
 


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

EPA Registration Division contact: PV Shah, Branch Chief Inert Assessment Branch (IAB) 703-308-1846



Sasol Chemicals (USA) LLC Petition Number: IN-10990
 EPA has received a pesticide petition (IN-10990) from Spring Trading Company on behalf of Sasol Chemicals (USA) LLC], 12120 Wickchester Ln., Houston, Texas 77079 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
Poly(oxy-1,2-ethanediyl), α-isooctyl-ω-hydroxy where the alkyl chain contains a minimum of six carbons, minimum number average molecular weight (in amu) 1,100.; (AAA's) in or on the raw agricultural commodity growing crops at under 40 CFR 180.910, 930, 940 or 960.

 This petition proposes the addition of the following CAS. No.: 61723-78-2	Alcohols, ethoxylated
 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


Residue chemistry data are not necessary since the request is for an exemption from the requirement of a tolerance.

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

 Magnitude of residues. Sasol Chemicals is petitioning the agency to amend an existing 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

 Acute toxicity. The AAAs are not acutely toxic by the oral and dermal routes of exposure under normal use conditions. Concentrated materials are generally moderate to severe eye and skin irritants and may be skin sensitizers. There is no evidence of mutagenicity in the Ames assay (bacterial strains).

 Genotoxicty. The AAA's showed no evidence of mutagenicity, or chromosome aberration.

 Reproductive	and	developmental	toxicity.	No	reproductive	or developmental/offspring toxicity was observed. It is generally accepted that increased ethoxylation decreases lipophilicity resulting in decreased absorption and decreased toxicity. The lower molecular weight AAAs would be expected to be absorbed and distributed more readily than higher molecular weight AAAs and therefore to potentially be more toxic. The representative ethoxylated compounds tested have the lowest weight percent ethoxylation and lowest molecular weight of the series and are potentially the most bioavailable of the series. Although metabolism data are not available, the major metabolic pathway for AAA surfactants is expected to include the hydrolysis of ether linkage to the corresponding alkyl alcohol and polyalkoxylate (POE or POE/POP) group which subsequently undergoes oxidative degradation and/or excretion.

 Subchronic toxicity. Following subchronic exposure to rats and dogs, decreases in body weight and food consumption were observed, but  no specific target organ toxicity or neurotoxicity was seen. No effects were detected in a functional observational battery (FOB) or motor activity assessment. In a 90 - day dermal toxicity study with AAA surfactant, no systemic toxicity was observed at doses up to 125 mg/kg/day (the highest dose tested).


 Chronic toxicity. There is no evidence that the AAA surfactants are carcinogenic. The Agency used a qualitative structure activity relationship (SAR) database, DEREK Version 11, to determine if there were structural alerts. No structural alerts were identified. In addition, there was little concern about any of the postulated metabolites having greater toxicity than the parent compounds.



Specific information on the studies received and the nature of the adverse effects caused by AAA, as well as, the no-observed-adverse-effect-level (NOAEL) and the lowest-observed adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Alkyl Alcohol Alkoxylates (AAA  -  JITF CST 1 Inert Ingredient). Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations at pp 13 - 20 and pp 61 - 75 in docket ID number EPA -  HQ - OPP - 2009 - 0145.


 Endocrine disruption. FQPA requires EPA to develop a screening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), ``may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect.
. .'' EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. As the Agency proceeds with implementation of this program, further testing of products containing AAA's for endocrine effects may be required.

    Aggregate Exposure

 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.

The AAAs are 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 the AAAs. EPA has concluded that the combined intermediate-term aggregated food, water, and residential exposures result in aggregate MOEs of 230 for both adult males and females, respectively. Adult residential exposure includes high-end post application dermal exposure from contact with treated pets. EPA has concluded that the



combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 110 for children. Children's residential exposure includes total combined pet exposure. As the level of concern is for MOEs that are lower than 100, these MOEs are not of concern.

The Agency has used various screening-level models to estimate some of the existing levels of exposure and those that could occur as a result of establishing this tolerance exemption.

    Cumulative Effects

We have not found a common mechanism of toxicity finding as Poly(oxy-1,2- ethanediyl), α-isooctyl-ω-hydroxy does not appear to produce a toxic metabolite produced by other substances. For the purposes of this requested tolerance action Poly(oxy-1,2- ethanediyl), α-isooctyl-ω-hydroxy does not have a common mechanism of toxicity with other substances.

    Safety Determination

 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 the AAAs.

 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 to residues of the lower weight AAAs.

    International Tolerances

Sasol Chemicals is not aware of any country requiring a tolerance for the AAAs nor have any CODEX Maximum Residue Levels been established for any food crops at this time.
