1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

MEMORANDUM 

DATE: February 23, 2015

SUBJECT: Science Review in Support of the Registration of 1,4Zap Technical, Containing 99.0% 

1-Octanol as its Active Ingredient.

Decision Number: 482298 

DP Number: 423496 and 425328

EPA File Symbol Number: 67727-A

Chemical Class: Biochemical

PC Code: 079037

CAS Number: 111-87-5

Active Ingredient Tolerance/Exemption: Pending: petition # 3F8195

MRID Numbers: 48964401-48964402, 49458901-49458902 and 49545601

FROM: Angela L. Gonzales, Biologist

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

TO: Gina Burnett, M.S., Regulatory Action Leader

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P) 

ACTION REQUESTED

In response to the Agency’s request for additional information discussed in the memorandum from A. L. 

Gonzales to L. Cole dated 7/23/14 and relayed in the deficiency letter to the applicant dated 7/29/14, the 

applicant has submitted a revised Confidential Statement of Formula (CSF) dated 9/3/14, a revised label, 

information in the cover letter dated 9/3/14, product chemistry data and information in MRID 49458901 and 

mammalian toxicology data and information in MRID 49458902. In response to the request for additional 

information discussed in the email from G. Burnett to A. Roberts dated 12/17/14, the applicant has submitted a 

revised CSF dated 1/16/15 and product chemistry data in MRID 49545601. 
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

RECOMMENDATIONS AND CONCLUSIONS

1. The product chemistry submission is ACCEPTABLE, pending submission and review of the data listed

below.

MRID 49458901: UPGRADEABLE MRID 49545601: ACCEPTABLE

a. The applicant indicated that storage stability and corrosion characteristics studies are in progress. These 

studies must be submitted upon completion. 

b. All other product chemistry data requirements have been satisfied at this time. The CSF dated 1/16/15 is 

acceptable and supersedes all others.

2. The toxicology submission for the active ingredient is ACCEPTABLE.

MRID 49458902: ACCEPTABLE

a. All mammalian toxicology data requirements have been satisfied at this time.

3. The nontarget organism toxicology submission is ACCEPTABLE.

a. The applicant submitted a revised label for the MP that indicates that the product is only to be formulated into 

EPs for indoor-use only. 

4. The petition for the exemption from the requirement of a tolerance for 1-octanol is ACCEPTABLE. 

a. Based on the data and information available, there is adequate justification for an exemption from the 

requirement of a tolerance for 1-octanol when used post-harvest on stored root, tuber, and bulb crops. This 

conclusion is based on the following:

i. Based on the data available to the Agency, no toxic endpoints have been identified. 

ii. Dietary exposure is anticipated to be negligible based on the volatility and expected rapid degradation of 

the active ingredient.

iii. Humans are already exposed to 1-octanol as it is found naturally in foods, in foods to which it has been 

added as a food additive, in cosmetics and in air. 

NOTE TO RAL:

1. The proposed MP label must be revised to include language that indicates the purpose of the MP (e.g.: for 

formulation into end-use products that are intended for use as sprout inhibitors on stored root and tuber crops in 

2
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

storage facilities). The label must also include language that EPs containing the proposed MP are to be applied 

from the outside of the building or storage facility. This requirement is based on the lack of exposure argument 

submitted by the applicant to satisfy the 90-day dermal and 90-day inhalation data requirements. 

2. Based on the acute toxicity category classification for 1-octanol, the label signal word and precautionary 

language must be revised.

3. The applicant should be notified that a complete copy of any reference cited should be submitted. In some 

cases, in lieu of copies, hyperlinks were provided for references. These hyperlinks may become out of date in 

the future and consequently difficult to find. 

