BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Carob Moth Pheromone Mimic

PC Code 128003

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

(Last updated May 8, 2013)
Carob Moth Pheromone Mimic Page 2 of 13

Biopesticides Registration Action Document

TABLE OF CONTENTS

I. EXECUTIVE SUMMARY ........................................................................ 4

II. ACTIVE INGREDIENT OVERVIEW ..........................................................5

III. REGULATORY BACKGROUND ............................................................. ..5

A. Classification ..........................................................................................5

B. Food Clearances and Tolerances ................................................................. 5

IV. RISK ASSESSMENT ................................................................................5

A. Active Ingredient Characterization .............................................................. 5

B. Human Health Assessment .........................................................................6

1. Toxicology .......................................................................................... 6

2. Dose Response Assessment ...................................................................... 7

3. Food Quality Protection Act (FQPA) Consideration .......................................7

 4. Occupational, Residential and School Exposure and Risk Characterization ...........7

5 Cumulative Effects .................................................................................8

6 Risk Characterization .............................................................................8

C. ENVIRONMENTAL ASSESSMENT ............................................................8

1. Ecological Hazards ................................................................................ 8

2. Environmental Fate and Ground Water Data ................................................8

3. Ecological Exposure and Risk Characterization .............................................8

 4. Endangered Species Assessment .................................................................9

D. EFFICACY DATA ..................................................................................9

V. RISK MANAGEMENT DECISION ............................................................. 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 ...............................................................10

VIII. APPENDIX B. Product Specific Information .................................................13

IX. APPENDIX C. REFERENCES .....................................................................13 
Carob Moth Pheromone Mimic Page 3 of 13

Biopesticides Registration Action Document

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs:

Biopesticides and Pollution Prevention Division

Biochemical Pesticides Branch (BPB)

Chris Pfeifer Regulatory Action Leader

Linda Hollis Branch Chief

Colin G. Walsh, M.S. Biologist

Russell S. Jones, Ph.D. Senior Biologist 
Carob Moth Pheromone Mimic Page 4 of 13

Biopesticides Registration Action Document

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 synthetic arthropod pheromone. This pheromone is structurally

similar to, and mimics, a naturally occurring pheromone produced by the female carob moth 

(Ectomyelois ceratoniae) to attract males for mating. Carob Moth Pheromone Mimic is intended for 

use in polymeric 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 registration 

for 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 required to 

support the registration of this biochemical active ingredient, under Section 3(c)(5) of the Federal 

Insecticide, Fungicide and Rodenticide Act (FIFRA). Product chemistry data requirements were 

satisfied by acceptable guideline studies. Adequate mammalian toxicology information was

submitted to support registration of Carob Moth Pheromone Mimic. Acceptable guideline studies 

were submitted for the acute toxicity data requirements. Data waivers were granted by the Agency

for the remaining toxicity requirements based on the lack of toxicity of the active ingredient.

Ecological effects data requirements for this arthropod pheromone were waived because of the use 

of this pheromone in retrievable, polymeric applications (40 CFR § 158.2060).

Based on the data available to the Agency, it has been determined 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 the active ingredient is not toxic following oral, inhalation, or dermal 

exposure. Moreover, the pesticidal usage of this biochemical in retrievable, polymeric applications

will not have any harmful environmental effects

Due to the negligible risk concerns when used as mating disrupter, Carob Moth Pheromone Mimic

meets the criteria as specified in §3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act 

(FIFRA), as amended, and is thus eligible for unconditional registration. It was 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 decisions before they occur. According to this policy, 

EPA provides a public comment period prior to making a registration decision for the following 

types of applications: new active ingredients, first food use, first outdoor use, first residential use; 

and any registration decisions for which the Agency believes there may be substantial public 

interest. 

Consistent with the policy of making registration actions more transparent, Carob Moth 

Pheromone Mimic is subject to a 15 day comment period as a “new biochemical active ingredient.”

