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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE 

PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: David Lieu (703-305-0079)

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.

TEMPLATE:

Suterra LLC, 20950 NE Talus Place, Bend, Oregon, 97701

2E8043

EPA has received a pesticide petition (2E8043) from Suterra LLC, 20950 NE Talus 

Place, Bend, Oregon, 97701 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 180.920 to establish an 

exemption from the requirement of a tolerance for n-heptane (CAS Reg. No. 142-82-5), in or on 

raw agricultural commodities, when used as an inert ingredient in aerosol, pheromone mating 

disruption products only, and only in concentrations less than forty percent of the total 

formulation, and applied to growing crops only. EPA has determined that the petition contains 

data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, 

EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data 

supports granting of the petition. Additional data may be needed before EPA rules on the 

petition.

Suterra, LLC agrees that this summary information pertaining to this petition may be published 

as a part of the notice of filing of the petition under FFDCA Section 408(d)(3), and as a part of 

the proposed and/or final regulation issued under FFDCA Section 408. 
40 CFR 180.7: Petitions Proposing Tolerances or Exemptions for Pesticide 

Residues in or on Raw Agricultural Commodities

Application to Establish an Exemption from the 

Requirement of a Tolerance for n-Heptane

A. Residue Chemistry

1. Plant metabolism. 

A complete petition for the proposed establishment of an exemption from the requirement of a 

tolerance for n-heptane, in or on raw agricultural commodities, when used as an inert ingredient 

in aerosol, pheromone mating disruption products only, and only in concentrations less than forty 

percent of the total formulation, and applied to growing crops only is included in this 

submission. 

Section A(1) of the petition contains confidential information and calculations regarding specific 

percentages of inert ingredients contained in an existing, currently registered, aerosol, 

pheromone mating disruption product for illustration purposes. Because this specific 

information about an existing product is confidential, the three confidential pages of Section 

A(1) have been moved to the Confidential Appendix of this submission. The location of these 

three pages can be found at CROSS REFERENCE NO. 1 , page 2 of the Confidential 

Appendix.
A. Residue Chemistry

2. Analytical method.

Not applicable. Suterra LLC is applying for an exemption from the requirement of a 

tolerance for n-heptane under 40CFR180.910. Therefore, no analytical method to 

analyze for n-heptane is enclosed with this petition.

3. Magnitude of residues.

Based upon the vapor pressure of 46 mm Hg at 25°C, n-heptane is expected to exist 

entirely in the vapor phase in ambient air (U.S. National Library of Medicine, Hazardous 

Substances Data Bank, 2012). Nonvolatile residue of n-heptane is <0.001 g/100ml 

(CITGO Petroleum Corp, 2007). Based upon these physical properties, and considering 

the specific use pattern and limitations under which this exemption from the requirement 

of a tolerance is being requested (please refer to details of typical application included in 

Section A(1) of this petition), n-heptane is not expected to accumulate on plant or soil 

surfaces. Therefore, no significant amount of n-heptane residue is expected to result 

from the type of application specified in this petition.

B. Toxicological Profile

1. Acute toxicity.

Acute Oral

Acute oral LD50 toxicity of n-heptane, via intravenous application to the mouse, has been 

estimated as 222mg/kg (Jeppsson, Di Paolo). 

Goel et al tested the effect on the liver when rats were injected with n-heptane at 1.0 

ml/kg. The results indicated that enzyme systems in the rat could be caused to 

malfunction when rats are poisoned by high levels of intraperitoneal injection.

Acute Dermal

Direct skin contact with n-heptane may cause pain, burning and itching (Bingham). 

Sittig reports that dermal exposure to n-heptane can cause dermatitis and mucous 

membrane irritation.

Skin contact with liquid n-heptane for one hour led to irritation and dermatitis. (Oettel, 

1936, Also cited in the MAK Collection for Occupational Health and Safety)

Jacobs et al tested the limit concentrations of several aliphatic hydrocarbons for skin 

irritation. Although n-heptane does not appear to have been tested individually, based 

upon structure-activity relationships and results found for similar substances within the 

same chemical family, the irritation potential for n-heptane was determined via 
interpolation. Test substances were diluted with almond oil at 5, 10, 25, 50 and 100% 

concentrations by weight. The highest tested concentration of n-heptane, via 

interpolation, at which the mean erythema score remained below 2 on the Draize scale 

was estimated to be 50%. From this test, a 100% concentration of n-heptane would be 

estimated to be a skin irritant, based upon results for similar aliphatic hydrocarbons.

