Document qaJ59nR3Rvon05bej44YQZv5j

BFGoodrieh The BFGoodrieh Company 3925 Embassy Parkway Akron. Ohio 44313-1799 May 20, 1991 AO- ff/3( Food and Drug Administration Center for Drugs and Biologies 12420 Parklawn Drive Room 2-14 Rockville, Maryland 20852 Dear Gentlereader: The BFGoodrieh Company wishes to establish a Device Masterfile for Geon 87390 trans 004. Geon is a BFGoodrieh brand name for polyvinyl chloride resins and compounds. I am enclosing two copies of the composition for the above compound which is confidential business information and therefore, *"hot subject to public disclosure under the provision of 21CFR 20.61 and 21CFR 10.111(d). I am also enclosing two copies of a technical data sheet for Geon 87390 trans 004. Any nonclinical laboratory test which may be performed on Geon 87390 trans 004 for, or by BFGoodrieh, will be performed in accordance with current FDA Good Laboratory Practice. Sincerely, THE BFGOODRICH COMPANY Robert K. Hinderer, Ph.D. Manager, Environment, Health and Safety Management Systems 0520-2/jp 22465001 bcc: Mark Hross Dr. George Wilson Masterfile BFG20988 CONFIDENTIAL BUSINESS INFORMATION GEON 87390 TRANS 004 INGREDIENT Polyvinyl chloride (9002--86--2)a WT.% 83.7633 Butadiene/methyl methacrylate/ styrene Copolymer (25053-09-2) 10.0516 Butylacrylate/methyl methacrylate Copolymer (25852-37-3) 1.8428 Paraloid K-175 Acrylic polymer (Rohm & Haas MSDS attached) 0.9214 Tin Stabilizer: 8-oxo-3,5- 1.8428 dithia-4-stannatetra- decanoic acid, 10-ethyl-4, 4-dioctyl-7-oxo-2-ethylhexyl ester [70%] (15571-58-1) and 8--oxo--3,5-dithia-4-stanna- tetradecanoic acid, 10-ethyl [(2-((2-ethylhexyl)oxy]-2- oxoethyl]thio]-4-octyl-7-oxo-, ethyl hexyl ester [30%] (27107-89-7) Epoxidized soybean oil (8013-07-8) 0.3351 C. I. Pigment Violet 15:77007 (12769-96-9) a * CAS NO. 0.0251 21..CfN Prior Sanctioned 178.3790 178.3790 178.3790 178.2650 181.27 178.3970 ,y r-. y 22465002 BFG20989 CONFIDENTIAL BUSINESS INFORMATION QEQM-a?390 TRANS 004 -2- INGREDIENT WT % 21 CFR Masterbatch: 0.0662 Butadiene/methylmethacrylate/styrene copolymer (25053-09-2) [88.5%) Epoxldlzed linseed oil (8016-11-3) [2.7%] Priop^sanctioned /'/>. I- V? Pigment blue 29 (57455-37-5) [8.8%) Glycerol monostearate (31566-31-1) 0.5863 175.300 176.200 1 ' Mixed ester of saturated fatty acids (Henkel MSDS attached) 0.3141 178.3280 178.3690 Oxidized polyethylene (68441-17-8) 0.0838 172.260 175.105 175.125 176.180 176.200 176.2010 177.1200 177.1620 Acrylic polymer (M&T MSDS attached) 0.1675 BFG20990 Features Geon* 87390 is formulated to conform to FDA regulations for food contact substances. This compound exhibits outstanding darttygjass* stability and blush characteristic* and is suppled In petet form In either bags, boxes or buk ral car* Applications Geon* 87390 is used for packages manu factured to FDA gukteftne* such as edible oil* food* cosmetic* and tofletrles or any products requiring packaging to FDA guideflne* Processing Geon*87390 is easily processed at cylnder temperatures between 310F (154C) and 380F (193*C) Die temperatures should be set be tween 350F (177"C) and 380T (193C> Melt temperatures should be between 390F (199*0) and 405F (207C> GEON*87390 Typical Properties PROPERTY TEST METHOD VAUUE General Specific Gravity Hardness Shore D ASTM D-792* ASTMD-2240 133 86 Mechanical Tensfle Yield psi Tensile Modulus Tensie Impact, fttbs/m* bod Impact 0/8") ftJb*/in notched Flexural Strength, psi ASTM D43& ASTMD-63T ASTM DT822f ASTMD-25*; ASTMD-79CP 6,600 