**BIOPESTICIDES REGISTRATION ACTION DOCUMENT**



# Carob Moth Pheromone Mimic

PC Code 128003

**U.S. Environmental Protection Agency Office of Pesticide Programs**  **Biopesticides and Pollution Preventio n Division** 

( Last updated May 8 , 20 13 )**Carob Moth Pherom one Mim** **ic Page**  **2 of**  **13**

**Biopesticides Registration Action Docum ent**  **TABLE OF CONTENTS I.**  **EXECUTIVE SUMMARY ... ............................................................**  **......... 4 II.**  **ACTIVE INGREDIENT OV ERVIEW ....................................**  **..................... .**  **5 III.**  **REGULATORY BACKGROUND ............... ..............................................**  **.. 5**  **A. Classification**  **......................................................................................... .**  **5 B.**  **Food Clearances and Tolerances ................................................................. 5**  **IV. RISK ASSESSMEN**  **T ................................................... ............................**  **. 5**  **A. Active Ingredient Characterization**  **.............................................................. 5**  **B. Human Health Assess**  **ment ......................................................................... 6**  **1. Toxicology**  **.......................................................................................... 6**  **2. Dose Response Assess**  **ment ...................................................................... 7**  **3. Food Quality Protection Act (FQP** **A) Consideration .................................... ...**  **7 4.**  **Occupational, Residential and School Exposure and Risk Characterization**  **........... 7**  **5 Cumulative Effects**  **...... ...........................................................................**  **8 6**  **Risk Characterization ...**  **.......................................................................... 8**  **C. ENVIRONMENTAL AS**  **SESSMENT ........................................................ ....**  **8 1.**  **Ecological Haza rds ................................................................................**  **8 2.**  **Enviro nmental Fate and Gro**  **und Water Data ........................................... .....**  **8 3.**  **Ecological Exposure and Risk Characterization .............................................**  **8 4.**  **Endangered Species As sessment**  **. .........................................................**  **. ......**  **9 D.**  **EFFICACY DATA ................................................................................. .**  **9 V.**  **RISK MANAGEMENT DECI SION**  **... .**  **......................................................... 9**  **A. Determination of Eligibility for Registration**  **... .**  **........................................... ..**  **9 B.**  **Regulatory Decision ................................................................................**  **9 C.**  **Environmental Justice ............................................................................**  **9 VI.**  **ACTIONS REQUIRED BY REGISTRANTS**  **.............................................. .**  **... 10**  **A. Reporting Adverce Effects**  **........................................................................10 B.**  **Reporting of Hypersensitivity Incidents ......................................................**  **.. 10**  **VII. APPENDIX A**  **. Data Requirements**  **.............................. ..................**  **............... 1**  **0 VIII.**  **APPENDIX B. Product Specific Information**  **............ ............**  **.................. ...**  **.... 1**  **3 I**  **X. APPENDIX C. REFERENC**  **ES ............................................................**  **........ .13** **Carob Moth Pherom one Mim** **ic Page**  **3 of**  **13**

**Biopesticides Registration Action Docum ent**  **BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM Office of Pesticide Programs:**  **Biopesticides and Pollution Prevention Division Biochemical Pesticides Branch (BPB)**  Chris Pfeifer Regulatory A ction L eader Li nda Hollis Branch Chief Colin G. Walsh, M.S. Biologist Russell S. Jones, Ph.D. Senior Biologist**Carob Moth Pherom one Mim** **ic Page**  **4 of**  **13**

**Biopesticides Registration Action Docum ent**  **I. EXECUTIVE SUMMARY**  **:** The new active ingredient Carob Moth Pheromone Mimic , also known as 7,9,11
- Dodecatrien

- 1
- ol, formate, (7Z,9E)

- , is a technical grade sy nthetic arthropod pheromone

. This pheromone is structurally similar to , and mimics , a naturally o ccurring pheromone produced by the female carob m oth ( Ectomyelois ceratoniae ) to attract males for mating. Carob Moth Pheromone Mimic is intended for use in poly

meric applications applied to the bark of date palm trees in crop and non - crop areas to disrupt the mating cycle of carob moths. Accordingly, EPA is considering the approval of a regis tration f or Carob Moth Pheromone Mimic under Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Biopesticides and Pollution Prevention Division (BPPD) has reviewed the data require d to support the registration of this bioch emical active ingredient, under Section 3(c)(5) of the Federal In secticide, Fungicide and Rodenticide Act (FIFRA). Product chemistry data requirements were satisfied by acceptable guideline studies. Adequate mammalian toxicology information was submitted t o support registration of Carob Moth Pheromone Mimic

