Document NE1pewvpQygXeN0YbwkRQm94Q

BFGoodrich The BFGoodrich Company Specialty Polymers & Chemicals Division 9911 Brecksville Road Cleveland, Ohio 44141-3247 216-447-5000 Specialty Polymers & Chemicals Division May 25, 1993 Rebecca Colino Additives Toxicology Group NSF International (NSF) P.O. Box 130140 Ann Arbor, MI 48113-0140 Dear Ms. Colino: Enclosed please find a completed TDRS-B form for Geon Resin 110X500. The composition of Geon Resin 110X500 is confidential to BFGoodrich and therefore subject to the generic secrecy agreement signed by BFGoodrich and the National Sanitation International, October 24, 1979. Sincerely, THE BFGOODRICH COMPANY Regulatory and Data System Specialist CND/jp Enclosure 21709001 bcc: J. C. Kelley/Doug Wetzig - CL-OTM-2 BFG16184 I BFGoodrich The BFGoodrich Company Specialty Polymers & Chemicals Division 9911 Brecksville Road Cleveland, Ohio 44141-3247 216-447-5000 Specialty Polymers & Chemicals Division May 25, 1993 Rebecca Colino Additives Toxicology Group NSF International (NSF) P.O. Box 130140 Ann Arbor, MI 48113-0140 Dear Ms. Colino: Enclosed please find a completed TDRS-B form for Geon Resin 110X500. The composition of Geon Resin 110X500 is confidential to BFGoodrich and therefore subject to the generic secrecy agreement signed by BFGoodrich and the National Sanitation International, October 24, 1979. Sincerely, THE BFGOODRICH COMPANY Regulatory and Data System Specialist CND/jp Enclosure Z00G 01TZ BFG16185 Initial if NSF Std. 60/61-Listed i NSF USE ONLY [ Document Control Code: Supplier Co. No. 10810 Accepted By ___ ] IA02471-005 TOXICOLOGY DATA REVIEW- SUBMISSION - FORM NSF International (NSF) STANDARD 60/61: DRINKING WATER SYSTEM COMPONENTS (CONFIDENTIAL INFORMATION) FOR ASSISTANCE: 1-800-252-6010 From 9am to 4pm Eastern Time 1 TO BE COMPLETED BY INGREDIENT SUPPLIER, unless the ingredient ifl currently Certified: lender NSF Standard 60 or 61 or has preliminary acceptance by NSF. (See InstructionB fiefore Completing) . Please return form within 30 days or call for assistance. I. IDENTIFICATION INFORMATION Company name B.F. GOODRICH GOn CO. Company contact JOSSpfr. KGllGV, JlT Address _______6100 Qafc TlTGG Blvd. Telephone Number: ( 216 ) 447--6567 Cleveland, Ohio 44131________ fax Number (216) 447-6262_____ Plant name Address Plant contact______________ TelephonexNumber ( iiEAX Number ( ) ) 1. Name of chemical or material (use acceptable chemical nomenclature) 2. Trade Designation ,:;GfiON 110X50$: Please specify othez names tinder which you market this product FVC 110X500 3. Structural formula, if applicable"(Note: C7Hi24 i NOT structural) 2170 >03 4 Chemical Abstracts Services (CAS) number (if applicable) 9002-86-2 1 of 5 BFG16186 04/05/91 Std60/61B i III. PRODUCTION AND CHEMICAL INFORMATION 1. Is the product__ manufactured or____mined? a. If mined, is it purified? YES___ NO____ If YES, how?___________________________________________________ Is It ground or mixed to a homogeneous mixture YES___ NO___ b. If manufactured or synthesized, provide the following: Please provide separate attachments as necessary. Manufactured: 1. Process description_______________________________________ 2. Literature and/or patent reference for synthesis method______ Synthesized: 1. Recognized name of synthesis:________________ 2. Literature and/or patent reference for synthesis method:. 