Validation of an In Vitro Human Airway Model for Regulatory Toxicity Testing

Results of Phase II research indicate that formal validation of the EpiAirwayin vitro human bronchial tissue model for predicting toxicity of inhaled chemicals is an attainable goalThe proposed Phase IIB cooperative agreement project is intended to realize this goal by conducting formal ring trial validation studies that will be submitted to regulatory agencies and the Organization for Economic Co operation and DevelopmentOECDin support of formal adoption for regulatory useAimwill develop the final validation plan in collaboration with an NIH Steering CommitteeSCIn Aiman expanded of setchemicals will be tested in the lead project laboratory to verify the accuracy and relevance of the final prediction modelIn Aimtraining of the participating ring trial testing laboratories will occurIn Aimthe transferabilityreproducibilityaccuracy and relevance of the EpiAirwaymodel and protocols will be established by conducting formal ring trials inGLP compliant contract research laboratoriesPreparing a final report of all study activities and submission of the study data to relevant US regulatory agencies and the OECD in support of adoption as a test guideline for regulatory use will be the goal of aimThe technology to be validated in the current Phase IIB proposal will be the first non animal model for use in regulatory inhalation toxicity testingSuccessful completion of the Phase II project will address a critical barrier to implementation of worldwide requirements for inhalation toxicity testing of chemicalsand provide a technical capability that is urgently needed but that does not presently existThe validated model and testing protocol will be utilized worldwide by a wide variety of chemical manufacturersconsumer product manufacturers and industries which utilize chemicals to produce other productsSpecific US federal agencies that may adopt and accept results of the validated test system include the Consumer Product Safety CommissionCPSCthe Environmental Protection AgencyEPAand the Occupational Safety and Health AdministrationOSHAThe European Chemicals AgencyECHAwill also be able to utilize data produced by the validated test system in support of hazard assessment in EU countriesFormal validation and adoption of the EpiAirwaymodel and test system will generate commercial sales resulting from direct utilization by chemical manufacturersconsumer product manufacturers and regulatory agenciesAdditional revenue will be generated by offering the EpiAirwayRespiratory Toxicity test as a contract service that may be offered by numerous contract testing laboratoriesincluding MatTek Corporation The proposed Phase IIB cooperative agreement project will validate the EpiAirway Respiratory Toxicity test by conducting formal ring trial studies that will be submitted to regulatory agencies and OECD in support of adoption for regulatory useThe technology will be the first non animal model for use in regulatory inhalation toxicity testingwill address a critical barrier to implementation of worldwide requirements for inhalation toxicity testing of chemicalsand provide a technical capability that is urgently needed but that does not presently existThe validated model and testing protocol will be utilized worldwide by a wide variety of chemical manufacturersconsumer product manufacturers and industries which utilize chemicals to produce other productsSpecific US federal agencies that may adopt and accept results of the validated test system include the Consumer Product Safety CommissionCPSCthe Environmental Protection AgencyEPAand the Occupational Health and Safety AdministrationOHSAThe European Chemicals AgencyECHAwill also be able to utilize data produced by the validated test system in support of hazard assessment in EU countries