. Acceptable gu ideline studies were submitted for the acute toxicity data requirements

. D ata waivers were granted by the Agency for the remaining toxicity requirements based on the lack of toxicity of the active ingredient

. E cological effects data requirements for this arthropod pheromone we re waived because of the use of this pheromone in retrievable, poly meric applications ( 40 CFR § 158.2060 )

. Based on the data available to the Agency, it has been dete rmined that no unreasonable adverse effects to the U.S. population and the environment will result from the use of this active ingredient when label instructions are followed and good agricultural practices are employed. Laboratory studies indicate that th e active ingredient is not toxic following oral, inhalation , or dermal exposure . Moreover, the pesticidal usage of this biochemical in retrievable , poly meric applications will not have any

harmful environmental effects Due to the negligible risk concerns when used as mating dis r upter , Carob Moth Pheromone Mimic meets the criteria as specified in §3(c)(5) of the Federal Insecticide, Fungicide and Rodenti cide Act (FIFRA) , as amended, and is thus eligible f or unconditional registration. Itwas determined that the data/information submitted adequately satisfy applicable data requirements at 40 C
. F
. R
. Subpart U §158.2000
. On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for the public to participate on major registration d ecisions before they occur. According to this policy , EPA provides a public comment period prior to making a registration decision for the following ty pes of applications: new active ingredients, first food use, first outdoor use, first residential use; an d any registration decisions for which the Agency believes there may

be substantial public interest. Consistent with the policy of making registration actions more transparent, Carob Moth Pheromone Mimic is subject to a 15 day comment period as a “new b iochemical active ingredient .” The notice for this comment period includes a draft of this Biopesticides Registration Action Document (BRAD) and the draft product labels for I SCA EC
- MP (EPA File Sy mbol No. 80286

- RO) and SPLAT EC
- O (EPA File Sy mbol No. 8028 6
- RI), which contain this new active ingredient, Carob Moth Pheromone Mimic. The docket identification (ID) number is EPA

- HQ
OPP
- 2012
- 0787. Altogether, the Agency believes that , based on the risk assessment and information submitted in support of the regis tration of the pesticide products containing Carob**Carob Moth Pherom one Mim** **ic Page**  **5 of**  **13**

**Biopesticides Registration Action Docum ent**  Moth Pheromone Mimic, it is in the best interests of the public to issue the registrations for I SCA EC
- MP and SPLAT EC
- O. The basis for this decision can be found in the risk assessment for Carob Moth Pheromone Mimic , which is characterized in this BRAD.
**II. ACTIVE INGREDIENT OVERVIEW**  **Common Name:** Carob Moth Pheromone Mimic **Chemical Names:** 7,9,11
- Dodecatrien

- 1
- ol, formate, (7Z,9E)

- **Trade & Other Names** : Carob Moth Pheromone Mimic **CAS Registry Nu mber:**  146321
- 32
- 6 **OPP Chemical Code:** 128003 **Type of Pesticide:** Mating disrupter for carob moths Application rates and methods vary depending on the product. For specific information regarding the product (s) refer to Appendix B

. **III. REGULATORY BACK** **GROUND** On January

13, 2012 , IS CA Technologies, Inc., submitted an application for the registration of an end

- use product (EP) SPLAT EC
- O ( 80286
- RI) , containing 2 % Carob Moth Pheromone Mimic , and a manufacturing

- use product (MP) I SCA EC
- MP ( 80286
- RO ) , cont aining 9 0.8 % Carob Moth Pheromone Mimic . A notice of receipt of the application for registration of Carob Moth Pheromone Mimic as a new active ingredient was published in the Federal Register on November 7, 2012 (7 7 FR 216 ) , with a 30

- day comment period. N o comments were received following this publication. **A. Classification**  T he Biochemical Classification Committee determined that Carob Moth Pheromone Mimic is a biochemical pesticide because this pheromone has a non toxic mode of action, and is structural ly similar to and mimics a naturally occurring p heromone produced by the carob moth

