Document Rp1GJ13ObJRqmLd0v9zb6q8nz
PETITIONER SUMMARY DATA SHEET ("P-SDS")
[SamUmBoSnTiAuNmCsEa:ltPerfluorofaceticacid, 2-(5-methoxy-1,3-dioxolan-4yljoxyl),
USEOF SUBSTANCE addiive REFN. notyetassigned CAS. N.: 1190931-27-1
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[WherethetechnicaldosserdoesnotcortainallI requesieddata(sssbelow)Gvereasons| [a4ip7npAhliopcxra9itDi2o,0n1af3mo,rmSotonhleivsuaamyfSseptaeytcei.vaalltuyaPtoiolnyomefrPsesrufubomriot{eadceattcaeccihdi,c2a(ld5o-smseitehroaxnyd-1a,P3-GSorDcSfloonr-the [lhoniFsotoecdhCnoicnatlacdtossMiaetrecornataoifntshaedScciissonntaflicinPfaonrmealtianonfroeoqduceosntteadcbtmyattheeriaElFsS,eAnWzoyrmkeisn,gGroup [f|avAoudraintgainneodntnproaorcilecssidnogt aairdse(pCrEoFv)i,deed.wEitFhSrAespQeucetstoiotnhensupmebcefrcEFmiSgAr.aQt.io2n0o1f3.c0on0f3i6d3en.tial oo hats,an ismrosniunigeaunsasnaaylymeattnhiioodacwriaatllaitoaurmgaettodnenotseocotniitrooefmn1ove iprovided. [JTahcetiiniotnealPin.fSoOrmSastuibomnciatenbdienr2ec0o1g3nihsaesdbesenexrtevoinseadarnedytbahcenkgerwoiunnfdo,rmmaatrikoendrReElaVte.dfo the [HdardocopwsiehseosfoAnnCineDx:eR1O3.Mr1c5,opr,eileastoefAtonanteox1n-a1l5aienformaprtoviidoen,areprovidedinthepresent
P.SDSofF-DioxAckdAmmoniSuamt CAS No 1190991271
2
RemARics:
`CONFIDENTIALITY
GTbeooerraasneesdetcotmotnaosmorbfetarrisissof,fElTFnhgSAcfaonndtoath cmoEsnomdaperenkaelndCbCuosomimnniefssessinfotonranmasctohinooenchtbitoornsewhvoiiuhedwhssotaavnbayelubayion SWotrhsspoculiaatyoftitehflpoowtilnognaodrsaubtsitoanncesaconussiediereodocdocnobnaancatlmaotemriaal,n: - spackoscopy data (00 12) ~ ptphuuetiptrsoypr(5ise0oto0ar1y122ma1.n)1u:2facturing process (see 1.2.10)
= thermal decomposition products (see 2.2.5)
~ ricmanaoxoinilmotounommilaprea3rpt0coe0onno3ta.fagennehdino)rfonsrkmaualrlatoicfoontnt(eesneeteco3of.mF5)p-DoisxioAnckprAodumctso: hno sSnaally1icnatmethod or gene mutation assay on decomposition product (see 8.1.4)
CTCilnheeooadrcmlyoo,pnpauadboolfpinScodlsliisnaocnaly,orsSm2upasroleccoooafnmltphhyoiatsPslibooneyfseomrncemarroteirpohrnpoovwcoeoedustlsf.edonmhahrIemmpSr"oonlv-vecahoyenSfrpedcoeiwnanlttapyrrPovoceleryssmsieorbnsy"oefatmhing fig. provided on CORON.
