BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Isopropyl Myristate

Tetradecanoic acid, 1–methylethyl ester

PC Code : 000207

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division
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August 24, 2011
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TABLE OF CONTENTS 

 I. EXECUTIVE SUMMARY ....................................................................5

II. ACTIVE INGREDIENT OVERVIEW ......................................................7

II. REGULATORY BACKGROUND ...........................................................8

A. Classification .......................................................................................8

B. Food Clearances and Tolerances ...............................................................8

 IV. RISK ASSESSMENT ...............................................................................8

A. Active Ingredient Characterization ............................................................8

B. Human Health Assessment .......................................................................8

1. Toxicology .....................................................................................8

2. Dose Response Assessment ................................................................11

Drinking Water Exposure and Risk Characterization..............................11

3. Occupational, Residential, School and Day Care Exposure and Risk 

Characterization............................................................................11

4. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and

Inhalation ...................................................................................12

5. Cumulative Effects ........................................................................12

6. Risk Characterization ....................................................................12

C. Environmental Assessment ......................................................................12

1. Ecological Hazards.........................................................................12

2. Environmental Fate and Ground Water Data ......................................13

3. Ecological Exposure and Risk Characterization ....................................13

4. Endangered Species Assessment ........................................................13

D. Product Performance/ Efficacy Data ........................................................14

 V. RISK MANAGEMENT DECISION ...........................................................14

A. Determination of Eligibility for Registration ..................................................14
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B. Regulatory Decision .................................................................................14

C. Environmental Justice ..............................................................................14

 VI. ACTIONS REQUIRED BY REGISTRANTS ....................................................15

A. Reporting of Adverse Effects ........................................................................15

 VII. APPENDIX A. Data Requirements (40 CFR Part 158) ........................................15

VIII. APPENDIX B. Product Specific Information ........................................................22

 IX. APPENDIX C. References .............................................................................22

 X. APPENDIX D. Bibliography.........................................................................23 

 XI. GLOSSARY OF ACRONYMS AND ABBREVIATIONS.................................. 28
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Biochemical Pesticides Branch (BPB)

Branch Chief

Linda A. Hollis, M.S.

Health Effects

Angela Gonzales, Biologist 

Product Performance

Clara Fuentes, Entomologist 

Environmental Effects 

Miachel Rexrode, Ph.D., Senior Biologist

Product Chemistry

Jacob Moore, Chemist

Regulatory Action Leader
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Cheryl Greene
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I. EXECUTIVE SUMMARY:

Isopropyl myristate is a pesticidal active ingredient intended for formulation into end-use insecticidal products

that are intended to kill ticks on cats and dogs. Isopropyl myristate is a clear, odorless liquid produced from 

the reaction of myristic acid and isopropyl alcohol. Myristic acid is a naturally occurring fatty acid found in 

plants, plant oils and animal fats including the nutmeg tree, palm oil, coconut oil, butterfat and sperm whale 

oil. Isopropyl alcohol, commonly known as rubbing alcohol, is a secondary alcohol produced and used since 

the 1920s in chemical experimentation and since 1957 in cosmetic, pharmaceutical and household products. 

Isopropyl myristate is commercially synthesized for use as a flavoring agent in a wide range of foods including 

baked goods and desserts. It is used in over 900 cosmetic and personal care products at concentrations ranging 

from 0.00008-78%. Such products include face powders, liquid makeup, beauty creams, body sprays, 

aftershave, deodorants, lotions, and hand sanitizers. Isopropyl myristate is also used as a carrier or solvent in a 

variety of pharmaceutical therapies that require good precutaneous absorption. Such products include hair 

rinses for killing and controlling head lice and transdermal patches for delivery of pain management drugs and

antibiotics. 

The Agency’s assessment of risks, hazards and benefits associated with isopropyl myristate is based on data 

submitted on the unregistered technical active ingredient formulated into the single end-use product containing 

isopropyl myristate as an active ingredient. 

The Biopesticides and Pollution Prevention Division (BPPD) has determined that the data submitted for 

Product Chemistry, Tier I Acute Toxicity, Ecological Effects and Environmental Fate for isopropyl myristate 

satisfy current guideline requirements. The Agency notes, however, that if the intended end-use applications 

result in different exposures to humans than is anticipated, then the registrant may be required to address 

additional data requirements in future submissions. Based on this information, the Agency has determined that 

use of isopropyl myristate as an active ingredient in end-use pesticide products to kill ticks on cats and dogs

will have No Effect on threatened and/or endangered species. The mode of action of the active ingredient is 

desiccation; the chemical dissolves the wax on the cuticle or exoskeleton of the insect which causes the insect 

to dry out or desiccate. 

Based on the acute toxicity data submitted for isopropyl myristate, the Agency classifies the active ingredient 

as a toxicity category II out of four categories with category I being the most toxic and category IV being the 

least toxic. EPA has no concerns about non-target organisms exposed to isopropyl myristate in accordance 

with approved label directions. There are no concerns for any threatened or endangered species. Given that 

isopropyl myristate is a lower toxicity substance and the potential for exposure to the environment is 

insignificant or unlikely, EPA concludes, based on the use pattern, that it is in the best interests of the public 

and the environment to issue the registration for isopropyl myristate.

The Biopesticides and Pollution Prevention Division (BPPD) has reviewed the data and information in support 

of the requirements for granting registration under Section 3(c)(5) of the Federal Insecticide, Fungicide and 

Rodenticide Act (FIFRA). We have determined that the data/information submitted adequately satisfy current 

guideline requirements (see 40 CFR Subpart U § 158.2000). 