. **B. F**  **ood Clearances/Tolerances** Arthropod pheromones are exempt from the requirement of a tolerance in or on raw agricultural commodities when used in retrievable, poly m eric matrix applications , and when the pheromone is applied to growing crops at a rate not to exceed 150 grams active ingredient per acre per ye ar in accordance with good agricultural practices (40 CFR §180.1124). Ina ddition, the A gency h as determined that the inert ingredients in the dollop used in the EP that contain this new active ingredient can be considered a retrievable poly meric application and can also be considered under the tolerance exemption for re trievable poly meric dispensers (40 CFR §180.11 2 2 ).
**IV. RISK**  **ASSESSMENT A.**  **Active Ingredient Characterization** Carob Moth Pheromone Mimic is a sy nthetic compound that mimics a naturally occurring**Carob Moth Pherom one Mim** **ic Page**  **6 of**  **13**

**Biopesticides Registration Action Docum ent**  pheromone produced by

female carob moth s . This compound is a colorless liquid with a slightly fatty , waxy smell. T he description s of the product formulation and production process , as well as the formation of impurities, were examined by the Agency and found to meet current standards. A preliminary analysis was conducted to identify Carob Moth Pheromone Mimic in five batches of the product, and the results were determined to be acceptable by the Agency

. The analy

tical method used to determine the content of the active ingredient is also acceptable. Physical and chemical properties were submitted for the a ctive ingredient and are adequate. Refer to Table 1 in Appendix A for a summary of produc t chemistry

data requirements. Refer to Table 2 in Appendix A for the summary of physical and chemical characteristics for Carob Moth Pheromone Mimic

. All product che mistry data requirements for registration of Carob Moth Pheromone Mimic have been satisfied. **B. Human Health Assessment**  **1. Toxicology**  Adequate mammalian toxicology data /information is available to support registration of Carob Moth Pheromone Mimic . Al l toxicology data requirements for Carob Moth Pheromone Mimic have been satisfied. Carob Moth Pheromone Mimic is structurally and functionally

similar to a naturally

occurring arthropod pheromone with a nontoxic mode of action. Arthropod pheromones are generally effective at very

low rates and are used in point source applications such as retrievable poly meric dispensers. The Agency

recognizes the low toxicity , negligible expected exposure, and lack of expected adverse effects on humans and non

- target organisms of arthropod pheromones when used in poly meric dispensers. Moreover, published subchronic studies on compounds similar in structure to arthropod pheromones have been submitted indicating these compounds have no significant human health effects. The applicant s ubmitted Tier I human health toxicity

information for the active ingredient as a series of Guideline by

Guideline rationales ( MRID 48857302 ) . T he information submitted supports registration and demonstrates that the new active ingredient, 7,9,1 1
- Dodecatrien

- 1
- ol, formate, (7Z,9E)

- (Carob Moth Pheromone Mimic), is sufficient ly similar to the naturally occurring straight

- chain Lepidopteran pheromone (SCLP ) to be evaluated as its equivalent

. Specifically , the applicant showed equivalency by making structural comparisons to the natural ly occurring carob m oth pheromone ( an SCLP) by the carbon chain length, terminal bond positioning, and geometry

. Inaddition, the applicant provided data demonstrating that the electrophysiological properties and environmental behavior of this mimic are indistinguishable from the naturally occurring pheromone. Tier I acute toxicity

data demonstrated that Carob Moth Pheromone Mimic is a toxicity category III
- IV (low toxicity

) compound via acute oral , acute dermal , eye i rritation, primary dermal, and acut e inhalation routes of exposure, and that Carob Moth Pheromone Mimic is not an eye or skin irritant. Subchronic toxicity , developmental toxicity and mutagenicity

data requirements were all satisfied by information submi tted in support of waiver requests. Data showed structural and functional similarity between the mimic and the naturally occurring carob moth pheromone, which is regarded**Carob Moth Pherom one Mim** **ic Page**  **7 of**  **13**

**Biopesticides Registration Action Docum ent**  as nontoxic. Information on the compound ’s volatility demonstrated that any

subchroni c and developmental exposure scenarios were highly un likely . And data on scientifically acceptable surrogates demonstrat ed that the mimic would not be subchronically or developmentally

toxic , and that it was not mutagenic. For more information on the human toxicity data submitted, refer to Tab le 3 in Appendix A

