BIOPESTICIDES REGISTRATION ACTION DOCUMENT



# Citral 3,7
- Dimethyl
- 2,6
- Octadienal 

## PC Code : 040510

U.S. Environmental Protection Agency Office of Pesticide Programs Biopesticides and Pollution Prevention Division

June 20, 2011Citral

Page 2 of 17 Biopesticides Registration Action Document TABLE OF CONTENTS I. EXECUTIVE SUMMARY: ................................ ................................ ................................ . 5 II. ACTIVE INGREDIENT OVERVIEW ................................ ................................ ............... 7 III. REGULATORY BACKGROUND ................................ ................................ ..................... 7 A. Classification ................................ ................................ ................................ ........................ 7 B. Food Clearances and Tolerances ................................ ................................ ........................ 7 IV. RISK ASSESSMENT ................................ ................................ ................................ ........... 7 A. Active Ingredient Characterization ................................ ................................ .................... 7 1. Toxicology...... .......................................................................................8 2. Dose Response Assessment ................................ ................................ ............................. 10 3. Drinking Water Exposure and Risk Characterization.................................... .10 4. . Occupational, Residential, School and Day Care Exposure and Risk Characterization ................................ ................................ ................................ ............. 10 5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation 10 6. Cumulative Effects ................................ ................................ ................................ .......... 11 7. Risk Characterization ................................ ................................ ................................ ..... 11 C. E NVIRONMENTAL ASSESSMENT ................................ ................................ .............. 11 1. Ecological Hazards ................................ ................................ ................................ .......... 11 2. Environmental Fate and Ground Water Data ................................ ............................. 11 3. Ecological Exposure and Risk Characterization............................................12 4. Endangered Species As sessment................................................................12 D. EFFICACY DATA ................................ ................................ ................................ ............. 11 V. RISK MANAGEMENT DECI SION ................................ ................................ ............... 12 3 A. DETERMINATION OF ELI GIBILITY FOR REGISTRAT ION ................................ . 1 3 B. Regulatory Decision.................................................................................13 C. Environmental Justice........................................................................... ...13 VI. ACTIONS REQUIRED BY REGISTRANTS ................................ ................................ . 12 A. Reporting of Adverse Effects .................................................................. ... 14 VII. Appendix A. DATA REQUIREMENTS (40 CFR PART 158) ................................ ....... 13Citral

Page 3 of 17 Biopesticides Registration Action Document VIII. APPENDIX B. Product Specific Information ............ ............ .................. ..... ...1 8 IX . APPENDIX C. References ................................ ................................ ................................ ... 15Citral

Page 4 of 17 Biopesticides Registration Action Document 

### 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/Nontarget Organisms Russell S. Jones, Ph.D., Senior Biologist Senior Regulatory Specialist Leonard S. Cole, Jr. M.S.Citral

Page 5 of 17 Biopesticides Registration Action Document I. EXECUTIVE SUMMARY : Citral is a technical grade active ingredient /manufacturing use product to be used in end
- use products that repel mosquitoes, biting flies, and biting midges. Citral is either of, or a mixture of, a pair of terpenoids . The two compounds are double bond isomers . The E
- isomer is known as gerani o l or citral A. The Z
- isomer is known as neral or citral B. Geraniol is a monoterpenoid C
10 (branched) alcohol found widely as a chief constituent in essential oils including ilang
- ilang oil, palmarosa oil, g eranium oil, orange flower oil, lemongrass oil, hops oil, and lavender oil. It is a clear to pale
- yellow liquid with a boiling point of 230 ° C , is insoluble in water , soluble in alcohol, ether and most common organic solvents It possesses a rose - like odor, and it is used in perfume s and flavoring. Nerol is the cis
- isomer of geraniol. Geranial and neral are the corresponding aldehydes. Citronellol is the dihydrogeraniol and citronellal is the corresponding aldehyde. Citral is the major constituent of l emongrass oil, verbena oil, lemon oil, nikkel oil, lime oil, ginger oil, and other essential plant oils. It is the main source of lemon odor. Neral has a less intense, but sweeter odor
. Citral is also used in the production of retinol which is a form of vitamin A. Geraniol is a pheromone of certain species of bees, being secreted by the scent glands of worker bees to signal the location of nectar
- bearing flowers and the entrances to their hives. Geraniol is a known insect repellant o r deterrant. The Biopesticides and Pollution Prevention Division (BPPD) has determined that the data/information submitted for Product Chemistry and Tier I Acute Toxicity for Citral satisfy the current guideline requirements. BPPD granted waivers /exempti ons from conducting Tier I Sub chronic, Developmental and Mutagenicity studies (OSCPP 870.3100 to 870.5375) due to the nature of the a.i. and its intended uses of potential new EP products
. However, BPPD notes that s hould the intended end
- use applications result in different anticipated exposures to humans, the data requirements may