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for the public to 

participate in major registration decisions. According to this new policy, EPA intends to provide a public 

comment period prior to making a registration decision for, at minimum, the following types of applications: 

new active ingredient, first food use, first outdoor use, first residential use; and any registration decisions for 

which the Agency believes there may be substantial public interest. 
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Consistent with the policy of making registration actions more transparent, isopropyl myristate and the 

end-use product containing isopropyl myristate as an active ingredient (RESULTIXTM, EPA Registration 

Number 86865-1) was subject to a 30-day comment period as a “new active ingredient”. During this 

comment period, no comments were received on the Agency’s preliminary decision to register. Therefore, 

the Agency maintains that, based upon the risk assessment and information submitted in support of 

registration of RESULTIXTM, it is in the best interest of the public and the environment to issue the 

registration for this pesticide product. The basis for this decision can be found in the risk assessment for 

isopropyl myristate which is characterized throughout this BRAD.
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II. ACTIVE INGREDIENT OVERVIEW

Common Name: Isopropyl Myristate 

 Chemical Names: Tetradecanoic acid isopropyl ester

 Myristic acid isopropyl ester

Trade & Other Names:

Tetradecanoic acid, 1–methylethyl ester Chemical/Systemic name 

Isopropyl myristate Other Common name

Starfol ISOPROPYL MYRISTATE Trade name

Kessco Isopropyl myristate95 Trade name 

Stepan D-50 Trade name

RESULTIXTM Trade name 

 CAS Registry Number: 110-27-0

OPP Chemical Code: 000207

Type of Pesticide: Biochemical Pesticide/Insecticide 

Molecular formula: C17H34O2

Molecular Weight: 270.46g/mol
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III. REGULATORY BACKGROUND

Isopropyl myristate was first registered by EPA on October 31, 1986, as an active ingredient for use in 

antimicrobial pesticides. By the end of 1987, all products containing isopropyl myristate as an active ingredient 

were cancelled following a generic data call-in. On December 3, 2009, EPA received an application filed by

Piedmont Animal Health, (204 Muirs Chapel Road, Suite 200, Greensboro, NC 27410) to register an end-use 

product containing isopropyl myristate as an insecticide to kill ticks on cats and dogs. RESULTIXTM, the enduse product contains 50.0 % isopropyl myristate as an active ingredient. A notice of receipt of this application, 

allowing for a 30-day comment period, was published in the Federal Register on March 10, 2010 (75FR 

28702). No comments were received following this publication.

A. Classification

Isopropyl myristate is classified as a synthetic substance, not naturally occurring. Moreover, some may 

question whether its mode of action is actually non-toxic. Nonetheless, on March 27, 2009, the Agency’s 

Biochemical Classification Committee completed a review of isopropyl myristate, which determined that,

although the substance is not naturally occurring, it nonetheless is eligible for a reduced set of data 

requirements, based on a mode of pesticidal action similar to sucrose octanoate, which is a registered 

biochemical pesticide. 

B. Food Clearances/Tolerances 

Currently this active ingredient is not registered on food or feed commodities. 

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

Isopropyl myristate is a pesticidal active ingredient intended for formulation into products to kill ticks on cats 

and dogs. It is a clear, odorless liquid produced from the reaction of myristic acid and isopropyl alcohol. 

Myristic acid is a naturally occurring fatty acid found in plant and plant oils and animal fats including the 

nutmeg tree, palm oil, coconut oil, butterfat and sperm whale oil. Isopropyl alcohol, commonly known as 

rubbing alcohol, is a secondary alcohol produced and used since the 1920’s in chemical experimentation, and 

since 1957 in cosmetic, pharmaceutical and household products. The end-use product (EP) is intended for use 

on cats and dogs to kill ticks. The mode of action of this active ingredient is physical in that isopropyl 

myristate de-waxes the cuticle or outer skeleton of the target pest (tick). Insects such as ticks need waxed 

cuticles in part to maintain body fluids. Once cuticle wax is destroyed or compromised the insect loses critical 

body fluids and simply dries up or undergoes desiccation. 

All data requirements have been satisfied per 40 CFR 158.2030 for registration of the end-use product 

RESULTIXTM. The data presented in Table 1 of the appendix to this document are a summary of the product 

chemistry data and information submitted to support the EP, RESULTIXTM. 

B. Human Health Assessment

1. Toxicology 

For acute toxicity data requirements, toxicity categories are assigned based on the hazard(s) identified from 

studies and/or information on file with the Agency. The active ingredient is classified into Toxicity Category I, 
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II, III or IV where Toxicity Category I indicates the highest toxicity and Toxicity Category IV indicates the 

lowest toxicity. 

Adequate mammalian toxicology data/information is available to support registration of isopropyl 

myristate. All toxicology data requirements for isopropyl myristate have been satisfied. The Agency has 

classified isopropyl myristate into Toxicity Category II.

a. Acute Toxicity

Acute toxicity testing is required to 1) determine systemic toxicity from acute exposure via the dermal, 

inhalation and oral routes, 2) determine irritant effects from exposure to the eyes and skin, and 3) 

determine the potential for skin sensitization (allergic contact dermatitis). 

All data cited by the registrant to satisfy the biochemical pesticide data requirements for isopropyl 

myristate as an active ingredient were submitted from the open scientific literature. Additional data were 

obtained using the Hazardous Substances Database (HSDB) from the National Library of Medicine. Data 

submitted to satisfy the one registered product show that isopropyl myristate has low acute oral, acute 

dermal and acute inhalation toxicity. An additional acute inhalation toxicity study from the HSDB (2011) 

indicates no mortality or significant adverse effects when rats were exposed to an aerosol formulation 

containing 4.7% isopropyl myristate (9.7 mg/L) for four 15-minute periods. Several eye irritation studies 

conducted on rabbits indicate that the chemical is nonirritating to minimally irritating. Studies on the 

dermal irritation of isopropyl myristate have yielded mixed results. The majority of these studies indicate 

that the chemical is minimally irritating when applied to rabbits. One study showed severe irritation in 

rabbits, moderate irritation in guinea pigs and mild irritation in rats. The Agency has conservatively 

classified isopropyl myristate into toxicity category II on a scale of IV for dermal irritation based on the 

results of this study. The results of the other studies demonstrate that the chemical is only mildly irritating

and meets the Agency’s classification of a toxicity category II active ingredient. The active ingredient is 

not considered to be a skin sensitizer.

For additional information regarding acute toxicity data requirements, refer to Table 2 in Appendix A of 

this document. 

b. Subchronic Toxicity

Subchronic data are required to determine a no-observed-effect-level (NOEL) and any toxic effects 

associated with repeated or continuous exposure to a test substance for a period of ninety days. 