RISK ASSESSMENT AND STUDY SUMMARIES

I. Active Ingredient Characterization 

1-octanol, or octyl alcohol, is a linear saturated aliphatic alcohol containing eight carbons. The chemical has 

been registered as a plant growth regulator (PGR) by EPA for use as a tobacco sucker control agent in pesticide 

products since 1980. In these products, 1-octanol is combined with conventional pesticide chemicals. As a 

biopesticide, 1-octanol is also considered a PGR and is intended for use as a sprout inhibitor in pesticide 

products to be applied post-harvest on stored potatoes and other sprouting root and tuber crops. The chemical is 

approved for use by EPA as an inert ingredient in pesticide products for food (as a solvent or co-solvent under 

40 CFR 180.910), nonfood and fragrance uses.

There is a significant history of exposure to humans and the environment as 1-octanol is found naturally in 

foods and in the environment and is also used as a food additive and as an ingredient in cosmetics. The chemical 

is approved by the FDA for use as a direct food additive under 21 CFR 172.230 in microcapsules for flavoring 

substances and under 21 CFR 172.515 as a synthetic flavoring substance and adjuvant. It has been found in the 

essential oils of green tea, grapefruit, California orange, bitter orange, Turkish rose and Bulgarian rose.

1-Octanol has been identified as a volatile component of fried bacon, roasted filberts, raw and roasted earth 

almonds, mutton, chicken, pork, raw beef, frankfurters, nectarines, apple juice, common guava, Gruyere cheese 

and in foods processed from Cassava root. The amount of the chemical has been quantified in some foods. 

Fermented soybean curds were found to contain 164.8 to 337.1 ug/kg of 1-octanol. Duck meat and duck fat were 

found to contain the chemical as a volatile component at 8.88 ppb and 12.69 ppb, respectively. 1-octanol has 

also been detected (but not quantified) in air samples from inside some houses and in some suburban areas, rural 

areas and forests. (HSDB, 2014)

A. Product Chemistry (MRIDs 48964401, 49458901 and 49545601)

3
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

All product chemistry data requirements have been adequately satisfied per 40 CFR 158.2030. Data Evaluation 

Records (DERs) were not created for the submitted MRIDs; however, the relevant data and information are 

summarized in Table 1 and in the subsequent sections. Refer to Table 1 below for summaries of physical and 

chemical properties data for 1,4Zap Technical containing 99.0% 1-octanol. Refer to the Confidential Appendix 

(CA) below for more information regarding product chemistry. The structure of 1-octanol is below:

TABLE 1. Physical and Chemical Properties of 1,4Zap Technical (99% 1-octanol) (40 CFR § 158.2030)

OCSPP Guideline Property Description of Result MRID

830.6302 Color Colorless 49458901

830.6303 Physical State Liquid 49458901

830.6304 Odor Sweet, orange-rose 49458901

830.6313 Stability to Normal and Elevated 

Temperatures, Metals and Metal 

Ions

Stable at normal and elevated temperatures. Will 

react with oxidizing material. No reported 

incompatibility with metals or metal ions.

49458901

830.6315 Flammability N/A: product does not contain combustible liquids 49458901

830.6317 Storage Stability A storage stability study is ongoing

830.6319 Miscibility N/A: product is not an emulsifiable liquid to be 

diluted with petroleum solvents

49458901

830.6320 Corrosion Characteristics A corrosion characteristics study is ongoing. 

830.7000 pH 5.9 49458901

830.7050 UV/Visible Light

Absorption

1.428-1.431 refractive index 49458901

830.7100 Viscosity < 10 cp 49458901

830.7200 Melting Point/Range -17 to -16°C 49458901

830.7220 Boiling Point/Range 194-195°C 49458901

830.7300 Bulk Density 0.827 @ 20°C 49458901

830.7520 Particle Size, Fiber Length and 

Diameter Distribution

Not required: not a fibrous substance.

