**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** **Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **2 of**  **32**
**August 2**  **4 , 2011** **Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **3 of**  **32**

**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 ..........................................**  **......... ...**  **. .**  **... .**  **....1 1**  **Drinking Water Exposure and Risk Characterization.....................**  **... .**  **. ....1**  **1 3.**  **Occupational, Residential, School and Day Care Exposure and Risk Characterization......**  **... .........................................................**  **. ...**  **...... 1**  **1 4.**  **Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation .........................................................**  **..... ............**  **... ......1**  **2 5.**  **Cumulative Effects ................................................... ...........**  **..........1 2**  **6. Risk Characterization .........................................................**  **.. .........1**  **2** 

### C. **Environmental Assessment ............................................................**  **.. ...**  **. ....1**  **2 1.**  **Ecological Hazards ..................................................................**  **.. .....1**  **2 2.**  **Environmental Fate and Ground Water Data ..............................**  **... ...**  **. .1**  **3 3.**  **Ecological Exposure and Risk Characterization .................................**  **.. .1**  **3 4.**  **Endangered Species Assessment .......................................**  **............ ..**  **...1 3**  

### D. **Product Performance/ Efficacy Data**  **...... ...............**  **.................. .**  **......... .**  **... ...**  **1 4**  **V. RISK MANAGEMENT DECISION**  **..................... .**  **............... ..**  **... ..........**  **... ...**  **. 1**  **4 A.**  **Determination of Eligibility for Registration ..................**  **... .....................**  **... ....**  **.1 4** **Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **4 of**  **32**

**B. Regulatory Decision**  **................................................... ...**  **........................ ...**  **14 C.**  **Environmental Justice ..................................................................**  **... ......**  **... 14**  **VI. ACTIONS REQUIRED BY REGISTRANTS**  **...... ..**  **...... ..**  **......... ...**  **...... ..**  **.. ..............**  **1 5**  **A. Reporting of Adverse Effects**  **................................................ .....**  **......... .**  **. .**  **... .**  **...15 VII.**  **APPENDIX A. Data Requirements (40 CFR Part 158) ..................**  **. ..**  **. ...**  **............... 1**  **5 VIII.**  **APPENDIX B. Product Specific Information ...............**  **...... ......**  **. .........**  **.... .....**  **. ....**  **... .**  **.2 2**  **IX. APPENDIX C. References .........**  **........... .............................**  **... .........**  **. ......**  **. ...**  **. ...**  **. 2**  **2 X. APPENDIX D. Bibliography..........................................**  **. ......................**  **. ...**  **. ...23**  **X I**  **. GLOSSARY OF ACRONYMS**  **AND ABBREVIATIONS... .**  **... ..**  **.................. ...**  **.... 2**  **8 Isopropyl m** **yristate PC Code 000207 Biopesticides Registration Action Document**  **Page 5**  **of 32**  **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 Isopropyl m** **yristate PC Code 000207 Biopesticides Registration Action Document**  **Page 6**  **of 32** 

Cheryl Greene**Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **7 of**  **32**

**I. EXECUTIVE SUMMARY**  **:** Isopropyl myristate is a pesticidal active ingredient intend ed 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 plant s, 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 192 0s in chemical experimentation and since 1957 in cosmetic, pharmaceutical and household products. Isopropyl myristate is commercially synthesized for use as a f lavoring agent in a wide range of foods including bake d 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, deodorant s , lotions, and hand sanitizers. Isopropyl myristate is also used as a carrier or solvent in a variety of pharmace utical 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 requireme nts. T he 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 a cute t oxicity 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. Th ere are no concerns for any threatened or endangered species. G iven 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 maj or registratio n decisions
. According to this new policy, EPA intends to provide a public comment period prior to making a registration decision f or, 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.**Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **8 of**  **32**



### 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

maintain s 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 ch aracterized throughout this BRAD.**Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **9 of**  **32**

**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 myristate 95 Trade name Stepan D
- 50 Trade name RESULTIXTM Trade n ame **CAS Registry Number:**  110
- 27
- 0 **OPP Chemical Code:** 000207 **Type of Pesticide:** Biochemical Pesticide/ Insecticide **Molecular formula:** C 17 H 34 O 2 **Molecular Weight:** 270.46 g/mol**Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **10 of**  **32**