90-Day Oral

In a 28-day non-guideline oral toxicity study, Wistar rats were exposed to the end-use product 

(RESULTIXTM) via gavage once per day for five days a week at 0, 100, 500 or 1000 mg/kg bw. No 

treatment-related mortality or adverse effects were observed. Hyperplasia of the fore stomach mucosa was 

recorded in all the test groups, including the control group. The injury was reversible following the 14-day 

recovery period. The NOAEL is ≥ 1000 mg/kg bw; the LOAEL could not be determined (no adverse 

effects at the highest dose tested). (HSDB, 2011). Repeat human oral exposure is not expected based on 

the use pattern; isopropyl myristate is not food-use and will be applied dermally to cats and dogs to kill 

ticks. 

90-Day Dermal
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In a 28-day non-guideline dermal toxicity study, Landrace-Duroc pigs were exposed to the end-use

product (RESULTIXTM) every three days. The applied doses were equivalent to 0, 20.31-33.89, 59.62-

94.43, or 196.3-321.3 mg/kg bw. No mortality or adverse treatment related effects were observed. At the 

highest dose, there was a slight increase in male pituitary weights and there was an equivocal increase in 

female adrenal weights. These changes were not detected by the end of the 14-day recovery period. These 

observations may be treatment-related, but are not considered toxicologically significant due to the lack of 

associated findings or changes in the evaluated toxicological parameters. The NOAEL is ≥ 196.3-321.3 

mg/kg bw and the LOAEL could not be determined as no adverse effects were identified at the highest 

dose tested. Prolonged dermal exposure to the human skin is not expected as the end-use product is not 

intended to be purposely applied directly to the skin.

90-Day Inhalation

In a 13-week inhalation study, guinea pigs were exposed for three one-hour periods every day to an 

aerosol formulation containing 16-20% isopropyl myristate at 0, 63.3, or 224 mg/m3. At four weeks, half 

of the animals were sacrificed. One female died during the course of the study from unknown causes. 

There was an increase in absolute and relative lung weights in the treated animals compared to the control 

animals. No other adverse treatment-related effects were observed during gross necropsy and histology in 

the animals that were sacrificed at four weeks and 13 weeks. 

In a 13-week inhalation study, cynomolgus monkeys were exposed for three one-hour periods every day to 

the same formulation used in the guinea pig study (above) at 0, 5.3, 8.4, 33.6, or 37.0 mg/m3. During the 

study, coughing and wheezing were observed and there was a bloody nasal discharge in two of the animals 

exposed to the 8.4 mg/m3dose. Accumulations of macrophages within the bronchiolar and alveolar walls 

were observed and were dose-related in treated monkeys. No other adverse treatment-related effects were 

noted.

Significant repeat inhalation exposure is unlikely based on the use pattern and low volatility of the active 

ingredient (<1 Torr at 20o C).

For additional information regarding subchronic toxicity data requirements, refer to Table 2 in Appendix 

A of this document. 

c. Developmental Toxicity 

Developmental toxicity data on technical grade active ingredients are a standard requirement for the 

registration of pesticide active ingredients. As described above, products containing isopropyl myristate, 

are commonly used by the general population, including human females. Due to the lack of reported 

adverse effects to humans females from the use of these products, the Agency is not requiring these data at 

this time. 

d. Mutagenicity

Results were negative in an Ames mutagenicity assay with and without metabolic activation using 

Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 at concentrations of 4, 20, 

100, 500 and 2500 μg/plate. In a similar Ames assay, results were negative using the same S. typhimurium 

strains with and without metabolic activation at a concentration of 50 mg/mL. Isopropyl myristate was 

non-mutagenic in these assays. 
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Data from an in vitro mammalian mutagenicity assay are unavailable. But, significant human exposure is 

unlikely; isopropyl myristate is not structurally related to a known mutagen and does not belong to a 

chemical class of compounds containing a known mutagen. Refer to Table 2 for product-specific 

information.

e. 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.

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 nine 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.

Isopropyl myristate is not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP. Under FFDCA section 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 our website: http://www.epa.gov/endo/.

A. Dose Response Assessment

 No relevant toxicological endpoints were identified; therefore, a dose response assessment is not required 

for this pesticidal active ingredient. 

B. Drinking Water Exposure and Risk Characterization

 Based on the use pattern of isopropyl myristate as a contact pesticide to kill ticks on cats and dogs, 

pesticide residues in drinking water are not expected when products containing isopropyl myristate are 

used according to label instructions. Pesticide application to pets is generally considered by the 

Agency to be an indoor use pattern; therefore, isopropyl myristate residues in drinking water are highly 

unlikely. 

C. Occupational, Residential, School and Day Care Exposure and Risk Characterization
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a. Occupational Exposure and Risk Characterization

An occupational exposure assessment was not conducted for isopropyl myristate. Based on the use pattern 

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

to humans including animal health care professionals and animal grooming professionals. No relevant 

toxicological endpoints were identified and significant exposure in an occupational setting is not expected. 
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D. Residential, School and Day Care Exposure and Risk Characterization

A residential, school and day care exposure assessment was not conducted for isopropyl myristate. Based 

on the use pattern, school and day care exposures are unlikely. Although the product will be used in 

residential settings, based on the use pattern and toxicity data available to the Agency, anticipated 

exposure is not likely to result in unreasonable risk to humans. No relevant toxicological endpoints were 

identified and significant exposure in a residential setting is not expected. 

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

There is reasonable certainty that no harm to the U.S. population will result from aggregate exposure to 

isopropyl myristate. This includes all exposures for which there is reliable information. The Agency 

arrived at this conclusion isopropyl myristate’s highly specific mode of action as a topical insecticide 

limited to use on cats and dogs, its low toxicity to mammalian systems and the intended non-food use. The 

risk from aggregate exposure (via oral, dermal and inhalation exposures) is negligible. The Agency has 

conservatively classified isopropyl myristate into toxicity category II for possible eye irritation. The 

Agency will mitigate the potential for eye irritation through product labeling language. 