3. Purification procedure................................................................................................................ w 4. Provide the analytical procedure for the analysis of your product Provide either a literature reference or a written procedure______________________________________ ______________ _ 5. Molecular weight (molecular weight distribution for polymers! ______________ _ 6. Itemize the reaction products of initiators, stabilizers, and catalysts used in the manufacture or synthesis of your product. a___ Product is handled/bagged by a single use (dedicated) system. ___ Product is handled/bagged by a multiple use(non-dedteated) system. If multiple products are handled, show other products handled by the system: 2. What is the specified purity range (if applicable)? m 3. Itemize below, known or suspected impurities in the product including, but not limited to, unreacted starting materials, by-products, low molecular weight polymers, etc. If available, provide literature reference(s) or written procedure(s) for the identification of Impurities in your product and starting materials. Chemical Name____________ CAS# ____ Analytical Method 21709004 BFG16187 3 civ3/vTDR-B-PM3 3. A toxicology literature search provided by your company may expedite the toxicology review and minimize costs to the applicant for obtaining toxicology data. For each literature search appended to this form, itemize as described below: Database File# Keywords Date (Check if no literature search has been, or will be, conducted by your Company.) VI. ATTACHMENTS AND SIGNATURE List Attachments to this formNo. of pages. I hereby certify that the information provided is accurate and complete, and that:!, and the Company I represent, know of no reason the product described herein should not be used in the Applicant's product which is used in contact with drinking water. QtTMUA-J~fi AjJuUr*_____ X Signature. Date 05/26/93 Typed or printed name__ Connie N. Dillon Positionmtle_Regulatory and Data Svafefem Specialist Company_______________ The HFGondncfr Crrnpany/The fimn Company. Phone 216/447-5182 .Telex. FAX 216/447-5710 The following authorization is OPTIONAL, fun no way authorizes NSF to share the Information with other Applicants. Authorized NSF staff ONLY wi be allowed access to this information. By completing this authorization, this Form B may be used to support the referencedingredient/material/product as part of another applicant's package. I give NSF permission to use the information contained in this TDRS Form B as a basis for reviewing/accepting other products which use thesreferenced ingredient/material/product covered by this form. Optional Authorization. WHERETO MAIL? Insert the completed form In an envelope marked 'CONFIDENTIAL BUSINESS INFORMATION,* seal in an outer envelope, and return to: VIA U.S. MAIL: VIA COURIER SERVICE: Additives Toxicology Group NSF International (NSF) PO Box 130140 Ann Arbor. Ml 48113-0140 Additives Toxicology Group NSF International (NSF) 3475 Plymouth Road Ann Arbor, Ml 48105 BfG16188 Copyright 1991 NSF All Rights Reserved cavS/k/TDRS-BJPM3 2170cJOS Permission to Use TDRS Form Information For Multiple Applicants To be completed when a TDRS form for a particular product has previously been submitted to NSF International (NSF) and that information is authorized for use with other applicants). Dear NSF: Our company,, previously submitted a TDRS form for our product __under the Document Control Code (found in the upper right hand comer of the original submission): Permission for NSF to use the above-referenced TDRS form, accompanying information, and appended toxicology data is now given for the following applicant(s) to the NSF's Drinking Water Additives Program. All applicants _______Only the following company Company Name: Document Control Code (found in the upper right hand comer