Document gQ9rvv2O86VLKneL9xEbYeoJ

BFGoodrich The BFGoodrich Company 3925 Embassy Partway Akron. Ohio 44313-1799 October 28, 1991 Hr. Julius Smith Indirect Additives Branch Division of Food and Color Additives Center for Food Safety and Applied Nutrition Food and Drug Administration 200 C Street, W. Washington, D.C. 20204 Dear Mr. Smith: Our customer, Becton-Dickinson, has asked us to provide a copy of our confidential recipe for our product E-10 which is being considered for use in vinyl gloves. I am enclosing two copies of the composition for the above PVC resin which is confidential business information and therefore, not subject to public disclosure under the provisions of 21CFR 20.61 and 21CFR 10.111(d). As described in the attached document, all of the ingredients function solely in the manufacture of this resin. Please call me at (216) 374-4534, if you need any further information. Sincerely, THE BFGOODRICH COMPANY Robert K. Hinderer, Ph.D. Manager, Health and Toxicology Environment, Health and Safety Management Systems 1022-1/jp Enclosures bcc: Dave Poledna BFG16544 21796001 THE BFGOOPRICH COMPANY CONFIDENTIAL COMPOSITION OF E-10 Ingredient: Vinyl Chloride Witcolate 4151 Lauryl/Stearyl Alcohol Di-Octyl Adipate Polyethylene glycol-600 MW Drew L-140 , rp)-j' Di-2-ethylhexylperoxydicarbonate (EHP) (CAS. No. 16111-62-9) r Alpha Cumyl Peroxyneodeconite ^ ' " (ACPND) (CAS. No. 26748-47-0) - Diisobutyl Peroxide , v (IBP) (CAS. NO. 3437-84-1) Weight % 96.8 0.6 0.3 0.1 0.2 0.04 0.04 0.03 Geon E-10 polyvinyl chloride resin is a water polymerized homopolymer made from vinyl chloride monomer. The ingredients used, such as dispersants and their levels, based on 100 parts monomer are: ohm 100 1.5 0.70 Vinyl Chloride Witco 4151 L/S Alcohol 0.40 0.20 di-octyl adipate Carbowax 600 0.30 Drew L-140 EHP ACPND IBP (The polymerization is exothermic. Due to changes in temperature caused by the different seasons, various combinations of the initiators, EHP, ACPND and IBP are used. A total of less than 0.1 phm total are used.) 2179600Z BFG16545 THE BFGOODRICH COMPANY CONFIDENTIAL COMPOSITION OF E-10 2- - The above ingredients are added to a premix vessel along with 100 to 200 parts of demineralized water, homogenized and pumped to a reactor where the polymerization is started by raising the but may be adjusted up or down several degrees to provide the needed end properties in the resin such as tensile strength. The reaction times vary from 6 to 10 hours with yields from 65 to 85% The reactions are carried out in 4300 gallon stainless steel or glass lined vessels. After the polymerization is completed, unreacted monomer is stripped from the resin. Current manufacturing regulations call for a maximum residual vinyl chloride monomer content of < 8 ppm in the resin when shipped. Residual monomer levels will be reduced further during subsequent storage and processing. Resin is separated from the water phase by spray drying. It is packaged by automatic equipment and shipped predominately in multi wall paper bags. All process equipment is made of stainless steel. Contamination with other materials does not occur because the equipment is used solely to manufacture poly vinyl chloride resin. All product testing is done according to ASTM D 1755. Supervision of the process and testing is under the direction of graduate chemical engineers and chemists. Robert K. Hinderer, Ph.D. Manager, Health and Toxicology Date: 10/28/91 Z1796003 BFG16546