F. Cumulative Effects

EPA has considered the potential for cumulative effects of isopropyl myristate and other substances in 

relation to a common mechanism of toxicity. However, because of its highly specific mode of action as a 

topical insecticide limited to use on cats and dogs, its low toxicity to mammalian systems and the intended 

non-food use, the Agency does not expect any cumulative or incremental effects from exposure to residues 

of isopropyl myristate. 

G. Risk Characterization

The Agency considered human exposure to isopropyl myristate in light of the relevant safety factors in 

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 isopropyl myristate when label 

instructions are followed. 

H. Environmental Assessment

Ecological Hazards 

The Agency has evaluated the potential for toxicity of isopropyl myristate and the end-use products

to aquatic and terrestrial ecosystems and concludes that the potential for exposure to the environment 

is insignificant or unlikely. Isopropyl myristate will be formulated into products that will be applied 

to dog and cats as a topical spray treatment to kill ticks and is not expected to impact nontarget 

species because of limited exposure due to its indoor use pattern. Therefore, Non Target Organisms 

and Environmental Fate Data Requirements were waived based on the rationales below. The Agency 

is requiring that the end-use product label carry environmental hazard information regarding potential 

toxicity to aquatic organisms and to prevent accidental release to aquatic environments and water 

bodies.

a. Acute Toxicity Aquatic Invertebrates (Daphnids) – TGAI & EP
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A search of available environmental databases for isopropyl myristate did not produce any acute 

toxicity data for aquatic invertebrates. This compound, however, is lipophilic and has a very low 

solubility in water (0.014 mg/L). However, isopropyl myristate is also semi volatile suggesting low 

potential exposure to aquatic organisms. 

b. Freshwater Fish Acute Toxicity - TGAI & EP

A search of available environmental data produced one acute fish 96-hour LC50 =100 mg/L that shows that 

isopropyl myristate is practically non-toxic to fish. This compound is lipophilic and has a very low solubility 

in water (0.014 mg/L) suggesting low exposure to fish and other aquatic organisms.

c. Avian Acute Oral and Dietary Toxicity Avian - TGAI & EP

The end-use product is intended to be used indoors and applied as a topical spray to cats and dogs and 

therefore exposure to birds as a result of this indoor use pattern is unlikely. In the event of label misuse, the 

potential routes of exposure to birds from the use of the product are inhalation, dermal, and oral. The route of 

exposure for these two studies is oral (gavage and dietary); the other routes are not applicable. Because the 

end-use product is a colorless and practically odorless liquid product, it is unlikely that the end-use product 

would be gastronomically attractive for birds to ingest. Usually toxicity to birds occurs from ingestion of 

pesticide products that resemble seeds (e.g., granular formulation) or from ingestion of pesticide residues on 

plant and other food items (insects). Additionally, the container is small (20 mL) and spillage of the colorless 

fluid would result in minimal amounts present on soil or plant surfaces. Birds are also unlikely to mistake 

accidental spillage of the end-use product as water, particularly because of the small volume and rapid 

volatilization of the product. 

d. Terrestrial Plant Toxicity Seedling Emergence and Vegetative Vigor - TGAI & EP

The target species for products containing isopropyl myristate are ticks found on domestic cats and 

dogs. Therefore, direct or indirect application of the end-use product to terrestrial plants is not 

expected to occur if label instructions are followed. 

e. Nontarget Insect Testing - TGAI & EP

Because isopropyl myristate is used to kill ticks by desiccation (solubilizing the cuticle), it is likely to have the 

same affect on all insects and other arthropods. However, the Agency believes that the use indoor pattern on 

domestic cats and dogs, and the limited application (20 ml) precludes contact with nontarget insects, 

particularly honeybees. 

f. Environmental Fate and Groundwater 

The need for environmental fate and groundwater data was not triggered because isopropyl myristate acute 

toxicity studies did not trigger any additional Tier I studies. 

g. Ecological Exposure and Risk Characterization 
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Based on the information submitted in the data waiver requests for nontarget plants and nontarget insects, 

exposure and risk from the use of isopropyl myristate is not expected to occur for other nontarget organisms. 

h. Endangered Species Assessment 

Based on the information discussed above, the Agency has determined that registered use of isopropyl 

myristate as an active ingredient will have No Effects on threatened and/or endangered species. When the 

product is used according to label use directions, there are no concerns for any nontarget organisms. 
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D. Product Performance (Efficacy)

Product performance data must be developed for all pesticides to ensure that pesticide products will perform as 

intended and that unnecessary pesticide exposure to the environment will not occur as a result of the use of 

ineffective products. The Agency reserves the right to require, on a case-by- case basis, submission of efficacy 

data for any pesticide products registered or proposed for registration that are intended to be used to control a 

pest of significant public health importance and any public health pest defined in FIFRA section 28(d) and 

section 2(nn). For further guidance on product performance regulatory requirements, refer to Pesticide 

Registration (PR) Notices 96-7,(http://www.epa.gov/PR _Notices/pr1996-7.pdf), 2002-1

(http://www.ea.gov/PR_Notices/pr2002-1.pdf) and the Agency’s “Explanation of Statutory Framework for 

Risk-Benefit Balancing for Public Health Pesticides” (http://www.epa.gov/pesticides/health/risk-benefit.htm).

As required by regulation (FIFRA section 28(d) and section 2(nn)) product performance data/information 

(MRID 479253-17 and MRID 479253-18) were submitted to support the efficacy of the end-use product 

RESULTIXTM. The Agency has determined that the submitted data/information submitted in support of the 

end-use product RESULTIXTM satisfies current testing requirements as described at 40CFR 158.2070 for this 

active ingredient and the end-use product. 

V. RISK MANAGEMENT DECISION

A. Determination of Eligibility for Registration

Section 3(c) (5) of FIFRA provides for the registration of a new active ingredient if it is determined that: (A) 

its composition warrants proposed claims; (B) its labeling and other materials comply with the requirements of 

FIFRA; (C) it will perform its intended function without unreasonable adverse effects on the environment; and 

(D) when used in accordance with widespread and commonly recognized practice, it will not generally cause 

unreasonable adverse effects on the environment. 