INFORMATION REoQnUESTED 1.. IDENTITY OF SUBSTANCE 11 indvidusl substance: 12 defiedmicure:
121 chemical namo:
122 synonym:
123 trade name(s):
124 cash 125 consents:
126 pTrorpor:tions nthe
INFORMATION PROVIDED
No ws
Acelicacid,2,2-dfluoro-2-{2.2 5-elrauoro-5-
{ify(trifluoromethoxy)-1,3-dioxolan-4-yfjoxy}-.ammonium salt Dio Acid Ammonium Sa, CB04 Cy
Cyclic C604 Ammonium Salt, cC604 Ammonium Salt
visugat2r1 TGaoseraebcsoamnocse anids eaach pparorccesos namnra e5050ofmifrouer ftw enantiomers. TGhonsaabmrsmaonneicueamvisdisootroaafmol(rpo4rwoi5scn.egs0sp5r.op2mo4riiSonuso: uofrf:our
5-{rifluoromethoxy)-1,3-dioxolan-4-yl] oxy) `acetate (~25%wiw)
+ aamcmoaniu(m2ifuuotres) ((47,59:2.2.4 Sottero: -(trifluoromethoxy)-1,3-dioxolan-4-yl] oxy}
P-SDSof -Diox AddAmmaniSuamt CASNo 1190991271
5
+ ammonium dilioro (45,551o.ta2tu2or,o`5-{trifluoromethoxy)-1,3-dioxolan-4o-xyly]}
+ a`mamocni(eu~mt25aa%lwutoirWed)(UR22..4SSekaRfor)eRet ArneS`5rc-o{t(tsrFilf(lau2No5rDom)mietnh)oxy)-1,3-dioxolan-4o-xyly)}
127 Smioluecctuulralrfaonrdmula:
SMoclaacrulearffoormmul:a: CEHAOBNFS era7 Y4coo,
Ne
1.28 na range: molecularweight(Mw) 120 spectroscopicdata:
357 gimol
conttomadtohoas bnoonrtomolvad
1240 manacuringdoals ~~ contdantlhafsbooro alvond
1241 purty (4: 12:12 impurities Ch:
contdantl tomatohsboonremoved Fon-lDyio2x AacqiudeoAumsmsounkiounm:Staypliciasllymacnounfcaecnttruarteidonanndwuasleodr sso contolinfomation has bonrmoved
1213 specications: 1244 otherinformation: 13 Nondetmedmistur:
No thr informationv'esn 10
14 Sader: `polymer usedas.
no
2 PHYSICALAND CHEMICAL PROPERTIESOFSUBSTANCE
20 physical properties
241 molingpoint(0): 242 bollng point (C):
1Ma0i2lslimcnagtphisnt has boo established accding to OECD dTehoerbmoinigndg psnociaofnttTh95nC-o14e0-sCubstlaancsecdoauclodmnpootsibnog.
P-oSfFD-DiSox Acid AmmoniumSalt GAS No 1190931-27-1
.
243 tdoomcpoemrpaotsuirteio(nC): 214 solubility gh):
215 opacrttaintoiloinw(laotgerPo) 21.6 ortehloarteidntfoorlimpaotpihoinlicity: 22 chomical properties 224 nature: 222 reactivity:
223 stability:
224 hydrolysis:
Decomposition starts at 140C
Rot. Amex 5
2Wa6t6e7rg/Lsowlaubtielrly has boon established according to `OECD 105 method
loPagrPtoorn c=oo-f0fc.eant3t282haCs.boon established according fo `OECD 107 method
Noother information is submitted
(T2h0e91p)Hiso1f0the rolled substance in aqueous solution
Tcohnedinoontisfideedscrsiubbesdtainncseectiison n3o.t reactive under the `Ndeevceormthpeolseisnsg adtuteemtpoeritastuproeorexcteheerdmianlg s1i4a0biCl.ly it starts
"stTahretsnoidfeecdomspuobsstianngce,dudriungtotihtse potohrertmhaelrmatlresattabmielnttys,
described in sacto3n.
Rol. Annex 5
Not relevant, hydrolysis wil not occur.
225 dinetceonmtpioonsailtion! transformation:
confidentialinformationhasbeenremoved
226 udneicnotmepnotsiiotnailon'
-
transformation
products):
227 sinutbesrtaacntcioens:with food "Thero aro no known Inoractonsvith food substances.
228 other Information:
3
INTENDED APPLICATION OF SUBSTANCE
31 food contact material: Tuhoerinnoatitfeidedpsoulbysmeirasnckaei:s used in the manufactuoref ~~ TCeotproalfyumoerroestohfylteenterahfloumoorpooetlhyymieern with ~ pCeorpfoiluyormoearlskyopfetrfluroarfolvuirnoyltheytlheenrso with hexafuoropropene
ofThaorsecsfl:uoropolymers aro protcoperodsucsoaerandge = Pvaalrvtessf)or food processing equipment (ting, ~ Tubes, sheets, pipes.
