Subacute administration of Plak-Lite sodium fluorescein solution in hamsters

The purpose of this research was to evaluate the potential toxic effects of Plak-Lite disclosing solution, which contains 0.75% sodium fluorescein U.S.P. in buffered glycerol in hamsters under defined and exaggerated conditions. In oral dosing experiments, volumes calculated at least 50, 200 or 1000 times the human daily use level were administered. For intraoral application the 1000 X human use level was selected. The control group was dosed orally with the 1000 X dose volume of water. All animals were treated once a day for 31 or 92 days. Daily examination of animals revealed no overt drug or dosing-related effects. Weights recorded at 31 or 92 days were similar for all groups. Histological evaluation performed on tongue, oral mucosa, cheek pouch, stomach (3 sections), liver, kidney, spleen, small intestine (3 sections), large intestine and bladder revealed no pathological changes. This study demonstrates the safety of Plak-Lite disclosing solution when administered at exaggerated dose levels via routes simulating human use.