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ORIGINAL DOCS NOT CONTAIN CBI -B A S F The Chemical Company { jr,. ... 1 V t.. Uri r> *" j Ti O,JrL' April 18, 2013 Via Federal Express United States Environmental Protection Agency - East Attn: TSCA Section 8(e) Room 6428 1201 Constitution Avenue, NW Washington, DC 20004 881 3 0 0 0 0 2 3 4 Subject: Notice in Accordance with TSCA Section 8(e): Results of an acute inhalation study in Wistar rats with CAS No. 61791-26-2 as liquid aerosol Dear Section 8(e) Coordinator: BASF Corporation is submitting information on an acute liquid aerosol inhalation study in Wistar rats (strain CrlGlxBrlHan:WI) with Amines, tallow alkyl, ethoxylated , CAS No. 61791-26-2 conducted by BASF SE, Ludwigshafen, Germany. The test substance is a surfactant used in the chemical, technical industry. The study was carried out in accordance with the requirements of the international guideline: OECD Guidelines for Testing of Chemicals, Guideline 403 Scope of the examination For determination of the acute inhalation toxicity (single 4-hour-exposure) with CAS No. 61791-26 2, five male and five female Wistar rats per test group were nose-only exposed to liquid aerosol of the test substance. The measured concentrations of 0.27, 0.6, 2.3 and 5.7 mg/l were tested. During the 14 days of post exposure observation period, body weights were determined, and examinations for clinical signs of toxicity were carried out. Gross necropsy was carried out at termination of the study, as well as in animals that died during the study. The following is a summary of the most relevant results: Cascade impactor measurements resulted in particle size distributions with mass median aerodynamic diameters (MMADs) between 1.0 and 2.2pm, which are well within the respirable range. 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. BASF Corporation 100 Park Avenue Florham Park, NJ, 07932 Tel (800) 526-1072 www.basf.com/usa OWTAINSNOCfll -B A S F The Chemical Company United States Environmental Protection Agency - East April 18, 2013 Page 2 Clinical signs of toxicity in animals comprised visually accelerated respiration, gasping, respiration sounds, crust formation around the nose, apathy, squatting posture, reduced general state, piloerection and smeared fur. The duration of the findings ranged from hO of the exposure until including study day 14. Attempts to escape were generally observed at the beginning of the exposure (hO). Substantially reduced body weights were observed in the surviving animals. Gross necropsy findings of the animals that died comprised diffuse red discoloration of all lung lobs, lung emphysema, congestion, severe dilatation of the gastro intestinal tract filled with gaseous matter. Histopathological examinations were carried out in the lungs of two randomly selected female animals (0.27 mg/l), which died shortly after exposure. Various lung lesions including lung congestion, alveolar edema and multifocal suppurative (partly necrotic) broncho pneumonia were observed in both of them. Under the described study conditions, the LC50 value for male and female animals was 0.473 mg/L. BASF Corporation understands that reporting of the results from this study under TSCA 8(e) is in accordance with EPA's policy. Please note the technical contact and address below and direct all correspondence regarding this submission accordingly. If you have any questions, please call (248) 948-2051. Sincerely, Technical Contact: Alisa Boucher BASF Corporation Product Regulatory Center of Expertise - North America 26701 Telegraph Road, Southfield, Ml 48033 BASF Corporation 100 Park Avenue Page 1 of 1 From: (248)948-2051 Alisa Boucher BASF 26701 Telegraph Road Origin ID: DETA Fec2. Express SOUTHFIELD, Ml 48033 SHIP TO: (202)564-8930 ATTN: TSCA Section 8(e) USEPA East Room 6428 1201 Constitution Ave., NW J13111302120326 BILL SENDER Ship Date: 18APR13 ActW gt 0.5 LB CAD: 4487533/INET3370 Delivery Address Bar Code 71201 CONSTITUTION AVE., NW R ef# Invoice # PO# D ept# US635018 WASHINGTON, DC 20004 FRI -1 9 APR3:00P STANDARD OVERNIGHT P # 7995 6012 4380 [)> 01 0220004 840 05 7995601243800201 FD02E01 201813921 108 1/1 0.5LB N 1201 Constitution Ave., NW WASHIN XC RDVA 20004 DC-US DCA 1001913732710002000400799560124380 518G1/64BES3AB After printing this 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 in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned. Warning: 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 with 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 will not be responsible for any claim in excess of $100 per package, whether 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 claim.Limitations 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 whether 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 within strict time limits, see current FedEx Service Guide. https://www.fedex.eom/shipping/html/en//PrintIFrame.html 4/18/2013