Document ppG7DYypxMzEVJ98KK9yZGZ0E

t> m&t juatinu p v <-.g AMgPlQAN CAN COMPAQ------' GENERAL OFFICES, RAHWAY, NEW JERSEY 07063 /' October 21, 1969 Dr. Alexander P. Mathers Chief Laboratory Branch Alcohol, Tobacco & Firearms Division Internal Revenue 1111 Constitution Avenue, N.W. Washington, D. C. 20250 Dear Dr. Mathers: As requested by members of the Alcoholic Beverage Industry, PVC bottle manufacturers and PVC compound manufacturers, we have completed the testing of alcoholic beverages in Octvltin stabilized pvn fta- The evaluation program was outlined in our report to you dated 9/19/69* The results of this testing, as attached, confirm that Octyltin stabilized PVC is suitable for packaging of distilled spirits and further that simulated testing following the time/ temperature conditions as outlined in FDA Regulation 21CFR 121.2526(c) is practical. Accordingly, we request that the Alcoholic Beverage Industry be advised that: PVC stablized with di-n-octyl tin compounds outlined in FDA Regulation 21CFR 121.2602, intended for packaging of distilled spirits shall be tested for tin transfer under the conditions outlined in FDA Regulation 121.2526(c) using distilled spirits or as the simulating solvents, 8% ethyl alcohol or 50$ ethyl alcohol, whichever is appro priate. Time/temperature storage conditions shall be as outlined in FDA Regulation 121.2526(c). Very truly yours. M&T CHEMICALS INC. A. W. Sheldon Manager of Product Registration 20688001 Market Manager AWS:WAL:bad cc: Mr. J'. G. Kaplan - M&T Chemicals Mr. R. J. Zedler - M&T Chemicals Mr. J. Asbock - B. F. Goodrich BFG04556 Mr. M. Smith - Owens-Illinois attach. INDUSTRIAL CHEMICALS ( PLATING SYSTEM PiNUC CH~M;Ca.S ' COJr|VCS <t INK'S ! MtlAl.S PEG'.'/PP/ -T r r TIN TRANSFER DATA FOR ALCOHOLIC BEVERAGE PACKAGING The PVC bottles used for the first series in this study were prepared by Owens-Illinois using Geon 85658 PVC compound manufactured by the B. F. Goodrich Chemical Company and M&T Food Grade Octyltin stabilizers* They were filled with Bourbon Supreme, an 86 proof straight whiskey, which is a product of the American Distilling Company, Inc. These containers were one-half gallon in size and provided 122 square inches of exposed surface area. This is equivalent to 155 ml of distilled spirits per square inch of surface area. The second series of PVC bottles used was also prepared from Geon 85658. This series consisted of 16 ounce cylinders manu factured in the B. F. Goodrich~Taboratories. "~They were filled with 86 proof bourbon whiskey manufactured by the Seagram Company. These containers provided 58 square inches of exposed surface area, equivalent to 8.6 ml of distilled spirits per square inch of surface area. All test containers were placed in an air-circulating oven and controlled at the desired test temperature. The caps of the con tainers were loosened periodically while the contents were being heated to the test temperature. At that point the caps were tightly sealed. 1. Tests with PVC Bottles - wRamsev Procedure" In this study the test containers were heated to 135 5F to establish the maximum amount of organotin stabilizer transferred. These tests were conducted at one and three weeks* at which time the plateau value was reached. The following data has been obtained: BFG04557 200SS90S r 1 week 3 weeks Series I f Dorn (me/liter) Tin Stabilizer 0.03 0.19 0.02 0.13 Series II Dom (m e/liter) Tin Stabilizer 0,02 - 0.13 - Control none found none found - Tests with PVC Bottles - Procedure of 121..2^26(c) Tests were conducted in accordance with 121.2526(c) Table 2. The conditions of use selected were: D. hot filled or pasteurized below 150P E. room temperature filled and store (no thermal treatment in the container). On this basis, tests were performed at 150F for 2 hours and 120P for 24 hours. V Although alcoholic beverages are packaged, stored and shipped at room temperature, we have included higher temperature testing (150P) to demonstrate that octyl tin stabilized PVC is satisfactory from the point of view of tin transfer even at these impractical temperatures. To further demonstrate that these conditions were practical for rapid testing, the above tests were carried to equilibrium. 20688003 BfOO*55 r -3- r Series I Series TT 190F 2 hours ppm (me/liter) Tin Stabilizer 0.03 0.19 ppm (rnsr/liter) Tin Stabilizer* 0. 02 0.13 4 hours 6 hours Control 0.03 0.19 -- none found - 0.03 0.03 0.01 0.19 0.19 0.06 1?0F 2I4. hours 48 hours Control 0.03 0.19 0.03 0.19 none found _ 0.02 0.02 0.01 0.13 0.13 0.06 3* Teats with PVC Bottles - Exaggerated Conditions In an effort to determine the effect of exaggerated conditions of test, we exposed sample bottles as above to l0F for 3 days. Although the amount of tin transfer was higher, it was still significantly below the maximum allowable limit of 1 ppm. It should be noted that these conditions of test resulted in a very distorted container as well as a loss of clarity of the PVC, indicating that such exposure would result in unsalable containers. These conditions are il lustrated in the photographs we have prepared. Series I Series II ppm (mg/liter)_____ Tin Stabilizer pom (mg/liter) Tin Stabilizer 3 days at 150F 0.06 O.38 0.10 O.63 Control none found - 0.01 0.01 20688004 BFG04559 r -4- r 4. Teats with Pressed Sheets - Simulated Media These test samples were made with 2 grams of Thermolite@ 83I to 100 grams of PVC Resin. The test sheets were cut to 3" x. 5" sizes and were 20 mils thick. Ten test sheets were used for each extraction for a total of 300 square inches in con tact with 750 ml of $0% ethyl alcohol (100 proof). This test was run at 135F. ppm (mg/liter) Tin Stabilizer 1 week 0.12 O.76 2 weeks 0.12 O.76 3 weeks 0.12 0.76 SUMMARY The PVC Stabilizers, di(n-octyl) tin S,S' bis (isooctyl mercapto acetate) and di (n-octyl) tin maleate polymer, meeting the specifi cations set forth in PDA Regulation 121.2602 are sanbtioned for use by the FDA in PVC intended for use in packaging of distilled spirits (with the exception of malt liquors). This regulation further states that no more than 3 parts per hundred of these stabilizers (total) may be used in the PVC and the packaged materials shall not contain more than 1 part per million of the stabilizer. The data presented shows that the stabilizers do not transfer to distilled spirits in excess of 1 ppm. Further, transfer testing using the time/temperature conditions of 121.2526(c) correlates with long term testing to equilibrium at 135 5F and that such accelerated testing is practical as a means of evaluating PVC compounds intended for use in distilled spirits packaging and for quality control purposes. BFG04560 20688005