Document qddzoRGmQN9DL2owp54EEQjjM

ORIGINAL DOES NOT CONTAIN CBI Akzo Nobel Services Inc. HSE Department 525 W. Van Buren Street Chicago, Illinois 60607-3835 United States T+1 312 544 7000 F +1 312 544 7125 www.akzonobel.com/te Ki !0: 53 AkzoNobel Tomorrow's Answers Today April 15, 2013 US EPA Office of Pollution Prevention and Toxics EPA East Building Room 6428 Attn: Section 8(e) 1201 Constitution Avenue, NW Washington, DC 20004 EHQ 906 3 SUBJECT: TSCA 8(e) Notice Dear TSCA Section 8(e) Coordinator: 8 8 13 000221 On behalf of Akzo Nobel Surface Chemistry LLC, we are reporting the results of an acute inhalation study (single 4-hour, head-nose exposure) under Section 8(e) of TSCA. This toxicology study was performed by BASF in Germany on its product Lutensol FA 15 T, which was described as Amines, tallow alkyl, ethoxylated, CAS# 61791-26-2. Lutensol FA 15 T was tested as a liquid aerosol generated at 60C/140F. The study was performed using male and female Wistar rats and was performed in accordance with OECD Guideline 403. (Note: CAS# 61791-26-2 is considered a skin irritant. This should be kept in mind when reviewing the results of the acute inhalation study where the ethoxylated amine came into direct contact with the sensitive tissues of the lung.) The test substance was administered as an aerosol that was produced by continuously pumping amounts of the test substance to a heated two-component atomizer at 60C/140F. The product as supplied was too viscous for an aerosol to be generated at ambient temperatures (communication from BASF). Therefore, to generate a respirable aerosol, the substance had to be heated to 60C/140F and atomized. Using compressed air, the aerosol was produced with the atomizer inside the exposure system. The following measured concentrations were tested: 0.27, 0.60, 2.3 and 5.7 mg/L (analytical concentration). Under the conditions of aerosol generation at 60C/140F, the results of cascade impactor measurements showed a particle size distribution with mass median aerodynamic diameters (MMADs) between 1.0 and 2.2 pm. One of five males and three of five females died at 0.27 mg/L, as well as two of five males and two of five females at 0.60 mg/L. At 2.3 and 5.7 mg/L, all the male and female died. Lethality was observed after exposure on study day 0, on study day 1 - 4, 9,10 or on study day 12. The mean body weights of the male animals surviving the exposure period decreased during the first post exposure observation week but increased during the second week. The mean body weights of the female animals surviving the exposure period decreased throughout the study period. Clinical signs of toxicity in exposed animals included comprised visually accelerated respiration, gasping, respiration sounds, crust formation around the nose, apathy, squatting posture, reduced general state, piloerection and smeared fur. Gross necropsy of the animals that died showed diffuse (dark)-red discoloration of all lung lobes: the surface of some part of the tissue was sunken. At the highest exposure level, findings were described as lung emphysema. Severe dilatation of the gastro intestinal tract filled with gaseous matter was observed. Histopathology of the lungs of one female animal showed distinct congestion, slight alveolar edema and a focal moderate suppurative necrotizing bronchopneumonia. The histopathological finding of a second female animal was similar to OOMTMN&NO CB> 0 AkzoNobel those described above but less severe. Based on these results, under the unique exposure conditions of this study, the acute LC50 for male and female rats after liquid aerosol inhalation exposure of Lutensol FA 15 T heated to 60C/140F and atomized was estimated to be 0.473 mg/L (analytical concentration). As stated previously, the test substance had to be heated to 60C/140F in order to generate a respirable aerosol. However, to the best of our knowledge, under normal industrial use and processing, this product would not be heated to 60C/140F. Please contact me at (312) 544-7061 if you have any questions regarding this letter. Sincerely, Louette Rausch Expertise Leader Regulatory Affairs Americas Akzo Nobel Services Inc. 525 W. Van Buren Chicago, II 60607 4/15/13 FedEx Ship Manager - Print Your Labei(s) From: (312)544-7089 Samantha Hart AKZO NOBEL INC 525 West Van Buren Street Chicago, IL 60607 Origin ID. GYYA Fedki. Express Ship Date: 15APR13 ActW gt 1.0 LB CAD: 103794831/INET3370 Delivery Address Bar Code 71201 CONSTITUTION AVENUE, NW _______________________________________________________________ J13111302120326 SHIP TO: (202) 564-8930 BILL SENDER Section 8(e) US EPA OFC of Poll. Prev. & Toxics 1201 Constitution Avenue, NW EPA East Bldg Rm 6428 WASHINGTON, DC 20004 R ef# Invoice # PO# D e p t# 7201 SH526 TUE -1 6 APR 10:30A PRIORITY OVERNIGHT 7995 2850 2339 [)> 01 0220004 840 01 7995285023390201 FDEI 00206105123487 105 1/1 1.0LB N 1201 Constitution Avenue, NW WASHINGT 20004 XC RDVA DC-US DCA 1001899932260002000400799528502339 518G1/34BB93AB After printing this label: 1. Use the 'FYint' button on this page to print your label to your laser or inkjet printer. 2. Fold the printed page along the horizontal line. 3. Race label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned. W arning: Use only the printed original label for shipping. Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges, along w ith the cancellation of your FedEx account number. Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide, available on fedex.com.FedEx w ill not be responsible for any claim in excess of $100 per package, w hether the result of loss, damage, delay, non-delivery .misdelivery,or misinformation, unless you declare a higher value, pay an additional charge, document your actual loss and file a timely claimLimitations found in the current FedEx Service Guide apply. Your right to recover from FedEx for any loss, including intrinsic value of the package, loss of sales, income interest, profit, attorney's fees, costs, and other forms of damage w hether direct, incidental,consequential, or special is limited to the greater of $100 or the authorized declared value. Recovery cannot exceed actual documented loss.Maximum for items of extraordinary value is $1,000, e.g. jewelry, precious metals, negotiable instruments and other items listed in our ServiceGuide. Written claims must be filed w ithin strict time limits, see current FedEx Service Guide. httns7AAAAAA/fertey r.nmMhinnnn /shinA rtinn hanHlp?mpthrv1=Hnnr>ntini ia I 1/1