Document 5Ln9EYM2m78waXjE32GpZEDz

t 1667 K Street, NW Suite 1000 Washington, DC 20006-1620 T 202.974.5200 F 202.296.7005 www.plasticsindustry.org or\Lr_CL' VV/ L1"r'. the society of the plastics industry, ine. 05 JUN30 PH 1: 5 1 Via Courier -Q&0& -! O TSCA Confidential Business Information Center (7407 M) EPA East - Room 6428 - Attn: U. S. Environmental Protection SAegcetinocny8(e) 1201 Constitution Avenue NW Washington, DC 20004-3302 June 30, 2005 CONTAIN NO CBI Attn: Re: CTSACSANu8(me)bNero7ti2c9e68-38-8, carboxylic acids, C7-13, perfluoro, ammonium salts This submission is made by: The Society o f the Plastics Industry (SPI), Inc. APFN Work Group 1667 K Street, NW - Suite 1000 Washington, DC 20006-1620 ,j ;1 f -j C.LlJ i l . _ C il O oCO mm3" 1-* Q_ CO _______l ZD LO c=> C> Dear TSCA Section 8(e) Coordinator: On behalf o f the members of the APFN Work Group (Arkema Inc.; Asahi Glass Co., Ltd. and Solvay Solexis, Inc.), SPI is reporting research results pursuant to Section G8(reo)uopf the has Toxic Substances Control Act. None determined that these results indicate o a f the members of the potential substantial APFN risk of Work injury to human health or the environment. This notice does not involve effects in humans. It does not contain confidential business information. It is to report findings contained in a draft audited study report. EA13.n,Pp.oAerra.fllOu(ogPraPovT,aSagme8)m7t0wo.n3oi8-ug0me0naesanrladttsiOo(nCECAreDSp#rGo7du2ui9dc6eti8lvi-ne3e8to4-8x1)i6cwittoaysesvctuaoldnuydauotecfttcehaderabpcoocxtoeyrnlditciianalgcaitddovsUeCr.Ss7e.. effects on the reproductive capabilities, including gonadal function, estrous cyclicity, mating behavior, conception, gestation, parturition, lactation and weaning o f the Fo and Fi generations litter was produced and Fi in each agnedneFr2atnioeno.naItnaladsudritvioivna,lb, lgoroodwltehvaenlsdodfetvheelotepsmt menatt.erOianle were determined one week prior to mating, and during gestation and lactation for maternal animals and their offspring. 88050000285 Plastics D ata Source 2 mo Dosage levels were 0.025, 0.125 and 0.6 mg/kg/day, administered at a dosage volume of 2 mL/kg, for the Fo and Fi generations. A concurrent control group o f 30 rats/sex/group received the vehicle deionized water. The test article was administered to offspring selected to become the Fi parental generation following weaning. In addition to the standard guideline parameters, blood samples were collected to assess the blood levels of the test material from four Fo satellite females per test article-treated group at 0 administration during the last week prior (prior to dosing), to mating and on g1e,s2ta, t4i,on8 and day 16 hours following 19. These females dose were euthanized, examined to determine pregnancy status, and discarded without further examination. Similarly, blood samples were collected from five Fo females per group and one randomly s1e3l.ecDteedvepluopp/mseexntfarol mlanthdemlairttkesrs(,b2alhanouorpsrefpoulltoiawlinsegpamraatteiornnaalnddovseagaidnmalinpiastterantciyo)nwoenrelacetvaatliuoantedday for selected F] necropsied on proaststn. aStaelledcateyd(PoNrgDan) s2w1.erSepweremigahteodgefnroicmenodnpeoFijntasn(dspoenremFm2 poutipli/tsyex[/ilnitctleurding progressive motility], morphology and numbers) were recorded for all Fo and Fi males, and ovarian groups. primordial follicle counts were recorded for all F1 females in the control and high-dose One 0.6 mg/kg/day group male in the Fo generation was euthanized in extremis during study week 14. Severe body weight loss and related clinical findings were attributed to test material administration. One Fi male in the 0.125 during study week 30, and one F] female mg/kg/day group died as a in the 0.6 mg/kg/day group rwesauslteuotfhaanniiznetdubinateioxntreermroisr on gestation day 24 due to dystocia. Based on the results o f this study, a dosage level of 0.6 mg/kg/day was considered to be the no observed adverse effect level (NOAEL) for reproductive toxicity of the test material when administered orally to rats. When evaluated across two generations, no effects on reproductive performance, mean estrous cycle length, spermatogenic endpoints, mean gestation length, parturition, former implantation sites, or unaccounted-for sites were observed. There were no test article-related effects on Fo or Fi reproductive organ weights or macroscopic or microscopic findings survival, for the reproductive tissues, mean general physical condition of the numbers pups and poufpF|boordyF2wpeuigphstbs odrunr,inpugpthseexprrea-twioe,apnuipng period. Mean ages and body weights at attainment of balanopreputial separation or vaginal patency in the FI and F2 pups were unaffected by Fo and F\ maternal and/or Fi direct test article administration. A dosage level of less than 0.025 mg/kg/day was considered to be the NOAEL for F0 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 F0 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 0.025 on higher liver mg/kg/day was weights at 0.125 considered to be and 0.6 mg/kg/day for Fi the NOAEL for neonatal taonxdicFit2yp. uTpsh,eaadnoaslyasgies level of of blood samples on lactation day 13 indicated, in general, that the total concentration of the major components of the test material (i.e., [ammonium salts of C7 - 13perfluorocarboxylic acids]) in the serum of male and female pups was 1.2- to 1.4-fold higher concentration in the serum of the pups than in the serum of the dams. Concentrations of the individual components ranged from approximately 2.5 fold lower to 2.5 fold higher in the pups than that of the dams. Please contact me if you have any questions or require additional information. I can be reached by telephone at (202) 974-5217. Sincerely, Lyiuie R. Harris Vice President, Science and Technology cc: APFN Work Group