe 

human exposure from cosmetic and personal care products show there is no risk 

to human health from 1,2-Octanediol. 1,2-Octanediol is not considered persistent 

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

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

toxicological concern.]
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ii. Drinking water. [Similarly, exposure to humans from residues of 1,2-

Octanediol 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 1,2-Octanediol is 

application to growing crops. The ingredient is not applied directly to water.

Acute toxicity studies have shown that 1,2-Octanediol is not toxic during acute or 

subchronic testing. Further, 1,2-Octanediol is not mutagenic as demonstrated in 

multiple studies. 

The results of toxicity testing on 1,2-Octanediol and its long history of safe 

human exposure from cosmetic and personal care products show there is no risk 

to human health from 1,2-Octanediol. 1,2-Octanediol is not considered persistent 

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

exposures would not be expected to pose any quantifiable risk due to 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 agricultural. 

The intended use of 1,2-Octanediol is application to food crops. Acute toxicity 

studies have shown that 1,2-Octanediol is not toxic during acute or subchronic 

testing. Further, 1,2-Octanediol is not mutagenic as demonstrated in multiple 

studies. 

The results of toxicity testing on 1,2-Octanediol and its long history of safe 

human exposure from cosmetic and personal care products show there is no risk 

to human health from 1,2-Octanediol. 1,2-Octanediol is not considered persistent 

based on its characteristics, properties or known degradation pathways. Nondietary exposures would not be expected to pose any quantifiable risk due to 

residues of toxicological concern.]

E. Cumulative Effects

[It is not expected that, when used as proposed, 1,2-Octanediol would result in residues 

that are of toxicological concern. The intended use of 1,2-Octanediol is application to 

growing crops to control insect pests. 1,2-Octanediol is not considered persistent based 

on its characteristics, properties or known degradation pathways. 

Acute toxicity studies have shown that 1,2-Octanediol is not toxic during acute or 

subchronic. Further, 1,2-Octanediol is not mutagenic as demonstrated in multiple 

studies. The results of toxicity testing on 1,2-Octanediol and its long history of safe 

human exposure from cosmetic and personal care products show there is no risk to 

human health from 1,2-Octanediol.]

F. Safety Determination

1. U.S. population. [Acute toxicity studies have shown that 1,2-Octanediol is not 
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toxic during acute or subchronic testing. Further, 1,2-Octanediol is not 

mutagenic as demonstrated in multiple studies. The results of toxicity testing on 

1,2-Octanediol and its long history of safe human exposure from cosmetic and 

personal care products show there is no risk to human health from 1,2-

Octanediol. 1,2-Octanediol is not considered persistent based on its 

characteristics, properties or known degradation pathways. 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, 1,2-Octanediol would result in residues that are of toxicological 

concern. There is a reasonable certainty of no harm for infants and children from 

exposure to 1,2-Octanediol from the proposed uses.]

G. Effects on the Immune and Endocrine Systems

[To date there is no evidence to suggest that 1,2-Octanediol functions in a 

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

H. Existing Tolerances

[There are no existing tolerances under 40 CFR for 1,2-Octanediol..]

I. International Tolerances

[A Codex Alimentarium Commission Maximum Residue Level (MRL) is not 

established for 1,2-Octanediol.]