of the requested submission): _____________ ;_______ ____________ I understand that the files will remain confidential and closed to all, but NSF authorized personnel, according to NSF Confidential Information Security Procedures. Name___________________________ 3 Signature* ______ m__________________________________________ Company (Ingredient Supplier) Telephone Number _________zDate 21709006 `Signature must be notarized: Subscribed and sworn to before me this ______________ day of, 19.. Notary Public My Commission Expires: Copyright 1991 NSF All Rights Reserved BFG16189 c*v/^OPT61-PM3 05/2-J--93 11:41.1 Q^lS 447 6262 GEUN TECH SVC 0 UU2 SPECIAL PURI )' A , _?/4 General Description Type Polymerization Process Appearance Polyvinyl Chloride Hom< Suspension White, tree flowing pow< 'h)C-rJ X ??3f ^ Features & Uses This resin is especially designed for application requiring low gels and contamination Blood bags Clear film & sheet Clear medical or food grade tubing Molded medical devices Extra low extractables for critical medical applications Typical Properties A5TM Classification Specific Gravity Inherent Viscosity Specific Viscosity Relative Viscosity "K" Value Heat Loss, % (maximum) Particle Si2e % thru 40 mesh % thru 200 mesh Flow Time Apparent Bulk Density gfcc Pounds/Cubic Ft. Powder Mix Time Fisheyes Contamination Syntron Clarity Porosity cc/gram GP-5-15353 1.4 1.06 1.47 2.47 72 0.3 100 3 18 .48 30 260 V. 1` 2/0 Excellent .37 Test Procedures ASTM-D-1243 1% Cyclohexanone 30C 1% Cyclohexanone 30C 1% Cyclohexanone 30C BFG 793-F BFG 812-G BFG 692-E ASTM-1895 BFG 488-H BFG 1233T HOM-1-12-2 O 0\ \o O /LyLA BFG 1094A ^ BFGoodrich The BFGoodrich Company, Geon Vinyl DMslon/6100 Oak Tree Blvd., Cleveland. Ohio 44131 PGoodrich Geon Vinyl Division Th intOOTiilhaft contained hgrom It MliwwJ to tw f&liablo, but aq rgpratmwlone. guerAMMBorwsmtniic; d my kJflO t* ffifidC ts tfi rt accuracy, .'.utausllfty hy particular hpfltaltont at ih r*5t>$ Id ba opia.nad Itonft&m Tha rnformct ch la DASfrd OA laboratory rti wnth fmpll-oCCile *guiprnn( tnd ooci not npcgMflflly indicate and produCi porformanot, Ba&ausa of the variations in mothers, C'Oh- dlllona and equipment UfieO OOmmeroaJly in procaaing thM material**. ftd wAtrantias Of are made os to the suitability of the product* for the application dis- ctoood- fvfl-SCflta tatting arid end product p*nomwL/'ue ore (he re$pone<Hiity of the user 6PCooancn er.au not bo hopio for and the cvSVjmef tMuittti 4JI nsK and Hib'lTy 01 any ute 0< handling of any material beyond EFGoodnen'. drreei contcof Tn SELLER MAK$ NO WARRANTIES. EXPRESS OR IMPLIED, INCLUDING. BUT NOT LIMITED to. the implied warranties of merchantability ANO FiTnESS FOR a PARTICULARPURPOSE. Nothing contained herein >s to be cortaidarod as permission, teeommendJtion. nor as an inducement to practice Any pateriteo invention without permiaaion of (ho patent owner j l j | Printed In IJS A. FefwtJAxv lean z n n firv .jy . U5- 2493 Georf 441x500 FG SPECIAL PURPOSE RESIN General Description Type Polymerization Process Appearance Polyvinyl Chloride Homopolymer Resin Suspension White, free flowing powder Features & Uses This resin is especially designed for applications requiring low gels and contamination. Blood bags Clear film & sheet Clear medical or food grade tubing Molded medical devices Extra low extractables for critical medical applications Typical Properties ASTM Classification Specific Gravity Inherent Viscosity Specific Viscosity Relative Viscosity "K" Value Heat Loss, % (maximum) Particle Size % thru 40 mesh % thru 200 mesh Flow Time Apparent Bulk Density, g/cc