Local Tolerance

Irritation, allergy and hemolysis refer to the toxicity to the local area of administration (e.g., irritation and local allergy, etc.) and/or systemic toxicity (e.g., systemic allergy and hemolysis, etc.) of the drug when administered via the skin, mucous membranes, cavities, blood vessels and other non-oral routes as part of the preclinical safety evaluation. The original form of the drug and its metabolites, excipients, related substances and physicochemical properties (e.g. pH value, osmolality, etc.) may cause irritation and/or allergy and/or hemolysis, so the drug should be investigated for local and/or systemic toxicity caused by its preparation at the site of administration prior to its clinical application, in order to predict the possible toxic reactions, toxic target organs, and the range of safety in the clinical application.