. **2. Dose Response Assessment**  No meaningful toxicological endpoints were identified on Carob Moth Pheromone Mimic when used as a pesticide ; therefore, a dose respon se assessment was not required. **3. Food Quality Protection Act (FQPA) Consideration a. Dietary Exposure and Risk Characterization**  Inaccordance with 40 CFR § 180.1124, arthropod pheromones are exempt from the requirement of a tolerance, and thus a dietary assessment is not required. Moreover, e xposure to Carob Moth Pheromone Mimic is expected to be minimal d ue to i t s use in point source dispensers, from which i t is released in very small quantities. Restricting the use of the Carob Moth Pheromone Mimic to retrievably sized dollops w ill significantly limit the possibility of dietary exposure to the pheromone. **b. Drinking Water Exposure and Risk Characterization**  No significant drinking water exposure or residues are expected to result from the pesticidal usage of Carob Moth Pheromon e Mimic . The active ingredient is intended for use in retrievable dollops and is not to be applied directly to water. If used in accordance with EPA

- approved labeling, it is not likely to accumulate in drinking water As a result, dietary

and drinking water exposure to residue s of Carob Moth Pheromone Mimic are expected to be minimal

. **4. Occupational, Residential, School and Day Care Exposure and Risk Characterization** 
**a. Occupational Exposure and Risk Characterization**  Carob Moth Pheromone Mimic is a sy nthetic compound that is structurally identical to , and mimics , the naturally

occurring pheromone of the carob moth, and acts via a nontoxic mode of ac tion to specific target pests. Lo w oral, dermal, and inhalation toxicity have been demonstrated by the dat a summarized above. The end

- use product will be applied via poly meric

- matrix applications to tree bark

. The potential for dermal, eye, and inhalation exposure to Carob Moth Pheromone Mimic for handlers is minimal and will be mitigated as long as products are used according to label directions. The Agency

will require labels to include the appropriate signal word , re - entry interval , and precautionary

statements
. **b. Residential, School and Day Care Exposure and Risk Characterization**  No indoor residential, school, or day care uses are currently

approved for products containing Carob Moth Pheromone Mimic

. The Agency has concluded that the potential for pheromone residues is not a dietary

hazard to the general population, including infants and children. This**Carob Moth Pherom one Mim** **ic Page**  **8 of**  **13**

**Biopesticides Registration Action Docum ent**  decision was based on the following criteria: 1) low acute and subchronic mammalian toxicity, 2) the known metabolism; and 3) the history of safe use of similar arthropod pheromones. Also, for food uses of pheromones, the toxicity and residue data support the conclusion that an exemption from the requirement of a tolerance is appropriate and adequate to protect human health, including that of infants and children (40 CFR § 180.1124)

. **5 .**  **Cumulative Effects** EPA has considered the potential for cumulative eff ects of Carob Moth Pheromone Mimic and other substances in relation to a common mechanism of toxicity

. B ecause of its low toxicity to mammalian systems, the Agency does not expect any

cumulative or incremental effects from exposure to residues of Carob Moth Pheromone Mimic when applied/used as directed on the label and in accordance with good agricultural practices. **6 .**  **Risk Characterization** The Agency

considered human exposure to Carob Moth Pheromone Mimic 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 Carob Moth Pheromone Mimic when label instructions are followed. **C. E**  **NVIRONMENTAL ASSESSMENT 1.**  **Ecological Hazards**  According to 40 CFR §158.2060(a) (2), arthropod pheromones , when applied at up to a maximum use rate of 150 grams active ingredient/acre/year, and that are not expected to available to avian species, are not required to provid e non - target organism toxicity data. Carob Moth Pheromone Mimic is a sy

nthetic arthropod pheromone that is structurally similar to , and mimics , the pheromone produced by

the carob moth

. T h is compound acts on a select group of insects and h as a nontoxic mode of action. Carob Moth Pheromone Mimic will be used in retrievably sized poly meric applications at a rate not exceeding 1 50 grams/acre/ye ar. Although not required , the applicant did provide Tier ITGAInon - target organism toxicity inf ormation under MRID 48857303. The information is summarized in Table 4 below. **2. Environmental Fate and Ground Water Data**  Environmental fate data are not required for this active ingredient because it is an arthropod pheromone applied at a maximum use rate of 150 grams active ingredient/acre/year and is not expecte d to available to avian species (40 CFR § 158.2060)