**III. REGULATORY BACKGROUND**  Isopropyl myristate was first registered by EPA on October 31 , 1986 , as an active ingredient for use in antimicrobial pesticide s . 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 app lication f iled 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 end
use 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 o n March 10, 2010 (7 5 FR 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 , w hich is a registered biochemical pesticide
. **B. F**  **ood Clearances/Tolerances** Currently this active ingredient is not registered on food or feed commodities. **IV. RISK ASSESSMENT**  **A. A**  **ctive 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, pharmaceuti cal and household products. The end
-use product (EP) is intended for use on cats and dogs to kill ticks. The mode of action of th is active ingredient is physical in th at isopropyl myristate de
- waxes the cuticle or outer skel e t on 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 simpl y 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 dat a and information submitted to support the EP, RESULTIXTM. **B. Human Health Assessment**  **1. Toxicology**  For acute toxicity data requirements, toxicity categories are assigne d based o n the hazard (s) identified from studies and/or information on file with the Agency. The active ingredient is classified into Toxicity Category I,**Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **11 of**  **32**

II, III or IV where Toxicity Category I indicates the highest toxicity and Toxicity Category IV indicates the lowest toxic ity. Adequate mammalian toxicology data/information is available to support registration of i sopropyl myristate
. All toxicology data requirements for i sopropyl myristate have been **satisfied.** The Agency has classified isopropyl myristate into **T oxicity**  **C a**  **tegory 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 i sopropyl myristate has low acute oral, acute dermal and acute inhalation toxicity. An additional acute inhalation toxicity study from the HSDB (2011) indicate s 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 i ndicate that the chemical is minimally irritating when applied to rabbits. O ne study showed severe irritation in rabbits, moderate irritation in guinea pigs and mild irritation in rats. The Agency has conservatively classified isopropyl myristate into toxi city category I I on a scale of IV for dermal irritation based on the results of this study . T he 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 ingr edient
. 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. Hyperp lasia 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 hi ghest 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**Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **12 of**  **32**

In a 28
- day non
- guideline dermal toxi city 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 eff ects 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% iso propyl 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/m3 dose. 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, in cluding human females. Due to the lack of reported adverse effects to humans fe males fro m 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 me tabolic activation at a concentration of 50 mg/mL. Isopropyl myristate was non - mutagenic in these assays.**Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **13 of**  **32**

Data from an in vitro mammalian mutagenicity assay are unavailable. But, significant human exposure is unlikely; isopropyl myristate is not structura lly 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 eff ect 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 ass ays 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 sys tems 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 o f 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**  N o relevant toxicological endpoints were identified; therefore, a dose response assessment is not required for this pesticidal active ingredient. B. **Drinking Water Exposure and Risk Characte rization**  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 an**  **d Day Care Exposure and Risk Characterization Isopropyl m** **yristate PC Code 000207 Biopesticides Registration Action Document**  **Page 14**  **of 32** 

**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 prof essionals and animal grooming professionals. No relevant toxicological endpoints were identified and significant exposure in an occupational setting is not expected.**Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **15 of**  **32**

**D. Residential, School and Day Care Exposure and Risk Characterization**  A residential, sch ool 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 avai lable 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 Rout**  **es 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 arri ved at this conclusion isopropyl myristate ’s highly specific mode of action as a topical insecticide limited to use on cats and dogs, its lo w toxicity to mammalian systems and the intended non
- food use. The risk from aggregate exposure ( via oral, dermal and inhalation exposure s) is negligible. T he 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. **Cumulativ e 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 expo sure 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 isopr opyl myristate when label instructions are followed. **H. E**  **nvironmental Assessment Ecological Hazards**  

### The Agency

has evaluated the potential for toxicity of isoprop yl my ristate and the end
- use product s to aquatic and terrestrial ecos ys tems and concludes that the potential for exposure to the environment is insignificant or unlikely
. Isoprop yl my ristate will be formulated into products that will be applied to dog and cats as a topical spray treatment to kill tick s and is not expected to impact nontarget spec ies 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
. T he Agency is requirin g that the end
- use product label c arry 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** **Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **16 of**  **32**



### A search of available environmental databases for isopropyl m yristate did not produce an y acute toxicity data for aquatic invertebrates. This compound, however, is lipophilic and has a very low solubi lity in water (0.014 mg/L). However, isopropyl m yristate 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 LC 50 =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 l abel 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., granu lar formulation) or from ingestion of pesticide residues on plant and other food items (insects). Additionally, the container is small (20 mL) and spilla ge 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 my ristate 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 trigger ed because isopropyl myristate acute toxicity studies did not trigger any additional Tier I studies. **g. Ecological Exposure and Risk Characterization** **Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **17 of**  **32**

Based on the information submitted in the data waiver requests for nontarget plants and nontarget ins ects, 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.**Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **18 of**  **32**

