Regular Article :AATEX 3(4):162-167
A collaborative validation study with laboratories was conducted to evaluate three-dimensional cultured cell method, SKINTM Model ZK1000R (SKIN2), as an alternative to the Draize rabbit eye irritation test (Draize test) using physiological saline and 9 surfactants. MTT (3-[4,5-dimethylthiazole-2-yl]-2,5-diphenyl tetrazolium bromide)-50 values. indicating the concentration of test materials which reduce cells survive to 50% of control, were compared to the results of the Draize test. Physiological saline (S-1) and POE hydrogenated castor oil (S-2) had MTT-50 values greater than 10,000ug/ml and were classified as non-irritants, which coincided with the classication by the Draize test. Correlation coefficients for comparison of the MTT-50 values for the other eight surfactants with the maximum average Draize total score (MAS), the score at 24-hours, and the area under the Draize score-time curve (AUC) were -0.92, -0.91, and -0.91, respectively. Higher correlations with cornea and conjunctive scores were noted. Interlaboratory differences in the results were not significant. These results indicate that SKIN2 test is promising as a useful and reliable alternative method to the Draize test.
Key words: validation study, Draize eye irritation test, alternatives, surfactant, dermal model, in vitro, MTT, 3D-culture.