P-oSfFD-DiSoxAcidAmmoniSualmt CAS No 1180931-27-1
5
~~ ATnatpiesst,ckcacsotatfiinmgss on cooking utensils `Acloopfotlhyemerasriareesfomrarnoupfoaacttuusroe.d fom these polymers and
32 technological function:
dTuhreinsgubthsetapnocleymiesruizsaetdioans parnoceemuslsosiffileuroirdoippoelrysminegrsa.gent f1orpmrseasosntcabeleendsiusrpeersstihoantotfhepaprotlcyemse.rt be synthesized
33 tmeamxpiormautmurporo(*cCe)s:s
34 fmoarxmuilmautimonp:orcentagein 35 conditionsofcontactin
practice 351 contactfood: 352 time and tomporature:
353 surtfovaolcumee ratio: 354 othorinformation: 36 ctornetaatcmtenmtatoefrfioaoldpiorto
uso: 37 otheruses:
o`fTyfpiicsalhetdemapretircalteusraerso:encountered in the manufacturing ~ Tubes, sheets and pipes up to 420C for min Toaqpueisp,mecnatstupftioms38a0ndC pfoarrt3smfionr mfaooxd. processing ~ tAnotmhpsotriactkurceoastuipngtos 4a2re0 dCriefodra1n6dmitnhomnaxb.aked at
confdanial informationhasbeanremoved
Altyposof oodstus T`choeatmedaxcoiomkuwmartoe,mpsourcahtuarsocoofatcionngascotnifsyeixnpgerpiaennsceadndby `arCtoiactliensgfsofroorvceonokbwakairneg.aro used at lemporaluros up fo 2`e3x0curCsifoonrs, uusputaoll2y5u0ptCofoonro16ormtinwuotehso.urs, Thoro may bo. sTuhrifsawcieltovavroylfumoemraatrotcoe6ftomargticdle, ibsuaptphleiccaobnl.ventional aAlrlotfhoer raerptcelaotsedmuasneu.factured from theso fluropolymors. sCooaopkywarweatearnd bobfaokreowarusoe;areothuesruallaryticwlaess,hesducihn haost. `wictohmhpootnweanttesr.of food procossing machinery, are rinsed Luuobrroipcoanltypmoewrdsomrgaryabdeesu,somdanausfaacddtiutrievdeswiitnhatvhaersieety of aporlycmoerfsorwchoincthacmtawyitbheaellxttryupdeesodfafnododmsotuulfdfe,datinatllo Ltuebmrpiecraanttuproewsdfoorrrsaepreeatuusseed. In tesa polymers o reduce friction and wear.
38 otherinformation:
sNuobsathanecre iIsnsfourbmmaititoend on Intended. application of the
P.$DSofF-DioxAcd AmmoniSualmt CAS No 1130831:27-1
.
.
AUTHORIOSFSAUBTSTIANOCNE
"4 EUcountes
411 inMombor tate: No
412 nCCoionbttseetadnocafas"onnhotwhe
ves REACH Rogsaton Number: 01-2116875655-19.0000
e CTRn:o of Dirn ective
413 other information: .
42 nonEU counties
421 mus
-
422 ndapam:
wo
425 nothercounts: "
424 other information: .
43 othrintomaton: .
5. DATAONMIGROAFSTUBISTAONCNE
51 specifmigraton(SW); GDSiMoonaaAcdinederAamnimdneod.nwIonrsStiaacda,sietnora arTotEsEeiniwcemsoChatoyoobsfoaaFrSaving 100% mircosaSoc.ios --
52 ovrallmigraOlMo)n: OMrotdeamined
53 QGueanntthtccaattoinnoatnd oaHB)Ymrmimogoraantonimnpgeroroldsiugcaotmnsedrsds.otairviendg
Substances and addiives
5-D2ioxhAecifdoAgmmonituam nSaofwisotahomaal ducrastmapls,iso0n0 pacdreayocdloumcctepisotosoefiorFn-naDiapsoxrioATdcnhiuad..Acmwo1m0noo0fs%nd,ianucimaaslSoalnptromoritinmognaaattPiooTonfnFE wfaniilessm BnaenlIomvoevsamdawnhcohf wero Ff-oDunxdA0dboA fomad durSionkg
(see 2.2.5).
cSTooFnetaoorectctkemmmaaontoni1sasdSoaoaatnsmirnntovtcooensfdooum.n content
Rel a7
hRreeo.vustpoct,omigrnatioolnmaofodnthHeoasmabnlon_odirocoonluposihosn
Soo csomin
--RafAmexta
P-5D8of -DioxAcAmmoniSuamlt GAS No 1190031271
'
531 test oample:
53.4 chomlcal compston: 53.2physical compositions 53.18 odfopnosn,emarltflowindox 53.14 Sdiammepns:ions atest
ast im, olied fom an aqueous dsparson ofPTFE
{ba S(apoblyartnetaraof(ipuocrbmoientihdyloee)nes), iicmopnrtemaginnianteged50wiRphprmmeeosfsFu-Doeioesx:
rSatamtveagnSTaOtonoer 2n4 s is apaad tee mes in
`RrSoaroevdievnrstgrtoaon erseia1nc,hSm etCahoectrheaki qAtuneeeHsnotosemn odnft8heicsknueopsnspor(6a0suumo).unofle
Tahiseeosdoarmspielbpseocso(tn51dcpoeonya1narnodeaerv gphotrshteo wtaoosrmateacrd aonosfnettaoos
Br eapat to oul
tol
of
ho
hoamaloodeemcoSmphestson
PreoGssaan,natc1a7l0oteinngmfnfmioydacnooouhmasnnebkotoAnnragem.olvpeods
ThTreoeavtFetMsaWmEplerowqauseitohd staomeecs aTiemsteetttdoo isa2mp0l1e.:
iE kL e E e
, di
eitihabyemodaltagiatieosneeisa
e EE a e SrT aep tn ras
eDomcpuameaes wbiam,Shporooctea sspedreacAearestvp,oronctewschaacnshga
SWaoamthioasbroioesoosmnesrotons or--t E AmeO x ts
TSTrooofTimmesaamplsteito ocsaaosPT3i .FS0Eo1 fTnimh,onmtaantouiftoancstuolrrpeDdflwhixn
R55eommoearreid S1alt1in BtvobaeotsoaushhPTFEcdaosnpeadroeirn a
ot Din ed momSo
homogeneofuism
Polymer dans = 22 gem
15cm x30 om hoot, ikness60m.
