Document ID: EPA-HQ-OPP-2018-0156-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2018-05-18T04:00Z

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.

      Evonik Corporation, P.O. Box 34628, Richmond, Virginia 23234
      
             EPA has received a pesticide petition (IN-11104) from Spring Trading Company on behalf of Evonik Corporation, P.O. Box 34628, Richmond, Virginia 23234 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 part180.

  To establish an exemption from the requirement of a tolerance for butoxypolypropylene glycol [CAS# 9003-13-8; BPG; α-butyl-ώ-hydroxy-poly-oxy(methyl-1,2-ethanediyl)], oxirane, 2-methyl-, polymer with oxirane, mono-2-propen-1-yl ether (CAS# 9041-33-2; polyether 1), poly(oxy-1,2-ethanediyl), α-acetyl-ώ-(2-propen-1-yloxy)- (CAS# 27252-87-5; polyether 2) and poly(oxy-1,2-ethanediyl), α-methyl-ώ-(2-propen-1-yloxy)- (CAS# 27252-80-8; polyether 3): under 40 CFR 180.910 and 180.930 to include CAS. Reg. No. 9003-13-8, CAS. Reg. No. 9041-33-2, CAS. Reg. No. 27252-87-5, & CAS. Reg. No. 27252-80-8. 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.  Evonik believes that the chemistry described by CAS. Reg. No. 9003-13-8, CAS. Reg. No. 9041-33-2, CAS. Reg. No. 27252-87-5, & CAS. Reg. No. 27252-80-8 is described by the published tolerance exemption and therefore would fall under the published tolerance exemption in 40 CFR 180.910 and 180.930. Since the current risk assessment was conducted on a range of chemistries to support the published descriptor range of chemistries and EPA has determined that this range of chemistries would be acceptable under this risk assessment Evonik believes this chemistry is supported by the current risk assessment.

 Residue Chemistry

  Since this request is for an exemption from the Establishment of a Tolerance, no additional residue studies are required.
  
  	1.  Analytical method. An analytical method is not required for enforcement purposes since the Agency has established an exemption from the requirement of a tolerance without any numerical limitation.

             2. Magnitude of residues.  Evonik is petitioning the Agency to add an exemption from the requirement of a tolerance for food use.  Therefore, information regarding the nature and magnitude of chemical residues resulting from the use of this inert ingredient is not required.

             B. Toxicological Profile

             1. Acute toxicity. Butoxypolypropylene glycol has low acute oral toxicity with LD50 values ranging from 5.84 to 17.3 g/kg placing into Toxicity Category IV for acute oral toxicity. The acute oral toxicity of the surrogate chemical polyoxyethylene poloxypropylene monobuty ether was 2 g/kg which places into Toxicity Category III. The acute dermal toxicity of butoxypolypropylene glycol is low with an LD50 of >16 g/kg which places into Toxicity Category IV. The acute inhalation LC50 reported in the Revised HED Chapter of the RED for Butoxypolypropylene Glycol was >2.62 mg/L. The LC50 of the surrogate chemical polyoxyethylene poloxypropylene monobutyl ether was 4770 mg/m3 or 4.77 mg/L which places into Toxicity Category IV for acute inhalation toxicity. Butoxypolyethylene glycol is an eye irritant causing corneal effects at 24 hours.  The eyes were apparently not examined at 48 or 72 hours.  The HED Revised Chapter of the RED for Butoxypolypropylene Glycol indicates that is Category III for eye irritation. Butoxypolypropylene glycol is not a dermal irritant, which places into Toxicity Category IV.

              Genotoxicity. Butoxypolypropylene glycol was evaluated in three genotoxicity assays, an Ames Salmonella assay, an in vitro SCE assay and in vivo mouse micronucleus assay.  It was negative in all three assays indicating that it is not genotoxic.
              Reproductive and developmental toxicity. A publicly available developmental toxicity study was not located on butoxypolypropylene glycol or any of the other polyethers.  Therefore, Evonik is citing MRID 42815501 which was conducted in 1993 to fulfill this data requirement.  A summary of this study is provided below with information from the revised RED for Butoxypolypropylene Glycol.  The LOAEL for maternal systemic toxicity in this study was 2000 mg/kg/day based on reduced body weight gain and the NOAEL was 400 mg/kg/day. The LOAEL for maternal dermal toxicity was 2000 mg/kg/day based on increased clinical signs of skin irritation (exfoliation) and the NOAEL was 400 mg/kg/day. No developmental toxicity was noted at the highest dose tested (4000 mg/kg/day).
                     
