Document ID: EPA-HQ-OPP-2008-0019-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-06-22T04:00Z

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, 2011
                                       
		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	8
A.	Active Ingredient Characterization	8
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	11
5.	Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation	11
6.	Cumulative Effects	11
7.     Risk Characterization	11
C.	ENVIRONMENTAL ASSESSMENT	11
1.	Ecological Hazards	11
2.	Environmental Fate and Ground Water Data	12
3.	Ecological Exposure and Risk Characterization............................................12
    4. 	Endangered Species Assessment................................................................12
D.	EFFICACY DATA	12
V.    Risk Management Decision	123
A.	Determination of Eligibility for Registration	13
B.	Regulatory Decision.................................................................................13

C.     Environmental Justice..............................................................................13
VI.	ACTIONS REQUIRED BY REGISTRANTS	13
A.	Reporting of Adverse Effects.....................................................................14
VII. Appendix A. DATA REQUIREMENTS (40 CFR PART 158)	14

VIII. APPENDIX B. Product Specific Information..................................................18
IX. Appendix C. References	18
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.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 geraniol 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, geranium 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 perfumes 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 lemongrass 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 or 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/exemptions 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 should 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 product labeling. As for Non-Target Organisms and Environmental Fate data requirements (OSCPP 850.2100 to 850.4450), the applicant satisfied these requirements either by 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 ingredient will have a provisional No Adverse Effects (NAE) on threatened 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 III. As stated above, Tier I Subchronic, Developmental 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 soil organisms. There are no concerns for any threatened and endangered species. Given 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.

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 adequately 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 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 new policy of making registration actions 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.  

                                        
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 Pesticide (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 226). 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.	Food Clearances/Tolerances 

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 Product 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 C10H16O. The two compounds are double bond isomers. The E-isomer is known as geranial or citral A. The Z-isomer is known as neral or 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 has low mammalian acute toxicity is likely to degrade rapidly in the environment.  

Descriptions 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 have 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 effects 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 2250 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, and definitive submitted information confirmed that Citral is 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 test substance for a period of ninety days.  
 
Waivers requested for the subchronic [90-day oral (OSCPP 870.3100), 90-day dermal (OSCPP 870.3250), and 90-day inhalation (OSCPP 870.3465)] were granted by BPPD, based on the product's toxicological and exposure profile below.

	i.	Low acute dermal toxicity (>2000 mg/kg; Tox Category III);
	ii.	Minimal dermal irritation (Toxicity 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 the same molecular formula but different structures.   The aforementioned aldehydes are relatively simple compounds that have low mammalian acute toxicity and are likely 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
potential new EP products (insect repellents).  

	d.   Tier II/Tier III 

The data requirements 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 systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data.  Tier 2 testing is designed to identify any adverse endocrine related effects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and nine inert ingredients.  This list of chemicals was selected based on the potential for human exposure through pathways such as food and water, residential activity, and certain post-application agricultural scenarios.  This list should not be construed as a list of known or likely endocrine disruptors.

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.  Accordingly, EPA anticipates issuing future EDSP test orders/data call-ins for all pesticide active ingredients. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website:  http://www.epa.gov/endo/.
   
2.	Dose Response Assessment

Because no toxicological endpoints were identified, a dose response 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 directly to water or to areas where surface water is present, and if used as labeled, is not likely 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, School 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 highly specific mode of action as a insect repellent, low toxicity to mammalian systems and the intended non-food use.  The risk from aggregate exposure (via oral, dermal and inhalation exposures) is negligible. 

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 only in connection with the registration of products directly pertaining to the mitigation of disease bearing human health organisms and certain designated quarantine pests, i.e., ticks, mosquitoes, fleas, Mediterranean fruit flies, gypsy moths, Japanese beetles, etc.  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).  

