Benzalazine (2-hydroxy-5-[(4-carboxyphenyl) azo] benzoic acid, CAS 648
96-26-0), a new agent for the treatment of ulcerative colitis and Croh
n's disease of the large intestine, was studied for genotoxic effects
by using the following short-term in vitro and in vivo test: 1. revers
e mutation test (Ames method) on Salmonella typhimurium, 2. HGPRT (hyp
oxanthine-guanine phosphoribosyl transferase) point mutation test on V
79 hamster cells, 3. in vivo cytogenetic test on Chinese hamster cells
, and 4. in vivo sister chromatid exchange test on Chinese hamster cel
ls. Benzalazine did not show any positive response in the reverse muta
tion test, HGPRT-point mutation test, in vivo cytogenetic and sister c
hromatid exchange test.