ORIGINAL

00118 NOT CONTAIN CII
Akzo Nobel Services Inc. 525 West Van Buren Street T ±1 312 544 7000

Chicago, IL 60607-3835 F +1 312 544 7125

United States g\~z jOf lO corn~te

OPPI CBIC

2011 SEP 20 AM 10: 49 AkzoNobel

Toirro :vv Ar o:, ,ers Twcay

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 1 11 1 H 11 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.

In the OECD 407 study, groups of 5 male and 5 female rats were treated by gavage

once daily for up to 29 consecutive days. In this 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 in treated 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 in the 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

8 81 1 0I 0I 003 13 0 c1118N B
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. In the low-dose group changes

in the 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 in the 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 in the fore stomach of all treated groups. However, in the

absence of a similar structure in the human stomach, the relevance of the findings in the

rat non-glandular portion of the stomach (fore stomach) with respect to human health is

not known.

Please contact me if you 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, IL 60607-3835
Page 1 of 1

From (312) 544-7089 Origin ID GYt'A j . Shp Datei 19SEPII

JenniferrWisnawki FedS2S Actffgt AS5 LB E CAD t0321A43a4NET3180

525 W Van Baten St

Suit. 1800DDf Delivry Address Bar Code

Chicago. IL 60807 L J1

SHIP T0- (202) 564-8940 BILL SENDER Rc# Bigr21-H6

Office of Pollution Prevent 8, Toxic mnorce #

U.S. Environmental Protection Agncy PO

1201 CONSTITUTION AVE NW Depti#

ATTN:SECTION 8(E); EPA EAST.RM 6428

WASHINGTON, DIC 20480

TUE-20 SEP Al

TRKtO 7952 0184 4241 STANDARD OVERNIGHT

20460

DC-US XC RDVA C

After printing this label

1 Use the 'Print' button on this5 page to print your label to your laser or inkjet printer

2 Fold the printed page along the horizontal line

3 Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned

Use of this system consttutes your agreement to the service conditions in the curreot FeAdE Service Guide, available on fedlex com PedEx will not be responsible for any claim in excess of $10t per package, 'whether the result ol loss da mage, delay. no-deiivery,misdelivery,or misintormation, unless you declare a higher value, pay an additional charge, document your actualoss aod tile a timely claim Limitations found in the cuffent FedEx Service

Guide apply Your right to recover fromi PedEx for any loss, including intrinsic valueot the package, loss of sales, income interest, profd, attormey's tees. costs, and other torms of damage wrhether diret, incideotai,Cunseituential, or special is lingted to the greater of $100 or the authorizedeclared value Recovery cannot exceed actual documented loss Maximum for items of extraordinary vaue is $00, ag jewelry precous metals. negotiahle instruments and other items listed in our ServiceGuide Written claims must he ined within stric time limits, see current FedEx Service Guide

https ://www.fedex.com/shipping/html/en/PrintIFrame.html 9/19/2011