need to be addressed in future submissions. BPPD also granted waivers/exemptions from conducting the 90
- Day Dermal
- Rat study (OSCPP 870.3250) based on low acute dermal toxicity , minimal irritation, intended low application rates, and little human exposure when used in accordance with USEPA/OPP approved pro duct labeling. As for Non
Target Organisms and Environmental Fate data requirements (OSCPP 850.2100 to 850.4450), the applicant satisfied these requirements either b y submitting acceptable data or the data were waived because the guideline study was not applicable. Based on this information, the Agency has determined that registered use of Citral as a technical grade active ingr edient will have a provisional No Adverse Effects (NAE) on threate ned and/or endangered species. A comprehensive Endangered Species Risk Assessment will be conducted upon submission of EP products containing this active ingredient. Based on the Acute Toxicity data for Citral , the active ingredient is toxicity category I II. As stated above, Tier I Subchronic , Developm ental and Mutagenicity data requirements are Not Applicable at this time due to the nature of the a.i. and intended uses of potential new EP products
. EPA has no concerns for any non - target organisms exposed to Citral when used in accordance with approved label directions. EPA has not identified any toxic endpoints for non
target mammals, birds, plants, aquatic, or so il organisms. There are no concerns for any thre atened and endangered species. G iven that Citral very low toxicity

and presents little if any risk to non
- target organisms, EPA concludes that it is in the best interests of the public and the environment to issue the registration for Citral
.Citral

Page 6 of 17 Biopesticides Registration Action Document The Biopesticides and Pollution Prevention Division (BPPD) has reviewed the data/information in support of the requirements for granting registration under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). It was determined that the data/information submitted adequatel y satisfy current guideline requirements (please refer to 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 on major registration decisions before they occur. According to this new policy , EPA intends to provide a public comment period prior to making a registration decision for, at minimum, the following types of applic ations: 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 new policy of making registration action s more transparent, Citral is subject to a 30 day

comment period as a “new active ingredient”. While a final decision on registration is contingent upon review and consideration of public comments, EPA presently believes that based on the risk assessment and information submitted in support of the registration of Citral that it is in the best interests of the public and the environment to issue the registration for Citral
. The basis for this preliminary decision can be found in the risk assessment for Citral , which is characterized in this BRAD.Citral

Page 7 of 17 Biopesticides Registration Action Document II. ACTIVE INGREDIENT OVERVIEW Common Name: Citral Chemical Names: 3,7
- Dimethyl
- 2,6
- Octadienal Trade & Other Names: Bedoukian Citral CAS Registry Number: 5392
- 40
- 5 OPP Chemical Code: 040510 Type of Pesticide: Biochemical P esticide (Repellent)
III. REGULATORY BACKGROUND On July 29, 2010 , EPA received an application filed by Bedoukian Research, Inc., 21 Finance Drive, Danbury , CT 06810
- 4192 to register the product, Bedoukian Citral Technical , containing the new biochemical active ingredient, Citral , a mixture of a pair of terpenoids
. A notice of receipt of this application, allowing for a 30
- day comment period, was published in the Federal Register of November 24, 2010 (75 FR 2 26 ) . No comments were received following this publication
. A. Classification On September 26, 2008 , the Biochemical Classification Committee determined that Citral can be classified as a biochemical pesticide due to its non - toxic mode of action, natural occurrence in the environment, and history of exposure to humans and the environment demonstrating minimal toxicity
. B. F ood Clearances/Tole rances Currently , this active ingredient is not registered for use on food or feed commodities. A tolerance or exemption from the requirement of a tolerance is not required
.