. **3. Ecological Exposure and Risk Characterization**  Carob Moth Pheromone Mimic is a sy nthetic arthropod pheromo ne that structurally and funct ionally mimics a naturally occurring pheromone produced by the carob moth. It acts on a select group of insects and has a nontoxic mode of action. Carob Moth Pheromone Mimic is intended for use in retrievably sized poly

meric dollops , which significantly li mits the possibility

of adverse effects on non - target avian, aquatic, or insect species. As a result, no toxicology or environmental fate and effects data are necessary for registration.**Carob Moth Pherom one Mim** **ic Page**  **9 of**  **13**

**Biopesticides Registration Action Docum ent** 
**4. Endangered Species Assessment** Based on the fact that Carob Mo th Pheromone Mimic is not toxic to non

- target organisms and on its use pattern in retrievable dispensers , EPA has determined it will have "No Effect" on any currently listed threatened or endangered species or any designated critical habitat

. **D. PRODUCT P**  **ERFORMANCE DATA (EFFICACY)** Submission of product performance data (OCSPP Guideline 810.3000) is listed as a requirement for all pesticide products. Customarily, the Agency requires efficacy

data to be submitted for review only in connection with the regis tration of products directly pertaining to the mitigation of disease bearing human health organisms and certain designated quarantine p ests, e. g . , ticks, mosquitoes, fleas, Mediterranean fruit flies, gyp sy m oths, Japanese b eetles. For a list of organisms c onsidered by

the Agency

as “public health pests”, please refer to Pesticide Registration Notice 2002
- 1 (http://www.epa.gov/PR_Notices/pr2002

- 1.pdf ).
**V. R** **ISK M** **ANAGEMENT D**  **ECISION A.**  **D ETERMINATI**  **ON OF E**  **LIGIBILITY FOR**  **R EGISTRATION**  Section 3(c)(5) of FIFRA provides for the registration of a new active ingredient if it is determined that (A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other materials requi red to be submitted 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 gene rally cause unreasonable adverse effects on the environment. The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied by the science assessments evaluating the subject registration application for products contai ning Carob Moth Pheromone Mimic . Such products are not expected to cause unreasonable adverse effects on the environment , and are likely to provide protection as claimed when used according to label instructions. Therefore , Carob Moth Pheromone Mimic is el igible for registration for the labeled uses. **B. R EGULATORY**  **D ECISION**  The data submitted fulfill the registration requirements of Carob Moth Pheromone Mimic when used as an arthropod pheromone

. Refer to Appendix B for product

- specific information.

**Con ditional/Unconditional Registration**  All data requirements are fulfilled, and EPA has determined that an unconditional registration of Carob Moth Pheromone Mimic is appropriate. **C. E NVIRONMENTAL JUSTICE**  EPA seeks to achieve environmental justice, the f air treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation,**Carob Moth Pherom one Mim** **ic Page**  **10 of**  **13**

**Biopesticides Registration Action Docum ent**  and enforcement of environmental laws, regulations, and policies. To help address potential environmental jus tice 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 aty pical, unusually high exposure to Carob Moth Pheromone Mimic , compared to the general population. Please comment if you are aware of any sub

- populations that may have aty pical, unusually

high exposure compared to the general population.
**V I**  **. ACTIONS REQUIRED BY REGISTRANTS**  The Agency

evaluated all of the data submitted in connection w ith the initial registration of Carob Moth Pheromone Mimic and determined that these data are sufficient to satisfy current registration data requirements. No additional data are required to be submi tted to the Agency at this time. For new uses and/or changes to existing uses, additional data may be required. Not withstanding the information stated in the previous paragraph, it should be clearly understood that certain, specific, data are required to be reported to the Agency as a requirement for maintaining the Federal registration for a pesticide product. A brief summary of these ty

pes of data are listed below. **A. R eporting of Adverse Effects**  Reports of all incidents of adverse effects to the environment must be submitted to the Agency under the provisions stated in FIFRA, Section 6(a)(2). **B. Reporting of Hypersensitivity Incidents**  Additionally , all incidents of hy persensitivity

