Assessment of surfactant cytotoxicity: comparison with the Draize eye test.

Synopsis We have compared the in vitro cellular toxicity and the in vivo ocular irritation potency of 16 surfactants (7 non ionics, 3 anionics, 2 amphoterics, 4 cationics) ranking from very weakly irritant to strongly irritant. In vitro, the cellular toxicity was estimated on Chinese hamster lung fibroblasts (V79) using a cell mortality test and a cell growth inhibition test. For each surfactant, a lethal concentration 50% without foetal calf serum (LC.50-0) and with 10% foetal calf serum (LC50-I0), as well as the concentration required to reduce 50% of the growth (CI.50) were determined. In vivo, each surfactant was applied directly to the cornea of six albino rabbits. The maximal ocular irritation score (I0 max) and the ocular irritation score obtained seven days later (I0 J7) were collected. Comparison of in vitro results with those obtained in vivo showed good correlations, particularly when I0 max and the difference (LC.50-10 - LC50-0) were considered (r= 0.845, P<0.001). These results suggest that the use of cell culture tests as pre-screening systems to appreciate eye irritation potency of surfactants could be a reliable alternative method in order to reduce the use of the Draize rabbit eye test. They can provide a better knowledge of the irritative process induced by surfactants (cellular toxicity and protein interaction potency).