830.7550

830.7560

830.7570

Partition Coefficient (nOctanol/Water) logPow = 2.54 49545601

830.7840 Water Solubility Insoluble 49458901

830.7950 Vapor Pressure 0.0794 mmHg @ 25°C 49458901

II. Human Health Assessment

4
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

A. Toxicology (MRIDs 48964402 and 49458902)

To satisfy the Tier I mammalian toxicology data requirements, data and information were submitted from the 

open scientific literature and from publically-available Agency documents. All toxicology data requirements 

have been satisfied per 40 CFR 158.2050. DERs were not created for the submitted MRIDs; however, the 

relevant data and information from these MRIDs are summarized in Table 2 and in the subsequent sections.

Table 2. Mammalian Toxicology Data for 1,4Zap Technical (99% 1-octanol) (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

Acute oral toxicity 

(870.1100)

LD50 > 5,000 mg/kg (rat)

LD50 = 1,800 mg/kg (mouse)

LD50 = 4,135 mg/kg (rat)

III

48964402

WHO, 1998

Acute dermal toxicity (rabbit)

(870.1200) LD50 > 5,000 mg/kg IV 48964402

Acute inhalation toxicity (rat)

(870.1300)

LC50 > 6.4 mg/L after 1-hour exposure (no deaths)

LC50 > 5.6 mg/L after 4-hour exposure (3 rats died 

within 2 days after exposure) IV HSDB, 2014

Primary eye irritation (rabbit)

(870.2400) Irritating1 II 48964402EPA, 2006

Primary dermal irritation (rabbit)

(870.2500) Slightly irritating IV 48964402

Dermal sensitization (guinea pig)

(870.2600) Not a sensitizer N/A 49458902EPA, 2006

90-Day oral toxicity 

(870.3100)

No adverse effects were reported when mice were 

dosed via gavage with 1-octanol at 179 mg/kg body 

weight for 30 days. NOAEL > 179 mg/kg

48964402

90-Day dermal toxicity

(870.3250)

Waived. Purposeful application and prolonged 

exposure to the human skin is not anticipated based 

on the use pattern: 1-octanol is intended to be applied 

inside crop storage facilities through ventilation 

systems from outside of the facility. Per label 

instructions, buildings are sealed until fully ventilated 

and early reentry requirements include the use of 

appropriate PPE. Applicators and handlers are 

required to wear appropriate PPE during use of the 

pesticide which mitigates the potential for repeated 

exposure. Prolonged dermal exposure is also not 

anticipated as 1-octanol is a volatile chemical 

(estimated half-life of 3.5 minutes) and is not likely to

remain on skin if exposure occurs.

48964402

49458902

5
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

Table 2. Mammalian Toxicology Data for 1,4Zap Technical (99% 1-octanol) (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

90-Day inhalation toxicity

(870.3465)

Waived. Significant repeat inhalation exposure to the 

active ingredient as a gas, vapor or aerosol is 

unlikely. Significant inhalation exposure is not 

anticipated based on the use pattern: 1-octanol is 

intended to be applied inside crop storage facilities 

through ventilation systems from outside of the 

facility. Per label instructions, buildings are sealed 

until fully ventilated and early reentry requirements 

include the use of a respirator. Additionally, humans 

are already exposed to 1-octanol in the environment 

as it has been detected in air samples. Prolonged 

inhalation exposure is also not anticipated as 1-

octanol is a volatile chemical (estimated half-life of 

3.5 minutes) and degrades rapidly once introduced 

into the environment.

48964402

Mutagenicity-in vitro studies

(870.5100)

Not mutagenic with or without metabolic activation 

(Ames assay) 49458902

Mutagenicity-in vivo micronucleus assay 

(870.5395)

Not mutagenic with or without metabolic activation 

(mouse lymphoma assay) 49458902

Developmental toxicity

(870.3700)

No developmental adverse effects occurred when 

pregnant rats were exposed to 100 mg/m3 1-octanol 

(the max. achievable vapor) for 7 hours/day on 

gestation days 1-19. 

No developmental adverse effects occurred when 

pregnant rats were dosed via gavage with a blend of 

55% decanol and 40.7% octanol at 0, 125, 375 and 

1,000 mg/kg/day on gestation days 6-16. 