IV. RISK ASSESSMENT A. Active Ingredient Characterization The new active ingredient Citral , a mixture of two terpenoids , will be formulated as an End
- Use P roduct for repelling mosquitoes, biting flies, biting midgets and no
- see - ums. Citral , or 3,7
- dimethyl
- 2,6
- octadienal , is a mixture of a pair of terpenoids with the molecular formula C 10 H 16 O
. The two compounds are double bond isomers . The E
- isomer is known as geranial or citral A.Citral

Page 8 of 17 Biopesticides Registration Action Document The Z
- isomer is known as neral o r citral B. Geranial has a strong lemon odor. Neral's lemon odor is less intense, but sweeter. Citral is therefore an aroma compound used in the perfume industry for its citrus effect. Citral is also used as a flavor and for fortifying lemon oil. It also has strong antimicrobial qualities and some pheromonal effects in insects
. Citral is a simple compound that ha s low mammalian acute toxicity is likely to degrade rapidly

in the environment.
D escriptions of the product formulation and production process , as well as the formation of impurities , were examined by BPPD and found to be acceptable in meeting current guideline standards. All product chemistry

data requirements for registration of Citral have been satisfied. B. Human Health Assessment 1. Toxicology For acute toxicity

data requirements, toxicity categories are assigned based on the hazard(s) identified from studies and/or information on file with the Agency . The active ingredient is classified into Toxicity

Category I, II, III or IV where Toxicity Category I indicates the highest toxicity and Toxicity

Category IV indicates the lowest toxicity
. Adequate mammalian toxicology data /information is available to support registration of Citral

. All toxicology

data requirements for Citral h ave been satisfied.
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 ef fects from exposure to the eyes, and 3) determine the potential for skin sensitization (allergic contact dermatitis). Tier I acute toxicity studies submitted and reviewed showed that Citral is a toxicity category III ( slightly toxic ) compound via acute dermal routes of exposure , based on testing at a limit dose of 2 250 mg a.i./kg
. Citral falls in Toxicity Category IV (not toxic) for acute inhalation toxicity, primary dermal irritation, and primary eye irritation
. Citral is not an eye irritant , an d definitive submitted information conf irmed that Citral i s a not a dermal sensitizer. For more information regarding acute toxicity data requirements, refer to Table 3 in Appendix A
. b. Subchronic Toxicity Subchronic data is required to determine a no
- observed
- effect
- level (NOEL) and any toxic effects associated with repeated or continuous exposure to a te st substance for a period of ninety days . Waivers requested for the subchronic [90
- day oral (OSCPP 870.3100), 90
- day dermal (OSCPP 870.325 0), and 90
- day

inhalation (OSCPP 870.3465 ) ] were granted b y BPPD, based on the product ’s toxicological and exposure profile below. i. Low acute dermal toxicity (>2000 mg/kg; Tox Category III);Citral

Page 9 of 17 Biopesticides Registration Action Document ii. Minimal dermal irritation (Tox icity Category IV); iii. Intended low application rates ; iv. Products containing Citral as an active ingredient are not intended for purposeful application to human skin , and use of products containing Citral would not result in comparable prolonged human exposure when used in accordance with approved product labeling. The two terpenoids comprising the active ingredient Citral , are double bond isomers containing 10 carbon atoms. Citral is a mixture of two aldehydes that have th e same molecular formula but different structures. The aforementioned aldehyd es are relativel y simple compounds that have low mammalian acute toxicity and are likel y to degrade rapidly in the environment. For more information regarding the subchronic data requirements, refer to Table 3 in Appendix A.

c. Developmental Toxicity and Mutagenicity BPPD granted waivers for Tier I Sub chronic, Developmental and Mutagenicity data requirements (OSCPP 870.3100 to 870.5375) due to the nature of the a.i. and its intended uses in po tential new EP products ( insect repellents )
. d. Tier II/Tier III The data requirement s were not required due to the nature of the a.i. and its intended uses in potential new EP products ( insect repellents )
. e. Effects on the Endocrine System As required under FFDCA section 408 (p), EPA has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally

occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two - tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal sy stems 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 pathway s 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.Citral

