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Final report on the safety assessrnent http://www.ncbi.nlm.nih.gov/pubmed/I 7365 I 3

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IntJ Toxicol. Suppl1:115-27


2O07;26

of polyethylene.
Final report on the safetyassessment
[,lo authors listed]

Abstract
Polyethylene is an ethylerepolymerusedfor a varietyof purposesin cosmeticsAs an abrasive,adhesive,birder or
bulkingagent,an emulsion a filmformer,an oralcareagent,and as a nonaqueous
stabilizer, viscosity-increasingagent.
Polyethylene is also usedin food packagingmaterialsand medicalproducts,includingprosthetics.The molecularweightof
Polyethylereas used in cosmeticsvariesovera wide range.The lowestreportedmolecularweightis 198 Daltonsand the
highestis 150,000.ln anygivenpolymerpreparation, therecanbe a broadrangeof molecular weights.Cellularandtissue
responsesto Polyethylene, determinedas part of implantbiocompatibilltytesting,inc[de fibrousconnecti\€tissuebuild-up
aroundthe implantmaterialthat variesas a functionof the physicalform of the implantmaterial.Specificassaysfor
osteoblastproliferationand collagensynthesisdernonstrated a reductionas a functionof eposure to Polyethylere
particlesthat is innerselyrelatedto particlesize.Tle effect of Polyurethareparticleson monocyte-derived macrophages,
howerler,had a stimulatoryeffect, prolongingthe survivalof thesecells in culture.The LD50for Polyethylene, with an
averagemolecularweigfrtof 450, in rats was > 2000 mg/kg.For Polyethylerewith an averagemolecularweightof 655,
the LD50was > 5.0 g/kg. Toxicitytestingin rats showsno adverseeffectsat Polyethylene (molecularweightnot given)
dosesof 7.95g/kg or at 1.25o/o, 2.50o/o,or 5.00%in feedfor 90 days.Dermalirritationstudieson rabbitsinwhich0.5 g of
Polyethylene (averagemolecularweightof 450) was administeredin 0.5 ml of water causedno irritationor corrosive
effects;Polyethylene with an a\erage molecularweigfrtof 655 was a mild irritant.Polyethylene (averagemolecularweigfrt
of 450) did not causedermalsensitization in guineapigs testedwith 50% Polyethylene (w/w) in arachisoil BP.
Polyethylene, with a molecularweightof 450 ard a molecularweightof 655, was a mild irritantwhentestedas a solid
materialin the eyes of rabbits.Rabbiteyes treatedwith a solntioncontaining13% Polyethylene beadsproducedminimal
irritationand no cornealabrasions.Nogenotoxicitywas fourd in bacterialassays.No chemicalcarcinogenicity has been
seen in implantation studies,althoughparticlesfrom Polyethylene implantscan induceso-calledsolid-statecarcinogenicity,
whichis a physicalreactionto an implantedmaterial.Occupational case reportsof ocularirritationand systemicsclerosis
in workerse4gosedto Polyettrylene havebeendifficultto interpretbecausesuchworkersare also e4cosedto other
irritants.Clinicaltestingof intrauterinedevicesmadeof Polyethylene failedto conclusively identifystatisticallysignificant
adverseeffects,althoughsquamousmetaplasiawas observed.The CosmeticIngredientReview(ClR) ExpertPaneldid
not expectsignificantdermalabsorptionard systemice4cosureto largePolyethylene polymersusedin cosmetics.The
Panelwas concernedthat informationon impurities,includingresidualcatalystand reactantsfrom the polymerization
process,was not available.The Panelconsideredthat the monomerunitin Polyethylene polymerization is ethylene.In the
UnitedStates,ethyleneis 99.9%pure.The other0.17oincludesethane,propylene, carbondioxide,carbonmono*de,
sulfur,hydrogen,acetylene,water, and orygen.The Panelbelievedthat the concentration of these impuritiesin any final
polymerwouldbe so low as to not raisetoxicityissues.Safetytests of cosmetic-gradePolyethylerehaveconsistently
failedto identifyany toxicityassociatedwith residualcatalyst.Althonghit was reportedthat one processusedto cross-link
Polyethylene with an organicperoxide,this processis not currentlyused. ln addition,cosmetic-gradePolyethylereis not
expectedto containtoxic hexanes.The Parel was concernedthat the onlygenotoxicitydata availablewas nonmammalian,
but takingthis informationin concertwith the absenceof any chemicalcarcinogenicity in implantstudiessuggestsno
genotoxicmechanismfor carcinogenicity. The solid-statecarcinoQenicityeffect was not seenas relevantfor Polyethylene
as usedin cosmetics.The availabbdata supportthe conclusionthat Polyethylene is safe for use in cosmeticformulations
in the practicesof use and concentrations described.

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