EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [PV Shah, Branch Chief Inert Assessment 

Branch (IAB) 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., “[insert 

company name],” with the information specific to your action.

TEMPLATE: 

[BASF Corporation 100 Campus Drive, Florham Park, NJ 07932]

[1E7931]

 EPA has received a pesticide petition ([1E7931]) from BASF Corporation, 100 

Campus Drive, Florham Park, NJ 07932, 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 amend an exemption from the requirement of a tolerance for N,N -Bis-α-ethylω-hydroxypoly(oxy-1,2-ethanediyl) C8-C18saturated and unsaturated alkylamines; the 

poly(oxy-1,2-ethanediyl) content is 2–60 moles; herein referred to as ALKYL AMINES 

POLYALKOXYLATES; under 40 CFR 180.920 and 180.930 to include CAS. Reg. No. 

1266162-49-5. 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. 

BASF believes that the chemistry described by the CAS. Reg. No. 1266162-49-5 is 

described by the published tolerance exemption N,N -Bis-α-ethyl-ω-hydroxypoly(oxy1,2-ethanediyl) C8-C18saturated and unsaturated alkylamines; the poly(oxy-1,2-

ethanediyl) content is 2–60 moles (74 FR 28616) and therefore would fall under the 

published tolerance exemption in 40 CFR 180.920 and 180.930. Since the current risk 

assessment was conducted on a range of chemistries to support the published descriptor 

range of chemistries and EPA has determined that this range of chemistries would be 

acceptable under this risk assessment BASF believes this chemistry is supported by the 

current risk assessment. 
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A. Residue Chemistry

The regulation published in 2009 for alkyl amine polyalkoxylates (74 FR 

28616 eliminates the need to establish a maximum permissible level for residues of 

alkyl amine polyalkoxylates. Since this chemistry fits the description under the 

established tolerance exemption additional residue studies are not required.] 

 2. Analytical method. [An analytical method is not required for enforcement 

purposes since the Agency has established an exemption from the requirement of a 

tolerance without any numerical limitation.]

 3. Magnitude of residues. [BASF is petitioning the agency to amend an 

exemption from the requirement of a tolerance. Therefore information regarding 

the nature and magnitude of chemical residues resulting from the use of this inert 

ingredient is not required.]

B. Toxicological Profile

 1. Acute toxicity. [Alkyl amine polyalkoxylates are not acutely toxic by the 

oral and dermal routes of exposure, or via inhalation under normal use conditions. 

Concentrated materials are generally corrosive, eye and skin irritants and may be 

dermal sensitizers. There is no evidence that alkyl amine polyalkoxylates are 

neurotoxic, mutagenic, or clastogenic.] 

 2. Genotoxicty. 

No significant mutagenicity was observed in either the initial assays or the 

subsequent confirmation assays.

 3. Reproductive and developmental toxicity. 

Maternal toxicity NOAEL for alkyl amine polyalkoxylates was established and the 

developmental toxicity NOAEL was also established and found to be acceptable.

There was no increased susceptibility to the offspring of rats following in utero 

exposure in two prenatal developmental toxicity studies. However, there is evidence 

of increased susceptibility in a reproductive screening study in rats.

 4. Subchronic toxicity. [A 4-week oral dietary subchronic toxicity study in rats 

using an amine, tallow alkyl, polyethoxvlate, resulted in NOAEL of 2000 ppm (160 

mg/kg/day) for females and 800 ppm (63.2 mg/kg/day) for males. A 90-day oral 

dietary subchronic toxicity study in rats using an amine, tallow alkyl, ethoxylate, 

resulted in a NOAEL of 500 ppm (33.0 mg/kg/day in males and 39.9 mg/kg/day in 

females). 

A 90-day oral subchronic toxicity study in rats was conducted on an amine, C13-15- 

derivates alkyl, ethoxylate. The NOAEL was 15 mg/kg/day. 
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Lastly, a 28-day rat oral toxicity study on an amine, tallow alkyl, ethoxylate 

propoxylate resulted in a NOAEL of 15 mg/kg/day] 

 5. Chronic toxicity. [There is no chronic toxicity data available for alkyl amine 

polyalkoxylates, but the Agency noted that the effects did not increase in severity 

over time (4 weeks to 13 weeks) in subchronic studies. The Agency also used a 

qualitative structure activity relationship (SAR) database, DEREK11, to determine 

if there were structural alerts for potential carcinogenicity of both a representative 

alkyl amine polyalkoxylate, as well as a possible metabolite/degradate of alkyl amine 

polyalkoxylate that had been extensively dealkylated, with the amine group intact. 