Page 10 of 17 Biopesticides Registration Action Document Citral is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Under FFDCA section 408(p) the Agency must screen all pesticide chemicals. Accordingl y, EPA anticipates issuing future EDSP test orders/data call
- ins for all pesticide active ingredients. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery , please visit our website: http://www.epa.gov/endo/. 2. Dose Response Assessment Because n o toxicolog ical endpoints were identified, a dose respon se assessment was not required. 3. Drinking Water Exposure and Risk Characterization No significant exposure via drinking water is expected when Citral is used according to the product label directions
. The active ingredient is not to be applied directl y t o water or to areas where surface water is present, and if used as labeled, is not l ikely to accumulate in drinking water . In the unlikely

event that exposure via drinking water did occur, the health risk would be expected to be minimal, based on the low acute oral toxicity of Citral
. 4. Occupational, Residential, School and Day Care Exposure and Risk Characterization
a. Occupational Exposure and Risk Characterization End
- use products were not available for review. Therefore, occupational exposure and risk cannot be assessed or characterized. This assessment and characterization will be conducted upon receipt of an end
- use product for review. b. Residential, Schoo l and Day Care Exposure and Risk Characterization End
- use products were not submitted for review. Therefore, residential, school, and day
- care exposure and risk cannot be assessed or characterized. This assessment and characterization will be conducted upon receipt of an end
- use product for review. 5 . Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation There is reasonable certainty that no harm to the U
. S
. population will result from aggregate exposure to Citral . This includes all exposures for which there is reliable information. The Agency arrived at this conclusion based on the pesticide’s highl y specific mode of action as a insect repellent , lo w toxicity to mammalian s ys tems and the intended non
- food use. The risk from aggregate exposure (via oral, dermal and inhalation exposure s) is negligible.Citral

Page 11 of 17 Biopesticides Registration Action Document 6 . Cumulative Effects Based on the information available to the Agency , there is no indication that toxic effects associated with exposure to Citral are of toxicological concern
. Because of the active ingredient’s low toxicity, cumulative effects with other substances that share a common mechanism of toxicity

are not expected. 7 . Risk Characterization The Agency

considered human exposure to Citral 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 Citral when label instructions are followed. C. ENVIRONMENTAL ASSESSMENT 1. Ecological Hazards Adequate non - target toxicology data /information are available to support registration of Citral

. All non
- target toxicology data requirements for Citral have been satisfied. Non
- Target Organisms and Environmental Fate data requirements were waived
. 2. Environmental Fate and Ground Water Data The need for environmental fate and groundwater data was not triggered because Citral acute toxicity studies did not trigger any additional Tier I studies. 3. Ecological Exposure and Risk Characterization Based on the information submitted in the data waiver requests for nontarget plants and data for nontarget insects, exposure and risk from the proposed use of Citral is not expected to occur for other nontarget organisms. 4. Endangered Species Assessment Based on the information discussed above, the Agency determined that registered use of Citral as an active ingredient will have No Adverse Effects (NAE) on threatened and/or endangered species
. When the product is used according to label use directions, there are no concerns for any nontarget organisms.

D. PRODUCT PERFORMANCE DATA (EFFICACY) Submission of product performance data (OSCPP 810.3000) is a requirement for all pesticide products. Customarily , the Agency requires efficacy data to be submitted for review onl y in connection with the registration of products directly pertaining to the mitigation of disease bearing human health organisms and certain designated quarantine p ests, i.e., ticks, mosquitoes,Citral

Page 12 of 17 Biopesticides Registration Action Document fleas, Mediterranean fruit flies, gyps y m oths, Japanese b eetles , etc. For a list of organisms considered b y the Agency as “public health pests”, please refer to Pesticide Registration Notice 20 02
- 1 (http://www.epa.gov/PR_Notices/pr2002
- 1.pdf ). No end
- use products were available for review. Therefore, product performance (efficacy) could not be evaluated. V. Risk Management Decision A. Determination of Eligibility for Registration Section 3(c)(5) of FIFRA provides for the registration of new active ingredients if it is determined that : (A) its composition warrant s proposed claims; (B) its labeling and other materials compl y 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 b y the science assessments supporting products containing C itral . Such products are not expected to cau se unreasonable adverse effects and are likel y t o provide protection as claimed when used according to label instructions. Therefore, Citral is eligible for registration for the labeled uses. B. Regulatory De cision The data submitted fulfill the registration requirements of Citral for use as an insect repellent

