Animals and Alternatives in Toxicology: Present Status and by Michael Balls, James Bridges, Jacqueline Southee

By Michael Balls, James Bridges, Jacqueline Southee

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I have several general comments to make before addressing the specific recommendations. As the Report notes, there has been a shift in focus over the last six years from the development of new assays to their validation as alternative tests. This was a much needed step, since we have been overwhelmed with numerous new tests, all claiming to provide the answer, but with insufficient data for making informed decisions. It's time to clean off the shelf and sort through these tests to select those truly worthy of a serious validation effort.

Data handling and hazard classification Different approaches to the classification of ocular hazard based on the rabbit eye test and the scoring system of the Draize eye test have been developed by the EEC, the US Federal Hazardous Substances Act (FHSA) and the US National Academy of Sciences (NAS; 56). The scores are made up of features of variable importance and are processed differently. Thus a different classification may result from the same experimental data. Systems for classifying ocular hazard should be harmonised at the international level, in order to produce a consistent rating for a given material.

In this case, one needed to use a large number of laboratories in order to avoid these criticisms. In other situations, I do not think it would be necessary-given a different endpoint, a different argument to be proved, it could well be that a much smaller number of laboratories would be sufficient. However, it will probably still be important to get some international involvement, preferably in both the EEC and other OECD countries. Michael Balls-1 would like to make one or two points. First, at the same time that the Fixed Dose Procedure was being validated, the BGA came up with a very good scheme, which was more or less dismissed out of hand, because the people who invested in the EEC trial on the Fixed Dose Procedure wanted a successful outcome.

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