(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. D**  **ATA R** **EQUIRMENTS (40 CFR Part 158**  **- Subpart U**  **)** *NOTE: MRID s listed in the following tables provide supporting data for the original registration of the product containing this active ingredient. Subsequent to this registratio n, there may be additional MRIDs that support registration of other products containing this active ingredient.
**TABLE 1. Product Chem istry Data Requirem**  **ents for Carob Moth Pherom one Mim** **ic (40 CFR § 158.2030) OCSPP**  **Guideline Reference No./ Study**  **Des cription of Result**  **MRID** 8 8 0. 1100 Product identity and composition The product identity and composition were adequately addressed. 48857301 8 8 0. 1200 Description of starting materials,

production, and formulation process The description of the starting materials, production, and formulation process were adequately addressed. 48857301 8 8 0. 1400 Discussion of formation of

impurities The discussion of formation of impurities was adequately addressed. 48857301 8 3 0. 1700 Preliminary analysis The preliminary analysis of the product was acceptable. 48857301 8 3 0. 1750 Certified limits The certified limits listed on the CSF are acceptable. 48857301 8 3 0. 1800 Enforcement analytical method The enforcement analytical method was adequately addressed. 48857301**Carob Moth Pherom one Mim** **ic Page**  **11 of**  **13**

**Biopesticides Registration Action Docum ent** 
**T ABLE**  **2 . Physical and Chem** **ical Properties for Carob Moth Pherom**  **one Mim ic**  **a (40 CFR § 158.2030)**  **Guideline Reference No./Property**  **Description of Result Methods** 
830.6302 Color Colorless Visual inspection at room temperature 830.6303 Phy sical State Liquid Visual inspection at room temperature 830.6304 Odor Waxy, fatty Olfactory inspection at room temperature 830.6313 Stability to normal

and elevated temperatures, metals and metal ions No decomposition detected when heated to 90°C for 48 hrs. Incompatible with metal hydrides. Stored in glass containers, will not come in contact with

metal. 830.6315 Flammability Flash point = 139.2 ± 12.7°C Flame extension = 282.0 ± 54°F b Calculated using Advanced Chemistry Development software v9.04 and the Scifind er Schoolar

. 830.6317 Storage Stability Ongoing 830.6319 Miscibility Not miscible in water. Miscible in mineral oil, hexane, toluene, acetone, and methyl alcohol

. Evaluated visually by adding 2 mL of solvent to 50 mg of product in test tube, agitating , and letting stand for 30 minute

at 15°C. 830.6320 Corrosion

Characteristics Ongoing
830.7000 pH Not applicable, the product is not soluble in water

. 830.7050 UV/Visible light absorption solvent λ max (nm) Absorbance Ethanol 231 0.755 Analysis carried out on Agilent 8453 UV

Visible spectrophotometer

. 830.7100 Viscosity 0.00543 Pa/sec at 15°C 0.00356 Pa/sec at 30.1°C 0.00236 Pa/sec at 50.1°C Controlled stress rheometer

830.7200 Melting Range 22
- 26°C Calcu lated using Advanced Chemistry Development software v9.04 and the Scifinder Schoolar

. 830.7220 Boiling Range 305.8 ± 21.0°C Calculated using Advanced Chemistry Development software v9.04 and the Scifinder Schoolar

. 830.7300 Density/Relative

Density/Bul k Density 0.909 ±0.06 g/cm3 at 20°C Calculated using Advanced Chemistry Development software v9.04 and the Scifinder Schoolar

. 830.7 520 Particle size, fiber

length, and diameter distribution N/A, is a liquid.
830.7550 Partition Coefficient Log P 4.244 + 0.297 at 25 o C Guideline acceptable datum 830.7840 Water Solubility Not soluble in water 830.7950 Vapor Pressure 8.05 x 10 - 4 Torr at 25°C Calculated using Advanced Chemistry Development software v9.04 and the Scifinder Scholar

. aData from MRID 488 57301 b Data from CSF**Carob Moth Pherom one Mim** **ic Page**  **12 of**  **13**

**Biopesticides Registration Action Docum ent**  **Table 3: Mam ma**  **lian Toxicology Data Requirem ents for Carob Moth Pherom**  **one Mim ic (40 CFR § 158.2050)**  **Study/ OCSPP**  **Guideline**

**No. Results**  **Toxicity Category/Description**  **MRID** Acute oral toxicity (rat) (870.1100) Submitted information is su fficient to satisfy the dat a requirement. Active ingredient is volatile and similar formates of about 10 carbon chain lengths ( a.i. has 13) and one or more double bonds, such as Geranyl formate ( LD 50 >6000 mg/kg) and Citronellyl formate (8400 mg/kg) , are v ery low in acute

oral toxicity

. **ACCEPTABLE.** Toxicity Category III

IV a 48857302
Acute dermal toxicity (rat) (870.1200) Submitted information is sufficient to satisfy the dat a requirement. Active ingredient is volatile and similar formates of about 10 carb on chain lengths ( a.i. has 13) and one or more double bonds, such as Geranyl formate ( LD 50 >6000 mg/kg) and Citronellyl formate (8400 mg/kg) , are very low in acute

oral toxicity

. **ACCEPTABLE.** Toxicity Category III

IV a 48857302
Acute inhalation toxicity (r at) (870.1300) S ubmitted information is sufficient to satisfy the data requirement

