Document oDx5o4Rk8Q5mVKDa86M2BNOO3

October 16, 1991 Dave Polenda SUBJECT: E--10 (BASED ON GEON 121X10^ As we discussed on 10/10/91, the proposed recipe (attached) for E-10 (based on Geon 121X10) would meet the guidelines stated in my letter of 6/21/91. However, since it cannot meet the current Good Manufacturing Practice (GMP) maximum volatility requirement of 3.0%, it does not meet the requirements necessary to claim prior sanctioned status. Still, resins made with this recipe would be acceptable under 177.2600, since the DOA level is well within the 30% limit for this ingredient. Bob Hinderer 1016-7/jp fi... BFG16570 r /OCl 11 '91 8 : 4 PAGE.001 DR. ROBERT HINDERER The e--10 recipe: PROPOSED-BBCJEE MA RUN 10/10/91 100 1.5 0.70 Vinyl Chloride P.s 100 witco 4151 1.1\mnuoo L/S Alcohol 0.65 I^S. ?,o0 . . 40 0.20 di-octyl adipate >/ 0.3 Carbowax 600 ^ 0.1 0.30 Drew L-140 0.046 EHP 0.0 0.046 0.05 0.04 IBP 3.236 Ql^0 \ TOTAL 0.05 2.246 (6611) (soap, surfactant) blend of lauryl, myristyl, cetyl, stearyl alcohols (GRW 33N is suppliers name for material) (BFG code 710075) part of soap system polyethylene glycol-600 molecular weight, peg 600, anti- stat defoamer di-2-ethylhexyl peroxydicarbonate, (BFG code G135) (initiator)^' TU. \ c-.> 11- i-t n a lph -'-cumy 1 -peroxyneodecanoate, (B: code G52)(initiator) dii butryl peroxide(initiator) (no BFG code yet, TSCA approved)(CAS 3437-84-1) The proposed recipe levels are what the plant has tentatively agreed to. The actual recipe we ran (HA) had less extractibles. Since we only ran 100,000# the plant wanted to maintain some flexibility i.n the recipe in case there was some polymerimtion instability. Connie Dillon as 1 whether I could agree to an IV and an extractibles spec, rcation. I can agree to the IV part easily since we will be at 1.35. I can't do so with the extracts. Our plant data for 6 hours cold methanol says we bounce from 2.7 t.o 3.3% extracts based on the recipe. They recently went from l.i ick to l.5phui soap. A+ the lower levels we were usually under :>%, e -t-racts. he uigher levels we were over 3% extracts. Since th jlant he <de so little of this new product and they have been for-.ed *' alter r 121x10 recipe to w,eet B&D's property requirements the} ere reluctant to agree to lower soap system levels. That's v : we proposed the higher levels. What are our options ? 21804002 OJP'KIO FDA RECIPE BFG16571