chemistry described by CAS Reg. No. 1266162-49-5 is covered by the published 

tolerance exemption for alkyl amines polyalkoxylates and that no further data or review 

is required to amend the existing tolerance exemption. A Notice of Filing for this petition 

was published in the Federal Register on March 14, 2012 (77 FR 15012). There were no 

comments received in response to this notice. 

The purpose of this document is to assess, as required under the Federal Food Drug and 

Cosmetic Act (FFDCA), the risk of the use of CAS Reg. No. 1266162-49-5 as an inert 

ingredient in pesticide products and is based on a previous assessment for alkyl amines 

polyalkoxylates and a rationale provided by the petitioner as to why CAS Reg. No. 

1266162-49-5 can be considered safe under the descriptor for alkyl amines 

polyalkoxylates; under 40 CFR 180.920 & 180.930. 

A previous assessment was completed on April 3, 2009 and a final rule establishing an 

exemption from the requirement of a tolerance for residues of alkyl amines 

polyalkoxylates under 40 CFR 180.920 & 180.930 was published on June 17, 2009 (74 

FR 28616). This exemption was established based on information submitted by the Joint 

Inert Task Force Cluster Support Team 4 (JITF CST 4) in response to a final rule 

published on August 9, 2006 (71 FR 45415) in which the Agency revoked, under section 

408(e)(1) of the Federal Food, Drug and Cosmetic Act (FFDCA), the existing exemptions 

from the requirement of a tolerance for residues of certain inert FFDCA section 

408(b)(2). 

Specific information on the studies received from JITF CST 4 to support the request to 

establish an exemption from the requirement a tolerance and the nature of the adverse 

effects caused by alkyl amine polyalkoxylates as well as the no- observed-adverse-effectlevel (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity 

studies can be found at http:// www.regulations.gov in document “Alkyl Amine 

Polyalkoxylates (JITF CST 4 Inert Ingredients), Human Health Risk Assessment to 

Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert 

Ingredients in Pesticide Formulations,” at pages 10-17 in docket ID number EPA– HQ–

OPP–2008–0738. 

The Agency has reviewed BASF’s claim that the addition of CAS Reg. No. 1266162-49-

5 is acceptable under the current tolerance exemption descriptor for alkyl amine 

polyalkoxylates. IIAB has confirmed that the requested CAS Reg. No. is acceptable for 

consideration under the currently approved descriptor and that no further review is 

required. The requested compound is a N,N-Bis-α-ethyl-ω-hydroxypoly(oxy-1,2-

ethanediyl) C10 saturated alkyl amine and, as such, falls within the existing tolerance 

exemption descriptor of N,N-Bis-α-ethyl-ω-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 

saturated and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl content is 2-60 

moles. The Agency has determined that the use of CAS Reg. No. 1266162-49-5 is 

adequately supported by the existing data and assessment for alkyl amine polyalkoxylates 

and that no additional data or review is required. 
Taking into consideration all available information, EPA concludes that there is a 

reasonable certainty of no harm to the general population or to infants and children from 

aggregate exposure to CAS Reg. No. 1266162-49-5 when used as an inert ingredient in 

pesticide formulations. Therefore, the amendment of the existing exemption from the 

requirement of tolerance under 40 CFR 180.920 and 180.930 for N,N-Bis-α-ethyl-ωhydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated and unsaturated alkylamines; the 

poly(oxy-1,2-ethanediyl content is 2-60 moles to include CAS Reg. No. 1266162-49-5 

can be considered safe under section 408 of the FFDCA.