The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied by the science 

assessments supporting products containing isopropyl myristate. Such products are not expected to cause 

unreasonable adverse effects and [are likely to provide protection, as claimed when used according to label 

instructions. Therefore, isopropyl myristate as a technical grade active ingredient is eligible for registration for 

the labeled uses. 

B. Regulatory Decision

The data submitted fulfill the registration requirements of isopropyl myristate for use as a topical spray 

treatment for killing ticks on cats and dogs. Refer to Appendix B for product-specific information.

1. Conditional/Unconditional Registration

All data requirements are fulfilled, and EPA has determined that unconditional registration of isopropyl 

myristate Technical Grade Active Ingredient is appropriate.

C. Environmental Justice

EPA seeks to achieve environmental justice—the fair treatment and meaningful involvement of all people 

regardless of race, color, national origin, or income—with respect to the development, implementation, and 

enforcement of environmental laws, regulations, and policies. To help address potential environmental justice 
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issues, the Agency seeks information on any groups or segments of the population who, as a result of their 

location, cultural practices, or other factors, may have atypical or unusually high exposure to isopropyl 

myristate compared the general population. Please comment if you are aware of any sub-populations that may 

have atypical or unusually high exposure as compared to the general population. 

For additional information regarding environmental justice issues, please visit EPA’s website at 

http://www.epa.gov/compliance/environmentaljustice/index.html.

VI. ACTIONS REQUIRED BY REGISTRANTS

Notwithstanding the information stated in the previous paragraph, it should be clearly understood that certain 

specific data are required to be reported to EPA as a requirement for maintaining the Federal registration for a 

pesticide product. A brief summary of these types of data are listed below. 

A. Reporting of Adverse Effects

Pursuant to FIFRA section 6(a)(2), reports of all incidents of adverse effects to the environment must be 

submitted to EPA.

B. Reporting of Hypersensitivity Incidents

Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) must be 

reported to the Agency under the provisions of 40 CFR Part 158.2050(d).

VII. APPENDIX A. Data Requirements (40 CFR Part 158-Subpart U)

*NOTE: Master Record Identification (MRID) numbers listed in the following tables are representative of 

supporting data for the original registration of the product containing this active ingredient. Subsequent to this 

registration, there may be additional MRIDs that support registration of other products containing this active 

ingredient. 
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TABLE 1. Physical and Chemical Properties for RESULTIXTM and isopropyl myristate TGAIa

Guideline Reference 

No./Property

Description of Result Methods

830.6302 Color TGAI: colorless

EP: colorless

Visual inspection

830.6303 Physical State TGAI: liquid

EP: liquid 

Visual inspection

830.6304 Odor TGAI: odorless

EP: odorless

Olfactory inspection

830.6313 Stability TGAI: stable

EP: stable 

Storage stability studiesb,c

830.6315 Flammability TGAI: flash point 164.4°C closed cup

EP: flash point 85.0°C closed cup; 95.0°C open 

cup

FDA, 16 CFR 1500.3 

(c)(6) and 43 (a)e

830.6317 Storage Stability TGAI: No loss of isopropyl myristate and no 

container leachate components identified.

TGAI: Stored in 100 mL 

carbon steel containers at 

25° and 40°C / 60% 

relative humidity for 48 

months.b

EP: No loss of isopropyl myristate and no 

container leachate components identified. 

EP: Stored in 1 oz. and 2 

oz. HDPE bottles at 25° 

and 40°C / 60% relative 

humidity for 48 months.c

830.6319 Miscibility TGAI: not required

EP: Not applicable, the product is not intended 

for dilution with petroleum solvents.

830.6320 Corrosion 

Characteristics

TGAI: Not required

EP: Not expected to be corrosive. 

Storage stability studiesb,c

830.7000 pH TGAI: not applicable

EP: not applicable

Both the TGAI and EP 

are not soluble or 

dispersible in water.

830.7100 Viscosity TGAI: not required 

EP: 3.5 – 3.7 cP

Storage stability studiesc
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 21 of 32

TABLE 1. (Cont.) Physical and Chemical Properties for RESULTIXTM and isopropyl myristate TGAIa 

Guideline Reference 

No./Property

Description of Result Methods

830.7200 Melting Range TGAI: Not applicable, the product is a liquid.

EP: not required

830.7220 Boiling Range TGAI: 192.6°C

EP: not required

CIR (1982)f

830.7300 Density/Relative 

Density/Bulk 

Density

TGAI: 0.85 to 0.86 g/mL

EP: 0.85 to 0.86 g/mL

CIR (1982)f

830.7370 Dissociation 

Constant in Water

TGAI: Not applicable, the product is not pure 

active ingredient and is insoluble in water.

EP: not required

CIR (1982)f

830.7550 Partition Coefficient TGAI: 7.17 – 7.43

EP: not required

CIR (1982)f

830.7840 Water Solubility TGAI: insoluble in water

EP: not required

CIR (1982)f

830.7950 Vapor Pressure TGAI: <1 Torr

EP: not required

CIR (1982)g
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 22 of 32

All toxicology data requirements have been satisfied per 40 CFR 158.2050. The data presented in Table 1 below are a 

summary of the toxicity data and selected endpoints for isopropyl myristate. Table 2. Mammalian Toxicology Data and 

Selected Endpoints for isopropyl myristate (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results1 Toxicity 

Category/Description MRID

Acute oral toxicity (rat)

(870.1100)

LD50 > 13.6 g/kg IV

47925309

48348202

Acute dermal toxicity (rabbit)

(870.1200)

LD50 = 5000 mg/kg III

47925309

48348202

HSDB, 

2011

Acute inhalation toxicity (rat)

(870.1300)

LC50 > 33-41 mg/L2IV

47925309

48348202

HSDB, 

2011

Primary eye irritation (rabbit)

(870.2400)

Minimally irritating III

47925309

48348202

HSDB, 

2011

Primary dermal irritation (rabbit, 

guinea pig, rat)

(870.2500)

Minimally - severely irritating3II

47925309

48348202

HSDB, 

2011

Dermal sensitization (guinea 

pig)

(870.2600)

Not a sensitizer N/A

47925309

48348202

HSDB, 

2011

Hypersensitivity incidents

(885.3400)

Must be reported N/A N/A
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 23 of 32

All toxicology data requirements have been satisfied per 40 CFR 158.2050. The data presented in Table 1 below are a 

summary of the toxicity data and selected endpoints for isopropyl myristate. Table 2. Mammalian Toxicology Data and 

Selected Endpoints for isopropyl myristate (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results1 Toxicity 

Category/Description MRID

90-Day oral toxicity 

(870.3100)

Repeat human oral exposure is not 

expected based on the use pattern. 

