ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Irritant

A chemical that is not corrosive but that causes a reversible inflammatory effect on living tissue by chemical action at the site of contact. A chemical is a skin irritant if, when tested on the intact skin of albino rabbits by the methods described in CFR 16 1500.41 for four hours exposure, or by other appropriate techniques, it results in an empirical score of 5 or more. A chemical is an eye irritant if so determined under the procedure listed in CFR 16 1500.42 or other appropriate techniques.

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