### Re: HPV 3 for CASRN for CASRN for CASRN

22527-63-5 22527-63-5 22527-63-5

- Submission of Test Plan by Eastman Submission of Test Plan by Eastman Submission of Test Plan by Eastman Chemical for review Chemical for review .

. Chuantung Lin Chuantung Lin to: Paul Campanella 02/21/2012 03:16 PM Cc: John Schaeffer, Marcus Aguilar, Tracy Williamson, Myrta Christian

From: Chuantung Lin/DC/USEPA/US
To: Paul Campanella/DC/USEPA/US@EPA
Cc: John Schaeffer/DC/USEPA/US@EPA, Marcus Aguilar/DC/USEPA/US@EPA, Tracy

Williamson/DC/USEPA/US@EPA, Myrta Christian/DC/USEPA/US@EPA History: This message has been replied to.

1 attachment

20120220_Test Plan for HPV 22527-63-5_Final.pdf

To: Campanella.Paul@epamail.epa.gov

Cc: Schaeffer.John@epamail.epa.gov, Aguilar.Marcus@epamail.epa.gov, Williamson.Tracy@epamail.epa.gov, Christian.Myrta@epamail.epa.gov Hi Paul,

I have reviewed the attached document sent by the sponsor of the HPV test chemical. Basically, the three chemicals on the products mixture are the three diesters of 2,2,4-trimethyl-1,3-pentanediol. There are mixture diester (the titled HPV test chemical; 22527-63-5), dibenzoate (68052-23-3), and diisobutyrate (6846-50-0).

From the chemical structural view point,, these three are very close analogs to each other and they are made by reacting the diol with benzoic acid and isobutanoic acid in the same reaction . These three related chemicals also have similar estimated values on some physical chemical properties . Based on this fact, it is fine to accept the sponsor's proposed approach to use the products that sold commercially as the test substance for obtaining the measured values of A1, A2, A3, A4, and A5 endpoints for the titled HPV test chemical.

Let me know if you have any question on this matter.

Daniel

______________________________________________________ Dr. Daniel Chuantung Lin Industrial Chemistry Branch Office of Chemicals Safety and Pollution Prevention US EPA 1200 Pennsylvania Ave., NW (7406M) Washington, DC 20460

[Deliveries to: 1201 Constitution Ave., NW, EPA East, Room#:5133E, Washington, DC 20460]202-564-8584 (direct)

202-564-8740 (branch) 202-564-8679 (fax)

Paul Campanella---02/21/2012 11:39:33 AM---Daniel., I am sending this test plan from Eastman for your review. You have commented on an earlier

From: Paul Campanella/DC/USEPA/US To: Chuantung Lin/DC/USEPA/US Cc: John Schaeffer/DC/USEPA/US@EPA, Marcus Aguilar/DC/USEPA/US Date: 02/21/2012 11:39 AM Subject: HPV 3 for CASRN 22527-63-5 - Submission of Test Plan by Eastman Chemical for review.

Daniel., I am sending this test plan from Eastman for your review. You have commented on an earlier question from Eastman and they have modified the test plan accordingly. They have requested a modification dealing with purity of the test substance. Eastman is anxious to start the testing as soon as possible. Can you please give me an estimate as to when this review will be available . Thanks.

Paul J. Campanella, Ph.D. Chemical Information and Testing Branch Chemical Control Division U.S. Environmental Protection Agency Washington, D.C. 202-564-8091 ----- Forwarded by Paul Campanella/DC/USEPA/US on 02/21/2012 11:37 AM -----

From: "Velsor, Leonard Wayne" <lvelsor@eastman.com> To: Paul Campanella/DC/USEPA/US@EPA Cc: "Shrum, Gary" <glshrum@eastman.com> Date: 02/20/2012 03:36 PM Subject: Attn 40 CFR 799.5089 for CASRN 22527-63-5 - Submission of Test Plan

Paul, A copy of our test plan was sent by overnight mail today but I've attached a PDF copy in advance. I believe information responsive to Dr. Lin's request is in the content of the letter. Gary Shrum, Eastman's Director of Product Safety and Health will be your primary contact going forward .