53.1.5 Sdhoismiemennsiofotnesst
-o0r5aemgah(m1as5 bfcoortmntrhiee3m0odovceetmedrmfinoatthion
of Confidential
dotominaton of
P-SDSof FlaxAckdAmmonluSamlt GAS No1100991.27-1
s
532 wTorstameentsoiftsst sample 533 teSSsiatmvtaoolnandnayioiroancdtion 534 contactmod: 535 Tcoontarcttinme and
536 seuviasccoitoovnoleustmeerrao
537 anatamath:
Contant formation as een rood Th iwas ct no small ios, rir o analysis conatodhas bo or r ova
rTheev Bon
sapmeocviedmawatsiodneloofmcionnefddeinn t3al%
afcoramataieond
asnsa
har
--RotAmex 13
oat immersin
DTraheaevnTomsopevciedmwiestodetoofmcionnefdiinnta3l% afcotostacod aansa
Sov oo vor.
-- et Anan 13
C7So0OntGannnimmtaanndocoranmveapnltaioanrvhaalnsovbeene,nlrowoeoddby 11 hhoouwr ast
hcamo perton .matot has bo een rel moved 4 hours
reT eav woO rtocoaI so. ateesdtasnwdosrehptasrorm1e8dC4.5nhcours at
oVSayn:otaAo leIrhran ess. ai,mgi etiaonand. gtps o oarsl nSseelhreaa sadr(eohpaooctot ndoiineltsao
TRE aan
--
Tc FHaEmEeo7r5010)nAfasoyronmdaaalcvietnreeagdeas0wnB3ieden5nttofrhoal xnvteascdiao0nl5vngoraamm
odyioonft|arwaam.st0h3 asala to vam sae
cSohoa Tensfwaortiamaw1tado.aososbtuotooot1se6h0la04mme4moi18ttonooxn5%40
com
xreyv-------- rRTlr Aman 15
aCCosngiohae nsnaindrdcahoomoanaagsmtabenannyndeTwoilsavHSSo.oGOmN,S
CcEotnrtdao,ntvitgnhatstrbaomnoastonoodnd
P-oSfFD-DiSox Ackd Ammonium Salt CAS No 1190831.27-1
558 detection! determination limit:
530 recovery:
rev oan romewaee a0 itonl, es (headspace gas chromatography with massRdeetteActninone)x. 18 confident omanhsboon avd yg bso e (fSeaecioq,iunaoltnhto.or htdehteSeinicutsoee rr0nc.ef0pl4ta3iomcfad teolhfeocaacoatnlnoibdraotioapnplcenunroverh.moTaaeklxiancghiiaonstno cCSoonomtoodspononntdTlionnkrgnmgato.tnilho.anscohoavoseu:nbientahhne arceomlnoocwevenesitdalc2oan2lb8raagcto.tn C=pornitorhooatdnoiaiGnlC-tchMoSmoaxantaalncysi1iosn8anTbodsot,athfethoos.muvrdfetaedcceilov0no0,l0um1Ieimragtoiafo
nTrhgeeivadleoarc2o0nnlghiiaolfn3thedmH.S.TGhCe-McSormeestphoonddswa10s 0240
Hg/6 dm.
