Document x5X9mVNJBZe3E6D7VVzDk0G3m

AR226-2377 X-** RC*. t-73 CC: R . J... DAHLEN . l_ TATE . BMUJMBm E. I. du Pont de N emours & C ompany SHERMAN. - CRSD - HASKELL " PF&H DEPARTMENT B _ X_f;FILERS . WILMINGTON. Delaware 1 9 & E n t s r e g u l a t o r y ' V^i RN'ANTHJKKRISH-HAN - FSF - a f f a ir s d ivisio n -:.UKBSHAHL LAB , LAB FLASTIC PRODUCTS AND RESINS DEPARTM ENT' Auo tnTC - <s iyD J _ . K w JLRUTSH-QRN - F&F - J ^ E.-0a8. - FSF - WINNEWOOD B.D. E.L. H-C. P .B . A.D. XP. P.V. V-N. JJ. P --P-r-TAWigR. -- ,WASJLINGTOH WORKS :w j:y23.x x d s o w SSL3GSBZICFXELD :zi- orali) 3xrr- is76 C. K. IKEDA PSP DEPARTMEHT B-2266 In our meeting- on; June 11. we; .agreedt t_hat=-ii-wani.Tfc -conduct Section 121.2555 specificatzimr. t e s t s o i l siirtered T^fz nradsr fmar. hiyh solids dispersion and on finished PEP: made: wi th C^rinarpersartgr. agent. We have completed, jthese.' tests- as- ftssi7-- as 3 =Z.im tfessrstests specified in 121.2555 end f i n i that hot* the XE .Che EE-P ana. well Within the limits specified. ..X- icnow. of- nzcsterrh.n ttssIs ccs ason whg finished products made f r o a thisse. resins, ycmid nrrfcrarcmforrsc. with 121.2555. .The level of extxactaMes= q k siarteriSJ -JlfSi nraden frenr. high solids TD-37X was as follows: Solvent a ) Total Ejcfcraestai tas ...mg/in2 fjl ` --'-R'gh-/-a cted .saEirsorrda ...mg/in2 Heptane 0.072 ~ " . Ethyl Acetate 0.105 ---- 50% Ethanol 0 .039 . . I B u D 0019 Water 0.12 ; . J . XU00012 All solvents were distilled. . (2) Corrected for solvent blank. PDJL mazimiim. adsL&wablzn-exJzxactables is 0.2. (3) poA maximum allowable fluoride is 0.03. RJZ026694 EID942018 C. JC. IKEDA 2 July 30, 1976 The thermal Instability index for TD-37X high solids sintered product as determined by ASTM D14S7-S6T was 20.4, well below the maxi mum specified 7alue o 50. Tlie FEP cubes produced from the added C-S recipe had the following level of extractables (duplicate determinations) : Solvent Total(2) Extractables, mg/in^ Sxtracted(3) Fluoride, mg/in Heptane 0.054/0.031 -- Ethyl Acetate 50% Ethanol Water 0.018/0.026 0.059/0.11 0.064/0.059 '-- 0.00055/0.001 0.00062/0.00064 All solvents were distilled. (2} Corrected for solvent blank. FDA maximum allowable extractables is 0.2. (3) -PA maximum allowable fluoride is 0.0 3. The melt viscosity of the FEP changed from 3.77 after five minutes holdup to 7.77 after 30 minutes holdup at 372 C. This is a 12% change. The FDA maximum allowable change is 50%. The infrared index requirement is also satisfied. These data confirm that the minor changes being made in our processes have no effect upon the ability of these products to be converted into finished, products which meet all the requirements of FDA regulation 121.2555. RJZ026695 BM/epr B. MOliCURE RESEARCH m a n a g e r ' fluorocarbons division . EID942019