Evaluation of a new approach to the safety assessment of biomaterials.

The effectiveness of a bacterial luminescence inhibition assay in assessing the toxicity of compounds which are released from biomaterials was evaluated. Luminescence from a strain of bacteria most closely resembling Photobacterium phosphoreum was measured. The concentration that inhibited luminescence by 50% (EC50) was determined for selected plasticizers, monomers and additives. The intraperitoneal (i.p.-ALD) and intravenous (i.v.-ALD) approximate lethal doses were determined using mice. By ranking the reference compounds toxic/non-toxic, a 37.5% agreement was obtained for the i.p.-ALD and i.v.-ALD toxicity data. While there was only a 12.5% agreement for the i.p. ALD and EC50 values, there was a 75% agreement between the i.v.-ALD and EC50 values. Although additional validation is required, these results provide preliminary indications that the bacterial luminescence inhibition assay is a promising alternative approach to the safety assessment of biomaterials.