365,000 4 75 I i&o 51950 Thermal Deflection Temp *C at 264 psi ' :;.Tfi' sm+ . &tmt* *1 . . v ' Optical Haze (.65 ml plaque) Transmittance % Brabender Data Equfcrtum Torque Stablty Time Mhutes ASTM D-IOOWK ASTMD40O*6f Electrtc Plastograph Na 6 RolerHead190*0 60 Gram Charge 75RPM 68.0 5.0 65.0 1200 30' bi)0S 9P Z Z BFGoodrich Th BFGoocMch Company G*on Vinyl DMdon/6100 Oak Tree Bvd. Cleveland. ONo 44W ;: B^GtopcWch Division ftwHbnnakonoontakikdhMttklMlMdtobktelaMBbutnoi^i--eakBmguanrt--cmimrtliiof anrMndannndk<BtoliaocuQOkarittByferp takernpptonUnraat--widteto bectrickudk--torn. 1h Hbtmakonk bated on tabanlay wall rik> analcate teMmnt art do not nkbteukirlndoateand paduct prirtbtmorck Ikaauw o* la vaMtaro kt mlhcA<rekOTandqu>iterriutedcamitectoAr WOuudAlfi iltelri uueuMhkaUMIMMimNOWMthpnc--togftete mntedrA nowanrkteorguacrt-- OMmSSMBKORMUnNCUIlMBaKNCf IMISD an mad* m to Nm n*aMhr at th product! to f m>C>MB>WMMNniOFMBaMMWUiyAND (rfdonkcndroTOrikAftAKtririteilkig end rind product nNMfOtAMnOMIIMMllNaMigconMnkd proferanokaMiwponfcayaruNtireosdlelt Mrohktobke*nMltetfapiMonrocon>mndaBn rote not b* kTOte tor and tt oteomro oteonte <i ite ncr a^Muoronat#topadkteanr pateftedteMtv and >TOvaa^teCTht*Tgatary rnuterinlbtebnrt anrthautpcteMona(ttropaMaM*i Printed In USA. BFG20991 Mach WW EEOP RACK ------------- COMI Next to your product there's nothing better. GEON*87390 FDA Status Geon87390 is an octyl tin stabilized FDA acceptable compound for use in food contact application! Geon87390 is composed of ingredients which meet the current requirements of the FDA for use In food contact applications when used in a manner consistent with Regulations 1782660 and 178.3790,21CFR. The Ingredents of Geon87390 are either listed on the following as ap plicable for FDA regulation! or are generally recognized as safe (GRAS), or have prior sanction for such use Octyl tin stabilized polyvinyl chloride compounds are permitted for use in contact with food type! I. H. ML IV (except Iquid mUk> V, VI (except malt beverages and carbonated non alcoholic beverages), VII, VIII and IX as described In Table T of 21CFR 176.170. The testing that has been performed on the compound In accordance with 178.3790 resulted In extractives wel below the limitations imposed by this regulation for use conditions D. E, F and G as described In Table 2 2TCFR 176.170. The final food contact article must meet the extractive limitations imposed by Regulations 1782650 and 1782790. / 22465005 BFGoodrich BFGoodrich Company Goon Vinyl 0lvWon/61OO Oak Tkm Btvd, Ctovetanct ONo 4413* KFGoodrich Geon Vnyl Division ThaHBnnallanocntalnKlhtnlnkbdawKltobawlab** but no npnaii adnna poor--a or vatartlm cl any Ik'd an mada a to to accurocyi idtaMly tor dokodor applanknraor kwaadi lobaotaaialkaaaun. ThoMcarnallonkbcaadcnldBoracrywortiwkhima*cPaaqukJmortcnddoatnotnacaacifyhcfcataand poduct poriPmanca Sacouta at tit* variakora In PlMadlnUSA moltadcoKinoraandaqulsranluMdcamMdQlr hpuuaa>nlt-- mgtalranowu'kPP|juuidd aw mod* at to Itw ndabay of *< pnduck ttartha npdmkonckclMad.fdaaJalHigandindpndMrt piamanoaklhiiiyaWvoti>--WCuuJkLli did not ba laMa tor aid Itia cudomw oum et d* and labPy atany laaptandkigafany malaWbayend NaocMclft dadcental 1ha9BllMMKES NO MMt MMBBMWCRMUQNCUCM&IUTNOriMIED IQ 1W MUBD WMMMNIBOF kBCHANTASUtV At HTtCHran A MRICULMt WOtt. NatrinQ cordodiad t--kiktebaudddnJoipitakdotviaoonynaidPlen noratonhduoamadlopiDedeadny potakadtuoo Hon aktiaut parmkdon ot k potart ana MachlW BFG20992