Maternal NOAEL = 375 mg/kg/day

Maternal LOAEL = 1,000 mg/kg/day (increased 

incidence of salivation)

Developmental NOAEL = 1,000

Developmental LOAEL = not established

48964402

49458902

1

The substance is classified as irritating because the available data indicate that 1-octanol is “irritating” or “an irritant”, but information regarding the 

degree of severity is unavailable. Additionally, studies cited in the EPA 2006 memo indicate that: 1) exposure of rabbits to a 100% fatty alcohol 

blend resulted in moderate to severe eye irritation (toxicity category II) and 2) exposure to varying levels of exposure to 1-decanol (similar to 1-

octanol) resulted in varying levels of eye irritation, resulting in toxicity category classifications of I-III. Because specific data on the eye irritation 

severity of 1-octanol is unavailable and data on similar substances indicate varying levels of irritation from moderate to severe, a toxicity category II 

classification is appropriate at this time. 

1. Acute Toxicity

With the exception that it is an eye irritant, 1-octanol is not considered to be acutely toxic based on the available 

data. The chemical is classified into toxicity category IV for acute dermal and inhalation toxicity and dermal 

irritation, toxicity category III for acute oral toxicity and toxicity category II for eye irritation. 1-octanol is not 

considered to be a dermal sensitizer. 

 

2. Subchronic Toxicity

6
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

90-Day Oral

The 90-day oral data requirement is required to be addressed for uses of a pesticide on foods. In MRID 

48964402, data were cited from the open scientific literature to satisfy the data requirement. The study has been 

reviewed and cited by the World Health Organization’s (WHO) International Programme on Chemical Safety in 

its assessment of 1-octanol as a food additive. The study is also cited in the National Library of Medicine’s 

(NLM) Hazardous Substances Database (HSDB) for 1-octanol. Mice were administered the chemical via gavage 

at a dose of 179 mg/kg body weight for 30 days. No adverse effects were reported. 

The metabolism in humans of 1-octanol has is well characterized. It is metabolized into innocuous and 

endogenous substances. The alcohol is metabolized into its corresponding aldehyde which is then rapidly 

oxidized to the acid which is metabolized in the fatty acid and tricarboxylic acid pathways. (WHO, 1998)

90-Day Dermal

The 90-day dermal data requirement is conditionally required to support uses involving purposeful application 

to the human skin or uses that would result in prolonged dermal exposure and if data from a 90-day oral study 

are not required or the active ingredient is known or expected to be metabolized differently by the dermal route 

of exposure than by the oral route and the metabolite is of toxicological concern. The Agency has waived this 

data requirement at this time. Purposeful application and prolonged exposure to the human skin is not 

anticipated based on the use pattern of the proposed product; 1-octanol is intended to be applied inside crop 

storage facilities through ventilation systems from outside of the facility. Per label instructions, buildings are 

sealed until fully ventilated and early reentry requirements include the use of appropriate PPE which includes 

coveralls over long-sleeved shirt, long pants, shoes plus socks, chemical resistant gloves, face-sealing goggles 

and a respirator. During use of the pesticide, applicators and handlers are required to wear appropriate PPE 

(long-sleeved shirt, long pants, shoes, socks, gloves and protective eyewear. These PPE requirements mitigate 

the potential for repeated dermal exposure. Additionally, prolonged dermal exposure is also not anticipated as 1-

octanol is a volatile chemical that is expected to degrade rapidly once introduced into the environment. The 

chemical has an estimated half-life of 3.5 minutes (US EPA, 2007) and is not likely to remain on skin if 

exposure occurs.

