Plasticizers in denture soft-lining materials: leaching and biodegradation.

The leaching from soft lining materials into an aqueous buffer with the same esterase activity as that of saliva was compared to leaching into buffer without esterase activity. The buffer contained 0.1% non-ionic detergent, giving the medium a capacity to dissolve phthalates to the same degree as saliva. The hypothesis that esterase in the immersion medium will increase the rate of diffusion of plasticizers from denture soft-lining material was confirmed by the results. The average leaching of phthalates from 5.5 g of one of the materials was 4.5 mg kg(-1) d(-1) within the first 2 d and 1.1 mg kg(-1) d(-1) within the first 28 d. These levels may be compared to a LOAEL (lowest observed adverse effect level) of 52 mg kg(-1). It is concluded that an esterase activity, equivalent to that in saliva, in the immersion medium for soft lining materials increased the rate of diffusion of plasticizer from the materials. The measured levels of phthalates leaching from these materials might in vivo only be slightly less than 1/10 of the LOAEL given above.