Document 0g8E330Bp168ZZGkqzOk7RYex

- lIFGoodrich INTER-ORGANIZATION CORRESPONDENCE TO FROM SUBJECT R.K. Hinderer Dave Poledna FIELD POINT OR DEPT. 8c BLDG. NO BATH/0020 FIELD POINT OR DEPT & BLDG NO ALTC/5057 DATE YOUR LETTER SEP 7 R mm__________ ~ 'wv'1 DATE THIS LETTER 9/24/91 E-10 RECIPE FOR SUBMISSION TO FDA We are in the process of developing a recipe for use in vinyl gloves acceptable under 21 CFR177.2600. The customer is Becton-Dickinson. The recipe is based on our current Geon 121X10 recipe. Based on the opinions of W.C. Bachtel1,2 initially, and you3, Geon 121X10 cannot be represented as being FDA acceptable. The recipe was modified so that the product would be acceptable under the previously mentioned paragraph of the Code Of Federal Regulations. From the stand point of manufacturing the product, it would be good to have some recipe flexibility. I propose that we list ingredient maximum levels in our letter to the FDA. The following would be reasonable maximums, assuming of course, that we do not exceed an allowable resin extract requirement. PROPOSED PHM P r l 1.50 Witco 4151 (proprietary surfactant blend) ^ r L* ' 0.70 L/S Alcohol blend ^ ^!Q 0<?$ < : <70 9 -' 0.40 Di octyl adipate ^ 1 0.20 polyethylene glycol 600 molecular weight (Qarbowax 600) 0.30 Drew L140 (proprietary defoamer blend) ^ k- We should retain thejlexibility to use diisobutyryl peroxide (IBP) in combination with either or both CJJHPj and^ACPNDTkThe IBP is a very fast initiator and would be beneficial for productivity, if we cairtfeep it from decomposing in the premix and starting polymerization prematurely. P 5 ,, ul. '"7C0 d.t c ? r ftJf f/[tPfOO) v Similarly, we might like to be able to use an FDA acceptable defoamer to improve performance during stripping. We are currently evaluating the effect of defoamer added after polymerization, but before recovery on the amount of foam carried over and on residual vinyl chloride monomer (RVCM) levels in the slurry. / 1} -------------------------------------------------- <+10% 1BFG IOC "GEQN121X10 - ABEX 33S" by W.C. Bachtel 4/9/87 2BFG IOC "GEON 121X110 - FDA STATUS" by W.C. Bachtel 10/?6/86 S10 ^ i 3Personal Communication from R.K. Hinderer to Dave Poledna "GEON 121X10/FDA 21CFR 177.2600" 6/21/91 E10_RECIPE_FDA_RKH_9-91 BFG-4966F 11/80 UTmq in US A BFGl 6547 21797001 Attached are claims from Witco (4151), Monsanto (DOA) and Drew (Drew L-140) that their products meet the requirements of 21 CFR177.2600, as well as copies of letters sent to Witco and Drew asking them to disclose the structures of their products to FDA. Witco and Drew are in the same situation as we are. They do not want to disclose the nature of thenproducts to their customers. We will need to coordinate the submission of all these documents to FDA so that we may obtain a timely response. Please note, in the letter from the Witco Governmental Regulations Manager, he referred to the product as Emcol 4151. The correct name is Witcolate 4151. Thank you for your help. If I can be of any assistance, please call. DJP:avk cc: Ashok Shah Walt Edwards Joel Simmons Ralph Purtell A1 Matyger Access File # 9283 21797002 E10 RECIPE FDA RKH 9-91 BFG16548 Witco Organics Division Witco Corporation, 3200 Brookfield Street, Houston, Texas 77045 Telephone 713-433-7281 April 23, 1990 Mr. David Poledna B. F. Goodrich P. O. Box 122 Avon Lakes, OH 44012 Subject: Witco's product, Emcol 4151 Dear Mr. Poledna: X am responding to your request for the FDA status of Witco's product, Emcol 4151. Witco's product, -Emcol 4151, meets the requirements of Title 21 CFR 177.2600. If you have any questions, please contact me. Sincerely, CRG:olb pv 0- .t BFG16549 21797003 