Article: Evolution of toxicological science: the need for change Journal: International Journal of Risk Assessment and Management (IJRAM) 2017 Vol.20 No.1/2/3 pp.21 - 45 Abstract: Evolution requires change but the field of toxicology has not kept pace. The top ten problems urging change are: 1) disparity of testing requirements and risk acceptance for different products and geographical areas; 2) throughput and testing costs versus testing needs; 3) limited predictivity for humans; 4) precautionary approaches from drug development adapted to other areas; 5) animal use; 6) traditional tests unsuitable for new products; 7) lack of coverage for new hazards; 8) failure to address mixtures of toxicants; 9) lack of coverage for individual susceptibilities and vulnerable subpopulations; 10) poor basic research and publication standards. The intransigence at the root of these problems is discussed with reference to current international toxicological policies and methods. For each, the limitations are reviewed with reference to key literature. While current approaches are still needed, there is room for substantial change. To meet the challenges of the 21st century, revolution rather than evolution is required. Inderscience Publishers - linking academia, business and industry through research

Title: Evolution of toxicological science: the need for change

Authors: Thomas Hartung

Addresses: Center for Alternatives to Animal Testing, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, W7032, Baltimore, MD 21205, USA; CAAT-Europe, University of Konstanz, Germany

Abstract: Evolution requires change but the field of toxicology has not kept pace. The top ten problems urging change are: 1) disparity of testing requirements and risk acceptance for different products and geographical areas; 2) throughput and testing costs versus testing needs; 3) limited predictivity for humans; 4) precautionary approaches from drug development adapted to other areas; 5) animal use; 6) traditional tests unsuitable for new products; 7) lack of coverage for new hazards; 8) failure to address mixtures of toxicants; 9) lack of coverage for individual susceptibilities and vulnerable subpopulations; 10) poor basic research and publication standards. The intransigence at the root of these problems is discussed with reference to current international toxicological policies and methods. For each, the limitations are reviewed with reference to key literature. While current approaches are still needed, there is room for substantial change. To meet the challenges of the 21st century, revolution rather than evolution is required.

Keywords: toxicity testing; high throughput; precautionary approach; susceptible populations; toxicological science; toxicology; testing requirements; risk acceptance; throughput costs; testing costs; testing needs; drug development; animal use; traditional tests; new products; new hazards; toxicant mixtures; toxicants; individual susceptibilities; vulnerable subpopulations; poor basic research; publication standards.

DOI: 10.1504/IJRAM.2017.082570

International Journal of Risk Assessment and Management, 2017 Vol.20 No.1/2/3, pp.21 - 45

Received: 21 Jan 2016
Accepted: 05 Feb 2016
Published online: 01 Mar 2017 *

Title: Evolution of toxicological science: the need for change

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