--RotAmex 13
cnooantthenspttplacnadbalt.rdomaadtdionhsmebtohoodnrwaos aipp:le, coversy L 1018Tu0covwaarys. doefamined ae fer rol for 4 hours Oaned: HFE7100/acetone (8:2). The --RotAmex 7 following results were
[Comet Tome [o2 om T [eo e ]|
I [-- 288 o-- e
CA C vegesSdn)[99%7|
Foca
Tirhemevarenceovaeroyrwassordageotmori4n5e hboyurasnaatly1si0n0gCs(p0e%dacoealdc
20) and 3 hours at 75C. (ove ol). Recovery of
iGheotroprsmrionesrdoinfnocefrfaoiolnd5. shmuoattu,100broth (in9%tahcatboseanccke) aanndd
Tovoaddeod |mComvaTaoubanodon tro[noFaca eyase|s aloAovRws:ettogAemex 13
(nghvial)
(ngHvial)
oF
jen
3%acelicacid, SE WR |.R. tSa
P.o$fFD-DiSox Acd Ammonium alt GAS No 1100831.27-1
0
[Emer popSlHlaceoloaadss
Sirs
"olive oil, in the. `absence of polymer "olive oil, in the presence of polymer
|[o i C L Ia --N r O
i-- --
ell
YJ es ey1
fez Teoo 1
[867
838
836165
IT s r
5310other formation: 5311 resus:
.
re tol coon of `removed was found to be nol-detectable. As a resul,
worst case removeids
migrationofconfidential < 0.045mg/6dr.
information
hasbeen
removed was found to be not-detectable. As a result the
`worst case migrationofconfidentialinformationhasboen remoisv<0e.0d01 mg/6 dm.
iIinnnteeheSSGoaC-mkaannatloaysgniasmnifnowrohrreeaseicdsutaoolocronsnfipdeeshnketsiarvleairmnsfaodrrmeoayteioodmn
Basedon the calibration curveof confidential information
hPasobaeen remeovsed,inthe wtrotatl caroeva aofntohesne oafdd0it0io3na4l
mg/6 dm.
ro Amex?
confidentialinformation hasbeen removed
rev
h The migraa tion of coo nfidential informatioenthaAsanbeexe1n3
6. DATAONRESIDUAL CONTENTOF SUBSTANCE INTHE FOOD CONTACTMATERIAL
61 actual conto: 62 substance 63 testaample:
631 chemicalcomposiion
J----
--Rot Anan?
DioxAcdAmmonium Sa
cheostam fonvmasiteosntreeaasadnessceroibneddepoercioonn 5.P3.TFLoE,
2 rman Sales an pop (polytetrafiuoroethylene), containing 50 ppm of F-Diox
see534.1
6.32 physical composition
homogeneous PTFE fim
P-SDS of F-Diox Acid Ammonium Salt CAS No 1180931-27-1
1"
633 odfonpsoiltyy,memrolt flow Index 634 sdaimpmleensiofotnesst 635 dspiecmiemenn:soifotnesst 64 troatment of sample: 65 testmethod:
651 Hidmeittec:tion!determination 652 `pmreetchiosdi:onoftest
653 recovery:
5005:3.13
18cm x30 cm sheets, thickn6e0usms
`one sheet (18em x 30 cm) pr test
th2e)sample was refluxedfor 4 hours in HFE7100lacetone rAesfidutahle rceofnltuexnpteroifod,F-tDhieoexxtrAaccitdwAamsmcooonlieudmdoSwanltanwdasa dFoert_eqrumainnteidibcyaiLoCn-,MSstaannadlaysrids_.soluions of F-Diox Acid `Ammonium Salt were prepared and analysed. sTihgenaldeotbetcatiinoendflirmitthwealsow4estngs/tmaln,daarnddsoilsutiboans.ed on the "sTthaendparrecdidseivoinaotfitohneoftteshtemteitpihcoadlecarnebcoevoebrtyaeixnpeedrfirmoenmtst.he Srde(poe-a1)ta=b5il%rl=y 2.83* Sa(n-1) = 14% dTehteermrienceodvearfyterofrefFl:uxDifooxr 4AchodursAminmoHnFEi7u1m00/saactetwoanes (8:2). The following results were obtained:
AF-mDmiooxniAcuimd Salt
2A
-- --
fogAsvera3gSean)Ti[a1a 24357]]
654 otherInformation:
-
66 results:
"tTohebroesindouta-ldectecotanblotefeoFr-nDi<tox4nAgmimmio.niAfutmerSaaltppwhaisngfoutnhde sduertfoaccoalbvlolruemsieduraalticoounsteordticnotrhreesepxotnradcstitoon<ts0i.,00t0h4e mngolnsam.
