Document ID: EPA-HQ-OPP-2022-0844-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2022-11-17T05:00Z

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

EPA Registration Division contact: 

Ingredion Incorporated

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from Ingredion Incorporated, 5 Westbrook Corporate Center, Westchester, IL 60154, United States requesting, 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 establish an exemption from the requirement of a tolerance for

      Dextrin, hydrogen 1-octenylbutanedioate (CASRN: 68070-94-0) in or on raw agricultural commodities pre-harvest as a seed treatment (40 CFR 180.920).  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.

A. Residue Chemistry

	1. Plant metabolism. NA Remove

	2. Analytical method. NA Remove

	3. Magnitude of residues. NA Remove

B. Toxicological Profile

The toxicity data presented in this petition was generated using Dry-Flo(R) (Starch, 1-octenylbutanedioate, aluminum salt (CASRN: 9087-61-0)).  Starch, 1-octenylbutanedioate, aluminum salt is the aluminum salt of dextrin, hydrogen 1-octenylbutanedioate.  The toxicity of dextrin, hydrogen 1-octenylbutanedioate is expected to be lower than that of the aluminum salt.

 Acute toxicity.  
         
      Acute Eye Irritation Study 
         
      The test substance, Dry-Flo(R) (Starch, 1-octenylbutanedioate, aluminum salt (CASRN: 9087-61-0)), batch # ECR-252-B was tested May 1984 for potential eye irritancy by Environmental Safety Laboratory, Unilever Research, Colworth House, Sharnbrook, Bedford, England.  The test method used was "Method of the United States Environmental Protection Agency (Primary Eye Irritation method), August, 1982".  
         
      The test substance powder (0.1 mL volume of compacted powder) was added in a single dose to one eye in 6 rabbits. The degree of irritation was assessed and scored at the following intervals: 1 hour, 24 hours, 48 hours, and 72 hours. The detailed results can be found in the report. The study concluded that 0.1 mL of this powder caused very slight transient irritation to the conjunctivae of the rabbit eye. Under the conditions of the study, the rabbit's cornea is unaffected by this product. Dry-Flo (R) (Starch, 1-octenylbutanedioate, aluminum salt (CASRN: 9087-61-0)) is therefore unlikely to be an eye irritant hazard in humans.  
         
	2. Genotoxicty. NA Remove

	3. Reproductive and developmental toxicity. NA Remove

	4. Subchronic toxicity

	Subchronic Toxicity Study
      
      In a study by Buttolph and Newberne (1980), Fischer 344 rats were fed diets containing 0%, 6%, 12%, or 30% (0, 3, 6, or 15g/kg/day) OS-modified food starch for 30 or 90 days after weaning. The test rats were chosen from the second litters of dams that had been fed the same diets throughout gestation and lactation. The rats were sacrificed at the study conclusion (after 30 or 90 days) and autopsied. No treatment-related effects were observed at any dose level compared to the control diet. 
         
      Mahadevan et al. (2014) added OSA-modified starch to the diets of 24 male and 24 female Domestic Yorkshire Crossbred Swine piglets at concentrations of 2, 4, and 20 g/L (1, 2, and 10g/kg/day) for 3 weeks. All animals were observed twice daily, and a detailed clinical examination was performed twice weekly. Gross necropsies were performed on all animals at termination on Study Day 21. There were no test article-related effects of any diet containing OSA-modified starch on piglet growth and development (clinical observations, body weight, feed consumption), or clinical pathology parameters (hematology, clinical chemistry, coagulation, urinalysis). In addition, there were no adverse effects at terminal necropsy (macro- and microscopic pathology evaluations). 
      
      Given that no adverse effects were observed in rats or piglets fed high doses of OS- and OSA- modified starches, Dextrin, hydrogen 1-octenylbutanedioate is unlikely to pose a risk of subchronic toxicity to humans. 
      

	5. Chronic toxicity. NA Remove

	6. Animal metabolism. NA Remove

	7. Metabolite toxicology. NA Remove

	8. Endocrine disruption. NA Remove

C. Aggregate Exposure

	1. Dietary exposure. NA Remove

	i. Food. NA Remove

	ii. Drinking water. NA Remove

	2. Non-dietary exposure. NA Remove

D. Cumulative Effects

	NA Remove

E. Safety Determination

	1. U.S. population. NA Remove

 Infants and children. NA Remove
         
F. International Tolerances

	NA Remove