Re: Fw: Response to Harcos Chemicals regarding review for CASRN 

31138-65-5 

Paul Campanella to: Ann Marie Savini 01/17/2012 12:38 PM

Cc: John Schaeffer, Marcus Aguilar

From: Paul Campanella/DC/USEPA/US

To: Ann Marie Savini <AnnMarie.Savini@harcros.com>

Cc: John Schaeffer/DC/USEPA/US@EPA, Marcus Aguilar/DC/USEPA/US

Ann Marie, I apologize for the confusion on this. The OECD Method 102 ( Melting Point) is an acceptable 

substitute for ASTM E 324-99. In addition, OECD Method 105 ( Water Solubility) is an acceptable 

substitute for ASTM E 1148-02. Thanks for calling to make sure we were discussing the same issue. Now 

to get the testing done. Good luck. Paul

Paul J. Campanella, Ph.D.

Chemical Information and Testing Branch

Chemical Control Division

U.S. Environmental Protection Agency

Washington, D.C. 

202-564-8091

Ann Marie Savini Paul, I was wondering if you had a chance to rev... 01/17/2012 11:04:38 AM

From: Ann Marie Savini <AnnMarie.Savini@harcros.com>

To: Paul Campanella/DC/USEPA/US@EPA

Date: 01/17/2012 11:04 AM

Subject: Re: Fw: Response to Harcos Chemicals regarding review for CASRN 31138-65-5

Paul,

I was wondering if you had a chance to review the change in the Boiling Point and Water Solubility 

protocols. 

Also, I am going to write a letter asking for an extension for the testing. It looks like we should be done 

testing around June. However, I had read that although EPA does grant extensions, they will most likely 

only grant one extension. Although we should be done by the end of June, I want to be sure that we have 

extra time in case any problems arise during the testing. Can you give me some guidance on how long of 

an extension EPA is likely to approve?

Thanks!

Ann Marie

Ann Marie Savini

Harcros Chemicals, Inc.

Phone: (913) 621-7802 

Fax: (913) 621-7876
Ann Marie Savini---01/04/2012 01:04:40 PM---Paul, The revised protocol mostly had to do with the 

request for a change in the method for Boiling

From: Ann Marie Savini/Harcros

To: Paul Campanella <Campanella.Paul@epamail.epa.gov>

Date: 01/04/2012 01:04 PM

Subject: Re: Fw: Response to Harcos Chemicals regarding review for CASRN 31138-65-5

Paul,

The revised protocol mostly had to do with the request for a change in the method for Boiling Point (per 

ASTM E 1719-05) and Water Solubility (per ASTM E 1148-02 or 40 CFR 799.67784). There was some 

miscommunication between us and the testing facility and they do not have the equipment to perform the 

ASTM methods but can run alternate methods which I included in my December 6th e-mail. I wanted to 

make sure that this would be ok with EPA. I sent copies of the revised protocols as well (mostly for your 

records).

Please let me know if you need any further explanations.

Best regards,

Ann Marie

Ann Marie Savini

Harcros Chemicals, Inc.

Phone: (913) 621-7802 

Fax: (913) 621-7876

Paul Campanella ---01/04/2012 12:51:24 PM---Ann Marie, Thanks you for the good wishes. I thought 

that our response answered your questions but,

From: Paul Campanella <Campanella.Paul@epamail.epa.gov>

To: Ann Marie Savini <AnnMarie.Savini@harcros.com>

Cc: John Schaeffer <Schaeffer.John@epamail.epa.gov>

Date: 01/04/2012 12:51 PM

Subject: Fw: Response to Harcos Chemicals regarding review for CASRN 31138-65-5

Ann Marie, Thanks you for the good wishes. I thought that our response

answered your questions but, since I have a lot of these requests,
reviews coming in, under review, etc I may have missed something.

Please take a close look and see if this meets your needs . If not we

will go back and do whatever is necessary. When you are satisfied and

have things under way please submit a request for an extension if you

think you will need one to meet the deadline of March 2012 for

submitting testing results. A happy and healthy New year to you. Paul

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 01/04/2012 01:44 PM

-----

From: Paul Campanella/DC/USEPA/US

To: Ann Marie Savini <AnnMarie.Savini@harcros.com>

Cc: John Schaeffer/DC/USEPA/US@EPA, Mike

Mattheisen/DC/USEPA/US@EPA, David Brooks/DC/USEPA/US,

Chuantung Lin/DC/USEPA/US

Date: 10/20/2011 03:26 PM

Subject: Response to Harcos Chemicals regarding review for CASRN

31138-65-5

Dear Ann Marie:

Regarding your letter of intent to test for D-gluco Heptonic acid ,

monsosdium salt (2.xi.)- [CASRN 31138-65-5] and the proposed

modifications to the testing and test methods specified in the final

rule, EPA has reviewed these and has made the following determinations:

Physical/Chemical Properties

1. Regarding the required testing for melting point (A.1.): EPA agrees

that OECD 102 in lieu of ASTM E 324-99 is acceptable.

2. Regarding the required testing for boiling point (A.2.): Your letter

specifies no change of the required test method (ASTM E 1719-05

(Ebulliometry).

3. Regarding the required testing for n-octanol/water partition

coefficient (A.4.): EPA accepts the estimated value provided in your

letter in lieu of testing.

4. Regarding the required testing for water solubility (A.5.): Your

letter specifies either of two of the specified test methods: Method A:

ASTM E 1148-02 (Reapproved 2008)(shake flask) or Method B: (40 CFR

799.6784 (shake flask). Either of these two methods is acceptable.
Biodegradation

1. Regarding the required testing for ready biodegradability: EPA agrees

that either OECD 310 or OECD 301F in lieu of one of the (ASTM or ISO)

methods specified in the final rule is acceptable.

Additional Toxicity testing required:

Aquatic Toxicity C1, Mammalian Toxicity D1,E1,E2 and F1. The Protocol

Review conducted by EPA’s Conractor and approved by the Risk Assessment

Division is attached. This review contains more explicit detail

including stipulations for conducting the tests and reporting the

results.

(See attached file: Harcos CASRN 31138-65-5_Protocol Final 10.19.11.pdf)

Compositional Analysis

Please note that the test rule specifies 99% purity. The substance used

for testing must be 99% pure. If that purity cannot be attained, please

explain and make a request for a modification specifying what purity

will be used.

Paul J. Campanella, Ph.D.

Chemical Information and Testing Branch

Chemical Control Division

U.S. Environmental Protection Agency

Washington, D.C.

202-564-8091[attachment "Harcos CASRN 31138-65-5_Protocol Final 10.19.11.pdf" 

deleted by Ann Marie Savini/Harcros]