No structural alerts for carcinogenicity were identified in either case. Alkyl amine 

polyalkoxylates are not expected to be carcinogenic. Therefore a cancer dietary 

exposure assessment is not necessary to assess cancer risk.] 

 6. Animal metabolism. [The mammalian metabolism may be predicted based 

on either environmental bacterial degradation or by analogy to documented 

studies.]

 7. Metabolite toxicology. [The animal metabolism of this chrmistry has not 

been investigated and metabolites have not been identified. However, based on the 

plausible metabolic pathways, no metabolites of toxicological concern are expected.]

 8. Endocrine disruption. [This class of chemistry does not belong to a class of 

chemicals known or suspected of having adverse effects on the estrogen receptor or 

endocrine system.]

C. Aggregate Exposure

 The Agency’s previous assessment for alkyl amine polyalkoxylates did not 

identify any concern for dietary (food and drinking water) or for non-dietary exposure. 

BASF believes that the use of the requested CAS. Reg. No. under the current descriptor is 

not expected increase the exposure profile. 

1. Dietary exposure. [BASF believes the assumptions used to estimate dietary 

exposures lead to an extremely conservative assessment of dietary risk due to a 

series of compounded conservatisms. First, assuming that the level of residue for an 

inert ingredient is equal to the level of residue for the active ingredient will overstate 

exposure.] 

 i. Food. [In conducting the acute and chronic dietary exposure assessments, 

EPA used food consumption information from the United States Department of 

Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to residue levels in food, no residue data were 

submitted for the alkyl amine polyalkoxylates. In the absence of specific residue 

data, EPA has developed an approach which uses surrogate information to derive 

upper bound exposure estimates for the subject inert ingredients. Upper bound 
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exposure estimates are based on the highest tolerance for a given commodity from a 

list of high-use insecticides, herbicides, and fungicides. ] 

 ii. Drinking water. [A screening level drinking water analysis, based on the 

Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) 

was performed to calculate the estimated drinking water concentrations (EDWCs) 

of alkyl amine polyalkoxylates. Modeling runs on four surrogate inert ingredients 

using a range of physical chemical properties that would bracket those of the alkyl 

amine polyalkoxylates were conducted. Modeled acute drinking water values ranged 

from 0.001 parts per billion (ppb) to 41 ppb. ] 

 2. Non-dietary exposure. [A screening level residential exposure and risk 

assessment was completed for products containing alkyl amine polyalkoxylates as 

inert ingredients. In this assessment, representative scenarios, based on end-use 

product application methods and labeled application rates, were selected. For each 

of the use scenarios, the Agency assessed residential handler (applicator) inhalation 

and dermal exposure for outdoor scenarios with high exposure potential (i.e., 

exposure scenarios with high end unit exposure values) to serve as a screening 

assessment for all potential residential pesticides containing alkyl amine 

polyalkoxylates. Similarly, residential postapplication dermal and oral exposure 

assessments were also performed utilizing high end outdoor exposure scenarios.] 

D. Cumulative Effects[BASF has not found alkyl amine polyalkoxylates to share a 

common mechanism of toxicity with any other substances, and alkyl amine 

polyalkoxylates do not appear to produce a toxic metabolite produced by other 

substances. For the purposes of this tolerance action, therefore, BASF has assumed 

that alkyl amine polyalkoxylates do not have a common mechanism of toxicity with 

other substances.] 

E. Safety Determination

 1. U.S. population. [Determination of safety. Based on these risk assessments, 

BASF concludes that there is a reasonable certainty that no harm will result to the 

general population] 

 2. Infants and children. [BASF has determined that reliable data show the 

safety of infants and children would be adequately protected.]

F. International Tolerances

[BASF is not aware of any country requiring a tolerance for alkyl amine 

polyalkoxylates nor have any CODEX Maximum Residue Levels been established 

for any food crops at this time.]