. The Agency notes that the active ingredient is a volatile substance, applied at extremely low rates (no more than 20 g a.i./acre/application), that would be unlikely to res ult in acute inhalation exposure . Also information provided on structurally equivalent compounds demonstrated Threshold Limit Values ( TLVs ) far in excess of wh ere toxic effects can

be observed. **ACCEPTABLE.** Toxicity Category III

IV a 48857302

Primary eye ir

ritation (rabbit) (870.2400) S ubmitted information is sufficient to satisfy the data requirement. Information on a surrogate demonstrated negligible eye irritation

. **ACCEPTABLE.** Toxicity Category III

IV a 48857302 Primary dermal irritation (rabbit) (870.25 00) Submitted information is sufficient to satisfy the dat a requirement. Active ingredient is volatile and similar formates of about 10 carbon chain lengths ( a.i. has 13) and one or more double bonds, such as Geranyl formate ( LD 50 >6000 mg/kg) and Citronel lyl formate (8400 mg/kg) , are very low in acute

oral toxicity

. **ACCEPTABLE.** Toxicity Category III

IV a 48857302

Dermal sensitization (guinea pig) (870.2600) S ubmitted information is sufficient to satisfy the data requirement. Information on a surrogate de monstrated negligible dermal sensitivity

. **ACCEPTABLE.** Not a sensitizer 48857302 90
- Day oral toxicity (870.3100) S ubmitted information is sufficient to satisfy the data requirement

. The active ingredient is a volatile substance with little likelihood of o ral exposure on either an acute or subchronic basis. Naturally

- occurring formates are ubiquitous in the environment, and humans and the environment are regularly exposed to these formates . Humans are also exposed to formates on a regular basis via their us e as cosmetics, fragrances, and food additives . A pplication rate s are very low relative to the likely ambient level of naturally

- occurring formates already present in the atmosphere. **ACCEPTABLE.** Information submitted to support waiver 48857302

90
- Day dermal toxicity (870.325 0) S ubmitted information is sufficient to satisf y the data requirement. The active ingredient is a volatile substance with little likelihood of dermal exposure on either an acute or subchronic basis. Naturally

- occurring formates are ub iquitous in the environment, and humans and the environment are regularly exposed to these formates . Humans are also exposed to formates on a regular basis via their use as cosmetics, fragrances, and food additives . A pplication rate s are very low relative to the likely ambient level of naturally

- occurring formates already present in the atmosphere. **ACCEPTABLE.** Information submitted to support waiver 48857302

90
- Day inhalation toxicity (870.3465 ) S ubmitted information is sufficient to satisfy the data requ irement. Information from the public literature demons trates negligible toxicity and minimal exposure.

**ACCEPTABLE.** Information submitted to support waiver 48857302 Developmental toxicity (870. 3700 ) S ubmitted information is sufficient to satisfy the data requirement. Information from the public literature on a surrogate compound demonstrates that there is no developmental toxicity associated with exposures to this Information submitted to support waiver 48857302**Carob Moth Pherom one Mim** **ic Page**  **13 of**  **13**

**Biopesticides Registration Action Docum ent**  **Table 3: Mam ma**  **lian Toxicology Data Requirem ents for Carob Moth Pherom**  **one Mim ic (40 CFR § 158.2050)**  **Study/ OCSPP**  **Guideline**

**No. Results**  **Toxicity Category/Description**  **MRID** compound

. **ACCEPTABLE.** Mutagenicity (870.510 0, 5300 and 5375) S ubmitted information is sufficient to satisfy the data requirements. Information from the public literature on a surrogate compound demonstrates that there is no mutagenicity associated with exposures to this compound

.