A 28-day non-guideline oral toxicity 

study was submitted on the EP but is 

classified as unacceptable due to 

deficiencies in the study.

A 28-day oral toxicity study conducted in 

rats at 0, 100, 500 or 1000 mg/kg bw-day

resulted in a NOAEL of ≥ 1000 mg/kg 

bw. The LOAEL could not be 

determined (no adverse effects at the 

highest dose tested). 3 

47925315

HSDB, 

2011

90-Day dermal toxicity (pig)

(870.3250)

No purposeful application to the 

human skin based on use pattern. 

Prolonged dermal exposure is not 

expected.

A 28-day non-guideline dermal 

toxicity study in pigs was submitted on 

the EP. The dermal LOAEL could not 

be determined (no adverse effects at 

the highest dose tested) and the 

NOAEL ≥ 196.3-321.3 mg/kg bw.

3

 

48348201

47925316
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 24 of 32

All toxicology data requirements have been satisfied per 40 CFR 158.2050. The data presented in Table 1 below are a 

summary of the toxicity data and selected endpoints for isopropyl myristate. Table 2. Mammalian Toxicology Data and 

Selected Endpoints for isopropyl myristate (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results1 Toxicity 

Category/Description MRID

90-Day inhalation toxicity

(870.3465)

No likelihood of significant repeat 

inhalation exposure based on use 

pattern and low volatility of the active 

ingredient.

A 13-week inhalation study conducted 

in guinea pigs with an aerosol 

formulation containing 16-20% 

isopropyl myristate at 0, 63.3, or 224 

mg/m3resulted in increased absolute 

and relative lung weights. No other 

treatment-related effects were 

observed.

A 13-week inhalation study conducted 

in cynomolgus monkeys with the same 

formulation at 0, 5.3, 8.4, 33.6, or 37.0 

mg/m

3

resulted in accumulations of 

macrophages within the bronchiolar 

and alveolar walls that were doserelated in treated monkeys. No other 

treatment-related effects were noted. 

47925309

48348201

HSDB, 

2011

Mutagenicity-bacterial reverse 

mutation test (Ames)

(870.5100)

Negative at 4, 20, 100, 500, 2500 

μg/plate with and without metabolic 

activation in Salmonella typhimurium. 

HSDB, 

2011
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 25 of 32

All toxicology data requirements have been satisfied per 40 CFR 158.2050. The data presented in Table 1 below are a 

summary of the toxicity data and selected endpoints for isopropyl myristate. Table 2. Mammalian Toxicology Data and 

Selected Endpoints for isopropyl myristate (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results1 Toxicity 

Category/Description MRID

Mutagenicity-in vitro mammalian 

cell assay (870.5300 and 

870.5375)

No data were submitted. However, 

significant human exposure is unlikely; 

isopropyl myristate is not structurally 

related to a known mutagen and does 

not belong to a chemical class of 

compounds containing a known 

mutagen. 

A life-time dermal carcinogenicity 

study conducted in mice at 10%, 50% 

and 100% isopropyl myristate diluted 

in acetone resulted in no difference in 

skin tumor frequency when compared 

to controls. 

48348201

47925309

HSDB, 

2011

Developmental toxicity

(870.3700)

No data submitted. However, 

significant exposure to female humans 

is unlikely based on use pattern and 

low volatility. 

47925309

48348201
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 26 of 32

Table 2. Mammalian Toxicology Data Requirements for RESULTIXTM (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description

MRID

Acute oral toxicity (rat)

(870.1100)

No data were submitted for the EP. 

Based on reported LD50 values for the 

active and inert ingredients, the estimated 

LD50 > 4,800 mg/kg 

III 47925309

Acute dermal toxicity (rat and 

rabbit)

(870.1200)

LD50 > 5,050 mg/kg (rabbit)

LD50 > 5,050 mg/kg (rat)

IV

47925310

47925311

Acute inhalation toxicity (rat)

(870.1300)

No data were submitted for the EP. 

Based on reported LD50 values for the 

active and inert ingredients, the estimated 

LD50 = 2.7 mg/L

IV 47925309

Primary eye irritation (rabbit)

(870.2400)

Minimally irritating IV

47925312

Primary dermal irritation 

(rabbit)

(870.2500)

Nonirritating IV 47925313

Dermal sensitization (guinea 

pig)

(870.2600)

Not a sensitizer 47925314

Hypersensitivity incidents

(885.3400)

Must be reported

VIII. APPENDIX B.

For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels.

IX. APPENDIX C.

REFERENCES

Environmental Canada (EC). 2008. Screening Assessment for the Challenge Decamethylcyclo-pentasiloxane

(D5). Excerpt only. http://www.ec.gc.ca/substances/ese/eng/challenge/batch2/batch2_541-02-6_en.pdf

Office of Environmental Health Hazard Assessment for the State of California (OEHHA).2007. Toxicity Data 

Review. Decamethylcyclopentasiloxane (D5). Excerpt only.

http://www.arb.ca.gov/toxics/dryclean/oehhad5review.pdf
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 27 of 32

(FDA Inactive Ingredients Database, 2011).

