Evaluation of a New Approach to the Safety Assessment of Biomaterials

Abstract

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 hoshoreum 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.