Risk Assessment – History and Future

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Methods validated by ICCVAM, ECVAM, and accepted for regulatory use by OECD Endpoint Method Validated and Recommended for Regulatory Use: Skin Penetration In Vitro Skin absorption OECD 428 Skin Irritation EPISKIN with MTT Reduction and IL-1α release ECVAM: as a replacement ICCVAM: as a screen in a tiered-testing strategy EpiDerm with MTT Reduction and IL-1α release ECVAM: as a replacement (a negative result may require further testing) ICCVAM: as a screen in a tiered-testing strategy Skin Corrosivity Corrositex ECVAM: as a replacement ICCVAM: as a screen in a tiered-testing strategy OECD 435 In Vitro Skin Corrosion: Human Skin Model Test OECD 431 Genotoxicity Ames-Bacterial Reverse Mutation Test OECD 471 In Vitro Mammalian Chromosome Aberration Test OECD 473 In Vitro Mammalian Cell Gene Mutation Test OECD 476 Skin Sensitization LLNA in mice OECD 429
Science and Decisions: Advancing Risk Assessment (2009) National Research Council Committee on Improving Risk Analysis Approaches Used by EPA Board on Environmental Studies and Toxicology The ‘Silver Book’
Page 1 and 2: Risk Assessment - History and Futur
Page 3 and 4: Risk assessment • A scientific pr
Page 5 and 6: Threshold or non-threshold? NEL = N
Page 7 and 8: Risk assessment: threshold Hazard I
Page 9 and 10: Risk assessment: non-threshold effe
Page 11 and 12: Margin of exposure (MOE) • DNA-re
Page 13 and 14: Key event • An empirically observ
Page 15 and 16: Toxicity Testing in the 21st Centur
Page 17: Perturbation of toxicity pathways E
Page 21 and 22: Advantages of focusing on MOA • U
Page 23 and 24: Consider ….. • “Some aspects
Page 25: HESI Risk 21 - Key areas of focus

Risk Assessment – History and Future

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