. 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 Citral 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. At this time , EPA does not believe that use of Citral pesticide products will cause harm or a disproportionate impact on at
- risk co mmunities. For additional information regarding environmental justice issues, please visit EPA’s website at http://www.epa.gov/compliance/environmentaljustice/index.html
. VI . ACTIONS REQUIRED BY REGISTRANTS EPA evaluated all data submitted in connection with the registration of the Citral pesticide products and determined that these data are sufficient to satisfy current registration dataCitral

Page 13 of 17 Biopesticides Registration Action Document requirements. At this time, n o additio products. For new uses and/or changes to existing uses, EPA may require additional data. 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 summa below. A. Reporting of Adverse Effects Pursuant to FIFRA section 6(a)(2), r must be submitted to EPA
. 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 VI I . Appendix A. Data Requirements (40 CFR Part 158 *NOTE: Mas ter Record Identification ( representative of supporting data for the original registration of the product containing this active ingredient. Subsequent to this registration, there may be additional MRIDs th registration of other products containing this active ingredient. Structures and Chemical Data for



### Citral Document o additio nal data must be submi tted to EPA for these particular products. For new uses and/or changes to existing uses, EPA may require additional data. 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 summa ry of these types of data are listed eporting of Adverse Effects Pursuant to FIFRA section 6(a)(2), r eports of all incidents of adverse effects to the environment 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). Appendix A. Data Requirements (40 CFR Part 158 - Subpart U ) ter Record Identification ( MRID ) numbers listed in the following tables are representative of supporting data for the original registration of the product containing this active ingredient. Subsequent to this registration, there may be additional MRIDs th at support registration of other products containing this active ingredient. Structures and Chemical Data for Citral



### Citral tted to EPA for these particular products. For new uses and/or changes to existing uses, EPA may require additional data. 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 ry of these types of data are listed
eports of all incidents of adverse effects to the environment
Additionally, all incidents of hy persensitivity

(including both suspected and confirmed incidents)

158.2050(d).
numbers listed in the following tables are representative of supporting data for the original registration of the product containing this active at supportCitral

Page 14 of 17 Biopesticides Registration Action Document
TABLE 1 . Physical and Chemical Properties for Bedoukian Citral Technical a Guideline Reference No./Property Description of Result Methods 830.6302 Color Pale
- yellow Visual inspection 830.6303 Physical State Liquid Visual inspection 830.6304 Odor Strong, lemon Olfactory inspection 830.6313 Stability Stable for 14 days at 54°C except in the presence of iron. Gas chromatography 830.6314 Oxidation/Reduction:

Chemical Incompatibility Not required for TGAI. 830.6315 Flammability 195°C Pensky Martens closed cup 830.6316 Explodability Not required for TGAI. Not applicable for MP, the product does not contain explosive ingredients. 830.6317 Storage Stability Estimated to be stable for one year at am bient temperatures. Based on 14 day tests at elevated temperatures. One year storage stability required . 830.6319 Miscibility Not required for TGAI. Not applicable for MP, the product is not to be diluted with oil or nonpolar solvents. 830.6320 Corrosion Characteristics Not required for TGAI Not addressed for MP 830.6321 Dielectric Breakdown Voltage Not required for TGAI/MP 830.7000 pH Not applicable, the product is practically insoluble in water. 830.7100 Viscosity 2.44 CST at 25°C ATSM D445 standard method 830.7200 Melting Range

- 26.74°C QSAR; Experimental data per EPISUITE 830.7220 Boiling Range 217.44°C Experimental data per EPISuite 830.7300 Density/Relative Density/Bulk

