# ORIGINAL
TSCA NON-CONFIDENTIAL BUSINESS INFORMATION
DOCUMENT DESCRIPTION DOCUMENT CONTROIL NUMBER DATE RECEIVED 

### 8EHQ-11- 9 

# 88110000182 q 4 lit COMMENTS:



# DOES NOT CONTAIN CBIAkzo Nobel Services Inc. 525 W Van Buren Street T+1312 544 7000 Technology &Engineering Chicago, Illinois F+1312544 7125 4 RALS Americas 60607-3835 www.akzonobel.com/te United States 

# AkzoNobel 

# 11 N 11 E 1 Hil 1 1 11 111 111 11 1 To mnorovvs Answers Today
April 1,2011 Office of Pollution Prevention and Toxics 77 ~rn 

### U.S. EPA 

## 2 Attn: Section 8(e) 1201 Constitution Avenue, NW Washington, DC 20004 Subject: TSCA 8(e) Notice Dear U.S. EPA: On behalf of Akzo Nobel Surface Chemistry LLC, we are submitting preliminary results from an OECD 422 Reproduction/Developmental Toxicity Screening Test on alkyl amidopropyl dimethyl amine, CAS# 68140-01 -2. NOTE: This substance isconsidered corrosive to skin and eyes, and this should be kept inmind when evaluating the results from the OECD 422 study. Inthe OECD 422 study, groups of 10 male and 10 female rats were treated by gavage once daily for up to 45 consecutive days (including atwo week maturation phase, pairing, gestation and early lacation for females). A Control Group was dosed with the vehicle only (corn oil). The following dose levels were selected as follows: Control Group: 0mg/kg body weight/day Low Dose Group: 5mg/kg body weight/day Mid Dose Group: 15 mg/kg body weight/day High Dose Group: 45 mg/kg body weight/day The test substance did not induce any significant adverse effects on: (1)the parental animals, (2)reproductive parameters, or, (3)the developing fetuses, except for one finding inthe parental animals. There were isolated histopathology findings inthe forestomnachs/stomachs of anumber of treated parental animals showing toxicityto the cellular lining. The cellular lining of the forestomach/stomach came into direct contact with the corrosive test article following oral administration.

~II ~ ~II i ocoi 8CONTAINS 

## NOC81

## AkzoNobel

Most of the reported histopathology effects were observed inthe rat forestomach. While not an unexpected finding for acorrosive substance delivered orally to rats, toxicityto the forestomach/stomach lining was not severe enough to be noticed during gross visual necropsy of thetreated animals, but was observed only under preliminary microscopic examination. The human relevance of the findings inthe non-glandular portion of the stomach (forestomach) is not known because this organ while present in rats, isnot present inhumans. Please contact me ifyou have any questions at 312-544-7191. Sincerely,

Edwin C.Bisinger Jr.,rPhD, DABT Director, Global Product Stewardship Business Support/HSE Department Akzo Nobel Services Inc. 525 W. Van Buren St. Chicago, IL60607-3835Page 1of 1

From. (312) 5447315 Origin ID:GYYA Slip Date: 01APR1I1 FRANKTHORNE Ac(Wgt 0.5 LB AI(ZO NOBELSERVICES INC bu CAD, 331253Si'ET3130 515WEST VAN BUREN STREET 

## CHIAGO,IL 8007 

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SHIPTO: M22 564-8940 BILL SENDER Rf 21H2 DOCUMENT CONTROL OFFCR SECTO 8 Woke# U.S. EPA

- POLLUTION PRVNTN &TXCS "c' # 1201 CONSTITUTION AVE NW Dept# WASHINGTON, DC 20480 

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S796942109187 STANDARD OVERNIGHT 

### 20460 DC-US 

# SA RDVA DCA

50DG3f26A&'7EFB After printingthis label: 1.Use the 'Print' button on this page to print your label to your laser or inkjet printer. 2. Fold the printed page along the horizontal line. 3. Place label inshipping pouch and affix itto your shipment sothat the barcode portion of the label can be read and scanned. V~/arnirng LI- only the,) intecl Driginal lbel ir 'f rn~,nc 'as r. " to f r1 rh pny purposes is fr-It.01-lent andi couild f catinal billing charqes along %vth J1a i iatio i , "C

- r Use of thissystem constitutes your agreement to the service conditions inthe current FedlEx Service Guide, available on fedexcom.FedEx will not be responsible for any claim inexcess of $100 per package, whether the result of loss, damage, delay, non-delivery,misdelivery,or misinformation, unless you declare ahigher value, pay an additional charge, document youractual loss andtile atimely claim.Limitations found inthe current FedlEx Service Guide apply. Your right to recover from FedEx for any loss, including intrinsic valueofthe package, loss of sales, income interest, profit, attorney's fees, costs, and other forms of damage whether direct, incidentalconsequential, or special islimited tothe greater of $100 orthe authorized declared value. Recovery cannot exceed actual documented loss.Maximum for items of extraordinary value is$500, e.g. jewelry, precious metals, negotiable instruments and other items listed inour ServiceGuide.Written claims must be filed within stricttime limits, see current FedlEx Service Guide.