The notice for this comment period includes a draft of this Biopesticides Registration Action 

Document (BRAD) and the draft product labels for ISCA EC-MP (EPA File Symbol No. 80286-

RO) and SPLAT EC-O (EPA File Symbol No. 80286-RI), which contain this new active 

ingredient, Carob Moth Pheromone Mimic. The docket identification (ID) number is EPA-HQOPP-2012-0787. Altogether, the Agency believes that, based on the risk assessment and 

information submitted in support of the registration of the pesticide products containing Carob 
Carob Moth Pheromone Mimic Page 5 of 13

Biopesticides Registration Action Document

Moth Pheromone Mimic, it is in the best interests of the public to issue the registrations for ISCA 

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 Number: 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 BACKGROUND

On January 13, 2012, ISCA 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) ISCA EC-MP (80286-RO), containing 90.8% 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 (77 FR 216), with a 30-day comment period. No comments were received following this 

publication.

A. Classification

The 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 structurally

similar to and mimics a naturally occurring pheromone produced by the carob moth.

B. Food Clearances/Tolerances 

Arthropod pheromones are exempt from the requirement of a tolerance in or on raw agricultural 

commodities when used in retrievable, polymeric matrix applications, and when the pheromone is 

applied to growing crops at a rate not to exceed 150 grams active ingredient per acre per year in 

accordance with good agricultural practices (40 CFR §180.1124). In addition, the Agency has 

determined that the inert ingredients in the dollop used in the EP that contain this new active ingredient 

can be considered a retrievable polymeric application and can also be considered under the tolerance 

exemption for retrievable polymeric dispensers (40 CFR §180.1122).

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

Carob Moth Pheromone Mimic is a synthetic compound that mimics a naturally occurring 
Carob Moth Pheromone Mimic Page 6 of 13

Biopesticides Registration Action Document

pheromone produced by female carob moths. This compound is a colorless liquid with a slightly

fatty, waxy smell. 

The descriptions 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 analytical method used to 

determine the content of the active ingredient is also acceptable. Physical and chemical properties 

were submitted for the active ingredient and are adequate. Refer to Table 1 in Appendix A for a 

summary of product 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 chemistry

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. All 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 polymeric 

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 polymeric 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 submitted Tier I human health toxicity information for the active ingredient as a 

series of Guideline by Guideline rationales (MRID 48857302). The information submitted supports 

registration and demonstrates that the new active ingredient, 7,9,11-Dodecatrien-1-ol, formate, 

(7Z,9E)- (Carob Moth Pheromone Mimic), is sufficiently 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 naturally occurring carob 

moth pheromone (an SCLP) by the carbon chain length, terminal bond positioning, and geometry. 

In addition, 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 irritation, primary dermal, and 

acute 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 submitted 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 Pheromone Mimic Page 7 of 13

Biopesticides Registration Action Document

as nontoxic. Information on the compound’s volatility demonstrated that any subchronic and 

developmental exposure scenarios were highly unlikely. And data on scientifically acceptable 

surrogates demonstrated 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 Table 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 response assessment was not required. 

3. Food Quality Protection Act (FQPA) Consideration

a. Dietary Exposure and Risk Characterization

In accordance with 40 CFR §180.1124, arthropod pheromones are exempt from the requirement of 

a tolerance, and thus a dietary assessment is not required.

Moreover, exposure to Carob Moth Pheromone Mimic is expected to be minimal due to its use in 

point source dispensers, from which it is released in very small quantities. Restricting the use of the

Carob Moth Pheromone Mimic to retrievably sized dollops will 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 Pheromone 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 residues 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 synthetic compound that is structurally identical to, and 

mimics, the naturally occurring pheromone of the carob moth, and acts via a nontoxic mode of 

action to specific target pests. Low oral, dermal, and inhalation toxicity have been demonstrated by

the data summarized above. The end-use product will be applied via polymeric-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 Pheromone Mimic Page 8 of 13

Biopesticides Registration Action Document

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 effects of Carob Moth Pheromone Mimic and 

other substances in relation to a common mechanism of toxicity. Because 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. ENVIRONMENTAL 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 provide non-target organism toxicity data. Carob Moth Pheromone 

Mimic is a synthetic arthropod pheromone that is structurally similar to, and mimics, the 

pheromone produced by the carob moth. This compound acts on a select group of insects and has a 

nontoxic mode of action. Carob Moth Pheromone Mimic will be used in retrievably sized 

polymeric applications at a rate not exceeding 150 grams/acre/year. 

Although not required, the applicant did provide Tier I TGAI non-target organism toxicity

information 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 

expected to available to avian species (40 CFR §158.2060).

