Document ID: EPA-HQ-OPP-2015-0213-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-05-20T04:00Z

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

EPA Registration Division contact: Kerry Leifer 703-308-8811

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

Cytec Industries Inc.

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from Cytec Industries Inc.,  5 Garret Mountain Plaza Woodland Park, NJ 07424 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 establish an exemption from the requirement of a tolerance for

	Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts CAS. No. 815583-91-6  under 40 CFR §180.910 when used as an inert ingredient (surfactant) not to exceed 20% in pesticide formulations applied pre-and post -harvest to all raw agricultural commodities.  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. No specific plant metabolism data is available, nor is it required for the establishment of a tolerance exemption.]

	2. Analytical method. [NA-Remove. 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.] 

	3. Magnitude of residues. [NA-Remove. Information regarding the nature and magnitude of chemical residues resulting from the use of this inert ingredient is not required for the establishment of a tolerance exemption.] 

B. 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.  Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts has low to very low acute oral toxicity and dermal toxicity.  The compound is of low concern for skin irritation but a moderate concern for eye irritation.  In addition, no evidence of dermal irritation or dermal sensitization was observed in a clinical study.   

	2. Genotoxicty. Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts was negative in tests for mutagenicity in bacteria.  In addition, the compound lacks concern for this endpoint based on structural alerts.

	3. Reproductive and developmental toxicity. Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts has been examined in a multigenerational study which included a teratology component.  No teratogenic effects were observed at either the 1% or 4% feeding levels. The NOAEL for reproductive and offspring toxicity was 1% (~ 750 mg/kg bw/day).  Effects observed included lack of consecutive pregnancies, decreased liveborn per litter, fertility index, viability index and lactation index and decreased weight gain in pups (average weaning weight of pups).  In addition, in animals examined during gestation there were fewer viable embryos/litter and fewer variable fetuses per litter.  None of the skeletal or soft tissue anomalies observed in the fetal examinations were different between treatment and control groups.

	4. Subchronic toxicity. Following subchronic treatment to rats, the only finding considered treatment related was decrease body weight gain at 4% feed concentration; as such the NOEL was 1%, equivalent to an intake of 0.77 g/kg bw/day for male rats and 0.90 g/kg bw/day for female rats.  In a 90 day oral subchronic study in dogs, the key findings in high dosed animals were decreased feed consumption, feed efficiency and weight loss.  In addition, testes weight (absolute and body weight relative) was significantly decreased in high dosed males.  Necropsy revealed testicular atrophy was in one mid-dose and three high-dose dogs and light yellow discoloration and hepatic fatty infiltration was observed in high dose animals.  The NOEL from this study is considered 0.12% for male dogs and 0.5% for females, corresponding to intakes of 0.03 g/kg bw/day and 0.14 g/kg bw/day for male and female dogs, respectively.  

	5. Chronic toxicity. There is no evidence that the butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts is carcinogenic. The compound was negative is the bacterial reverse mutation assay and does not contain structural alerts for genotoxicity via DNA reactivity (covalent binding) or non-genotoxic mechanisms; as such, it would not be predicted to be a concern for carcinogenicity.  In addition, similar structures evaluated by EPA do not indicate a concern for genotoxicity or carcinogenicity.  

	6. Animal metabolism. The compound is predicted to be bioavailable and data on similar compounds with ester linked sulfosuccinates have been reviewed by EPA and would be expected to share similar metabolism.  Moreover, the chemical is expected to be readily hydrolyzed by carboxylesterases resulting in the corresponding alcohol and the sulfosuccinic acid.  The sulfosuccinic acid would be conjugated with glucuronic acid and/or excreted via the urine.  The fatty alcohol would be expected to be metabolism via normal metabolic pathways (oxidative metabolism).   

	7. Metabolite toxicology. No concern is noted for the metabolites.  Following hydrolysis, an alcohol would be released which would be subjected to further oxidative metabolism and consumed per normal biochemical processes. The sulfosuccinate moiety is not concerning, based on read across to other additives sharing this same structure via an ester linkage which are currently considered safe for use in food (dioctyl sodium sulfosuccinate and sodium 1,4-dialkyl sulfosuccinates).   

	8. Endocrine disruption. No data were identified addressing the endpoint of endocrine disruption; however, based on the structure, no concern is noted for binding to the estrogen receptor.  The effects of the test compound on the testes observed in the subchronic dog study are uncertain as collaborating effects on the testes were not observed in the rat.  Nonetheless, the rat reproductive study addresses any functional impairment; the NOEL of this study was 1% as opposed the dog study with a NOEL of 0.12%.     

C. Aggregate Exposure

      1. Dietary exposure. The exposures numbers used to calculate the %cPAD are taken from the EPA review of similar surfactants, the Alkyl Alcohol Alkoxylates (AAA), which have similar use patterns to those covered in this petition.
Exposure (mg/kg/day)
                       100% Crop Treated, 10% Surfactant
                                cPAD 0.30 %cPAD
General U.S. Population
                                   0.038302
                                      13
Infants (< 1 year old)
                                   0.079416
                                      26
Children 1-2 years old
                                   0.124801
                                      42
Children 3-5 years old
                                   0.092392
                                      31
Children 6-12 years old
                                   0.051062
                                      17
Youth 13-19 years old
                                   0.028824
                                      10
Adults 20-49 years old
                                   0.028880
                                      10
Adults 50+ years old
                                   0.030415
                                      10
Females 13-49 years old
                                   0.029078
                                      10
         

	i. Food. The dietary exposure above is the result of modeling to represent residues on food with 100% crop treated with a maximum concentration of 10% surfactant in the formulation.  This is a worst case scenario, since it is expected that these materials will be used at a maximum percent crop treated of 1%.

	ii. Drinking water. In their review of similar surfactants, the Alkyl Alcohol Alkoxylates, EPA modeled expected drinking water concentrations and considered that the maximum concentration would be 100 parts per billion.  This result is included in the exposure estimates in the dietary exposure table.
 	2. Non-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). Because this petition is for use in pesticide formulations pre- and post-harvest to crops, the only expected exposure will be dietary.

D. Cumulative Effects

	We have not found a common mechanism of toxicity finding as to the butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts and any other substances. Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts may metabolize to Alkyl Alcohol Alkoxylates but with respect to this petition, the exposures to both materials are considered since there is an assumption that 100% of the crops are treated. 

E. Safety Determination

      1. U.S. population. Based on these risk assessments, 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 Disodium (C10-rich C9-11-isoalkyl) sulfosuccinate.

	2. Infants and children. Based on these risk assessments 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 butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts.

F. International Tolerances

	Cytec Industries Inc. is not aware of any country requiring a tolerance for the butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts nor have any CODEX Maximum Residue Levels been established for any food crops at this time.

4818-2384-8477, v.  2