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

July 20, 2011
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TABLE OF CONTENTS 

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

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

III. 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 ......................................................................9

1. Toxicology ....................................................................................9

2. Dose Response Assessment ..............................................................13

Drinking Water Exposure and Risk Characterization.............................13

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

Characterization...........................................................................13

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

Inhalation ..................................................................................13

5. Cumulative Effects ......................................................................14

6. Risk Characterization ..................................................................14

C. Environmental Assessment ...................................................................14

1. Ecological Hazards.......................................................................14

2. Environmental Fate and Ground Water Data .....................................16

3. Ecological Exposure and Risk Characterization ..................................16

4. Endangered Species Assessment ......................................................16

D. Product Performance/ Efficacy Data .......................................................16
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V. RISK MANAGEMENT DECISION ..........................................................16

A. Determination of Eligibility for Registration ................................................16

B. Regulatory Decision ...............................................................................17

C. Environmental Justice ............................................................................17

VI. ACTIONS REQUIRED BY REGISTRANTS ..................................................17

A. Reporting of Adverse Effects ....................................................................17

VII. APPENDIX A. Data Requirements (40 CFR Part 158) ....................................19

VIII. APPENDIX B. Product Specific Information ..............................................26

IX. APPENDIX C. References .....................................................................26

 X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS............................ 32
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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

Cheryl Greene
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I. EXECUTIVE SUMMARY:

I. BACKGROUND

RISK ASSESSMENT AND STUDY SUMMARIES FOR ISOPROPYL MYRISTATE

I. Introduction

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 esters 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, butter fat 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. 

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

including bake 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 sanitizer’s. Isopropyl myristate 

is also used as a carrier or solvent in a variety of pharmaceutical, therapies that require good 

precutaneous absorption is needed. 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 
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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 has very low toxicity and the 

potential for exposure to the environment is insignificant or unlikely, EPA concludes, based on the 

proposed 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. 

Consistent with the new policy of making registration actions more transparent, isopropyl myristate is

subject to a 30-day comment period as a “new active ingredient. The intent of the 30-day comment 

period is to provide a more meaningful opportunity for the public to participate in major registration 

decisions before they occur. The docket identification for this action is EPA-HQ-OPP-2010-0082. 

While a final decision on registration is contingent upon review and consideration of public 

comments, at this time the Agency believes that the risk assessment and information submitted 

support the registration of isopropyl myristate and that it is in the best interest of the public and the 

environment to issue the registration for isopropyl myristate. The basis for this preliminary decision 

can be found in the risk assessment for isopropyl myristate which is characterized in 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 

Chemical Structure 

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 (EP) containing isopropyl myristate as an insecticide to kill 

ticks on cats and dogs. RESULTIXTM, the EP 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 

esters 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, butter fat 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 proposed 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. 
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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, 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 3) 

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

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

registered product containing isopropyl myristate were submitted from the open scientific 

literature. Additional data were obtained using the Hazardous Substances Database (HSDB) from 

the National Library of Medicine. 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 III 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. 
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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 isopropyl myristate 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; the proposed use of 

isopropyl myristate is not food-use and will be applied dermally to cats and dogs to kill ticks. 

90-Day Dermal

In a 28-day non-guideline dermal toxicity study, Landrace-Duroc pigs were exposed to the 

proposed 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 proposed 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.
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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; however, because end-use products containing 

isopropyl myristate under widespread and commonly recognized practice are reasonably not 

expected to result in significant exposure to female humans (e.g., occupational exposure or 

repeated application of insect repellents directly to the skin) the Agency is not requiring these data 

at this time. The Agency believes that under the proposed use pattern, oral exposure to isopropyl 

myristate is not expected and would be incidental. Further, based on the proposed use pattern and 

the low volatility of isopropyl myristate, significant inhalation exposure is not expected when 

labeling instructions are followed. While dermal exposure may occur during application of the 

product and while handling animals post-application, the Agency does not expect significant 

exposure based on the proposed use pattern as a contact pesticide used to kill ticks. Additionally, 

female humans already are exposed to isopropyl in cosmetic, personal care and pharmaceutical 

products. 

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. 

Data from an in vitro mammalian mutagenicity assay are unavailable. 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. 