3. Ecological Exposure and Risk Characterization

Carob Moth Pheromone Mimic is a synthetic arthropod pheromone that structurally and 

functionally 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 polymeric dollops, which significantly limits 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 Pheromone Mimic Page 9 of 13

Biopesticides Registration Action Document

4. Endangered Species Assessment

Based on the fact that Carob Moth 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 PERFORMANCE 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 registration of products directly pertaining to the mitigation of 

disease bearing human health organisms and certain designated quarantine pests, e.g., ticks, 

mosquitoes, fleas, Mediterranean fruit flies, gypsy moths, Japanese beetles. For a list of organisms 

considered 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. RISK MANAGEMENT DECISION

A. DETERMINATION OF ELIGIBILITY FOR REGISTRATION

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

that (A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other 

materials required 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 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 evaluating the subject registration application for products containing 

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 eligible for registration for the 

labeled uses. 

B. REGULATORY DECISION

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.

Conditional/Unconditional Registration

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

Carob Moth Pheromone Mimic 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, in the development, implementation, 
Carob Moth Pheromone Mimic Page 10 of 13

Biopesticides Registration Action Document

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have atypical, 

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 atypical, unusually high 

exposure compared to the general population.

VI. ACTIONS REQUIRED BY REGISTRANTS

The Agency evaluated all of the data submitted in connection with 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 submitted 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 types of data 

are listed below. 

A. Reporting 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 hypersensitivity (including both suspected and confirmed incidents) 

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

VII. APPENDIX A. DATA REQUIRMENTS (40 CFR Part 158-Subpart U)

*NOTE: MRIDs listed in the following tables provide 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. 

TABLE 1. Product Chemistry Data Requirements for Carob Moth Pheromone Mimic (40 CFR § 158.2030)

OCSPP Guideline Reference No./Study Description of Result MRID

880.1100 Product identity and composition The product identity and composition were adequately 

addressed. 48857301

880.1200 Description of starting materials, 

production, and formulation process

The description of the starting materials, production, and 

formulation process were adequately addressed. 48857301

880.1400 Discussion of formation of 

impurities

The discussion of formation of impurities was adequately 

addressed. 48857301

830.1700 Preliminary analysis The preliminary analysis of the product was acceptable. 48857301

830.1750 Certified limits The certified limits listed on the CSF are acceptable. 48857301

830.1800 Enforcement analytical method The enforcement analytical method was adequately addressed. 48857301
Carob Moth Pheromone Mimic Page 11 of 13

Biopesticides Registration Action Document

TABLE 2. Physical and Chemical Properties for Carob Moth Pheromone Mimic a(40 CFR § 158.2030)

Guideline Reference 

No./Property

Description of Result Methods

830.6302 Color Colorless Visual inspection at room temperature

830.6303 Physical 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°Fb

Calculated using Advanced Chemistry 

Development software v9.04 and the 

Scifinder 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 λmax (nm) Absorbance

Ethanol 231 0.755

Analysis carried out on Agilent 8453 UVVisible 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 Calculated 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/Bulk Density

0.909 ±0.06 g/cm3at 20°C Calculated using Advanced Chemistry 

Development software v9.04 and the 

Scifinder Schoolar.

830.7520 Particle size, fiber 

length, and diameter 

distribution

N/A, is a liquid.

830.7550 Partition Coefficient Log P 4.244 + 0.297 at 25 oC 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 48857301

bData from CSF
Carob Moth Pheromone Mimic Page 12 of 13

Biopesticides Registration Action Document

Table 3: Mammalian Toxicology Data Requirements for Carob Moth Pheromone Mimic (40 CFR § 158.2050)

Study/OCSPP Guideline 

No. Results Toxicity Category/Description MRID

Acute oral toxicity (rat)

(870.1100)

Submitted information is sufficient to satisfy the data

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 (LD50 >6000 mg/kg) 

and Citronellyl formate (8400 mg/kg), are very low in acute 

oral toxicity. ACCEPTABLE.

Toxicity Category IIIIVa 48857302

Acute dermal toxicity (rat)

(870.1200)

Submitted information is sufficient to satisfy the data

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 (LD50 >6000 mg/kg) 

and Citronellyl formate (8400 mg/kg), are very low in acute 

oral toxicity. ACCEPTABLE.