90-Day Inhalation

The 90-day inhalation data requirement is conditionally required if there is a likelihood of significant levels of 

repeated inhalation exposure to the pesticide as a gas, vapor or aerosol. The Agency has waived this data 

requirement at this time. Significant inhalation exposure is not anticipated based on the use pattern: 1-octanol is 

intended to be applied inside crop storage facilities through ventilation systems from outside of the facility. Per 

label instructions, buildings are sealed until fully ventilated and early reentry requirements include the use of a 

respirator. Additionally, prolonged inhalation exposure is also not anticipated as 1-octanol is a volatile chemical 

that is expected to degrade rapidly once introduced into the environment. The chemical has an estimated half7
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

life of 3.5 minutes (US EPA, 2007). Furthermore, humans are already exposed to 1-octanol in the environment 

as it has been detected in air samples (HSDB, 2014). 

3. Developmental Toxicity

Developmental toxicity data are required for to support food uses and are available for 1-octanol. In MRIDs 

48964402 and 49458902, data were cited from the open scientific literature and from studies previously 

submitted to the Agency to satisfy the data requirement. The cited studies have already been reviewed and used 

in previous Agency risk assessments (US EPA, 2006). No adverse effects (maternal or developmental) were 

observed in a developmental toxicity study where pregnant rats were exposed to 100 mg/m3 1-octanol (the 

maximum achievable vapor) for seven hours per day on gestation days 1-19. No developmental toxicity 

occurred in a study were pregnant rats were dosed via gavage with a blend of 55% decanol and 40.7% octanol at 

0, 125, 375 and 1,000 mg/kg/day on gestation days 6-16. Increased salivation was observed in dams at the 

highest dose. The maternal NOAEL = 375 mg/kg/day and the maternal LOAEL = 1,000 mg/kg/day. In this 

study, increased salivation is not considered a toxic endpoint; the effect occurred at the highest dose tested (the

limit dose) which is a very high dose to which humans are extremely unlikely to be exposed. The developmental 

NOAEL = 1,000. The developmental LOAEL was not established because there were no adverse effects at the 

highest dose tested. 

4. Mutagenicity

Mutagenicity data are required to support food uses and are available for 1-octanol. In MRID 49458902, data 

from the open scientific literature were cited to satisfy the mutagenicity data requirements. In an Ames assay, 

five strains of Salmonella typhimurium were exposed to 2,000 nl/plate of 1-octanol with or without metabolic 

activation. 1-octanol was not considered mutagenic in the assay. In a mouse lymphoma assay (L5178Y TK+/-), 

cells were exposed to 100 μg/ml 1-octanol with or without metabolic activation. 1-octanol was not considered 

mutagenic in the assay. 

5. 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.

8
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 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.

1-octanol is not among the group of 58 pesticide active ingredients on the initial list to be screened under the 

EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA 

anticipates issuing future EDSP test orders/data call-ins for all pesticide active ingredients. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, the test 

guidelines and the Tier 1 screening battery, please visit the website: http://www.epa.gov/endo/.

B. Dose Response Assessment

Based on the data available to the Agency, there is insufficient hazard concern to warrant a dose-response 

assessment as no toxic endpoints have been identified for 1-octanol. This conclusion is in accord with previous 

Agency conclusions regarding the risk assessment of 1-octanol as a conventional pesticide chemical. 

C. Food Quality Protection Act (FQPA) Considerations

1. Dietary Exposure and Risk Characterization

Human exposure to 1-octanol via dietary exposure to treated commodities is unlikely. Based on this and the low 

hazard concern (lack of toxic endpoints), a quantitative risk assessment is not necessary. Therefore, a qualitative 

assessment is appropriate for 1-octanol. The Agency has determined that there is reasonable certainty of no 

harm to humans when 1-octanol is used according to label instructions. This conclusion is based on the 

following: 1) toxic endpoints have not been identified for 1-octanol based on the available data and information; 

2) residues on food commodities are not anticipated as the chemical is expected to degrade rapidly once applied 

and 3) humans are already exposed to 1-octanol in air, in foods that naturally contain the chemical, and in foods 

to which the chemical has been added as food additive. A detailed discussion of how the Agency arrived at its 

conclusion is provided in the subsequent paragraphs.

