ABSTRACT
In an attempt to build the evaluation strategies to assess the human eye irritation, a reassessment of some in vitro tests is necessary, particularly concerning the non-irritants, mild and moderate irritants. Thus, the correlations between results obtained from the Draize test with the in vitro methods HET-CAM (Hens Egg Test-Chorion Allantonic Membrane) and RBC haemolysis assay to assess the ocular irritancy potential of 20 eye drops were examined. Parameters such as accuracy (%) and specificity (%) were determined. All results were correlated with RBC correctly with the results obtained in the Draize test. The HET-CAM presented four false-positive results, showing a tendency of data overestimation. Despite the high specificity provided mainly by the RBC, it would be necessary to test a wider range of products representing all the scales of irritation to confirm its ability to be used as a first alternative to test products that could be presumptive non-irritants.
ABSTRACT
The aim of this work was to determine the correlation between results obtained from the Draize test and from the Total Protein Content Determination (TPC) to assess the ocular irritancy potential of 20 shampoos. For TPC, two established cell lines (SIRC and 3T3) were used. The concentration that induced 50 percent inhibition relative to controls (IC50) was calculated for each product. Among shampoos tested with SIRC, only one had a false positive result. However, for the 3T3, three false-negative results were found. Pearson coefficient related to the in vivo value of maximum average score (MAS) was -0.58 (p=0.007) with SIRC and -0.73 (p=0.007) with 3T3. These results showed that the TPC assay was capable to predict the ocular irritant potential of shampoos, and therefore was a promissory tool to be used as a preliminary assay for the detection of irritant products and to be part of a battery of screening tests to minimize the animal use in the Draize Test.