Document ID: EPA-HQ-OPP-2021-0273-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2021-06-07T04:00Z

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

EPA Registration Division contact: [insert name and telephone number with area code]

Ingredion Incorporated

[Insert petition number]

	EPA has received a pesticide petition (IN-11458) 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

	Starch, 1-octenylbutanedioate, aluminum salt (CASRN: 9087-61-0) in or on raw agricultural commodities pre-harvest and 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  FFDCA; 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

 Acute toxicity.  
Acute Eye Irritation Study 

The test substance, 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 (0.1ml 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. In conclusion 0.1ml 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. As such Starch, 1-octenylbutanedioate, aluminum salt (CASRN: 9087-61-0) is unlikely to be an eye irritant hazard in humans.  

Skin Sensitization Study 
The test substance Starch, 1-octenylbutanedioate, aluminum salt (CASRN: 9087-61-0), was tested May, 1950 to determine the possibility of skin sensitization from exposure to Starch, 1-octenylbutanedioate, aluminum salt at Food Research Laboratories, Inc in Long Island City, New York. 
The test method involved the intracutaneous injection of repeated doses of Starch, 1-octenylbutanedioate, aluminum salt into 10 adult albino guinea pigs and 3 albino rabbits. The animals were injected 3 times during the first week and then once weekly for the next 7 weeks. Total injections: 10 during an 8-week period. The animals were examined 24 hours following each injection. Observations continued 2 weeks after the final injection. Complete study details can be found in the study report. In conclusion, intermittent injections of Starch, 1-octenylbutanedioate, aluminum salt to guinea pigs and Rabbits over an 8-week period suggests that there wouldn't be skin sensitization resulting from contact with the product.  

	2. Genotoxicty. NA Remove

	3. Reproductive and developmental toxicity. NA Remove

	4. Subchronic toxicity
Subchronic Toxicity Study  -  8 Week Feeding Study(Rat)

The test substance Starch, 1-octenylbutanedioate, aluminum salt (CASRN: 9087-61-0), which is named RX12K4 for the purpose of this study, was tested August, 1950 to determine the possible toxicity of Starch, 1-octenylbutanedioate, aluminum salt if ingested at relatively high levels. This was compared to the effects of ordinary (native) cornstarch (AK31) and starch sodium octenylsuccinate (RX12K1). The study took place at Food Research Laboratories, Inc in Long Island City, New York. 

The study feeding levels were based on the article "Procedures for the Appraisal of the Toxicity of Chemicals in Foods" by Lehman, et al, Food Drug Cosmetic Law Quarterly, Sept. 1949, p. 412.  The product was fed at 
 A low dosage level  -  which is approximately 10 times the level that would likely be found in a particular use
 In a diet containing at least 100 times as much of the ingredient as is proposed for use in food. 
 On the basis that no toxic symptoms were observed by the 4[th] week, the level of RX12K4 was increased to 25 percent of the ration for the remainder of the study.
   
Additional details are found in the study report. 

Four groups of Weanling albino rats consisting of 6 males and 6 females were used in the experiment. An 8 week growth study was conducted and the results looked at a comparative responses to Starch, 1-octenylbutanedioate, aluminum salt (RX12K-4), a single level of starch sodium octenylsuccinate (RX12K-1) and a single level of cornstarch (AK31)
 Results as per the study report: 
1) The groups fed Starch, 1-octenylbutanedioate, aluminum salt (RX12K-4) at 1, 10, and 25 per cent levels in the ration ate and grew as well as did the control animals receiving standard cornstarch. 
2) The group fed sample RX12K-1 grew at a slower rate than did the others and ate less food. However it utilized this food just as effectively in the conversion to body tissue as did the other groups. 
3) Neither on the basis of growth, food consumption, efficiency of food utilization, hematological evidence, nor blood chemical values can it be concluded that either sample RX12K-1 nor RX12K-4 are toxic when ingested by the rat. Some unwillingness to consume RX12K-1 was evident.

The study concluded that Starch, 1-octenylbutanedioate, aluminum salt is safe to use in contact with food wrappings as that was the purpose of the study. However, since the results show that is was not toxic when ingested by the rats and as such would not be considered toxic to ingest in the amounts discussed in the study report. 

	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