Toxicological studies on bestatin. IV. Studies on antigenicity, ocular mucosal irritation and mutagenicity.

The antigenicity, local irritation and mutagenicity tests of bestatin (NK421) were carried out as special toxicity studies. The antigenicity tests in rabbits and guinea pigs were as follows: active and passive anaphylactic shock tests, Schultz-Dale reaction test, PCA (passive cutaneous anaphylaxis) reaction test, agar gel precipitation test, hemagglutination test of tannic acid-treated erythrocyte and the test according to the appraisal in the U.S.A. The ocular mucosal irritation test in rabbits was performed as a local irritation test. The mutagenicity test was made using S. typhimurium TA100, TA98 strains by means of preincubation method. The results were that NK421 had no antigenicity, irritation on the ocular mucosa and mutagenicity.