Document BRx20v3q14VbxK6J9yo8L0mZJ

OECD polymer of low concern (PLC) criteria and additional customeer related criteria OECD = Organisation for Economic Co-operation and Development Polymers currently in use Polymer composition MW, Mn, MWD Fluoropolymer PTFE TFM-PTFE PFA FEP Flourpolymer Coating Alternative Materials (just as examples) UHMW-PE PEEK PA 1014 PMMA PPS PI Glass Symbols Meaning Accept Not fulfilled Accept with limitations Nearly not fulfilled Legend Polymer composition Polymer composition, structure & elemental composition; including CAS no. MWN,uMmnb,eMr aWveDrage molecular weight and oligomer content are used criteria for PLC assessment. MWD --> polydispersity Wt-% oligomer Weight % of oligomers < 1000 Da ElecEtlr.icCahl.cohrairogneic character can be: anionic, cationic, amphoteric, nonionic; cationic polymers associated with aquatic toxx Reactive functional groups (RFG) Atom or associated group of atoms in a chemical structure that is intende Functional group equivalent weight (FGEW) FGEW is defined as the ratio of Mn to the number of functional groups in Low MW leachablAerse chemical molecules, either inorganic or organic, that migrate (i.e. leach) out of the polymer Water/lipid solubility,octanol water partition Water solubility = extent to which a compound will dissolve in water; neg Particles tPhaarttiacrle smizeall enough to reach the deep lung upon inhalation are associated with adverse health effects. Polymer particles to physical, Pchoelymmiecarls,tbaiboilloitgyical transformation. Breaking down into smaller particles is ccritical. Molecules with Mn<1000 Da are capa ThTeormbealasstsaebsislietyd when used as intended or in extreme temperature during dosposal. Theermal stability testing may involv Abiotic stability Polymers are stable, monomers are not. Abiotic degradaton may involve sunlight, water or oxygen. BIsioatsiscesstsaebdilibty whether the polyymer is degraded by microorganisms under oxygenated (aerobic) or anoxic ( anaerobic) co Acid resistance In presence of acid media the polymer may not change its properties sign Caustic resistance In presence of caustic media the polymer may not change its properties s Solvent resistant In presence of solvents the polymer may not change its properties signific Wt-% oligomer Electrical charge Reactive functional groups (RFG) Functional group equivalent weight (FGEW) uding CAS no. ssment. MWD --> polydispersity index mers associated with aquatic toxxicity hemical structure that is intended or can be reasonable expected to undeergo facile chemical reaction e number of functional groups in the polymer ach) out of the polymer pound will dissolve in water; negligible water solubility < 1x10E-6 mg/L = 1 ppt health effects. Polymer particles should be > 5 m cules with Mn<1000 Da are capable of crossing cell membranes ermal stability testing may involve TGA unlight, water or oxygen. aerobic) or anoxic ( anaerobic) conditions ay not change its properties significantly r may not change its properties significantly not change its properties significantly Low MW leachables Water/lipid solubility,octanol water partition Particle size Polymer stability Thermal stability Company: 2mag AG Abiotic stability Biotic stability Acid resistance Caustic resistance Solvent resistance