https ://www.fedex.com/shipping/html/en//PrintIFrame.html 04/01/2011Akzo Nobel Services Inc. 525W Van Buren Street T +1312 544 7000 Technology &Engineering Chicago, Illinois F+1312 544 7125 RAILS Americas 60607-3835 www.akzonobel com/te United States 

# AlzoNobeI Tomnorrow's Answiers Today April 1,2011 -7o Office of Pollution Prevention and Toxics U.S. EPA Attn: Section 8(e) ~- 1201 Constitution Avenue, NWWashington, DC 20004 C Subject: TSCA 8(e) Notice Dear U.S. EPA: On behalf of Akzo Nobel Surface Chemistry LLC, we are submitting draft results from an oral (gavage) fourteen day range-finding study in rats on alkyl amidopropyl dimethyl amine, CAS# 68140-01-2. This fourteen day range-finding study was performed to identify appropriate dose levels for an OECD 422 Reproduction/Developmental Toxicity Screening Test. NOTE: CAS# 68140-01 -2isconsidered corrosive to skin and eyes, and this should be kept in mind when evaluating the resultsfrom the fourteen day range-finding study. For the fourteen day range-finding groups of six rats (3M/3F) were dosed via oral gavage at levels of 25, 50, or 100 mg/kg/day. One control group was dosed with the vehicle only (corn oil). With respect to clinical signs, animals inthe 100 mg/kg/day group showed increased salivation, noisy respiration and reduced bodyweight gain. The 50 mg/kg/day group showed reduced body weight gain. At necropsy, some animals inthe 100 mg/kg/day and 50 mg/kg/day groups showed thickening of the non-glandular (forestomnach) region of the stomach. One male inthe 25 mg/kg/day group showed this same effect.



# AMS. A N OCB1

## AlizoNobel

The necropsy findings are not unexpected following oral dosing of askin corrosive test articleto rats because the corrosive test article would come into direct contact with the forestomnach. Further, the human relevance of the findings inthe non-glandular portion of the stomach (forestomach) is not known because this organ while present in rats, isnot present inhumans. Please contact me ifyou have any questions at 312-544-7191. Sincerely,

Edwin C. Bisinger Jr., PD, DABT Director, Global Product Stewardship Business Support/HSE Department Akzo Nobel Services Inc. 525 W. Van Buren St. Chicago, IL60607-3835Page 1of 1

From: (312) 544-7315 OrignD.GYYA Fe I K Ship Date: 0 1APR11 FRANKTH-ORNE ActWgt 0.5 LB WKO NOBEL SERVICES INC &4v-s CAa)3312538ANET3130 525*WEST VAN BUREN STREET DeliveryAddress Bar Code CHICAGO, IL 60607 J 

# I

SHIP TO: (202) 564-8948 BILLSENDER Ref# 7201SH526 DOCUMENT CONTROL OFFCR SECTION 8(q invoice# U.S. EPA

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### 04016184 

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# DlA DC-u

51OG326A8/7EFB After printingthis label: 1.Use the 'Print' button on this page to print your label to your laser or inkjet printer. 2. Fold the printed page along the horizontal line. 3. Place label inshipping pouch and affix itto your shipment so that the barcode portion of the label can be read and scanned. 4Varning Use only tile pinited origln~il s i

- rg of~*~y. thiis label ior shiping pLurPOSeS IS'rI L..i nt aod cld resuit Inadditional billing charges,longnrF ,it li-' ac

- .<~cFount nulba r Use ofthis system constitutes your agreement to the service conditions inthe current FedEx Service Guide, availableon fedexcom.FedEx will not be responsible for any claim inexcess of $100 per package, whether the result of loss, damege, delay, non-delivery,misdelivery,ormisinformation, unless you declare ahighervalue, pay an additional charge, document youractual loss and file atimely claim.Limitations found inthe current FedEx Service Guide apply. Your right to recover from FedEx for any loss, including intrinsic valueof the package, loss of sales, income interest, profit, attorney's fees, costs, and other forms ofdamage whether direct, incidentalconsequential, orspecial islimited to the greater of $100 or the authorized declared value. Recovery cannot exceed actual documented loss.Maximum for items of extraordinary value is$500, e.g. jewelry, precious metals, negotiable instruments and other items listed inour ServiceGuide. Written claims must be filedwithin strict time limits, see current FedEx Service Guide.

https://www.fedex.com/shipping/html/en//PrintIFrame.html 04/01/2011