Low temperature plasticizer for PVC resins and synthetic rubbers Publication No. 1539 C 0 C8H,, (CH2)4 c-o-c8h17 General Description DOA is a high quality plasticizer for imparting low-temperature flexibility to polyvinyl chloride and synthetic rubber compositions. In polyvinyl chloride and synthetic rubber, DOA imparts a degree of softness, hand, and good heat and light stability. It offers good processing performance despite being a lowtemperature plasticizer. DOA is a recommended plasticizer for films requiring good low temperature properties such as those used for food wrap. In vinyl dispersions, DOA makes formulations that have good flow properties because of low initial viscosity. The viscosity does not build up greatly during storage, nor do the dis persions significantly increase in viscosity on exposure to high speed mixing (dilatency) or rapid spreading equipment. The high yield value of DOA aids in making no-sag spray coatings or no-drip plastisol dip coatings. DOA is compatible and contributes a valuable plasticizing effect to nitrocellulose, ethyl cellulose, vinyl copolymers, and chlorinated rubbers. It is also useful in plastizing polyvinyl butyral, cellulose acetate-butyrate, polystyrene, and dammar wax. In applications where the general performance provided by DOA is sought, even better low temperature flexibility and lower volatility performance can be obtained with the com panion adipate ester, Santicizer 97 plasticizer. Toxicity & Handling Based upon toxicity studies, DOA has a low order of toxicity and does not require special handling. Handle in accordance with good industrial hygiene and safety practices. These practices include avoiding unnecessary exposure and removal of the material from eyes, skin and clothing. Complete toxicity and handling information can be found on the Material Safety Data Sheet which is available upon request. DOA complies with Food and Drug Administration regula tions for use in food packaging matficjalsj&Sections 175.105, 175.300, 177.1200, 177.1210.(j77.266d> and 178.3740 of the 21 Code of Federal Regulations. It also complies with U.S. Department of Agriculture regulations for use as an acceptable component of packaging materials in contact with meat or poultry food products prepared under Federal inspection. Properties Molecular Weight Acidity (meq/100 gm. max) Appearance Color (APHA) [max.] Moisture (KF in Methanol) %, max. Odor Refractive Index (@25C) Specific Gravity (25/25C) Density (@ 25C) ca. lbs./gal. Crystallizing Point (C) Pour Point (C) Boiling Point @ 10mm Hg, C Vapor Pressure (mm Hg) @ 200C @ 250C Viscosity (Centistokes) @ 37.8C @ 98.9C Surface Tension @ 20C (dynes/cm) Thermal Expansion Coefficient @10-40C (cc/ccC) Flash Point (C.O.C.) [F.] Fire Point (C.O.C.) (F.) Solubility In Water @ 25C,% CAS Number Specification 371 0.25 Clear, oily liquid 25 0.10 Mild 1.444-1.448 0.921-0.927 7.72 <-70 -65 224 2.3 32 8.2 2.4 29 0.00078 377 450 <0.01 103-23-1 Registered Trademark of Monsanto Company BpG 16550 IS) <1 to 3 2 MEMORANDUM TO: FROM: E. Antonucci Vivienne Gaudette SUBJECT: DREWPLUS L-140 - FDA DATE: July 24, 1991 CC: J. Baron T. Brennan R. Stangs, A. Chron Romano Ed As requested by G. Tirpak on 7/17/91 (attachment 1) the subject product was reviewed (R. Stangs) for FDA acceptability (177.2600) - rubber art icles intended for repeated use, and found to be acceptable. However, referring to T. Brennan's attached memo, (attachment 2) I noticed that the customer has concluded that 177.2600 includes use in flexible medical gloves. I do not see any reference to this application in the regulations. (attachment 3). i Regards VG:nvd attachment Vivienne 21797005 BFG16551