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 warrants proposed claims; (B) its labeling and other materials comply with the requirements of FIFRA; (C) it will perform its intended function without unreasonable adverse effects on the environment; and (D) when used in accordance with widespread and commonly recognized practice, it will not generally cause unreasonable adverse effects on the environment. 

The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied by the science assessments supporting products containing Citral.  Such products are not expected to cause unreasonable adverse effects and are likely to provide protection as claimed when used according to label instructions. Therefore, Citral is eligible for registration for the labeled uses.  
   
B.	Regulatory Decision

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 communities.

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 data requirements. At this time, no additional data must be submitted 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 summary of these types of data are listed below. 

A.  Reporting of Adverse Effects
   
Pursuant to FIFRA section 6(a)(2), reports of all incidents of adverse effects to the environment must be submitted to EPA.
B.REPORTING OF HYPERSENSITIVITY INCIDENTS
   
Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) must be reported to the Agency under the provisions of 40 CFR Part 158.2050(d).

VII.	 Appendix A. Data Requirements (40 CFR Part 158-Subpart U)

*NOTE:  Master Record Identification (MRID) numbers listed in the following tables are representative of supporting data for the original registration of the product containing this active ingredient.  Subsequent to this registration, there may be additional MRIDs that support registration of other products containing this active ingredient.   

Structures and Chemical Data for Citral

                                    Citral
                                       
                                       

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 ambient 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
Acute Oral Toxicity
OPPTS 870.1100

6,800 mg/kg
                                      IV
                              (Waiver Acceptable)
                                       
                                   48172502
Acute Dermal Toxicity
OPPTS 870.1200

2,250 mg/kg
                                      III
                              (Waiver Acceptable)
                                       
                                   48172502
Acute Inhalation Toxicity
OPPTS 870.1300

Used extensively as a fragrance. 
                                      IV
                                  > 2 mg/L
                              (Waiver Acceptable)
                                       
                                   48172502
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
                                     LD50
                               Toxicity Category
                                     MRIDs
Acute Avian Oral Toxicity
OPPTS 850.2100; 850.2200
No oral exposure. Product is odorous repellent
                                        
                              (Waiver Acceptable)
                                       
                                   48172502
Acute Fish Toxicity
OPPTS 850.1075

LC50 4.6 -10 mg/L
                               Moderate toxicity
                              (Waiver Acceptable)
                                       
                                   48172502
Acute InvertebrateToxicity
OPPTS 850.1010

EC50 = 7  -  11 mg/L
                                        
                              (Waiver Acceptable)
                                       
                                   48172502
Daphnia Reproduction
OPPTS 850.1300
NOEC = 1mg/L
EC50 = 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

VIII. Appendix B.

For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels.

IX.	Appendix C.
                                       
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 Chemistry 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-1994
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 Application 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
Whitmire 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), Phantom Pressurized Insecticide (0.5% Chlorfenapyr) and Mother Earth Exempt Contact Insecticide (6.0% geraniol, 0.5% Lemongrass Oil) When Applied as Direct Spray Applications to Carpenter Bees (Xylocopa virginica). Project Number: BASF/1653/1663, 2687, 1653. Unpublished study prepared by Snell Scientifics, LLC. 32 p.
                                  19-Oct-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
   LD50	median lethal dose. A statistically derived single dose that can be expected 
   	to cause death in 50% of the test animals when administered by the route 
   	indicated (oral, dermal, or inhalation). It is expressed as a weight of 
   	substance per unit weight of animal (e.g., mg/kg).
   MRID No.	Master Record Identification Number
   mg	milligram
   mL	milliliter
   MP	manufacturing-use product
   MPCA	microbial pest control agent
   NE	"No Effect"
   NIOSH 	National Institute for Occupational Safety and Health
   OPP	Office of Pesticide Programs
   OPPTS 	Office of Prevention, Pesticides, and Toxic Substances
   PCR	polymerase chain reaction 
   PPE 	personal protective equipment
       TGAI 	   technical grade of the active ingredient