Pounds/Cubic Ft. Powder Mix Time Fisheyes Contamination Syntron Clarity Porosity cc/gram G P-5-15353 1.4 1.06 1.47 2.47 72 0.3 100 3 18 .48 30 260 r, r 210 Excellent .37 ' Test Procedures ASTM-D-1243 1 % Cyclohexanone @ 30C 1 % Cyclohexanone @ 30C 1 % Cyclohexanone 30C BFG 793-F BFG 812-G BFG 692-E ASTM-1895 BFG488 H BFG 1233 T HOM-1-12-2 BFG-1094A BFGoodrich The BFGoodrich Company, Geon Vinyl DivialorweiOU Oak Tree Blvd., Cleveland. Ohio 44i3i H^Goodrich Geon Vinyl Divisor. Tnr nvormatigm contained norein a beii<tvj to be re liable. dot no fepfeaent.ition*. gurant*es or warrannas ot ny kino 4r* mode as to Ili accuracy, aUiLtbrfny tor pan.cvla' applications or the results to De ubuinofl tnareirom lru Inlosmajion $* boxed on laboratory won nun smail-SCSle equipment inn qm$ not necetaartfy md'daia end product pvtfotmanod Sccauftp ot the vorjnriortt in mothooa. ton- Oltiona ana eOJipmenl u$W commercially in prpceeilnp thexo materials, rto warranties or guarantee* are made od to WO Huri.ih.hly 01 Iho p'OOuClu I' me applie.iHon fliaclosod Pyti-ecale mating and end product performance arc tnc responsibility outwoict.BFGooorcr.Bhall not bo UftDItr lot and me customer assumes all nek and liaolFly Ol arty uf.o or handling ot any materia! beynno BFGoodrich's direct Comro!. Tne SELLER MAKES NO WARRANTIES, EXPRESS OR IMPLIED. INCLUDING. GUT NOT LIMITED TO. THE JMPlJEO WARRANTIES op MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Nothing contained herein is to bo considered as permis'-iOi*. |*cOffimcndatlofl, nor ao an inducement to practice iny patenteg invention w.dtout po'mliiiOn 01 me paierit owner Printed m li S a Fcoruarv 21709008 SPECIAL PURPOSE RESIN General Description Type Polymerization Process Appearance Polyvinyl Chloride Homopolymer Resin Suspension White, free flowing powder Features & Uses This resin is designed for applications requiring good physical properties. Wire and cable applications General flexible compounds Calendering Typical Properties ASTM Classification Specific Gravity Inherent Viscosity Specific Viscosity Relative Viscosity "K" Value Heat Loss, % (maximum) Particle Size % thru 40 mesh % thru 200 mesh Flow Time Apparent Bulk Density,g/cc Pounds/Cubic Ft. Powder Mix Time Porosity cc/gram GP-5-15353 1.4 1.06 1.47 2.47 72 0.3 100 3 18 .48 30 260 SI Test Procedures ASTM-D-1243 1% Cyclohexanone & 30C i% Cyclohexanone @ 30C 1% Cyclohexanone @ 30C BFG 793-F BFG 812-G BFG 692-F ASTM-1895 BFG 468-H BFG 1094A 21709009 BFG16192 BFGoodrich The BFGoodrlch Company, Geon Vinyl Divrsion/6100 Oak Tree Blvo., Cleveland, Ohio 44131 [^Goodrich Geon Vinyl Divider. Tho information OOntalPOd hafdiP 14 06lrirv*a W W fb- liable, Diit no roproeenlAlionS. guarantees or rranl.es of wry kind m made ac loi& accuracy. tuUoWty for particular applications or me roiultt to bd Obtained Ihemtrom The lAlUftnfcliUft ta based on laboratory wprti with vr'all-iCAlC equipment ano eo*a not necessarily Mdicai* one product portormarwo. BecduM Of (ho variations .n methods, can e-iions and equipment used commcicidlty In ptocoastng ihecn mmnn.tfs no vrrjr|iM o' guarantee* am made as id the suitability of the products lor the application oljeloeod rull-sCflJo testing and ore p'OOuCl peilontwincv are the tvsporisiDHiry o( ire ueec BFGooortch ehaii on bo Iodio lor and the customer assumes oil nsk and U&Dlllty ot any use O' handling of any mitef'81 beyond BFGoodfich's ditea conuo: The $u.6r MAKES NO WARRANTIES EXPRESS OR IMPLIED. INCLUDING. BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Nowtng contained herein is io be cons.dorao as permission rec ommendation nor 04 an incucement to