(Household Products Database, 2010)

X. Appendix D.

BIBLIOGRAPHY

MRID Citation Reference

78632 Institut Francais de Recherches et Essais Biologiques (19??) A Study of the Irritant and 

Cough Provoking Potential of Ru 15 525 in the Guinea Pig and the Beagle: I.F.R.E.B.-R 

760363. (Unpublished study received on unknown date under unknown admin. no.; 

submitted by McLaughlin, Gormley, King Co., Minneapolis, Minn.; CDL:238269-L) 

90603 Union Camp Corporation (19??) Material Safety Data Sheet: Unimate 605. (Unpublished 

study received Feb 21, 1978 under 40195-1; submitted by Reaenge Insect Repellent Corp., 

Savannah, Ga.; CDL:232894-C) 

90604 Union Camp Corporation (1976) Unimate Fatty Esters for Use in Cosmetics. Wayne, N.J.: 

Union Camp. (Product specifications, Jun; also In unpublished submission received Feb 21, 

1978 under 40195-1; submitted by Reaenge Insect Repellent Corp., Savannah, Ga.; 

CDL:232894-D) 

90606 Bio-Toxicology Laboratories, Incorporated (19??) Summary & Conclusions of Toxicity 

Data: Unimate 605 B 8126. Summary of studies 232895-B through 232895-D. (Unpublished 

study received Feb 21, 1978 under 40195-1; submitted by Reaenge Insect Repel- lent Corp., 

Savannah, Ga.; CDL:232895-A) 

90614 Bio-Toxicology Laboratories, Incorporated (19??) Draize Eye Irritation Study: Unimate 605 

B 8126. (Unpublished study received Feb 21, 1978 under 40195-1; submitted by Reaenge 

Insect Repel- lent Corp., Savannah, Ga.; CDL:232895-B) 

90615 Bio-Toxicology Laboratories, Incorporated (19??) Primary Irritation Study: Unimate 605 B 

8126. (Unpublished study received Feb 21, 1978 under 40195-1; submitted by Reaenge 

Insect Repel- lent Corp., Savannah, Ga.; CDL:232895-C) 

90616 Bio-Toxicology Laboratories, Incorporated (19??) Acute Oral Toxicity Study: Unimate 605 

B 8126. (Unpublished study received Feb 21, 1978 under 40195-1; submitted by Reaenge 

Insect Repellent Corp., Savannah, Ga.; CDL:232895-D) 

123292 Weil, C.; Scala, R. (1971) Study of intra- and interlaboratory variability in the results of 

rabbit eye and skin irritation tests. Toxicology and Applied Pharmacology 19:276-360. (Also 

In unpublished submission received Sep 16, 1982 under 3134-23; submitted by Evsco 

Pharmaceutical Co., Bulna, NJ; CDL:248947-A) 

5000045 Stenbaeck, F. (1977) Local and systemic effects of commonly used cutaneous agents: 

Lifetime studies of 16 compounds in mice and rabbits. Acta Pharmacologica et Toxicologica 

41(5):417-431. 

5004319 Stenback, F.; Shubik, P. (1974) Lack of toxicity and carcinogenicity of some commonly 

used cutaneous agents. Toxicology and Applied Pharmacology 30:7-13. 
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 28 of 32

47811700 Piedmont Animal Health (2009) Submission of Product Chemistry and Toxicity Data in 

Support of the Petition for Tolerance of (Inert Ingredient). Transmittal of 1 Study.

47811701 Phillips, S. (2009) Chemistry and Toxicological Information for (Inert Ingredient). 

Unpublished study prepared by Piedmont Animal Health. 83 p.

47925300 Piedmont Animal Health (2009) Submission of Product Chemistry, Toxicity, and 

Environmental Fate Data in Support of the Application for Registration of RESULTIXTM

Transmittal of 20 Studies.

47925301 Phillips, S. (2009) Miscellaneous Chemistry Information: RESULTIXTM. Unpublished study 

prepared by Piedmont Animal Health. 77 p.

47925302 Ballard, T. (2009) Determination of the Percent Active Ingredient and Impurities in Five 

Batches of Isopropyl Myristate Technical Grade Active Material: (RESULTIXTM). Project 

Number: 09/0033, PAH/09/0057. Unpublished study prepared by En-Cas Analytical 

Laboratories. 107 p.

47925303 Omoruan, P. (2005) The Forced Degradation Study for Isopropyl Myristate Drug Substance 

and Isopropyl Myristate Solution (50% w/w) by GC: (RESULTIXTM). Project Number: 

PED/AR/014/0105/R0. Unpublished Study Prepared by Patheon, Inc. 79 p.

47925304 Carr, G. (2009) Storage Stability of Isopropyl Myristate Manufacturing-Use Product at 25 

degrees Celsius and 40 degrees Celsius in Carbon Steel Containers for up to 48 Months: 

RESULTIXTM. Project Number: PED/SP/019/0706/R1. Unpublished study prepared by 

Patheon. 41 p.

47925305 Kaminsky, M. (2007) Isopropyl myristate Solution: Flammability/Flash Point: 

(RESULTIXTM). Project Number: 10633/07. Unpublished study prepared by Stillmeadow, 

Inc. 9 p.

47925306 Serrano, S. (2007) Analysis of Extractables and Leachables in HDPE Bottles and PP Caps 

Used to Package the Isopropyl Myristate D5 Formulation (Feasibility Study): 

(RESULTIXTM). Project Number: R061229B. Unpublished study prepared by Guidelines, 

Inc. 47 p.

47925307 Serrano, S. (2007) Photostability Protocol, Testing Schedule and Results for Isopropyl 

Myristate Solution (50% w/w), ANDA: (RESULTIXTM). Project Number: 

PED/SP/022/0107/R0. Unpublished Study Prepared by Patheon, Inc. 10 p.

47925308 Carr, G. (2007) An Investigation of the UV/Visible Absorbance Properties of Isopropyl 

Myristate 50% Solution, Isopropyl Myristate and Cyclomethicone: (RESULTIXTM). Project 

Number: PED/MIS/024/0307/R0. Unpublished Study Prepared by Patheon, Inc. 14 p.

47925309 Phillips, S. (2009) Miscellaneous Toxicology Information: (RESULTIXTM). Unpublished 

study prepared by Piedmont Animal Health. 315 p.

47925310 Kuhn, J. (2002) Piedmont Pediculicide 2: Final Report: Acute Dermal Toxicity Study in 

Rabbits. Project Number: 7205/02. Unpublished study prepared by Stillmeadow, Inc. 31 p.