Inhalation

Inhalation LC50 toxicity of n-heptane to the rat has been calculated by Babanov as 

103,000 mg/m3/4-hour. (Also cited by Bingham, Lewis, U.S. National Library of 

Medicine, ChemIDplus Lite, and Fisher Scientific). 

Bingham also reports that inhalation exposures to 10,000-15,000 ppm n-heptane 

produced central nervous system depression in mice within 30-60 minutes. At 

concentrations higher than 20,000 ppm, exposures caused convulsions and death in mice. 

Bingham reports that concentrations of 16,000 ppm are fatal in humans. 

All of these levels of exposure are at concentration levels that are literally thousands of 

times greater than would occur via the use of n-heptane via aerosol, pheromone mating 

disruption products, as illustrated in Section A(1) of this petition.

2. Genotoxicity.

Brooks, et al tested n-heptane, as well as several other solvents for genotoxic effects. nHeptane did not induce reverse gene mutation in bacteria, did not cause mitotic gene 

conversion in yeast, or damage to chromosomes in mammalian cells.

Bingham et al also report that n-heptane was not mutagenic in the Ames Salmonella 

typhimurium test.

The United States Environmental Protection Agency, Integrated Risk Information System 

reports that after a comprehensive review of toxicity data associated with n-heptane, this 

material belongs to Classification D – Not classifiable as to human carcinogenicity.

n-Heptane has been shown to be negative in the rat liver chromosome. (Sullivan, Also 

cited in U.S. National Library of Medicine, Hazardous Substances Data Bank, 2012

3. Reproductive and developmental toxicity.

No Information found.

4. Subchronic toxicity.

Studies in which rats were exposed to n-heptane for 26 weeks found no evidence of 

neurological disturbances or organ toxicity. (Snyder, Bingham)

5. Chronic toxicity.
No evidence of chronic toxicity is indicated by Bingham. The neurotoxicity of n-heptane 

was studied and compared to the potential neurotoxicity n-pentane and n-hexane by

Takeuchi et al. Wistar strain male rats were exposed to 3000 ppm of n-heptane for 12

hours a day for 16 weeks. The experiment demonstrated that n-heptane did not disturb 

the conduction velocity of the motor nerve or prolong the distal latency in the tail of the 

rat. The experiment also showed that n-heptane did not impair the peripheral nerve, 

neuromuscular junction or muscle fiber of rats that were exposed to high levels of nheptane for 16 straight weeks (Takeuchi). 

Snyder, et al describe an American Petroleum Institute study in which male and female 

rats were exposed to n-heptane concentrations of 400 and 3,000 ppm for six hours a day / 

five days a week / for 26 weeks. No evidence of neurological disturbances or organ 

toxicity was found.

Populations continuously exposed to the highest levels n-heptane are likely to be oil 

refinery operators, transport drivers and retail gasoline station attendants (Rappaport). 

These personnel are continually exposed to n-heptane (and other saturated hydrocarbons), 

on a day to day basis, at much higher levels than would be released into the air via 

aerosol, pheromone mating disruption products as limited by this proposed exemption 

from the requirement of a tolerance. 

Sullivan and Krieger estimate that n-heptane is present in U.S. finished gasoline at an 

estimated range of <1 to 5%, with a weighted average of 2%. Rappaport estimates that 

oil refinery operators, transport drivers and retail gasoline attendants are continually

exposed to air concentrations of n-heptane of 0.243 mg/m3, 0.275 mg/m3, and, 0.200 

mg/m3, respectively. Although these concentrations are difficult to measure and are 

likely to be highly variable during the course of any given workday, it is interesting to 

compare these reported levels to the hypothetically calculated maximum, total 24 hour 

accumulated concentration of 0.0135 mg/m3(ppm) that has been calculated to result from 

the use of n-heptane as proposed in this tolerance exemption petition. Please recall that 

the 0.0135 mg/m3figure is derived by assuming that all n-heptane released in a 24 hour 

period accumulates in the airspace of the orchard. In reality the n-heptane released from 

an aerosol pheromone mating disruption product immediately flashes off into the 

atmosphere and out of the treated area, resulting in much lower actual n-heptane 

concentrations.

