Document yr9Q5ebwdwnppJVRz4bLzLn14

a BLEEIVED ARR&E. 272] the society of the plastics industry, inc 1667 K st. ow _-- Washer 0020008160 Tavera 5200 202.206.7008 or lca 2= 72. 2= = OSJUN3D PM 1:5) Via Courier FEtp-asos=16079 TSCA Confidential Business Information Center (7407 M) EUP.SA. EEasntvi-roRnomoenmta6l42P8ro-teActtiino:nSAegcetinocny8() 1201 Constitution Avenue NW Washington, DC 20004-3302 June 30,2005 CONTAIN NO CB! Atta: TSCA 8(e) Notice Re: CAS Number 72968-38-8, carboxylic acids, Cr.15, perfluoro, ammonium salts "This submission is made by "The Societyofthe Plastics Industry (SPI), Inc. APEN Work Group 1667 K Street, NW -- Suite 1000 Washingyton, DC 20006-1620 OIGEA0 FA mn Dear TSCA Section 8(e) Coordinator: On behoaflthfe members of the APEN Work Group (Arkema Inc.; Asahi Glass Co. Ltd. and Solvay Solexis, Inc.) SPI is reporting research results pursuant to Section G8(reo)uofpthhaes TdeotxeircmiSnuebdsttahnactesthCeosnetrreoslulAtcst.indNiocanteeo2f tpohteentmieamlbseurbsstoafnttihale rAisPkFoNf iWnojurrky to human health or the environment. This notice does not involve effects in humans. It does not contain confidential business information. It i to report findings contained in a draft audited study report. An oral (gavage) two-generation reproductive toxicity study of carboxylic acids C. 13 perfluoro, ammonium salts (CAS# 72968-38-8) was conducted according to U.S. EP.A. OPPTS 870.3800 and OECD Guideline 416 10 evaluate the potential adverse effects on the reproductive capabilites, including gonadal function, estrous cyclicity, `mating behavior, conception, gestation, parturition, lactation and weaningof the Fy and F, generations and F and F, neonatal survival, growth and development. One liter was produced in each generation. In addition, blood levelsofthe test material were determined one week prior to mating, and during gestation and lactation for `maternal animals and their offspring. ERI TE @ Br mgm" 2 {NID mDLo/skagg,e floervetlhsewFeoraen0d.0Fy25g,e0n.er1a2t5ioannsd.0.A6cmogn/ckugr/rdeanyt,caondtmrionlisgtreoruepdoaft a30dorsatasg/esevxo/lguromueporef2ceived tthhee Fvyehpiacrleentdaeliogneinzeerdatwiaotner.folTlhoewitnegstwaeratniiclneg.waIsn aadddmiitniiosntetoretdhetostofafnsdparridnggusiedleelcitneedptaorabmeectoermse, bfleomoadlessapmeprletesstwearrteiccloel-lterceatteedd tgoroausspesats0th(eprbiloorotdoldeovseilnsg)o,f t1,he2,te4s,t 8maatnedria1l6 fhroourmsffooulrlFoywisnagtedlloistee administration during euthanized, examined the last week to determine prior to mating and on gestation pregnancy status, and discarded day 19. without These further females were examination. sSeilmeicltaerdlyp,ubpl/osoedx sfarmopmltehsewleirteersc,ol2lehcotuerdsffroolmlofwiivnegFmoafteemrnaallesdpoesregardomuinpiastnrdatoinoenroanndlaocmtlaytion day 13. for Developmental selected Fy rats. landmarks (balanopreputial separation and Selected organs were weighed from one F vaginal patency) were evaluated and one Fa pup/sexlitter pnreocgrroepsssiievdeomnotpiolsittnya]t,amlodrapyho(lPoNgDy)a2n1d. nSupmebremrast)owgeenriecreencdoprodiendtfsor(sapllerFmg amontdilFi)tyma[liensc,luadnidng ovarian groups. primordial follicle counts were recorded for all Fi females in the control and high-dose wOeneek0.164.mSge/vkegr/edabyodgyrowuepigmhatleloisns tahnedFroelgaetneedracltiinoincawlafsineduitnhgasniwzeerdeiantterxitbruetmeidstdoutreistngmastteurdiyal dadumriinnigstsrtautdiyonw.eeOkne30,FyanmdaloeneinFthefe0m.a1l2e5 imngt/hkeg/0.d6aymgg/rkogu/pdadiyedgraosuap rweasuslteuotfhaanniiznetdubianteixontreermriosr on gestation day 24 due to dystocia. oBbasseerdvoedn atdhveerresseuletfsofefctthliesvesltu(dNy,OAaEdLos)afgoerlreevperloodufcti0.6vmegt/okxigc/idtayoyfwathsectoenstsimdaetreerdiatlowbheetnhe no administered orally to rats. When evaluated across two generations, no effects on reproductive performance, mean parturition, former estrous cycle length, implantation sites, or spermatogenic endpoints, mean gestation length, unaccounted-for sites were observed. There were no test artcle-related effects on findings for the reproductive Foor Fy tissues, reproductive organ weights or macroscopic or microscopic mean numbers of F\ or F> pups born, pup sex ratio. pup pseurrivoidv.al,Mgeeanenraalgepshyasnidcablocdoyndwietiigohntsofatthaettpauipnsmeanntdopfubpalbaondoyprweepuitgihatls sdeuprairnagtitohne oprreva-gwienaanling patency in the administration. F1 and F2 pups were unaffected by Fo and Fy maternal andor F, direct test article A dosage level of less than 0.025 mg/kg/day was considered to be the NOAEL for FO and FI parental systemic toxicity based on the microscopic hepatic findings of hepatocellular hypertrophy and vacuolation observed in the 0.025, 0.125 and 0.6 mg/kg/day group males and 0.6 mg/kg/day group females. Clear cell foci and higher incidences foci of hepatocellular necrosis were also noted for several FO and FI males at all dosage levels. Higher kidney weights correlated to the microscopic finding of renal tubule hypertrophy in both sexes at 0.6 mg/kg/day. Based on higher liver weights at 0.125 and 0.6 mg/kg/day for Fi and F pups, a dosage level of 0.025 mg/kg/day was considered to be the NOAEL for neonatal toxicity. The analysis of blood samples on lactation day 13 indicated, in general, that the total concentration of the major componentsofthe test material (i..,3. [ammonium salts of C;_ 1perfluorocarboxylic acids]) in "tphuepssetrhuanm oinftmhaelseearnudm foefmtahleedpaumpss. wCaosnc1e.n2t-rtaoti1o.n4s-foofldthheigihnedrivciodnucaelnctroamtpioonneinnttsherasnegreudmofrfomt.he approximately 2.5 fold lower to 2.5 fold higher in the pups than that of the dams. Pblyetaesleecpohnotnaectatm(e2i0f2y)o9u74-h5a2v1e7a.ny questions or require additional information. I can be reached Singerely, Fp Ll Lyphe R. Harris Vice President, Science and Technology cc: APEN Work Group