# ORIGINAL

00118 NOT CONTAIN CIIAkzo Nobel Services Inc. 525 West Van Buren Street T ±1 312 544 7000 Chicago, IL60607-3835 F+1 312 544 7125 United States g\~z jOf lO corn~te 

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## 2011 SEP20 AM 10: 

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# AkzoNobel
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### September 19, 2011 Office of Pollution Prevention and Toxics EPA East

- Room 6428 Attn: Section 8(e) 

### U.S. Environmental Protection Agency 

### 1201 Constitution Avenue, NW Washington, DC 20004-3302 1 N1HH 111 1 H11 1
ATTENTION: TSCA 

### 8(e) Notice
Dear U.S. EPA: On behalf of Akzo Nobel Surface Chemistry LLC, we are submitting results from an OECD 407, 4-week repeated dose study including a 4-week recovery period on Coco amidopropyldimethylamine (CAS# 68140-01-2) under Section 8(e) of TSCA. 

### Inthe OECD 407 study, groups of 5 male and 5 female rats were treated by gavage once daily for up to 29 consecutive days. Inthis study two satellite groups of 

### 5 male and 

### 5 female rats were included in the control group and the high-dose group. These animals were kept for a 4-week recovery period after treatment for observation of reversibility, persistence or delayed occurrence of systemic / irritative effects. The Control Group was dosed with the vehicle only (corn oil). The following dose levels were selected as follows:

- Control Group: 0 mg/kg body weight/day

- Low Dose Group: 30 mg/kg body weight/day

- Mid Dose Group: 60 mg/kg body weight/day

- High Dose Group: 120 mg/kg body weight/day A trend towards a lower body weight gain was noted intreated animals associated with a decrease in food consumption in high-dose group when compared to control group. 

### These effects were reversible during the recovery period. At necropsy white discoloration of the fore stomach was observed inthe mid- and highdose groups confirming the strong irritative/corrosive properties of the test substance. In the satellite groups no test item-related changes were observed at necropsy. Microscopic examination revealed signs of pronounced irritation of the fore stomach in

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### Page 2 of 2 September 19, 2011
the mid- and high-dose groups. These signs consisted of acanthosis, hyperkeratosis, erosion/ulcer, edema with mixed infiltrate of inflammatory cell in the submucosa and correlated with the white discoloration seen at necropsy. Inthe low-dose group changes inthe fore stomach were also present but with lower severity and incidence. Furthermore, the microscopic examination after a 4-week recovery period showed a pronounced decrease in the incidence and severity of changes observed inthe fore stomach but the recovery was not complete. Acanthosis and hyperkeratosis were still observed. The NOAEL with respect to systemic toxic effects was considered to be 60 mg/kg/day because of lower food intake and slight reduction in body weight gain observed in animals treated at 120 mg/kg/day. A NOAEL for local effects could not be established because of irritation observed inthe fore stomach of all treated groups. However, inthe absence of a similar structure inthe human stomach, the relevance of the findings inthe rat non-glandular portion of the stomach (fore stomach) with respect to human health is not known. Please contact me ifyou have any questions at 312-544-7191. Sincerely,

Edwin C.Bisinger Jr., PhD, DART Director, Global Product Safety HSE Department Akzo Nobel Services Inc. 525 W. Van Buren St. Chicago, IL60607-3835Page 1 of 1

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