**D. P**  **roduct Performance (Efficacy)** Product performance data must be developed for all pesticides to ensure that pesticide products will perform as intended and that unnecessary pesticide expo sure 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 product s registered or proposed for registration that a re 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 requirement s , 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 sect ion 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 RESULTIX TM
. T he Agency has determined that the submitted data/inf ormation submitted in support of the end
-use product RESULTIXTM satisfies current testing requirements a s described at 40CFR 158.2070 for this active ingredient and the end
-use product. **V. R** **ISK 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 warrant s 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 re cognized 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 is opropyl myristate . Such products are not expected to cau se 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 el igible 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**Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **19 of**  **32**

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 t o 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
.
**V I**  **. 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. R eporting 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). **VI I**  **. A**  **PPENDIX A.**  **Data Requirements (40 CFR Part 158 -**  **Subpart U )**  *NOTE: Master Record Identification ( MRID ) num bers 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 m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **20 of**  **32 TABLE 1. Physical and Chemical Properties for**  **RESULTIXTM and isopropyl myristate TGAI**  **a Guideline Reference**  **No./Property Description of Result**  **Me thods**  830.6302 Color TGAI: colorless EP: colorless Visual inspection 830.6303 Phy sical 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 studies b,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 mo nths. 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 studies b,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 studies c**Isopropyl m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **21 of**  **32**

**TABLE 1. (Cont.) Physical and Chemical Properties for RESULTIXTM**  **and isopropyl m yristate TGAI**  **a Guideline Reference**  **No./Property Description of Result**  **Me thods**  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 m yristate 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. Results**  **1 Toxicity**  **Category/Description MRID**  Ac ute oral toxicity (rat) (870.1100) LD 50 > 13.6 g/kg IV 47925309 48348202 Ac ute dermal toxicity (rabbit) (870.1200) LD 50 = 5000 mg/kg III 47925309 48348202 HSDB, 2011 Ac ute inhalation toxicity (rat) (870.1300) LC 50 > 33
- 41 mg/L 2 IV 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 irritating 3 II 47925309 48348202 HSDB, 2011 Dermal sensitization (guinea pig) (870.2600) Not a sensitizer N/A 47925309 48348202 HSDB, 2011 Hy persensitivity incidents (885.3400) Must be reported N/A N/A**Isopropyl m yristate 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. Results**  **1 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) an d the NOAEL ≥ 196.3
- 321.3 mg/kg bw
. 3 48348201

47925316**Isopropyl m yristate 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. Results**  **1 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/m 3 resulted in increased absolute and relative lung weights. No other treatment - related effects were observed. A 13
- week inhalation study con ducted 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 dose
related in treated monkeys. No other treatment - related effects wer e 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 m yristate 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. Results**  **1 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 carcinogenic ity 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 m yristate 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**  Ac ute oral toxicity (rat) (870.1100) No data were submitted for the EP. Based on reported LD 50 values for the active and inert ingredients, the estimated

LD 50 > 4,800 mg/kg III 47925309 Ac ute dermal toxicity (rat and rabbit) (870.1200) LD 50 > 5,050 mg/kg (rabbit)

LD 50 > 5,050 mg/kg (rat) IV 47925310

47925311 Ac ute inhalation toxicity (rat) (870.1300) No data were submitted for the EP. Based on reported LD 50 values for the active and inert ingredients, the estimated

LD 50 = 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 Hy persensitivity incidents (885.3400) Must be reported

**VII I**  **. A PPENDIX**  **B. For product specific information, please refer to**  **http://www.epa.gov/pesticides/pestlabels .** 
**IX .**  **A PPENDIX**  **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 Californ ia (OEHHA).2007. Toxicity Data Review. Decamethylcyclopentasiloxane (D5). Excerpt only. http://www.arb.ca.gov/toxics/dryclean/oehhad5review.pdf**Isopropyl m yristate 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.; sub mitted 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., S avannah, 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 Ins ect 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 un der 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 re ceived 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 m yristate 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 Tran smittal 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 Isopr opyl 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 Leachabl es 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, Te sting 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 Properti es 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 Repor t: Acute Eye Irritation Study in Rabbits. Project Number: 7089/02. Unpublished study prepared by Stillmeadow, Inc. 16 p.**Isopropyl m yristate 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. Unp ublished 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 a nd 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 RES ULTZ 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

p repared 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

Applic ation 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 m yristate 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 m yristate PC Code 000207**  **Biopesticides Registration Action Document Page**  **31 of**  **32**

**X I**  **. 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

cm3 cubic 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 LD 50 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 m yristate 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 ag ent NE “No Effect” NI OSH 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 equ ipment TGAI technical grade of the active ingredient