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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
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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 
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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 
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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 
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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).
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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.
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4818-2384-8477, v. 2