# BayerMaterialScience fO 

## «MY -10 

## r,N 6: 00

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: 

# i111111/1111/1111 1111/1111111111111111111111111111111111111111 il 11111 Ii 1111 8810000020,;/,:;


### Under TSCA § 

### 8(e), Bayer MaterialScience LLC (the "Company") hereby submits the attached summaries ofthe following laboratory studies ofa 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) SubmissionNo. 8EHQ-09-17616 ofAugust 10,2009, the Company previously submitted a summary ofan 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 ofconcern identified by EPA as apotential "substantial risk ofinjuryto 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" 

## informationthatisreportableunderTSCA § 

## 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-waterpartition 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 referto 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 bufferbecause 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 aKoc-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 ofdissolved oxygen. The amount of oxygen taken up by the test chemical, corrected for uptake by the blank inoculumrun in parallel, was expressed as a percentage ofchemical 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