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By Shayne Cox Gad; Christopher P Chengelis
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Observe all animals at 24, 48, and 72 hr after injection. 5. Reclip the fur as necessary during the observation period. If each animal at any observation period shows an average reaction to the test sample that is not significantly greater than that to the blank, the test sample meets the requirements of this test. If at any observation period the average reaction to the test sample is questionably greater than the average reaction to the blank, repeat the test using three additional rabbits. On such a repeat test, the average reaction to the test sample in any of the three animals is not significantly greater than the blank.
IN VITRO ALTERNATIVES Extensive progress has been made in devising alternative (in vitro) systems for evaluating the dermal irritation potential of chemicals since this author last reviewed the field (Gad and Chengelis, 1988). This is an effort that extends back to the early 1960s (Choman, 1963), but which saw little progress until the 1990s. Table 6 overviews 20 proposed systems that now constitute five very different approaches. The first set of approaches (I) uses patches of excised human or animal skin maintained in some modification of a glass diffusion cell which maintains the moisture, temperature, oxygenation, and electrolyte balance of the skin section.
A r e there possible interactions between measurements? Can they be separated/identified? w I s our N (sample size) both sufficient and efficient? J W h a t is the controlmformal or informal? Is it appropriate? - - A r e we needlessly adding confounding variables (asking inadvertent or unwanted questions) ? w A r e there "lurking variables" present? There are undesired and not readily recognized differences which can affect results, such as different technicians observing different groups of animals.