67 calculated migration (worst case:
TSahteicsal0c.u0l0a0t4edmwgo/rgstac.ase migration of F-Diox Ammonium
68 rosiduslcontentversus -
specific migration:
7 MICROBIOLOGICAL PROPERTIES OF SUBSTANCE
711s the`saunbtismtiacnrcobeiaulseadgeansta?n Not applicable
P-oSfFD-DiSox Acid Ammonium Salt CAS No 1190931-27-1
2
8 TOXICOLOGICAL DATA
81 Gonotoiclty 81.1 Gono mutation In bacteria:
Tthhee atbelsittytetmo Cin6d0u4ceCgYeCnLeICmuwtaastieonxsamiinnetdestfeorr sEtsachienrsichioafcoll,Saalsmomneealsluaredtbyyphriemvuerrisiuomn ofand `TahweolfriovpehitcesrtearinstsrationspoTlAotTr5o3p5h,y.TATS7, TASS, `ETxAp1o0r0imaonndtsWP2weurvorA pweerrfooursmeedd. both inthe ausbisnegnclieveranSd9 fprraecsteionncefroofm mreattsabporlei-ctraecattievdatwiiotnh, Tphheenotebsatrbflioomnewaasndubseetdanaasphaihsooflauvtioonne.in stelle distlled water.
TMheethotedstB.w13a/s14paenrdfotrhmeedOEaCccDorGduiindgeli(n0et4h7e1.EC
tTohxiecitteystttesotmatC6a04maCxYiCmLuImCdwoassealsosvealyeodf i5n0t0h0e
aptolpalpaptreoxainmdataetlfyouhraoltwleorg cionntcerevnatlrs:ati1o5n8s0s,pa5c0e0d,
`1C5o8ncaenndtr5a0t.io0nysgairpeatee.xpressed in terms of active
ionbgsreerdiveendt.atNothepreecnidpoitfatitohne oifnctuhbeatfieosnt pleermiowdasa.l
aannyy dcoosnceelnotvrealtiwoint.h aNnoy tteosxtiecrtystwraains. observed al
ImnetMhaoidn, AtshsoaylesI,t uslienmg twhaesplaatsesaiynecodrpoarlattiohne
afocliliovweiinnggreddoisenet:l5e0v0el0s, 2e5x0p0r,es1s2e5d0,6i2n5taernmds31o3f
ulegvlellatwei.thNaonytotseiscitteyrwstarsainobbsoetrhveidn tahieaanbysednocsee
A`asndnporerseelnecvaeontf Sin9crmoeatsaobsoliinc raocvtievraitainotn.numbers
were observed preincubation
astteapnywcaosncenInicrlautdoend
tefsotred,
alal
arsesaatymeedntast tofheMsaaimneAscosnacyenItl.raTthieonsteestmptleomyewdasi.n
TMoaxiinctAys,sayas|. indicated by thinning of the
nbuamcbkegrrso,undwalsawonbsaenrdvleodr arteduhcitgihoenr dInosreevelretvaenlts
wpirehsealnlcetoofsoSr9smiertaanbso,libcotahctiInvattihoon.absance and
Nenodopfretchiepiaitnicounbaotfiotnhepetersitodfamt awnaysconnoctoendlraattitohne
"tTehsetetde,sintaenmycedxpneortimiennd.uce twofold increases in
tihnec.ornpuormabteiorn oforrepvreer-iiannctubcaotlioonnieasssnay,theatplaantye
dose love, inany tester tain, in the absence or
P.SDSofF-DioxAcid AmmoniSualmt GAS No 1190831-27-1
LpiressceonncceluofdeSdOhmaeltatbnoltissmi.fem C604CYCLIC ossnolInducereversemulationiSaimonel
typhimuriumor Escherichiacol inthe absenceor `pm resee nceotfSa 9 boluni derts herm epor, ted experimentalconditions.