In a life-time dermal carcinogenicity study, 10%, 50% and 100% isopropyl myristate diluted in 

acetone applied to the backs of female Swill mice resulted in no difference in skin tumor 

frequency when compared to controls. Negative and positive controls were employed. In another 

dermal carcinogenicity study conducted in Swill albino mice, isopropyl myristate was applied 

once per week for 19 months at a concentration of 1% in acetone (42.5-56.6 mg.kg/wk-initiallydose decreased as mice grew). Negative and positive controls were employed. Of the 20 mice 

treated with isopropyl myristate, five escaped during treatment and four died before the end of the 

exposure period. No tumors were observed on the remaining 11 surviving mice or the four mice 

that died before the end of the exposure period. 
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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/.

2. Dose Response Assessment

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

required for this pesticidal active ingredient. 

3. Drinking Water Exposure and Risk Characterization

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

and cats, 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. 
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4. Occupational, Residential, School and Day Care Exposure and Risk Characterization

a. Occupational Exposure and Risk Characterization

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

proposed 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 an occupational setting is not expected. 

b. 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 

proposed product will be used in residential settings, based on the proposed 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. 

5. 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 based on isopropyl myristate 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. 

6. 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. 

7. Risk Characterization

The Agency considered human exposure to isopropyl myristate 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 isopropyl 

myristate when label instructions are followed. 

C. ENVIRONMENTAL ASSESSMENT

1. Ecological Hazards
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The Agency has evaluated the potential for toxicity of isopropyl myristate and the proposed 

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.

Acute Toxicity Aquatic Invertebrates (Daphnids) – TGAI & EP

A search of available environmental fate and toxicity databases indicate no acute toxicity data for 

daphnids were available for isopropyl myristate. The environmental fate data available indicate 

that isopropyl myristate would be readily metabolized by aquatic organisms, although it is highly

lipophilic and may potentially bioaccumulate. Isopropyl myristate is also semi volatile and would 

not persist in aquatic environments.

Freshwater Fish Acute Toxicity - TGAI & EP

A search of available environmental fate and toxicity databases indicate one acute 96-hour LC50

(100 mg/L; slightly toxicity) in fish was reported for isopropyl myristate. The environmental fate 

data available show that isopropyl myristate would be readily metabolized by aquatic organisms. 

However, although isopropyl myristate it is highly lipophilic and may potentially bioaccumulate, it 

is also semi volatile and therefore we believe it will not persist in aquatic environments when used 

according to labeling instructions. 

 Avian Acute Oral and Dietary Toxicity Avian - TGAI & EP

The proposed 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 proposed 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 EP is a colorless and practically odorless 

liquid product, it is unlikely that the EP would be gastronomically attractive for birds to ingest. 

Usually toxicity to birds is 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 proposed EP 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 proposed end-use product as water, particularly because of the small 

volume and rapid volatilization of the proposed product. 

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

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

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

expected to occur if label instructions are followed. 
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Nontarget Insect Testing - TGAI & EP

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

to have this affect on all insects and other arthropods. However, the use pattern and limited 

application (20 ml) precludes contact with nontarget insects, particularly honeybees. 

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. 

Ecological Exposure and Risk Characterization 

Based on the information submitted in the data waiver requests for nontarget plants and nontarget

insects, exposure and risk from the proposed use of isopropyl myristate is not expected to occur for 

other nontarget organisms. 

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. 

D. PRODUCT PERFORMANCE DATA (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 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 proposed end-use

product. 
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V. Risk Management Decision

A. Determination of Eligibility for Registration

Section 3(c) (5) of FIFRA provides for the registration of new active ingredients 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 is eligible for registration for the 

proposed 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 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 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 t 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.
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 17 of 34

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).
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 18 of 34

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. 
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 19 of 34

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.
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 20 of 34

830.7100 Viscosity TGAI: not required 

EP: 3.5 – 3.7 cP

Storage stability

studiesc

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 21 of 34

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
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 22 of 34

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

Hypersensitivity incidents

(885.3400)

Must be reported N/A N/A

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
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 23 of 34

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 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 34

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 34

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 34

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
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 27 of 34

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 Decamethylcyclopentasiloxane (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

(FDA Inactive Ingredients Database, 2011).

(Household Products Database, 2010)
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 28 of 34

X. Appendix DC.

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) 
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 29 of 34

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. 

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
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 30 of 34

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.

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.
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 31 of 34

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 
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 32 of 34

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. 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 33 of 34

X. 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 
Isopropyl myristate PC Code 000207 Biopesticides Registration Action Document Page 34 of 34

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

substance per unit weight of animal (e.g., mg/kg).

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