6. Animal metabolism.

Based upon the vapor pressure of 46 mm Hg at 25°C, n-heptane is expected to exist 

entirely in the vapor phase in ambient air. (U.S. National Library of Medicine, Hazardous 

Substances Data Bank, 2012). Nonvolatile residue of n-heptane is <0.001 g/100ml. 
(CITGO Petroleum Corp, 2007). Based upon these physical properties, and considering 

the specific use pattern and limitations under which this exemption from the requirement 

of a tolerance is being requested (please refer to details of typical application included in 

Section A(1) of this petition), n-heptane is not expected to come into significant contact 

with non-target animal species.

However, studies have been completed to identify metabolites of n-heptane in the urine 

of animals that have been exposed to large amounts of this material for several weeks. 

Bingham, and also Bahima, indicate that n-heptane is primarily metabolized into its 

parent alcohols, then those alcohols are conjugated by glucuronates or sulfates and then 

eliminated in urine. The primary alcohol metabolites in urine of animals exposed to large 

amounts of n-heptane via inhalation have been identified as 2-heptanol and 3-heptanol 

(Bingham and Bahima). These substances are naturally occurring in many commonly

consumed food and drinks, such as banana and coffee, and are currently utilized in the 

flavoring and fragrance industry (The Good Scents Company)

Soil Degradation by MicroFlora

Garnier et al tested the biodegradation of gasoline and its components when added to a 

soil consortium. After 6 days of incubation, 97% of the overall gasoline was 

biodegraded. The study also singled out the degradation of n-heptane and several other 

individual aromatic alkanes. After 4 days, it was found that 100% of the original 

concentration of n-heptane was degraded (Garnier).

Another study by Haines et al indicates that n-heptane is fully metabolized by soil 

microorganisms, as measured by the biological oxygen demand. Hydrocarbons of lower 

molecular weight (e.g. n-heptane, a straight chained alkane with seven carbons and a 

molecular weight of 100.2) were found to be degraded at relatively higher rates than 

those with higher molecular weights (Haines). 

Solano-Serena also studied the degradation of gasoline and its individual components by

microflora from an urban waste water activated sludge. n-Heptane was found to 

completely biodegrade after 25 days. Mineralization into CO2 and microbial cell 

production were the main products of the carbon in the degraded gasoline.

These studies indicate that even if some small amount of n-heptane did not immediately

flash off and were to reach the soil surface and somehow become exposed to soil 

microorganisms that are present there, the n-heptane would be readily degraded.

7. Metabolite toxicology. 

The primary alcohol metabolites of n-heptane in urine of animals exposed to large 

amounts of this substance via the inhalation route have been identified as 2-heptanol and 

3-heptanol (Bingham). These substances are naturally occurring in many commonly

consumed food and drinks, such as banana and coffee, and are intentionally added to 

products in the flavoring and fragrance industry (The Good Scents Company)
The toxicity of these alcohols in their concentrated form has been determined. This 

information is included herein in the attached Material Safety Data Sheets for these 

substances (TCI America and Sigma-Aldrich). These metabolites are not of scientific 

concern because, as noted in details of the typical application of aerosol pheromone 

mating disruption products, included in Section A(1) of this petition, the maximum 

concentration of n-heptane that can be expected to be present in the treated orchard 

airspace, even if all released n-heptane is conservatively assumed to remain in the 

airspace for an entire 24 hour period, is estimated at approximately 5.5 x 10-5 mg/L, or 

0.0135 ppm. This figure assumes that all of the released formulation stays within the first 

20 vertical feet of the orchard air space for a period of 24 hours. Of course, in reality, the 

n-heptane is quickly flashed off and carried out of the treated orchard area by the wind, 

resulting in much lower expected n-heptane concentrations. 

Perbellini et al report the same major n-heptane biotransformation products from testing 

completed with rats exposed to 1800 ppm of n-heptane for 6 straight hours. The data 

from these tests indicate that one metabolite, 2,5-heptanedione, was detected. However, 

because only small amounts of this substance were detected in the urine of animals that 

were exposed to very high amounts of n-heptane, the authors conclude that this urinary

metabolite is highly unlikely to cause clinical damage to the nervous system (Perbellini). 