Thanks,

Leonard

-----Original Message----- From: Paul Campanella [ mailto:Campanella.Paul@epamail.epa.gov ] Sent: Tuesday, February 14, 2012 4:11 PMTo : Velsor

, Leonard Wayne

Subject: RE: [I] Re: Attn 40 CFR 799.5089 for CASRN 22527-63-5: Request for clarification from EPA reviewer

Leonard, below is an additional request from our reviewer Dr Daniel Lin . Can you please respond to me so that I will not lose any information in the exchange and we will try and get this settled quickly . Thanks.

Hi Paul,

In order to respond the sponsor's question correctly on this matter: we need to know the contents of actual product that Eastman proposed to use for the testing. I assume that the proposed product contains the mixture of regioisomers of the test rule substance, 22527-63-5 (i.e., 2,2,4- vs. 2,4,4-trimethylpentyl; which will be treated as a Class 2 chemical substance or a mixture of isomers). If the sponsor could provide the detail formulation information of the product which is to be used in the testing, we could have a clear picture to comment on such approach. If the product contains only such two structural isomers (2,2,4 and 2,4,4- ) without other components, then it should be fine to use that product mixture for testing to obtain the required data for the physical chemical endpoints required under the HPV test rules . Therefore, could you ask the sponsor to provide us the contents of the product formulation that will be used in the testing?

Daniel

___________________________________________________ Dr. Daniel Chuantung Lin Industrial Chemistry Branch Office of Chemicals Safety and Pollution Prevention US EPA 1200 Pennsylvania Ave., NW (7406M) Washington, DC 20460

Paul J. Campanella, Ph.D. Chemical Information and Testing Branch Chemical Control Division U.S. Environmental Protection Agency Washington, D.C. 202-564-8091

From: "Velsor, Leonard Wayne" <lvelsor@eastman.com> To: Paul Campanella/DC/USEPA/US@EPA Date: 02/10/2012 01:44 PM Subject: RE: [I] Re: Attn 40 CFR 799.5089 for CASRN 22527-63-5Dear Dr

. Campanella

,

Eastman will be submitting its test plan next week for propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester (CASRN 22527-63-5). As we mentioned in our Letter of Intent, Eastman acquired the company that manufacturers this substance in 2010 and to the best of our knowledge, no comments were filed in response to the proposed rule. As a result, we expect to propose some modifications to the testing requirements and wanted to provide the agency with advanced notice of one significant modification we expect to propose to assist you with the review. Subsequent to our submission of the Letter of Intent, we have discovered that the substance notified in the test rule was not produced as an individual substance but rather as part of a reaction mass for commercial products. As the pure substance is not sold into commerce, and we are uncertain if the product could be refined to achieve the 99% purity required under the rule, we intend to propose that the studies designated in the test plan be conducted on the actual Eastman product that contains the test rule substance. We look forward to discussing this issue with you following the submission of our test plan . Sincerely, Leonard Velsor

-----Original Message----- From: Paul Campanella [ mailto:Campanella.Paul@epamail.epa.gov ]<mailto:[ mailto:Campanella.Paul@epamail.epa.gov ]> Sent: Thursday, December 22, 2011 1:04 PM To: Velsor, Leonard Wayne Subject: [I] Re: Attn 40 CFR 799.5089 for CASRN 22527-63-5

Thanks for sending a copy of this Letter of Intet to Test to me. Please continue to send me electronic versions of anything you submit to the docket. This often will speed up reviews and transfer of information as we go forward.

Paul J. Campanella, Ph.D. Chemical Information and Testing Branch Chemical Control Division U.S. Environmental Protection Agency Washington, D.C. 202-564-8091

(See attached file: 20120220_Test Plan for HPV 22527-63-5_Final.pdf)