Tiered testing strategies--acute local toxicity

More work has been done to develop alternatives to animal use in the areas of eye and skin irritation than in any area other than carcinogenicity. There has long been a belief both in the scientific community and among the public that the development of nonanimal tests in these areas should be simple and straightforward. After more than 20 yr of research, we can identify materials corrosive to the skin without using animals, but the assessment of irritation using in vitro methods alone is still an illusive goal. This review of current recommendations and industry practices that reduce the number of animals needed for these two tests concludes that animal use for skin irritation testing is not necessary today, with currently available and accepted methodology, except for regulatory reasons. Scientifically sound improvements in current eye irritation methods are also available. Advances in the understanding of the mechanisms of eye irritation that have been made in the last 5 yr should lead to improved in vitro methods for this endpoint. In the meantime, changes should be made in the current animal protocol to reduce pain and distress. This paper provides an overview of the progress that has been made toward discontinuing the use of animals in tests to determine the potential of materials to cause skin or eye damage after a single acute exposure. It also discusses some additional changes that could be made now to reduce animal use further or to reduce pain and distress in the testing that must still be done until such time as we can meet the ultimate goal--validated and accepted nonanimal methods for these endpoints.