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5 ml is carefully poured from a glycine weighing paper onto the gauze patch, which is held in a horizontal (level) position 3 Tests for Dermal Irritation and Corrosion 9. 10. 11. 12. 13. 14. 15. 16. 39 with the other hand. The patch containing the test sample is then carefully placed into position onto the skin by raising the remaining three edges with tape dorsally until they are completely secured. 5 ml of physiological saline. If the test substance is a liquid, a patch is applied and secured to the appropriate skin site.

This is a 2 Acute Toxicology Program: Study Design and Development 29 question which can only be resolved by reference to experience or historical control data. III. , what answers are possible to both our subquestions and our major question? - - H o w do we use these answers? - - D o the possible answers offer a reasonable expectation of achieving the objectives that caused us to initiate the study? - - W h a t new questions may these answers cause us to ask? Can the study be redesigned before it is actually started so that these "revealed" questions may be answered in the original study?

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.

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Acute toxicology


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