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AR226-2377 X-** HCT. It-73 CC; BZ--2SSD - E. 1. DU FONT DE NEMOURS S COMPANY "---------- pp&a DEPARTMENT . WtLMlNGTON. DELAWARE 19^-ENTs a REGULATORY. AFFAIRS DIVISION W-ASTIC PRODUCTS AND RESINS DEPARTMENTA.U3 21976 - . R. J... DAHLEN .. 2,..- ra're 4^e"aM^g^j.^.j-^ift.-j^>-a^a 0^ SffERHAIf. - I^RSD - SJISKELL 3 _ ^^.^i-Z^LBRS V-^. SifAtSTU.KKRISH-flAtI - F SF - -:MBSStLA.iX. LAB 3 ^.EL~^ ajiKT.SS-QRtt - F&F - -Mft-ggH-ay.T. LAB LAB B.D. <tM& E.L. P.B. H-C. A.DV.N. HJ. J.P. -" - P.V.. J ~. ^ --- LOSS.. - FSF - HyiltrEWOOD . P^ SC.-s.-KISt-WE-R. --.f/asa-CWGTOM WORKS . Jf^.'R.^^Ei.VIDSOll ... .R_ A.. ^i-a3!^CrXD : J.:JK -.-- -P5. - h'VSittSWOOD C. K. IKEDA PSF DEPARTMENT B-2266 -Sill} 33'^ 1976 Section la our 221.2555 meet-ing' on:- .Tune IJ.- was self cs&chi t-haafc-i^.j/carfafcxmmduct speciicataza tests; ore: -sisAejc&d aa'= araaie- mar. high solids dispersion aad on -f-iLir-ishj&d FfiJ?; marfE: w-i bh C^-^^kLsaa-exaaLag-.-a^ent. We have completed j:he-ss.~ te-s-ts-as-Kasiio-a-s s'i': xiLlnsm-sbests specified in 121.2555 and f-inji-tha. boish C-hs 1.EE -soal .Qie PE-P .ace. well within, the limits specifie.d. .-J- kziow. of~ jrjgi^-eT-^mj'-r-yJsarsason (/hy finished products Blade from- .the^f ce s-n^- ygirijJ rtrrfc-3srz3i-a:r3ic. WAtA 122.2555. .The 2eve2 o^ exi abless rnT .TT tt.te.cs3 Efe= nraaie^ AaMin hi?a solids TD-37X was as follows: Solvent (1) Total (2) E.. able-s ...icv/in2 cactedf3; jrnie ,- .'ay/in2 .Heptane J3.072 Sthyl Acetate 50% Bthanol Water . 0.205 ..0.039 --0.22 S .Si.DOOJ-9 gto 00\\ SUD0012 VO -t^ (1) All solvents were ciist-illed. (2) Corrected for solvent blanks FDA- jnaxiauuit. aaLLai/abJs^- e.y.t'rTixsta.bles is 0.2. (3) FDA maximum allowable fluoride is 0.03. EID942018 C. 1C. XKSDA 2 - July 30, 1976 The thermal instability index for TD-37X high solids sintered product as determined by ASTM D1457-56T was 20.4, well below the maxi mum specified value of 50. The FEP cubes produced froa the added C-3 recipe had the .following .level of extractables (duplicate determinations) : So^vent^^ Total (2) Extractables, nig/in2 extracted^3) Fluoride, mg/in2 Heptane 0.054/0.031 Bthul Acetate SO* Sthanol 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. Corrected ror solvent blank. FDA is 0.2. FDA .maximum allowable jfluoride is maxiniuffl 0.03. allowable extractables minutes The melt viscosity holdup to 7.77 arter of 30 the FEP Minutes changed from 8.77 holdup at 372"C. after five This is a 12X chang-e. The PDA maxiaun allowable change is 50%. The infrared index requirement is also satis-fied. These data confirm processes have no effect that upon the the minor chanyes being- inade in ability or these products to be our converted into finished, products which meet all the .t-eguirements of PDA regulation 121.2555. BM/epr > ;.^; //..-;' ; ~. B. IfOtfCURE RESEARCH MANAGER FI.UOROCARBONS DIVISION o 0 cr> CT> \m o EID942019