For a discussion of the toxicology data available for the active ingredient refer to the section entitled, “II.

Human Health Assessment” above. At this time, no toxic endpoints have been identified for risk assessment 

purposes for 1-octanol. 

Dietary exposure from the proposed use of 1-octanol on root, tuber and bulb crops is not anticipated because the

chemical is expected to degrade rapidly once applied. The half-life of 1-octanol is estimated to be from 3.5 

minutes (US EPA, 2007) to 1.3 days (HSDB, 2014). The chemical is volatile and is expected to degrade in the 

9
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

atmosphere by reaction with photochemically-produced hydroxyl radicals (HSDB, 2014). Residues of the 

pesticide are not anticipated on treated commodities at the time of consumption. 

As discussed previously in this document, humans are already exposed to 1-octanol in the air, in the diet and in 

cosmetics. Dietary exposure, if any, of 1-octanol when used as a pesticide on root, tuber and bulb crops is 

expected to be negligible. Additionally, no endpoints of toxicological concern have been identified for the 

purposes of this risk assessment. In consideration of the available information, unreasonable risks to humans 

from dietary exposure (if any) are unlikely. This conclusion is also in accord with previous Agency conclusions 

regarding the risk assessment of 1-octanol as a conventional pesticide chemical. Further, no safety concerns for 

1-octanol have been identified thus far by the FDA or by the WHO in their assessments of the chemical as a 

food additive. 

 2. Drinking Water Exposure and Risk Characterization

Residues of 1-octanol in drinking water are not expected when products are used according to label instructions. 

The active ingredient is a volatile compound that is already present in the environment. Additionally, 1-octanol 

is expected to degrade rapidly once applied. The pesticide will be used indoors only on stored root, tuber and 

bulb crops and will not be applied directly to water. Therefore, residues of 1-octanol in drinking water are 

unlikely. 

3. Acute and Chronic Dietary Risks for Sensitive Subpopulations Particularly Infants and Children

The Agency has determined that there are no foreseeable dietary risks to sensitive subpopulations, including 

infants and children, from the use of 1-octanol when label instructions are followed. This conclusion is based on 

the following: 1) no toxic endpoints have been identified and there is no evidence to suggest that 1-octanol 

causes increased susceptibility in infants and children; 2) significant dietary exposure is not anticipated when 

label instructions are followed and 3) humans are already exposed to 1-octanol in the diet, in the environment

and in cosmetics.

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

1. Occupational Exposure and Risk Characterization

An occupational exposure assessment was not conducted for sarmentine. Based on the proposed use pattern and 

toxicity data available to the Agency, anticipated exposure is not likely to result in unreasonable risk to 

applicators/handlers. Significant occupational exposure is not anticipated because applicators and handlers are

required to wear PPE that will mitigate exposure to the active ingredient. Additionally, 1-octanol is anticipated 

to degrade rapidly once applied which would preclude significant post-application exposure. No toxic endpoints 

have been identified and significant exposure in an occupational setting is not expected if label instructions are

followed. 

10
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

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

A residential, school and day care exposure assessment was not conducted for 1-octanol. Significant exposure to 

the chemical is not anticipated in residential, school, and day care settings, as products containing this active 

ingredient are intended for indoor use only on crops in storage facilities. 

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

The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA, Section 

408(b)(2)(A)(ii)) require “that there is a reasonable certainty that no harm will result from aggregate exposure to 

pesticide chemical residue, including all anticipated dietary exposures and other exposures for which there are 

reliable information.” Aggregate exposure will typically include exposures from food, drinking water, 

residential uses of a pesticide, and other nonoccupational sources of exposure.

In consideration of the above information, the Agency has determined the risk from aggregate exposure (via 

oral, dermal, and inhalation exposures) is negligible; there is reasonable certainty that no harm will result to the 

general population or to infants and children from aggregate exposure to 1-octanol. No toxic endpoints have 

been identified and exposure for all routes of exposure is anticipated to be insignificant. Therefore, an aggregate 

exposure assessment is not necessary for 1-octanol. 