practice any patontod invention without perm,.en el me paten* i j Pnntpd m IJ^j.A. February 1$0C SPECIAL PURPOSE RESIN General Description Type Polymerization Process Appearance Polyvinyl Chloride Homopolymer Resin Suspension White, free flowing powder Features & Uses This resin is designed for applications requiring good physical properties. Wire and cable applications General flexible compounds Calendering Typical Properties ASTM Classification Specific Gravity Inherent Viscosity Specific Viscosity Relative Viscosity K" Value Heat Loss, % (maximum) Particle Size % thru 40 mesh % thru 200 mesh Flow Time Apparent Bulk Density, g/cc Pounds/Cubic Ft. Powder Mix Time Porosity cc/gram GP-5-15353 1.4 1.06 1.47 2.47 72 0.3 100 3 18 .48 30 260 .37 Test Procedures ASTM-D-1243 1 % Cyclohexanone @ 30C 1 % Cyclohexanone 30C 1 % Cyclohexanone @ 30DC BFG 793-F BFG 812-G BFG 692-E ASTM-1895 BFG 488-H BFG-1094A 0 T O C fyZ T ? r BFG16193 p BFGoodnch The BFGoodnch Company, Geon Vinyl Dlvision/6100 Oak Tree BlvcJ , Clevelano, Omo 44131 IFGoodrich Geon Vinyl Division I Thp rnlormB'.ion contained beri'r 1$ Odiidvad lo DO r- Irjpl*. UjI no rcprwanfitlons. Qt,i*rantfes or tvgUtMittC of I arty kind nae as to <tk accuracy, svUGDiliry for particular 1 appiicai.ont: or r3uiu to cotamt-d iMratrorri The inlorrratiQA >S Dacd on laCOitlOry work wllh emili-ccafe I equipment and coos no! necessarily ihditoio enfl ptOduCI padOrmancc $C6iiSc of fhq varlehom m rrwtnodv. con ditions and equipment uOPC commercially in niocct-'.iQ tn3 matonafi. no warranties c< guarantee:: am mac* as (o the *vkao<i<iy ot the produce (or th appit&tvcn $<% ;>Q360 Full'seafo tpitinq and end pfOOuCt performance are tf rc^ponsiDility of the un*r. PFGoodrich *rqw net be tabic tor Ana W* customer MSUfiies ail 'ijK and liflbihrv c' imy uaa or handing at any m.\:ai.ai beyond v.-tvs direct control. Tna SELLER MAKES KO WARRANTIES. EXPRESS OR IMPJ60. INCLUDING. BUT NOT LIMITED TO. THE IMPLIED WARRANTIES OF MERCHANTABILTTt AND Fitness FOR a PARTICULAR PURPOSE. Nothing contained heroin a ID be confiaored permiviKin, rec ommendation. nor as an mouCfittom to prJClic** any patontea invention witpoul permission of We patent owner j ! Prjniec in u S a February' 13H? ROUTE TO: BATH COMPUTER ROOM * LAPORTE TECHNICAL DOCUMENT #*#**#*******>!*****'#'*******- **#***#**#tt****#***'M-*'**--*-t|-*tt***#*-**#-K-*--*--K-#1H R103360 LAPORTE RECIPE 10/15/91 13:53:' GEON RESIN 110X500 COMMODITY NO.: OOl10 SBC NBR: 11IB LAB REF: BASED ON: APPLICATION: 500 0000 LOC: 30 DEPT: El20 ISSUE: EFFECTIVE DATE: 01/01/91 DELETE FLAG: NO CMPR: S91 PARTS INGREDIENTS SEG LOC PERCENT 100.40080 .05771 .06333 .03547 963 000094 06611 EOO 957 710502 KLUCEL J 953 709160 PVA, 72.57. 953 709395 LUPERSOL 10M75 010 020 030 040 99.790 .057 . 06S . 085 100.61232 TOTAL 100.000 TYPE SAMPLE MATCHED TO ISSUED MARKETING APPROVAL I!' f J: * 21709011 BFG16194 ROUTE TO: BATH COMPUTER ROOM tt*###***#****#*******##***##*********#**#******#***#**#*#******-* *#*#***#****!*** * LAPORTE TECHNICAL DOCUMENT * tt******#*******###***#**##*#**#**#*#*********#****#*********'*-#*#**-**##'****'***-*** R103360 LAPORTE RECIPE 10/15/91 13:53:51 GEON RESIN 110X500 COMMODITY NO.: 00110 SBC NBR: 11 IB LAB REF: BASED ON: APPLICATION: 500 OOOO LOC: 80 DEPT: El20 ISSUE: EFFECTIVE DATE: 01/01/91 DELETE FLAG: NO CMPR: S91 PARTS INGREDIENTS SEQ LOC PERCENT 100.40080 .05771 .06833 .08547 968 000094 06611 EOO 957 710502 KLUCEL J 953 709160 PVA, 72.57. 953 709395 LUPERSOL 10M75 010 020 030 040 99.790 .057 .068 .085 100.61232 TOTAL 100.000 TYPE SAMPLE MATCHED TO ISSUED MARKETING APPROVAL r. 21709011 BFG16195