TABLE IV

Summary of Available Literature for Key Leachables

CompoundGenetic ToxicityOcular Irritation/ToxicitySensitization
AntioxidantNo data availableMinimal reversible irritancy observed at 800× concentration on eyeNo indication of sensitization at doses higher than leachable level
PlasticizerNegative genotoxicity but listed on California Proposition 65 list of hazardous substances with a recommended safe level of 9.8 µg/day (from all sources)NonirritantNo indication of sensitization at doses higher than leachable level
Resin intermediateNegative in all test systemsStrongly irritating when tested neat (10 mg) on rabbit eye; no data at lower concentrationsNo indication of sensitization