Amounts of n-heptane present in the orchard that would result from the application of 

aerosol, pheromone mating disruption products are several orders of magnitude lower 

than 1800 ppm.

Because the level of exposure to n-heptane is expected to be extremely low, the major 

metabolites of n-heptane are naturally occurring in many commonly consumed food and 

drinks, and the major metabolites of n-heptane are readily metabolized, no significant 

concern for n-heptane metabolites exists. 

8. Endocrine disruption. No Information found

C. Aggregate Exposure

1. Dietary exposure.

i. Food.

Based upon the vapor pressure of 46 mm Hg at 25°C, n-heptane is expected to exist 

entirely in the vapor phase in ambient air (U.S. National Library of Medicine, Hazardous 

Substances Data Bank, 2012). Nonvolatile residue of n-heptane is <0.001 g/100ml 

(CITGO Petroleum Corp, 2007). Based upon these physical properties, and considering 

the specific use pattern and limitations under which this exemption from the requirement 

of a tolerance is being requested (please refer to details of typical application included in 

Section A(1) of this petition), n-heptane is not expected to accumulate on plant or soil 
surfaces. Therefore, dietary exposure via food is not a significant concern.

ii. Drinking water.

Based upon the vapor pressure of 46 mm Hg at 25°C, n-heptane is expected to exist 

entirely in the vapor phase in ambient air (U.S. National Library of Medicine, Hazardous 

Substances Data Bank, 2012). Nonvolatile residue of n-heptane is <0.001 g/100ml 

(CITGO Petroleum Corp, 2007). Based upon these physical properties, and considering 

the specific use pattern and limitations under which this exemption from the requirement 

of a tolerance is being requested (please refer to details of typical application included in 

Section A(1) of this petition) n-heptane is not expected to accumulate in water. 

Therefore, dietary exposure via water is not a significant concern.

2. Non-dietary exposure.

After release into the airspace of an orchard via an aerosol, pheromone mating disruption 

product, n-heptane flashes off into the airspace of the orchard. Based upon the vapor 

pressure of 45.8 mm Hg at 25°C, n-heptane is expected to exist entirely in the vapor 

phase in ambient air (U.S. National Library of Medicine, Hazardous Substances Data 

Bank, 2012). Nonvolatile residue of n-heptane is <0.001 g/100ml (CITGO Petroleum 

Corp, 2007). Due to these physical properties, and considering the specific use pattern 

and limitations under which this exemption from the requirement of a tolerance is being 

requested (please refer to details of typical application included in Section A(1) of this 

petition) n-heptane is not expected to significantly accumulate on the skin or clothing, or 

in the eyes of applicators/handlers/farm workers or any other surfaces. Therefore, nondietary exposure is not expected to be a significant concern.

D. Cumulative Effects

After release into the airspace of an orchard via an aerosol, pheromone mating disruption 

product, n-heptane flashes off into the airspace of the orchard. Based upon the vapor 

pressure of 46 mm Hg at 25°C, n-heptane is expected to exist entirely in the vapor phase 

in ambient air (U.S. National Library of Medicine, Hazardous Substances Data Bank, 

2012). Nonvolatile residue of n-heptane is <0.001 g/100ml (CITGO Petroleum Corp, 

2007). Due to these physical properties, and considering the specific use pattern and 

limitations under which this exemption from the requirement of a tolerance is being 

requested (please refer to details of typical application included in Section A(1) of this 

petition) n-heptane, as applied according to the limitations of this petition for the 

exemption from the requirement of a tolerance, is not expected to be present in quantities 

large enough to cause cumulative effects to applicators/handlers or any other incidental 

farm workers. Therefore, cumulative effects of exposure to n-heptane resulting from the 

application of aerosol, pheromone mating disruption products, are not a significant 
concern.