-- Ret. Amex
812 Imnutvatiitoonmteasmt:malian call gone
Tpohleenisatludoyf wcaCsB0p4erAfomrmmoendiutom iSnvaestlogaIendutchee nmuatsateiolnoscussfustihneg tmhoeuosle nhoymLphYoBmaY tahcycmoirddiinneg toh EC Method 8.17 and he OECD Cusine
Texhpeoraimsasnatys,waussinpgertfwoormepdarian ltwcouirnedsepegnadcehd. Tanhd fwristomuainveerxpmoircirmoesnotmawlasacpaerloirnmadonwdiha erxopaemreimnetnt pewraiso.d peofrfo4rehdourwsi.lh T8he.rosaemceonntd Spceirviaodtioofn 2a4nhdou4rs hIoutrhse aibnsetnheceporfesmeentcseb.olocf mTehteahbiogheasctvacotnocno.ntaton tested, 3640 poi, aTpoplgiaedtIontthhee mplreoc-uexlpaerriwmeeingthtwoafshcehotsoetn ewimh G7o0rtmeisd.ponTdhinegctoonc8enmtorlaatriocnonrceanntgreatoifontohfe smbaoiunt pCexorpneeccreiinmaietrnoltnosnwsarosfeiriettpheoodrtbedylebcsetylocw:lfeom.efectTsesotnedd WExipbeoruime$n9|t mix: 86.9; 13 227.5 and 455 Wpoirnn!59 mix 569; 113.8; 227.5 455 and 910 porn WEixhpoeur!imSe9nImtIi:x: 28.1 55.3 1125 225 ana 337.5 sWganh!59 mix: 563 1125; 225; 450 and 675 vNoosiubstantial an reproduciti dose dependant ionbcsreerasvee.d inIn.botmhutmaanitn excpoelroinmyeninsu.mbNeorse.lvwaans wSensoofbthse eraurop ovfteshmealmlaivmeraslucsonlacregnetcaotloonnieosf iRhpopfreoptriosme reference mutagen (MMS and aCPdA)inertoIunscreedasaes piosIinidvuecceodntmroultsanatndcoslhooniweesd, iinndiccoantcilnugshioensaIfnsciatnvibyeansdtavtaeldidthaotf dnuoritnegsst.he emxuplaargmeennitlayl ctoensdtitidoensscroibpeodrtasdnd.thounodsetr ftohme h0ymindlinIandkuicneasmoutlaotcuisonaissstahye umsoiungsethyamcplhloImnae LSwi1a7ndwi8houtY$5.
Therefore thetestedsubstanceisconsideredto
P-SDSofF-Diox Acid Ammonium Salt CAS No 1180931-27-1
1"
basseay_nonimnuthilsmaougseelyrmpihocma -- Rol. Amex 9
813 I`nchromosvoimoe aberratmiaomnmtaeslti:an GAcuciodradlinneg 4t7o3thteheECteMstettahmodCB8.O104anCdYtChLeIOCEwCaDs adsasmaaygeed fionr thCehianbelslety thoamcsaluosre cohvraorymoscoamllasl, prfoelsleownicnegoifn Sv9imrettarbeoaltimceancttiIvnattihoen.absence and wTewroompaeirnfoerxmpeedr.iments for chromosomal damage I3nhtohuersfrwstitehxpCe6r0im4enCtY,CtLhIeCcoinlsthweerproetsreenacteedafnodr haabrsveenscteedof aSlOtermet2a0.bolhiosumr.s,Thceorcreellsspownedriengthetno 5ap0p0r0o,x2i5m0a0t,el1y2510.,562co5l,l 31c3y,cle1.66,Do7s8.e1, laonvdols30.o1f g`59mmetwaebroeliussme.d Sionltuhtoioanbsseofnctehoantedstprteemsewnercooef. prepared In stor disiled water of injectable gNroadien.duction of chromosomal aberrations were. orbetaamineendt wiinththteheftrssttmtaaimnianstshaeyprboust,enfcoeloowfiSn3g nmdetoarbaodluipslm,camtaerdkedcelilnscreoavseers inthtehe cnounmcburerrenotf Anesgaetciovnedcmonatirnolewxeprereiombesnetrwveads.performed where caeblslesnwceereof t$r9eatmeedtawbiotlhisCm6a0n4d ChYarCvLeIsCtedinattehre 52903,ho3u9r5s, a263t,he1d7o6saenldev1e1ls7 oygfi2ml0.00A,co1n3t3i0n,u8o8u9s,. rAeamtomdeinfiteudnldohsaerversatngweaswuassed.adopted for this rtheoastementdoinseosrdermotostinvesftkieglayte mloore celxohsiebliyt `eanpdporroepdruipaltiecanteigoanl.iveBoatnhd peoxspietriivmeecnotnstrolisn.clTudweod cDoollsecullteuvreelss wweerroe psreolpeacrteedd afloreathcoh stceosrtinpgolno.f cyhtroolmooxsiotmyaalsadbeertreartmiionnesdobny tthhee braesdiusctoifonthoof Oponpoulahtuinodnrdeodubmleintgaphase sproads ware scored fwoirthcthhreoemoxscomeapl toafbieoornrneatiroenpslicfartoemcuelatcurhecruelatulreed, wwith hC7y5clemoeptharopshpahesaemsidweer(forsetxammaiinnede.xperiment), Fthoer ttheestfsttoemxpeCri0m4ent,CYfColLlIoCwi,ngnto.reasttamteinstticwailtlhy sbieganriifnigcanatberIrnactriooansso ininclutdhiengionrciedxecnlcuedinogf gcaalplss wmeatsabooblsisemr.vedIninthteheparbasseonnccee oofr SpOrosmeetnacbeoolfisSmO, emnadrokreeddupliicnactreedasecsells Inoverthtohe cnounmtrboelrweroef o`ebnsdeorrveeddu.pliAcantedicneclrlosawseasianlsothoebsenruvmebdeirn thoef
P-SDSofF-DioxAcidAmmonium Salt CAS No 1190931-27-1
1
sabseenlcoofoocrfstc$o9roinmdge,tabolism at the highest dose wFiotrhthtehesecteosntd etxopmeriimnent,hofoalobwsienngcetreoaftmeSnOt metabolism, light increases but not statistically
saibgenrirfaitciaonnts,Inextchleudiinngcigdeanpcse, oofvercaltlhse bceoanrtirnogl voablsueersvweadrset al dose levels selected for scoring. wMeorreeorebmarskawblheeanirnIcnrcelvuadsienseggoafdpsa.berrant coll
saibgenrirfaitciaonnts,Inextchleudiinngcigdaepnsc,e oovfercaltlhse bceoanrtionlg
fvoarluesscowrianrg.obMsoerrveedraelmaairlkdabolsee leIvneclrseasseelsecteodf
aberant cells were observed whon Including
gIanpst.he presence of So metabolism, statistically
cseilglnsifIinccanltudiinngcraonadseesxcinlutdhiongingcadposnwceeroefoabbseerrrvaendt
at the vgimi).