47925311 Kuhn, J. (2002) Piedmont Pediculocide 2: Final Report: Acute Dermal Toxicity Study in 

Rats: Final Report. Project Number: 7204/02. Unpublished study prepared by Stillmeadow, 

Inc. 33 p.

47925312 Kuhn, J. (2002) Piedmont Pediculicide 1: Final Report: Acute Eye Irritation Study in 

Rabbits. Project Number: 7089/02. Unpublished study prepared by Stillmeadow, Inc. 16 p.
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 29 of 32

47925313 Kuhn, J. (2002) Piedmont Pediculocide 1: Final Report: Acute Dermal Irritation Study in 

Rabbits. Project Number: 7090/02. Unpublished study prepared by Stillmeadow, Inc. 11 p.

47925314 Kuhn, J. (2009) RESULTIXTM Tick Spray: Final Report: Skin Sensitization Study in Guinea 

Pigs. Project Number: 13304/09. Unpublished study prepared by Stillmeadow, Inc. 16 p.

47925315 Goldenthal, E. (2003) 28-Day Oral Toxicity Study in Rats with a 14-Day Recovery: 

RESULTIXTM. Project Number: 1016/001. Unpublished study prepared by MPI Research, 

Inc. 603 p.

47925316 Goldenthal, E. (2003) 28-Day Dermal Toxicity Study in Pigs with a 14-Day Recovery: 

RESULTIXTM. Project Number: 1016/002. Unpublished study prepared by MPI Research, 

Inc. 442 p.

47925317 Young, D. (2009) Pivotal Study to Determine Safety and Efficacy of Isopropyl Myristate 

(ISOPROPYL MYRISTATE) Tick Spray against Rhipicephalus sanguineus and 

Dermacentor variabilis on Dogs. Project Number: PAH/09/0036. Unpublished study 

prepared by Young Veterinary Research Services. 19 p.

47925318 Young, D. (2009) Pivotal Study to Determine Safety and Efficacy of Isopropyl Myristate 

(ISOPROPYL MYRISTATE) Tick Spray against Rhipicephalus sanuineus and Dermacentor 

variabilis on Cats. Project Number: PAH/09/0065. Unpublished study prepared by Young 

Veterinary Research Services. 18 p.

47925319 Garg, D. (2005) Pharmacokinetic, Safety and Tolerance Study of RESULTZ Pediculicide 

Rinse in Pediatric Subjects with Pediculosis Capitis. Project Number: 04/123941/108. 

Unpublished study prepared by Hill Top Research, Inc. 103 p.

47925320 Phillips, S. (2009) Environmental Fate Information: RESULTIXTM. Unpublished study 

prepared by Piedmont Animal Health. 76 p.

48132300 Piedmont Animal Health LLC (2010) Submission of Product Chemistry Data in Support of 

the Application for Registration of RESULTIXTM. Transmittal of 1 Study.

48132301 Chastain, L. (2010) Stability Study of RESULTIXTM 1 oz. and 2 oz. Bottles: Interim Report 

(6 Month). Project Number: 9/066, 09/0066. Unpublished study prepared by Span Packaging

Services, LLC. 14 p.

48348200 Piedmont Animal Health, LLC (2011) Submission of Toxicity Data in Support of the 

Application for Registration of RESULTIXTM End-Use Product. Transmittal of 4 Studies.

48348201 Phillips, S.; Barer, G. (2011) Discussion of Submitted Information: (RESULTIXTM End-Use 

Product). Unpublished study prepared by Piedmont Animal Health. 67 p.

48348202 Phillips, S.; Barer, G. (2011) Published Articles Concerning the Safety of Myristic Acid and 

its Derivatives, Including Isopropyl Myristate. Unpublished study prepared by Piedmont 

Animal Health. 123 p.

48348203 Young, D. (2011) Pivotal Study to Determine Safety and Efficacy of Isopropyl Myristate 

(ISOPROPYL MYRISTATE) Tick Spray against Rhipicephalus sanguineus and 

Dermacentor variabilis on Dogs: Amended Final Report. Project Number: PAH/09/0036. 

Unpublished study prepared by Young Veterinary Research Services. 83 p.

48348204 Young, D. (2011) Pivotal Study to Determine Safety and Efficacy of Isopropyl Myristate 

(ISOPROPYL MYRISTATE) Tick Spray Against Rhipicephalus sanguineus and 

Dermacentor variabilis on Cats: Amended Final Report. Project Number: PAH/09/0065. 
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 30 of 32

Unpublished study prepared by Young Veterinary Research Services. 85 p.

48491400 Piedmont Animal Health LLC (2011) Submission of Product Chemistry Data in Support of 

the Registration of RESULTIXTM. Transmittal of 1 Study.

48491401 Chastain, L. (2010) Final Report (12 Month) Stability Study of RESULTIXTM 1 oz and 2 oz 

Bottles. Project Number: PAH/09/0066. Unpublished study prepared by Span Packaging 

Services, LLC. 14 p.
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 31 of 32

XI. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

a.i. Active Ingredient

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticide Registration Action Document

CFR Code of Federal Regulations

cm3cubic centimeter

CSF Confidential Statement of Formula

°C degrees Celsius

EDSP Endocrine Disruptor Screening Program

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee

EPA Environmental Protection Agency (the “Agency”)

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

g gram

kg kilogram

L liter

LD50 median lethal dose. A statistically derived single dose that can be expected 

to cause death in 50% of the test animals when administered by the route 

indicated (oral, dermal, or inhalation). It is expressed as a weight of 

substance per unit weight of animal (e.g., mg/kg).
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 32 of 32

MRID No. Master Record Identification Number

mg milligram

mL milliliter

MP manufacturing-use product

MPCA microbial pest control agent

NE “No Effect”

NIOSH National Institute for Occupational Safety and Health

OPP Office of Pesticide Programs

OPPTS Office of Prevention, Pesticides, and Toxic Substances

PCR polymerase chain reaction 

PPE personal protective equipment

 TGAI technical grade of the active ingredient