Density 0.885
- 0.891 at 25°C Anton Parr Density meter, model DMA 4500 830.7370 Dissociation Constant in Water Not applicable, the product is not pure active ingredient. 830.7550 Partition Coefficient Log Pow 3.45 QSRA: EPISuite 830.7840 Water Solubility 1340 mg/L at 37°C 1101 mg/L at 25°C QSAR: EPISuite (WSKOW v1.41) 830.7950 Vapor Pressure 0.0913 mm Hg at 25°C QSAR: EPISuite 830.2240 Photolysis (water) 1.14 years Sunlight epsilon = 6.25x10 3 at 300 nm. 835.2120 Hydrolysis pH 4 9.54

– 9.81 days pH 7 106
- 230 pH 9 22.8

– 30.1 days

Table 3.0. Toxicological Data for Citral Technical (98% ai) Data Requirement LD50 Toxicity Category MRIDs Ac ute Oral Toxicity OPPTS 870.1100 6,800 mg/kg IV (Waiver Acceptable) 48172502 Ac ute Dermal Toxicity OPPTS 870.1200 2,250 mg/kg III (Waiver Acceptable) 48172502 Ac ute Inhalation Toxicity OPPTS 870.1300 Used extensively as a fragrance. IV > 2 mg/L (Waiver Acceptable) 48172502Citral

Page 15 of 17 Biopesticides Registration Action Document Table 3.0. Toxicological Data for Citral Technical (98% ai) Data Requirement LD50 Toxicity Category MRIDs Primary Eye Irritation OPPTS 870.2400 Citral was irritating to rabbit eyes (Waiver Acceptable) 48172502 Primary Dermal Irritation OPPTS 870.2500 Irritating to rabbits (Waiver Acceptable) 48172502 Dermal Sensitization OPPTS 870.2600 Dermal sensitizer (Waiver Acceptable) 48172502 90
- Day Inhalation Subchronic (870.3465) Used extensively as a fragrance. IV > 2 mg/L (Waiver Acceptable) 48172502 Prenatal Development (870.3700) NOAEL = 200 mg/kg/day. No teratogenicity at 68 ppm . (Waiver Acceptable) 48172502 Mutagenicity (870.5100, 870.5300, 870.5375) 10 mg/plate produced negative results with and without metabolic activation (Waiver Acceptable) 48172502 Reproduction (870.3550) Rats given 0, 40, 200, and 1000 mg/kg/day citral tech with no statistically significant effects. NOAEL=1,000mg/kg/day 48172502 MHW, Japan, 2000

Table 4.0. Ecological Toxicological Data for Citral Technical (98% ai) Data Requirement LD 50 Toxicity Category MRIDs Ac ute Avian Oral Toxicity OPPTS 850.2100; 850.2200 No oral exposure. Product is odorous repellent (Waiver Acceptable) 48172502 Ac ute Fish Toxicity OPPTS 850.1075 LC 50 4.6
- 10 mg/L Moderate toxicity (Waiver Acceptable) 48172502 Ac ute InvertebrateToxicity OPPTS 850.1010 EC 50 = 7

– 11 mg/L (Waiver Acceptable) 48172502 Daphnia Reproduction OPPTS 850.1300 NOEC = 1mg/L EC 50 = 1.6 mg/L 4817250 Seedling Emergence OPPTS 850.4100 Odorous repellent no direct exposure to plants (Waiver Acceptable) 48172502 Vegetative Vigor OPPTS 850.4150 Odorous repellent no direct exposure to plants (Waiver Acceptable) 48172502 Nontarget Insect OPPTS 870.2600 Odorous repellent no direct contact to insects (Waiver Acceptable) 48172502

VII I . Appendix B. For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels . IX . Appendix C.Citral

Page 16 of 17 Biopesticides Registration Action Document REFERENCES
MRID Citation Receipt Date 42552800 Sun Deep, Inc. (1992) Submission of product chemistry data to support registration

of Buzz Away. Transmittal of 1 study. 09 - Nov 1992 42552801 Gill, J. (1992) Product Chemistry : Buzz Away. Unpublished study prepared by Sun

Deep, Inc. 13 p. 09 - Nov 1992 43272600 S.C. Johnson & Son Inc. (1994) Submittal of Product Chemistry Data in Support of Registration for Off! Moth Proofer 3. Transmittal of 1 study

. 13 - Jun 1994 43272601 Schinkowitch, D.; Rudin, R. (1994) Off! Moth Proofer 3: Product Chemistry Data:

Lab Project Number: 7867P100: 7867P100 - C1. Unpublished study prepared by S. C. Johnson & Son Inc. 30 p. 13 - Jun 1994 43275600 S. C. Johnson & Son Inc. (1994) Submittal of Product Chemistry Data in Support of Registration of Off! Moth Proofer 4. Transmittal of 1 Study. 13 - Jun 1994 43275601 Schinkowitch, D.; Rudin, R. (1994) Product Chemistry Data: Off! Moth Proofer 4:

Lab Project Number: 7867P101: 7867P101 - C1. Unpublished study prepared by S. C. Johnson & Son Inc. 26 p. 13 - Jun 1994 43278600 L&F Products (1994) Submission of Product Chemist ry Data for TRYSOL in Support of Registration. Transmittal of 1 study. 22 - Jun 1994 43278601 Herrity, M. (1994) Product Chemistry : TRYSOL: Lab Project Number: 93.0810.

Unpublished study prepared by L&F Products, Research Development Lab. 56 p. 22 - Jun 199 4 43941900 Avon Products, Inc. (1996) Submission of Product Chemistry Data in Support of the Application for Registration of Skin So Soft Moisturizing Outdoor Protection After Sun Spray. Transmittal of 1 Study. 29 - Feb 1996
43941901 Garey, J.; Garrison, M.; Luo, Q.; et al. (1996) 5 Batch Analysis of Skin So Soft

Moisturizing Outdoor Protection After Sun Spray: Lab Project Number: 7222 - 24. Unpublished study prepared by Avon Products, Inc. 129 p. 29 - Feb 1996 48033000 E. I. du Pont de Nemours and Co., Inc. (2010) Submission of Product Chemistry

and Toxicity Data in Support of Risk Assessment. Transmittal of 13 Studies. 19 - Feb 2010 48033013 Roncaglioni, A.; Piclin, N.; Pintore, M.; et al. (2008) Binary Classification Models for

Endocrine Disrupter Effects Mediated Through the Estrogen Receptor. SAR and QSAR in Environmental Research 19(7 - 8): 679 - 733. 19 - Feb 2010
48172500 Bedoukian Research Inc. (2010) Submission of Product Chemistry and Toxicity Data In Support of the Applicatio n for Registration of Bedoukian Citral Technical. Transmittal of 2 Studies. 02 -Aug 2010
48172501 Maher, M. (2010) Application for Pesticide Registration: Bedoukian Citral

Technical: Product Chemistry. Unpublished study prepared by Bedoukian Research, Inc . 116 p. 02 -Aug 2010
48172502 Maher, M. (2010) Application for Pesticide Registration: Bedoukian Citral

Technical: Toxicity Testing. Unpublished study prepared by Bedoukian Research, Inc. 399 p. 02 -Aug 2010
48265800 Wh itm ire Micro - Gen Research Laboratories, Inc. (2010) Submission of Product

Chemistry , Toxicity and Efficacy Data in Support of the Application for Registration of TC - 314. Transmittal of 26 Studies. 19 - Oct 2010 48265813 Snell, E.; Smith, T.; Garrett, B. (2010) Efficacy of TC - 314 (0. 5% Chlorfenapyr), 19 - Oct -Citral

Page 17 of 17 Biopesticides Registration Action Document

Phantom Pressurized Insecticide (0.5% Chlorfenapyr) and Mother Earth Exempt Contact Insecticide (6.0% geraniol, 0.5% Lemongrass Oil) Wh en Applied as Direct Spray Applications to Carpenter Bees (Xylocopa virginica). Project Number: BASF/16 53/1663, 2687, 1653. Unpublished study prepared by Snell Scientifics, LLC. 32 p. 2010

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS a.i
. Active Ingredient BPPD Biopesticides and Pollution Prevention Division BRAD Biopesticide Registration Action Document CFR Code of Federal Regulations
cm 3 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 dos e. 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). MRID No. Master Record Identification Number mg milligram mL milliliter MP manufacturing
- use product MPCA microbial pest control agent 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 poly

merase chain reaction PPE personal protective equipment TGAI technical grade of the active ingredient