Toxicity Category IIIIVa 48857302

Acute inhalation toxicity

(rat)

(870.1300)

Submitted 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 

result in acute inhalation exposure. Also information provided 

on structurally equivalent compounds demonstrated Threshold 

Limit Values (TLVs) far in excess of where toxic effects can 

be observed. ACCEPTABLE.

Toxicity Category IIIIVa 48857302

Primary eye irritation 

(rabbit)

(870.2400)

Submitted information is sufficient to satisfy the data 

requirement. Information on a surrogate demonstrated 

negligible eye irritation. ACCEPTABLE.

Toxicity Category IIIIVa 48857302

Primary dermal irritation 

(rabbit)

(870.2500)

Submitted information is sufficient to satisfy the data

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 (LD50 >6000 mg/kg) 

and Citronellyl formate (8400 mg/kg), are very low in acute 

oral toxicity. ACCEPTABLE.

Toxicity Category IIIIVa 48857302

Dermal sensitization 

(guinea pig)

(870.2600)

Submitted information is sufficient to satisfy the data 

requirement. Information on a surrogate demonstrated 

negligible dermal sensitivity. ACCEPTABLE.

Not a sensitizer 48857302

90-Day oral toxicity

(870.3100)

Submitted information is sufficient to satisfy the data 

requirement. The active ingredient is a volatile substance with 

little likelihood of oral 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 use as cosmetics, 

fragrances, and food additives. Application rates 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

(870.3250)

Submitted information is sufficient to satisfy 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 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 use as cosmetics, 

fragrances, and food additives. Application rates 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)

Submitted information is sufficient to satisfy the data 

requirement. Information from the public literature 

demonstrates negligible toxicity and minimal exposure. 

ACCEPTABLE.

Information 

submitted to support 

waiver

48857302

Developmental toxicity

(870.3700)

Submitted 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 Pheromone Mimic Page 13 of 13

Biopesticides Registration Action Document

Table 3: Mammalian Toxicology Data Requirements for Carob Moth Pheromone Mimic (40 CFR § 158.2050)

Study/OCSPP Guideline 

No. Results Toxicity Category/Description MRID

compound. ACCEPTABLE.

Mutagenicity

(870.5100, 5300 and 5375)

Submitted 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 III-IV, 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

(850.2100)

The a.i. is substantially-similar to an arthropod pheromone, volatile (3.2 x 10-6atm 

m

3

/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 LD50 > 2,000 mg/kg (practically nontoxic). 

Submitted information is sufficient to satisfy the data requirement. ACCEPTABLE.

48857303

Avian dietary toxicity

(850.2200)

The a.i. is substantially-similar to an arthropod pheromone, volatile (3.2 x 10-6atm 

m

3

/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 LD50 > 5,000 ppm (practically nontoxic). 

Submitted information is sufficient to satisfy the data requirement. ACCEPTABLE.

48857303

Fish acute toxicity, 

freshwater

(850.1075)

The a.i. is substantially-similar to an arthropod pheromone, volatile (3.2 x 10-6atm 

m

3

/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 data requirement. ACCEPTABLE.

48857303

Aquatic invertebrate acute 

toxicity, freshwater

(850.1010)

The a.i. is substantially-similar to an arthropod pheromone, volatile (3.2 x 10-6atm 

m

3

/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 data requirement. ACCEPTABLE.

48857303

Nontarget plant testing

(850.4100 and 850.4150)

The a.i. is substantially-similar to an arthropod pheromone, volatile (3.2 x 10-6atm 

m

3

/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 data requirement. ACCEPTABLE.

48857303

Nontarget insect testing

(880.4350)

The a.i. is substantially-similar to an arthropod pheromone, volatile (3.2 x 10-6atm 

m

3

/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 data requirement. ACCEPTABLE.

48857303

VIII. APPENDIX B.

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

IX.APPENDIX 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. Science Review in Support of the 

Registration of SPLAT EC MP, Containing 90.8% of 7,9,11-Dodecatrien-1-ol, formate, (7Z,9E)- As Its 

Active Ingredient . Response to Deficiencies. U.S. Environmental Protection Agency Office of Pesticide 

Programs. April 4, 2013.

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. Environmental Protection Agency Office of Pesticide Programs. 

April 8, 2013.