Regulations and guidelines exist for the safe marketing, labelling, and (in some cases) transportation of chemicals, pesticides, pharmaceuticals, and consumer products. Many of the provisions require manufacturers to conduct testing to identify potential hazards to human and animal health, and to submit the test data to regulatory authorities.
Most of the toxicity tests for hazard assessment are animal tests that were developed decades ago. There are many scientific, ethical, and economic advantages to replacing these animal toxicity tests with non-animal (in vitro and in silico) test systems.
This section has been adapted from the AltTox, Non-animal Methods for Toxicity Testing website.
For more information on toxicity testing, the following resources may be useful.
- This organization aims to advance non-animal methods of toxicity testing. It is produced through the collaboration of Procter & Gamble Company (P&G) and the Humane Society of the United States (HSUS). The website's informational section, Toxicity Testing Resource Center (TTRC), provides a comprehensive source of information on non-animal methods of toxicity testing.
- Johns Hopkins Center for Alternatives to Animal Testing (CAAT)TestSmart
- The Johns Hopkins Center for Alternatives to Animal Testing (CAAT) established a toxicology risk assessment model called TestSmart, and seeks to identify newer, better testing methods than those commonly used or accepted today. TestSmart symposiums have been held on the following topics: High Production Volume (HPV) Chemicals, Pharmaceutical Safety Assessment, Endocrine Disruptors, and Developmental Neurotoxicity. Proceedings and recommendations from these workshops can be accessed online.
- Burden N, Sewell F, Chapman K (2015) Testing Chemical Safety: What Is Needed to Ensure the Widespread Application of Non-animal Approaches? PLoS Biol 13(5): e1002156. doi:10.1371/journal.pbio.1002156
- Chapman K. and Robinson S. (2007) Challenging the regulatory requirement for acute toxicity studies in the development of new medicines: A workshop report. The National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs).
- Chapman K., Sewell F., Allais L., Delongeas J.-L., Donald E., Festag M., Kervyn S., Ockert D., Novues V., Palmer H., Popovic M., Roosen W., Schoenmakers A., Somers K., Start C., Stei P. and Robinson S. (2013) A global pharmaceutical company initiative: An evidence-based approach to define the upper limit of body weight loss in short term toxicity studies. Regulatory Toxicology and Pharmacology. (in press)
- Committee on Toxicity Testing and Assessment of Environmental Agents, National Research Council (2007) Toxicity Testing in the 21st Century: A Vision and a Strategy. Washington DC: The National Academies Press.
- European Centre for the Validation of Alternative Methods (ECVAM) Workshop Reports.
- US Consumer Product Safety Commission (CPSC) (2012) Recommended Procedures Regarding the CPSC's Policy on Animal Testing. Bethesda MD: CPSC.
- Phillips B., Smith D., Combes R., Descotes G., Jacobsen S.D., Hack R., Kemkowski J., Krauser K., Pfister R., Rabemampianina Y., Sparrow S., Stephan-Gueldner M. and von Landenberg F. (2004) An approach to minimise dog use in regulatory toxicology: production of a best practice guide to study design. Alternatives to Laboratory Animals (ATLA) 32(Suppl.1):447-451.
- Robinson S., Delongeas J.- L., Donald E., Dreher D., Festag M., Kervyn S., Lampo A., Nahas K., Nogues V., Ockert D., Quinn K., Old S., Pickersgill N., Somers K., Stark C., Stei P., Waterson L. and Chapman K. (2008) A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development.Regulatory Toxicology & Pharmacology 50(3):345-352.
- Smith D., Combes R., Depelchin O., Jacobsen S.D., Hack R., Luft J., Lammens L., von Landenberg F., Phillips B., Pfister R., Rabemampianina Y., Sparrow S., Stark C. and Stephen-Gueldner M. (2005) Optimising the design of preliminary toxicity studies for pharmaceutical safety testing in the dog. Regulatory Toxicology & Pharmacology 41(2):95-101.
- Whitehead A. and Stallard N. (2004) Opportunities for reduction in acute toxicity testing via improved design. Alternatives to Laboratory Animals (ATLA) 32(Suppl.2):73.
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