highest
dose
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cSetlaltsisbtiecaarlliyngsiagbneifrircaatnitonisnc(rienacsleusdiinng tahnedneuxmcbleudrinogf
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L`ciosndailtsiooncso.ncludedthatthetes fem inibiscoll
``p ecuuncdlxeer rthperoeeporgrtediranmdecherosnmosts coonmdaeiisleolgnrsoe.galnion
--RotAmex 10
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Gene mutation in bacteria on confidential inforhasmbaeentriemoovned
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In_coit cnancbelstu ates d thi atcoC6n 04 Am_moS nia umlt_di indd uce_chn romo osot me `mutationsinthebonemarrowcells oftheratin
condo formaionhas--bReaenrtooe1d1 vo,
cononma t hasbr anroaod
P-SDSofF-Diox Acid Ammonium Salt CAS No 1190931-27-1
"
inforhasmbeaentriemoovned
82 General toxicity
821 Subchronlc (90d) oral toxilty: -
822 Ccahrrcoinniocgetnoixciictityy:!
823 Roproductionfieratogenleity: .
824 Other Information:
.
83 Metabolism
b8l3o4transfAobrsmoartpitoinona,nddiesxtcrriebuttiioonn:,
-
832 Accumulation in man:
-
833 Othor Information:
-
84 Miscollancous
844 Effects on Immuno systom: :
842 Neurotoxicity:
-
843 Introduction on poroxisome -
proliferation:
844 Other information:
2
P-5DS of F-Diox Acid Ammonium Salt GAS No 1190931271
LIST OF ANNEXES
Annex1:confinfiormdatioen hans btoeniremaoveld, P-SDS item 1.2.9; Annex 2: confinfiormadtioen hans btoenireamovled, P-SDS item 1.2.9;
Annex 3:coniidential informationhas been removed, P-SDS tem 1.2.10; Annex 4:coniidnialinformationhas boen removed P-SDS item 1.2.11, 1.2.12;
Annex 5: TGA Curve F-Diox Acid Ammonium Salt, P-SDS item 2.1.3, 2.2.3;
Annex 6:cionfnidafnt ormhaastboein reomovned P-SDS item 2.2.5; Anne7x:conlidential informationhasbeen removed P-SDS item 5and 6;
Annex 8 RTC report no. 76250: C604 Cyc-Bl actierical Mutation Assay 20 October 2009, P-SDS item 8.1.1;
Annex 9 HARLAN report no. 1305602 cC604 Ammonium Sal--t Mutations in L5178Y TK" mouse lymphoma cells (fluctuations method), 14 July 2010, PSDS item 8.1.2;
Annex 10 RTC report no. 76240: C604 Cy--c Chrl omi osoc me aberrations in Chinese Hamster Ovary cells in vitro, 9 October 2009, P-SDS item 8.1.3.
Aonox RBror, 3050: C604 Ammonium Sat --
C20h1r0o,mPo-sSoDmSe ialtem 8.1.t4i.ons in Bone Marrow Cells of the Rats in vivo, 13 July
Annex12:confiniformdatieonhans btoonireamovled P-SDS item 8.1.4 Annex 13:coniidentialinformationhas been removed P-SDS item 5.3; Annex 14: confidanial information hasbeenremoved P-SDSitem 8.1.4 Annex 15 canfinfoirmatdionhoasnbootnroirovled P-SDS item 5.3.1