             4. 	Subchronic toxicity. A limited 90-day oral toxicity study is available on butoxypolypropylene glycol.  The NOAEL in this study was considered to be 0.67 g/kg/day or 670 mg/kg/day based on decreased body weight gain and mortality observed at 3.28 g/kg/day. A 90-day oral toxicity study was available on the surrogate chemical polyoxyethylene poloxypropylene monobutyl ether.  The NOAEL was considered to be 0.01% in the diet based on histopathology findings in the kidney and liver at high concentrations.  This dietary concentration corresponds to 7.8 and 9.0 mg/kg/day in males and females, respectively.  Because a commercial product was used in this study, some of the toxicity observed could be related to impurities and not to the polyether component of the tested material.  The results of this study are in contrast to the findings in the 90-day study summarized above for butoxypolypropylene glycol.  A 90-day dermal toxicity study was available on butoxypolypropylene glycol.  The systemic NOAEL was 1000 mg/kg/day based on reduced body weights and effects on hematology parameters observed at 4000 mg/kg/day.  The dermal toxicity NOAEL was 500 mg/kg/day based on the observed skin effects at higher dose levels. A 9-day repeated dose inhalation study was available on the surrogate chemical polyoxyethylene poloxypropylene monobutyl ether.  Although this study is stated to be a 9-day study, it was conducted over a 2-week period with exposures occurring on weekdays.  The NOAEL is considered to be 100 mg/m3 based on clinical signs in females, decreased body weight and body weight gain, hematology, clinical chemistry and urinalysis findings and microscopic findings in the lung observed at 500 mg/m3. 
             
             5. Chronic toxicity. No Chronic studies were available on butoxypolypropylene glycol or any of the other polyethers. The open literature was carefully searched (TOXNET, PubMed, Google Scholar and the internet in general) for any information on the potential carcinogenicity of structurally similar compounds and none was located. 

              Animal metabolism. The mammalian metabolism may be predicted based on either environmental or bacterial degradation or by analogy to documented studies.
                     
              Metabolite toxicology. The animal metabolism of this chemistry has not been investigated and metabolites have not been identified. However, based on the plausible metabolic pathways, no metabolites of toxicological concern are expected.

              Endocrine disruption. This class of chemistry does not belong to a class of chemicals known or suspected of having adverse effects on the estrogen receptor or endocrine system.

             C. Aggregate Exposure
             
             The Agency's previous assessment for butoxypolypropylene glycol and the three polyethers determined that there was a reasonable certainty that no harm to any population subgroup would result from aggregate exposure (dietary and non-occupational sources of exposure) when used as inert ingredients in pesticide formulations. Evonik believes that the use of the requested CAS. Reg. No.'s is not expected to increase the exposure profile.

             1. Dietary exposure. Evonik believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure.

             i. Food. In conducting the acute and chronic dietary exposure assessments, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, no residue data was submitted for butoxypolypropylene glycol and the other three polyethers. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredients. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides.

             ii. Drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for butoxypolypropylene glycol and the other three polyethers, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for both the acute and chronic dietary risk assessments. These values were directly entered into the dietary exposure model.

             2. Non-dietary exposure. A screening level residential exposure and risk assessment was completed for products containing butoxypolypropylene glycol and the other three polyethers as inert ingredients. In this assessment, representative scenarios, based on end-use product application methods and labeled application rates, were selected. For each of the use scenarios, the Agency assessed residential handler (applicator) inhalation and dermal exposure for outdoor scenarios with high exposure potential (i.e., exposure scenarios with high end unit exposure values) to serve as a screening assessment for all potential residential pesticides containing butoxypolypropylene glycol and the other three polyethers. Similarly, residential post-application dermal and oral exposure assessments were also performed utilizing high end outdoor exposure scenarios.

             D. Cumulative Effects 
             
             		Evonik has not found butoxypolypropylene glycol and the other three polyethers to share a common mechanism of toxicity with any other substances, and butoxypolypropylene glycol and the other three polyethers do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, Evonik has assumed that butoxypolypropylene glycol and the other three polyethers do not have a common mechanism of   toxicity with other substances.

             E. Safety Determination

             1. U.S. population. Determination of safety. Based on these risk assessments, Evonik concludes that there is a reasonable certainty that no harm will result to the general population.

             2. Infants and children. Evonik has determined that reliable data shows the safety of infants and children would be adequately protected.

             F. International Tolerances

             Evonik is not aware of any country requiring a tolerance for butoxypolypropylene glycol and the other three polyethers nor have any CODEX Maxim um Residue Levels been established for any food crops at this time.