Bayer MaterialScience

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April 28,2010

By Certified Mail

PUBLIC COpy Product Safety & Regulatory Affairs and

Management Systems

Bayer MaterialScience LLC

100 Bayer Road

Pittsburgh, PA 15205-9741

TSCA Confidential Business Information Center (7407M)

EPA East - Room 6428 Attn: Section 8(e)

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW

Washington, DC 20460-0001

Dear Sir or Madam:

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8810000020,;/,:;

Under TSCA § 8(e), Bayer MaterialScience LLC (the "Company") hereby submits the attached

summaries ofthe following laboratory studies of a chemical substance designated by CAS

Registry Number 68650-79-3 (amides, tall-oil fatty, N-[3-(dimethylamino)propyl], which the

Company imports, processes, and distributes in the United States:

1. Determination ofPartition Coefficient (Pow) by High Performance Liquid Chromatography

(HPLC) Method

2. Determination ofAdsorption Coefficient (Koc) by High Performance Liquid Chromatography

(HPLC) Method

3. Biodegradation

In TSCA § 8(e) Submission No. 8EHQ-09-17616 ofAugust 10,2009, the Company previously

submitted a summary of an acute immobilization test ofthe same chemical substance in Daphnia.

The attached summaries ofphysical/chemical property, environmental transport, and biological

studies performed entirely in the laboratory do not report any effect of concern identified by EPA

as a potential "substantial risk ofinjury to health or the environment" in part V ofthe Agency's

current TSCA § 8(e) policy statement and reporting guidance, 68 Fed. Reg. 33,129,33,138-39

(June 3, 2003). Furthermore, the importation, processing, distribution, and known commercial

uses ofthe chemical substance involve only potential occupational exposures and do not involve

any environmental releases or exposures, to the best ofthe Company's knowledge. Consequently,

the Company does not expect or have evidence that the chemical substance is currently present in

the environment or in any living organism, including man. For these reasons, the Company does

not believe that the attached summaries oflaboratory studies contain any "substantial risk"

information that isreportable under TSCA § 8(e). In an abundance ofcaution, however, the
Company is making the present submission under TSCA § 8(e) to supplement its August 10, 2009

submission on the same chemical substance.

This submission contains TSCA confidential business information ("CBI"). Accordingly, the

Company is providing both original and redacted versions ofthis submission to EPA, along with

the enclosed substantiation ofthe Company's CBI claims. In keeping with recent guidance from

EPA, the Company does not claim as CBI any chemical identity information contained in this

submission. The Company invites any questions that EPA has about this letter.

Sincerely,

Attachments (6 pp.)

PUBLIC COpy

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PUBLIC COpy

COMPOUND: N-[3-(dimethylamino)propyl] amides, tall-oil fatty

(CAS Registry Number 68650-79-3)

STUDY TITLE: Determination ofPartition Coefficient (Pow) by High Performance Liquid

Chromatography (HPLC) Method ofN-[3-(dimethylamino)propyl] amides, tall-oil

fatty

The test was performed according to OECD Guidelines for Testing ofChemicals, Section 1 - OECD TG

117 (2004) EC Guidelines Part A - Methods for the Determination ofthe physical-chemical properties

A.8 (1992)

The octanol-water partition coefficient (Pow)ofthe test item N-[3-(dimethylamino)propyl] amides, tall-oil

fatty was determined by the HPLC method. The reference log Pow- values in the OECD- guideline

presumably refer to 25°C. The column temperature was 40°C. However, the influence ofthis temperature

difference on the calculated log P value lies within the range ofthe error ofthe method.

The chromatogram showed a partially unresolved band ofsignals. The following upper and lower limit of

the log Pow was obtained:

Partition coefficient, log Pow: = 4.3 - 5.6
PUBLIC COpy

COMPOUND: N-[3-(dimethylamino)propyl] amides, tall-oil fatty

(CAS Registry Number 68650-79-3)

STUDY TITLE: Determination ofAdsorption Coefficient (Koc) by High Performance Liquid

Chromatography (HPLC) Method ofN-[3-(dimethylamino)propyl] amides, tall-oil

fatty

The test was performed according to OECD Guidelines for Testing ofChemicals, Section 1 - PhysicalChemical Properties OECD TG 121 (2001) EC Guidelines Part A - Methods for the Determination of

Ecological Toxicity C.l9 (2001)

The adsorption coefficient (Koc) ofN-[3-(dimethylamino)propyl] amides, tall-oil fatty was determined

according to the HPLC method at 40°C. In order to comply with the demand ofthe guideline OECD 121

and considering environmental relevance, pH 6 was chosen as pH value for the buffer because the test

substance has no ionic able structures. The references Koc- values in the OECD-guideline presumably

refer to 25°C. However the column temperature was 40 "C, this temperature is without influence on the

result ofthe determination. The calibration was done referring to Koc- values ofreference substances

determined at 25°C. No reference substance with a Koc-value above the value for the test item was

available. For this reason the result was extrapolated.

The chromatogram showed a partially unresolved band ofsignals. The following upper and lower limit of

the log Koc was obtained:

The adsorption coefficient: log Koc = 8.2 - 8.5
PUBLIC COpy

COMPOUND: N-[3-(dimethylamino)propyl] amides, tall-oil fatty

(CAS Registry Number 68650-79-3)

STUDY TITLE: Biodegradation with N-[3-(dimethylamino)propyl] amides, tall-oil fatty

A study was performed to assess the ready biodegradability ofthe test substance. The study was

conducted in accordance with the Council Regulation (EC) 440/2008 Method C.4-E: Closed Bottle Test.

This test method is in all essential parts identical with OECD Guideline 301 D. The test item N-[3-

(dimethylamino)propyl] amides, tall-oil fatty in a mineral medium was inoculated with secondary effluent

to result in completely filled, closed flasks and incubated under aerobic conditions at 22°C for 28 d.

During this period, the biodegradation was followed by analysis of dissolved oxygen. The amount of

oxygen taken up by the test chemical, corrected for uptake by the blank inoculum run in parallel, was

expressed as a percentage of chemical oxygen demand (COD).

The test substance showed:

21 % degradation after 4 days

31 % degradation after 7 days

37 % degradation after 11 days

39 % degradation after 14 days

26 % degradation after 18 days

37 % degradation after 21 days

53 % degradation after 25 days

33 % degradation after 28 days