**ACCEPTABLE .**  Information submitted to support waiver 48857302

aBased on historical mammalian toxicity data for arthropod pheromones, the toxicity categories for the TGAI/MP are: 1) acute oral toxicity

– category I II
- I V, 2) acute dermal toxicity

– category III
- IV, and 3 ) minimal skin irritation. **Table 4: Nontarget Organism Toxicity Data Requirements for Carob Moth Pheromone Mimic (40 CFR § 158.2060) Study/**  **OCSPP Guideline** 

**No. Results**  **MRID** Avian acute oral toxicity (8 5 0. 2100 ) The a.i. is substantially

- similar to an arthropod pheromone, volatile ( 3.2 x 10 - 6 atm m3 /mol ) , and is applied at a maximum application rate of less than 150 g a.i./acre/year. EP testing (2% a.i.) indicated that the LD 50 > 2,000 mg/kg (practically nontoxic ). Submitted information is sufficient to satisfy the dat a requirement. **ACCEPTABLE.** 48857303
Avian dietary toxicity (8 5 0. 2200 ) The a.i. is substantially

- similar to an arthropod pheromone, volatile ( 3.2 x 10 - 6 atm m3 /mol ) , and is applied at a maximum application rate of less than 150 g a.i./acre/year. E P testing (2% a.i.) indicated that the LD 50 > 5,000 ppm (practically nontoxic ). Submitted information is sufficient to satisfy the dat a requirement. **ACCEPTABLE.** 48857303 Fish acute toxicity, freshwater (8 5 0. 1075 ) The a.i. is substantially

- similar to an arthropod pheromone, volatile ( 3.2 x 10 - 6 atm m3 /mol ) , and is applied at a maximum application rate of less than 150 g a.i./acre/year. Submitted information is sufficient to satisfy the dat a requirement. **ACCEPTABLE.** 48857303 Aquatic invertebrate acute toxi city, freshwater (8 50.1010 ) The a.i. is substantially

- similar to an arthropod pheromone, volatile ( 3.2 x 10 - 6 atm m3 /mol ) , and is applied at a maximum application rate of less than 150 g a.i./acre/year. Submitted information is sufficient to satisfy the dat a requirement. **ACCEPTABLE.** 48857303 Nontarget plant testing (8 50
. 4100 and 850.4150 ) The a.i. is substantially

- similar to an arthropod pheromone, volatile ( 3.2 x 10 - 6 atm m3 /mol ) , and is applied at a maximum application rate of less than 150 g a.i./acre/year. Submitted information is sufficient to satisfy the dat a requirement. **ACCEPTABLE.** 48857303 Nontarget insect testing (8 8 0. 4350 ) The a.i. is substantially

- similar to an arthropod pheromone, volatile ( 3.2 x 10 - 6 atm m3 /mol ) , and is applied at a maximum application rate of less than 150 g a.i./acre/year. Submitted information is sufficient to satisfy the dat a requirement. **ACCEPTABLE.** 48857303

**VIII. APPENDIX B.** For product specific information, please refer to http://oaspub.epa.gov/pestlabl/ppls.home

. **IX. A**  **PPENDIX C.**  **REFERENCES** 1. EPA. 2012. Memorandum from Colin G. Walsh to Chris Pfeifer. Science Review in Support of the Registration of SPLAT EC

- O, Containing 2.0% of 7,9,11

- Dodecatrien

- 1
- ol, formate, (7Z,9E)

- As Its Active Ingredient (A.I.). U.S. Environmental Protection Agency Office of Pesticide Programs. December 10, 2012. 2. EPA. 2012. Memorandum from Colin G. Walsh to J. Chris Pfeifer. Science Review in Support of the Registration of ISCA MP
- O), Containing 90.8% of 7,9,11

- Dodecatrien

- 1
- ol, formate, (7Z,9E)

- As Its Active Ingredient (A.I.). U.S. Environmental Protection Agency Office of Pesticide Programs. December 10, 2012. 3. EPA. 2012. Memorandum from Russell S. Jones to J. Chris Pfeifer. S cience Review in Support of the Registration of SPLAT EC MP, Containing 90.8% of 7,9,11

- Dodec atrien

- 1
- ol, formate, (7Z,9E)

- As Its Active Ingredient . Response to Deficiencies. U.S. Environmental Protection Agency Office of Pesticide Programs. April 4, 20 13. 4. EPA. 2012. Memorandum from Russell S. Jones to J. Chris Pfeifer. Science Review in Support of the Registration of SPLAT EC

- O, Containing 2.0% of 7,9,11

- Dodecatrien

- 1
- ol, formate, (7Z,9E)

- As Its Active Ingredient . Response to Deficiencies. U.S. Envir onmental Protection Agency Office of Pesticide Programs. April 8, 2013.