F. Cumulative Effects

EPA has considered the potential for cumulative effects of 1-octanol and other substances in relation to a 

common mechanism of toxicity. Unlike other pesticides for which EPA has followed a cumulative risk 

approach based on a common mechanism of toxicity, the Agency has not made a common mechanism of 

toxicity finding for 1-octanol and any other substances and 1-octanol does not appear to produce a toxic 

metabolite produced by other substances. The active ingredient is a biopesticide that has a nontoxic mode of 

action. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of 

toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by the 

Agency’s Office of Pesticide Programs concerning common mechanism determinations and procedures for 

cumulating effects from substances found to have a common mechanism on EPA’s website at 

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

G. Risk Characterization

The Agency has considered human exposure to 1-octanol 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 1-octanol as a pesticide when label 

instructions are followed.

11
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

III. Environmental Assessment

A. Nontarget Organism Toxicology 

Based on the indoor-only use pattern of EPs containing the proposed MP, 1,4Zap Technical, all nontarget 

organism toxicology data requirements have been waived. Significant exposure to nontarget organisms is not 

anticipated. The pesticide will be applied in indoor storage facilities. Once applied, if 1-octanol is released into 

the outside air via ventilation systems, environmental fate data and information indicate that the chemical will 

degrade rapidly. The half-life of 1-octanol is estimated to be from 3.5 minutes (US EPA, 2007) to 1.3 days 

(HSDB, 2014). The chemical is volatile and is expected to degrade in the atmosphere by reaction with 

photochemically-produced hydroxyl radicals (HSDB, 2014).

B. Environmental Fate and Groundwater 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. 

C. Ecological Exposure and Risk Characterization

A risk assessment was not conducted for nontarget organisms, including endangered/threatened organisms due 

to the unlikelihood of exposure based on the indoor-only use pattern of end-use products containing the MP, 

1,4Zap Technical. Exposure and risk to nontarget organisms are not anticipated when products are used 

according to label instructions. 

D. 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 

1-octanol’s use has “no effect” or “may effect” federally listed threatened or endangered species (listed species) 

or their designated critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed 

species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or 

National Marine Fisheries Services (the Services) as appropriate.

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1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

REFERENCES

HSDB, 2014. Hazardous Substances Data Bank. National Library of Medicine. Search Term: 1-octanol. 

 <http://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~lUFAi6:1> 

US EPA, 2006. Memorandum from Elissa Reaves and Shanna Recore to Tawanda Spears. Aliphatic Alcohols: 

Human Health Chapter of the Reregistration Eligibility Decision (RED) Document. Reregistration Case 

Number 4004. June 20, 2006. 

US EPA, 2007. Reregistration Eligibility Decision (RED) for Aliphatic Alcohols (Document EPA 738-07-004; 

 March 2007). Docket number EPA-HQ-OPP-2007-0134 at http://www.regulations.gov. 

WHO, 1998. International Programme on Chemical Safety, Safety Evaluation of Certain Food Additives and 

Contaminants, Series 40, Saturated Aliphatic Acyclic Linear Primary Alcohols, Aldehydes and Acids. 

Geneva. http://www.inchem.org/documents/jecfa/jecmono/v040je10.htm. 

CONFIDENTIAL APPENDIX

STUDY SUMMARIES

I. Active Ingredient Characterization 

A. Product Chemistry (MRIDs 48964401 and 49458901)

13 
1-Octanol DP Number: 423496 and 425328

PC Code: 079037 EPA File Symbol No.: 67727-A and 3F8195

Type of Review: Product Chemistry, Human Health, Nontarget Organisms, Tolerance Exemption

 

cc: A. L. Gonzales, G. Burnett, BPPD Science Review File, IHAD/ARS

A. L. Gonzales, Biologist, FT, PY-S: 2-23-15 

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