EPA REGISTRATION DIVISION COMPANY CORRECTED NOTICE OF FILING 

FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [P.V. Shah, 703-308-1846] 

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., “[Croda Inc.],” with the information 

specific to your action 

[Croda Inc.]

[Insert Petition Number]

EPA has received a pesticide petition ([Insert Petition Number]) from [Croda Inc., EPA 

Company Number 86095], [315 Cherry Lane New Castle, DE 19720]

proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 

U.S.C. 346a(d), to establish an exemption from the requirement of a tolerance for Polymerized 

Fatty Acid Esters with Aminoalcohol Alkoxylates (PFAEAA) under 40 CFR §180.910 preand post-harvest uses and 40 CFR §180.930 animal uses, including: 

CAS RN’s supported under the following tolerance exemption descriptor: 

“Fatty acids, unsaturated, dimers and/or trimers, esters with [alpha] - 

alkylaminoalkyl -[omega]- hydroxy poly (oxyethylene) or [alpha] - 

alkylaminoalkyl -[omega]- hydroxy poly (oxyethylene) poly (oxypropylene) 

copolymers where the poly (oxyethylene) content is 10-30 moles and the poly 

(oxypropylene) content is 0-20 moles, the resulting alkoxylated aminoalcohol 

esters are derived and limited to 2-(N,N Dimethyl) aminoethanol, 2-(N,NDimethyl) aminopropanol, 2- (N,N-Diethyl) aminoethanol, 2-(N,N-Diethyl) 

aminopropanol, 2-Hydroxyethylmorpholine, and 2-Hydroxyethylpiperidine 

and have a minimum molecular weight (in amu) of 1,200.”] 

PFAEAA 

CAS RN Chemical Name 

1173188-38-9 Dimethylaminoethanol, ethoxylated, reaction products 

with fatty acid dimers 

1173188-42-5 Dimethylaminoethanol, ethoxylated, propoxylated, reaction 

products with fatty acid dimmers 

1173188-72-1 Diethylaminoethanol, ethoxylated, reaction product with fatty 

acid dimers 

1173188-75-4 Diethylaminoethanol, ethoxylated, propoxylated, reaction 

products with fatty acid dimers 
CAS RN Chemical Name 

1173188-49-2 Dimethylaminoethanol, ethoxylated, reaction products 

with fatty acid trimers 

1173189-17-7 Dimethylaminoethanol, ethoxylated, propoxylated, reaction prod

with fatty acid trimers 

1173188-81-2 Diethylaminoethanol, ethoxylated, reaction products 

with fatty acid trimers 

1173188-83-4 Diethylaminoethanol, ethoxylated, propoxylated, reaction 

products with fatty acid trimers 

1173189-00-8 Hydroxyethylmorpholine, ethoxylated, reaction products with 

fatty acid dimers 

1173189-06-4 Hydroxyethylmorpholine, ethoxylated, propoxylated, reaction 

products with fatty acid dimers 

1173189-20-2 Hydroxyethylpiperidine, ethoxylated, reaction products with 

fatty acid dimers 

1173189-22-4 Hydroxyethylpiperidine, ethoxylated, propoxylated, reaction 

products with fatty acid dimers 

1173189-09-7 Hydroxyethylmorpholine, ethoxylated, reaction products 

with fatty acid trimers 

1173189-17-7 Hydroxyethylmorpholine, ethoxylated, propoxylated, reaction 

products with fatty acid trimers 

1173189-25-7 Hydroxyethylpiperidine, ethoxylated, reaction products 

with fatty acid trimers 

1173189-28-0 Hydroxyethylpiperidine, ethoxylated, propoxylated, reaction 

products with fatty acid trimers 

The PFAEAA surfactants can be generically described as polyethylene or 

polyethylene/polypropylene glycol polymers consisting of a dialkylaminoalcohol end group 

molecule that has undergone polymerization with either 10-30 polyoxyethylene units or 10-

30 polyoxyethylene units followed by 0-20 polyoxypropylene units and esterified with cross 

linked fatty acids containing 2 or 3 fatty acid residues. 

Croda Inc. has provided information that confirm that the PFAEAA pesticide inert 

surfactants supported by way of this petition meet the criteria for low risk polymers as 

specified in 40 CFR §723.250(b) and that the data included within the petition also address 

the exclusion criteria cited as applicable under 40 CFR 723.250 (d)(1) and (e)(1)(ii)(C). 

 The molecular weight and polymer stability were determined as follows: 

• Conventional gel permeation chromatography using both polystyrene based and 

polyethylene glycol calibrations, confirmed that an example PFAEAA polymer, CAS 

Number 1173188-81-2, an the oligomer content less than 10% (w/w) below a NumberAverage Molecular Weight of 500 and less than 25% (w/w) below a Number-Average 

Molecular Weight of 1,000. 
• MALDI mass spectrum for two manufacturing batches of CAS Number 1173188-81-2 

confirmed that the distribution and molecular weight range of the polyethoxylate esters 

that comprise the polymeric mixture ranged from 759 to 3017 mass units. 

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. [Not applicable/Not required for the establishment of a 

tolerance exemption for inert ingredients.] 

