Local Tissue Tolerance in Pharmaceutical

IRRITATION AND LOCAL TISSUE TOLERANCE IN PHARMACEUTICAL SAFETY ASSESSMENT 

Both irritation and local tolerance studies assess the short-term hazard of pharmaceutical agents in the immediate region of their application or installation. In particular, these studies are done (expected) to assess topically or parenterally administered drugs. 

For the skin, this scale is used in the primary dermal irritation test, which is performed for those agents that are to be administered to patients by application to the skin. As with all local tolerance tests, it is essential that the material be evaluated in condition of use, that is, in the final formulated form, applied to test animals in the same manner that the agent is to be used clinically. 

Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4 

Slight edema (edges of area well-defined by definite raising) 2 

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