Document ID: EPA-HQ-OPP-2017-0312-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2017-09-15T04:00Z

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Registration Division contact: [PV Shah,  (CITAB) 703-308-1846]
Oxiteno USA, LLC
IN-11046

	EPA has received a pesticide petition (IN-11046) from Spring Trading Company (203 Dogwood Trail, Magnolia, TX 77354) on behalf of Oxiteno USA, LLC, (9801 Bay Area Blvd., Pasadena, Texas 77507) proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.  To amend the exemption from the requirement of a tolerance for 1-Octanamine, N,N-dimethyl-, N-oxide CAS No. 2605-78-9 in or on the raw agricultural commodity growing crops at 40 CFR 180.910.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

 Residue Chemistry

	1. Analytical method.  An analytical method is not required for enforcement purposes since the request is for an exemption from the requirement of a tolerance without any numerical limitation.

	2. Magnitude of residues. Oxiteno USA, LLC is petitioning the agency to establish an exemption from the requirement of a tolerance.  Therefore information regarding the nature and magnitude of chemical residues resulting from the use of this inert ingredient is not required.

 Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
	1. Acute toxicity.  An acute oral toxicity study in rats is available on octyldimethylamine oxide as well as dermal and eye irritation and dermal sensitization studies.  Octyldimethylamine oxide was not acutely toxic by the oral route (LD50 >5000 mg/kg), was a severe eye irritant and a moderate skin irritant and was not dermal sensitizer.
	2. Genotoxicty. Octyldimethylamine oxide (82.3% purity[1]) was tested for its potential to induce chromosomal aberrations in human lymphocytes in the presence and absence of metabolic activation.  Concentrations evaluated were 0, 432, 865 and 1730 ug/mL.  Octyldimethylamine oxide did not induce a positive response in either experiment in the presence or absence of metabolic activation and was concluded to be negative for inducing chromosomal aberrations in human lymphocytes.  The positive controls produced the expected response
Four genotoxicity studies were located on dodecyl dimethylamine oxide.  These studies includes two Ames Salmonella assays, a cell transformation assay and a rat dominant lethal study.  All studies were negative.
	3. Reproductive and developmental toxicity. Studies available on dodecyl dimethylamine oxide were a 2-generation rat reproduction study and rat and rabbit developmental toxicity studies.  No reproductive toxicity was observed in the rat and no developmental toxicity in the rabbit developmental toxicity study.  In the rat study, developmental toxicity was observed only in the presence of maternal toxicity.
	4. Subchronic toxicity. A 90-day (gavage) toxicity study is available on octyldimethylamine oxide in Sprague-Dawley rats.  The NOAEL was considered to be 150 mg/kg/day based on decreases in body weight and food consumption, mortality, clinical signs of toxicity, decreased motor activity, histopathology of the kidney and spleen and effects on hematology and clinical chemistry parameters observed at 750 mg/kg/day. 
	5. Chronic toxicity. There is no evidence that 1-Octanamine, N,N-dimethyl-, N-oxide is carcinogenic. In addition, there was little concern about any of the postulated metabolites having greater toxicity than the parent compounds.
	6. Endocrine disruption. 1-Octanamine, N,N-dimethyl-, N-oxide is not considered an endocrine disruptor.   As the Agency proceeds with implementation of this program, further testing of products containing 1-Octanamine, N,N-dimethyl-, N-oxide for endocrine effects may be required.
C. Aggregate Exposure
	1. Dietary exposure. In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).
	EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
	1-Octanamine, N,N-dimethyl-, N-oxide is used as inert ingredients in pesticide products that are currently registered for uses that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to 1-Octanamine, N,N-dimethyl-, N-oxide.  Adult residential exposure includes high-end post application dermal exposure from contact with treated pets. The potential MOEs are not of concern.
D. Cumulative Effects
	We have not found a common mechanism of toxicity finding as to 1-Octanamine, N,N-dimethyl-, N-oxide and any other substances. 1-Octanamine, N,N-dimethyl-, N-oxide does not appear to produce a toxic metabolite.  For the purposes of this requested tolerance action 1-Octanamine, N,N-dimethyl-, N-oxide does not have a common mechanism of toxicity with other substances. 

E. Safety Determination
	1. U.S. population. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of 1-Octanamine, N,N-dimethyl-, N-oxide.
	2. Infants and children. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure from residues of 1-Octanamine, N,N-dimethyl-, N-oxide
F. International Tolerances
	Oxiteno USA, LLC, is not aware of any country requiring a tolerance for 1-Octanamine, N,N-dimethyl-, N-oxide nor have any CODEX Maximum Residue Levels been established for any food crops at this time.