E. Safety Determination

1. U.S. population.

After release into the airspace of an orchard via an aerosol, pheromone mating disruption 

product, n-heptane flashes off into the airspace of the orchard. Based upon the vapor 

pressure of 46 mm Hg at 25°C, n-heptane is expected to exist entirely in the vapor phase 

in ambient air (U.S. National Library of Medicine, Hazardous Substances Data Bank, 

2012). Nonvolatile residue of n-heptane is <0.001 g/100ml (CITGO Petroleum Corp, 

2007). Due to these physical properties, and considering the specific use pattern and 

limitations under which this exemption from the requirement of a tolerance is being 

requested (please refer to details of typical application included in Section A(1) of this 

petition) n-heptane, as applied according to the limitations of this petition for the 

exemption from the requirement of a tolerance, is not expected to be present in quantities 

large enough to expose applicators/handlers or any other incidental farm workers or 

passersby to significant levels of n-heptane. 

For the same reasons, n-heptane is not expected to accumulate on leaves, fruit, or any

other parts of treated orchards. Residues of n-heptane as applied according to the 

limitations of this petition for the exemption from the requirement of a tolerance, are not 

expected to be present in any significant quantity.

Even if any member of the U.S. population were to be exposed to n-heptane via the 

application of aerosol pheromone mating disruption products, studies have shown 

(Bingham and Bahima) that n-heptane is metabolized primarily into its parent alcohols 

(which are normal components of many foods and drinks [The Good Scents Company]) 

and these metabolites are readily eliminated in urine. 

Therefore, application of n-heptane as present in formulations subject to this proposed 

exemption from the requirement of a tolerance, within the limitations of this petition, are 

not expected to cause any significant safety concern to the general U.S. population.

2. Infants and children. 

After release into the airspace of an orchard via an aerosol, pheromone mating disruption 

product, n-heptane flashes off into the airspace of the orchard. Based upon the vapor 

pressure of 46 mm Hg at 25°C, n-heptane is expected to exist entirely in the vapor phase 

in ambient air (U.S. National Library of Medicine, Hazardous Substances Data Bank, 

2012). Nonvolatile residue of n-heptane is <0.001 g/100ml (CITGO Petroleum Corp, 

2007). Due to these physical properties, and considering the specific use pattern and 

limitations under which this exemption from the requirement of a tolerance is being 

requested (please refer to details of typical application included in Section A(1) of this 

petition) n-heptane, as applied according to the limitations of this petition for the 

exemption from the requirement of a tolerance, is not expected to be present in quantities 
large enough to expose infants, children, farm workers or any other incidental passersby 

to significant levels of n-heptane. 

For the same reasons, n-heptane is not expected to accumulate on leaves, fruit, or any

other parts of treated orchards. Residues of n-heptane as applied according to the 

limitations of this petition for the exemption from the requirement of a tolerance, are not 

expected to be present in any significant quantity.

Even if any member of the U.S. population were to be exposed to n-heptane via the 

application of aerosol pheromone mating disruption products, studies have shown 

(Bingham and Bahima) that n-heptane is metabolized primarily into its parent alcohols 

(which are normal components of many foods and drinks [The Good Scents Company]) 

and these metabolites are readily eliminated in urine. 

Therefore, application of n-heptane as present in formulations subject to this proposed 

exemption from the requirement of a tolerance, within the limitations of this petition, are 

not expected to cause any significant safety concern to infants and children.

F. International Tolerances

No specific tolerances have been located for n-heptane as an inert ingredient to be 

contained in pesticidal formulations. However, these occupational exposure limits have 

been defined in the U.S.:

The current Occupational Safety and Health Administration (OSHA) permissible 

exposure limit (PEL) for n-heptane is 500 ppm. (United States Department of Labor, 

2012).

The current National Institute for Occupational Safety and Health (NIOSH) 

recommended exposure limits (RELs) for n-heptane are: 85 ppm as a time weighted 

average for up to a 10 hour workday and a 40 hour workweek (United States Department 

of Labor, 2012). The NIOSH 15 minute ceiling limit is currently set at 440 ppm (United 

States Department of Labor, 2012).

Quantitative comparison of any of these current cautionary workplace exposure limits for 

n-heptane to the hypothetically calculated maximum, total 24 hour accumulated 

concentration of 0.0135 ppm that would result from a typical aerosol, pheromone mating 

disruption product (please refer to theoretical calculations in Section A(1) of this 

petition), quantifies why the application of n-heptane, under the limitations of this 

proposed exemption from the requirement of a tolerance, presents no significant increase 

to the risk for unreasonable adverse effects man, non-target species, or the environment.