 2. Analytical method. [Not applicable/Not required for the establishment of a 

tolerance exemption for inert ingredients.] 

 3. Magnitude of residues. [There is no specific crop residue information available for 

PFAEAA surfactnats and this information is typically not available nor required for the 

establishment of a tolerance exemption for polymeric inert ingredients.] 

B. Toxicological Profile 

1. Acute toxicity. [Human exposure from the use of PFAEAA as pesticide inert 

ingredients will primarily occur via the oral route through the consumption of food or 

drinking water. PFAEAA pesticide inert ingredients are polyethylene or 

polyethylene/polypropylene glycol polymers that may include compounds with molecular 

weights exceeding 3,500 amu. As noted in 40 CFR §723.250(b), substances with molecular 

weights greater 400 are not absorbed through the intact skin and substances with 

molecular weights greater than 1,000 are not absorbed through the intact gastrointestinal 

(GI) tract. 

Polymeric PFAEAA pesticide inert ingredients are also not volatile and therefore, 

post-application inhalation exposure is unlikely. An example test compound, CAS 

1173188-81-2 showed low acute toxicity (limit dose LD50 > 2,000 mg/kg body weight by the 

oral route of exposure. Additionally, skin and eye irritation were not reported in animal 

laboratory studies.] 

 2. Genotoxicity. [CAS 1173188-81-2 was not mutagenic in bacterial in vitro cell 

systems.]

 3. Reproductive and developmental toxicity. [Testing was not conducted because 

substances with molecular weights greater than 1,000 are not absorbed through the intact 

gastrointestinal (GI) tract.]

 

 4. Subchronic toxicity. [Testing was not conducted because substances with molecular 

weights greater than 1,000 are not absorbed through the intact gastrointestinal (GI) tract.]
 5. Chronic toxicity [Testing was not conducted because substances with molecular 

weights greater than 1,000 are not absorbed through the intact gastrointestinal (GI) tract.] 

 6. Animal metabolism. [PFAEAA metabolism is unlikely because substances with 

molecular weights greater than 400 are not absorbed through the intact skin and 

substances with molecular weights greater than 1,000 are not absorbed through the intact 

gastrointestinal (GI) tract or skin.]

 

 7. Metabolite toxicology. [No metabolites of toxicological concern are expected based 

on the fact that substances with molecular weights greater than 400 are not absorbed 

through the intact skin and substances with molecular weights greater than 1,000 are not 

absorbed through the intact GI tract or skin; therefore, animal metabolism is unlikely to 

occur.]

8. Endocrine disruption. [The PFAEAA surfactants are polyethylene 

polyethylene/polypropylene glycol polymers do not belong to a class of chemicals known or 

suspected of having adverse effects on the estrogen receptor or endocrine system.]

C. Aggregate Exposure

Dietary exposure. [Chemicals not absorbed by ingestion through the GI tract cannot be 

distributed or metabolized by organisms. Therefore, it is not necessary to conduct a dietary 

exposure evaluation or a related FQPA aggregate and cumulative risk assessment for the 

PFAEAA pesticide inert ingredient surfactants.] 

E. Safety Determination

[Croda Inc. has provided relevant information to confirm that the PFAEAA surfactants 

can meet the definition of low risk polymers as specified in 40 CFR §723.250(b) and that 

the data address the exclusion criteria cited as applicable under 40 CFR 723.250 (d)(1) and 

(e)(1)(ii)(C). 

• As noted in 40 CFR §723.250 (b), substances with molecular weights greater than 

400 are not absorbed through the intact skin, and substances with molecular 

weights greater than 1,000 are generally not absorbed through the intact GI tract. 

• Chemicals not absorbed by ingestion through the GI tract cannot be distributed or 

metabolized within organisms. Therefore, it is not necessary to conduct a dietary 

exposure evaluation or a related FQPA aggregate and cumulative risk assessment. 

• The EU Technical Guidance Document (ECB, 2003) contains information relating 

potential dermal absorption to molecular weight and specifies that molecular weight 

of less than 100 favors dermal absorption whereas at a molecular weight greater 

than 500, the molecule may be too large for dermal absorption to occur. 

• The average molecular weights of PFAEAA surfactants exceed 1000 Daltons and 

thus qualify PFAEAA surfactants as polymeric substances. 
• The PFAEAA polymers contain a substantial portion of cross-linked fatty acid 

residues that are resistant to chemical and biological degradation. 

• Steric protection, as a result of polymeric/molecular folding and intra-molecular 

association, also prevents ester linkage hydrolysis and the PFAEAA end group 

tertiary amine and acid functionalities from undergoing additional chemical 

reactions. 

• HPLC analysis of duplicate manufacturing batches of CAS 1173188-81-2 indicated 

that there is < 0.5 ppm of formaldehyde. Thus, the polyethyelene glycol polymeric 

units are not considered susceptible to oxidative degradation (due to ester 

hydrolysis).] 

F. International Tolerances

 [There are no known international tolerances for Polymerized Fatty Acid Esters 

with Aminoalcohol Alkoxylates (PFAEAA) pesticide inert surfactants.]