Document oDV4eRY9VGY8Z7gxDQ4r6ZnxE

AR226-3339 Roy S Thompson Ilaria Colombo Watze de W olf (AstraZeneca, Brsxham, UK) (Solvay Solexis, Bolteie, Italy) (DuPont, Mechelen, Belgians) David G Farrar Robert A Hoke Jacques L'Haridon for:(ineos Chlor, Runcorn, UK) (DaPant, Newark, DE, USA) (CIT, Evreux, France) APME (Association ofPlastics Manmcterera in Earops) d-Hoc APFO Eavimaffisatsl Woridag Group _____________ _____ A p ME / Acute & Cfer@icCAoqunatetinctToxicity of APFO Background Physico-chemical properties of APFO Acute toxicity Chronic toxicity Risk assessment Potential role of ammonium ion in APFO toxicity Conclusions Acknowledgements AJpME 1 ArairAtucfutitielii&iitiCphtrrollniiic Arquacttic Tsio#xaitcit-yBoaf AckPgFrOtjiiiid Most commonly used salt o f perfluorooctanoic acid (PFOA) Essential processing aid in fluoropolymer and fluoroelastomer production (e.g. FIFE) and application (e.g. non-stick cookware) KyiRting data on aquatic toxicity, but with various test substance formulations, purity etc. and o f variable quality - Variability in toxicity values Need for complete and uniform set o f data to current regulatory guidelines and to Good Laboratory Practice For this9w9.o7r%k:Purity; 78% nonnal-chain: 12% branched _____________________________________ __ ajPm e Ammonium Perffluorooeteiioate (APFO) CF3.tF 2.CF2.CF2.CP2,,CF2.CF2.C(0 )0 'NH4+ (CAS No: 3825-26-1) H20 Solubility: 3400 fng/P] (Fully ionised Log Kow: in water at enUvnircoenrtmaienn(tasilspfaHc)tani) Log Roc: 1.7 - 2.4 Bioconcn. factor (BCF): 4 (Rainbow trout)1 1.8 (Fathead minnow) 1j USEPA (2002) [2] Dekieva et at (2003) (31 Martin el ai (2003) 7 Kmmmkwm Prfflwirctate(AFFO) Acote Txtettf Fish (Onmrhynchm mykms) (OECD 203) - 96 hr LC 50: 7 1 0 m g /I (nominal) (Mo effect at 500 mg/1; 100% mortality at 1000 mg/1) Crostcea (Daphnia magm) (OECD 202) - 48 hr EC50: 4 8 0 m g/1 (nominal) (24 hr EC50 600 mg/1; No effect at 320 mg/I; 100% effect at 1000 mg/1) Algae (PsmdoMrcImerleih subcapitaia) (OECD 201) -- 72 & 9 6 hr EpCSO: > 4 0 0 mg/1 (measured) (72 & 96 hr EbC (biomass) also > 400 mg/1) CAmtama&iimiewTmPexrMfIiityr-@SkcytpaikMmitme (wAmFFgOm) 21-day Growth & Reproduction (o e c d 211 - semi-static) No effect on mortality at highest concn: 89 mg/1 Length o f parents at 21days, NOEC - 44 mg/1 Reproduction: NOEC = 20 mg/1 (mean measured) a firn e 7 ChAromamkoTnimumfcWii&y M- Ommmmmtmkpmmttk\ m myMm Early Life Stage test (85 days) (oecd 210-Continuousflow) > No significant effect on survival, length or weight o f the fish at highest concentration tested rtfhmu ` NOEC = 40 mg/1 (mean measured)____________ 40j .-*35 ' iI -- -- ------- f ------ f ------- ? -- 821 3D 2250 fg 10 ~J - E6 0 Control 2.2 4.5 11 21 APFO Concn. (mg/l) I ! 40 1000 3E. 800 QC+O1 tSc(00> 600 400 200 0 -H -H Controi 2.2 4.5 H- 11 21 A P F O C o n c n . (mg/l) 40 h F Ml Acute & Ornate Aquatic Toxicity offAPPO Chronic NOECs for 3 trophic levels Fish 50 mg/1 Crustacea 20 mg/1 Algae 12.5 mg/1 Assessment (safety) factor: Therefore: PNEC = 1 0 (EU Technical Guidance Doc) 1.25 mg/1 Predicted No Effect Concentration Few data on environmental concns (ic;i: Generally < LOD Lake Ontario: ca. 10_<5mg/1 (PFOA) (Scott i,2003) (P Local to manufacture: < )EC/PNECs < It)*3- Very 1L0o"3wmRgi/s1k(PtoFAOqAu)a(toics eOf ar,g2a n)isms^ ^ Ammonitimi PerftaoreoetaiMMt (APFO) a l as APFO dissociates in water yielding NH^ n h 4+ n h 3+ h + Ammonia Dissociation Curve (20C) ammonia mmmmmmmMmmmsmm ua2_* 5 0 ' 6.5 7 7.5 pH Free ammonia ca. 100 times more toxic than ionised mmmiMm PerftaorwMtanoate (AFFO) f tentiti Ente of Am m sa^am Ioa Calculate free ammonia concn from EC/LC50 and test pH S p ecies Oncorynchus mykiss Pimephales promelas Daphnia magna Daphnia magna L C 50 (m g A P FO /1) 710 300 480 240 m g N H j-N /l 0.38 0.3 0.47 0.61 R ef T his study U S E P A (2002) T his study U S E P A (2002) Free ammonia EC/LC50: Oncoryynchus mykiss 0.16 - 1.1 Daphnia magna ____________________________ __ 0.53 - 4.9 mgNH3"N/1 __________{_U_S_E_PA_,_1_9_84_)_ jPME / Acute & Chronic Aquatic Toxicity ffAFFO Cadnsliiii APFO shows relatively low acute & chronic aquatic toxicity (Lowest NOEC = 12.5 mg/1) Based on available date, concentrations (PFOA) occurring in the aquatic environment are orders o f magnitude below die PNEC, indicating negligible risk The ammonium content o f APFO may contribute to the acute (and possiby chronic) aquatic toxicity, and may explain some o f the apparent variability in the historical data. A f,i ME 3