Ocular irritancy assessment of cosmetics formulations and ingredients: fluorescein leakage test

Toxicology in Vitro : an International Journal Published in Association with BIBRA
A ZanvitM Buiatti-Tcheng

Abstract

During a COLIPA multicentre study carried out on 'Alternatives to Eye Irritation' two laboratories undertook the evaluation of the samples with the fluorescein leakage test (FLT). The lead laboratory (L'Oréal) proposed a prediction model (PM), which converts the in vitro data from this assay to a prediction of eye irritation. All the surfactant-containing substances were tested using the FLT if they were soluble in Hanks' balanced salt solution (HBSS). Briefly, confluent MDCK cells were exposed for 15 minutes to five fixed concentrations of the test substance. The amount of damage caused to the cellular monolayer was determined by the amount of fluorescein that leaked through the cell layer after a 4-hour period. The amount of test substance that produced 20% leakage compared with a cell-free control was determined (FL(20) H4). The FLT results transformed using the PM, generally predicted the in vivo classification (linear Kappa: 0.87+/-0.17 and 0.75+/-0.25). Where there were misclassifications, the category assigned was only one different from the observed in vivo score. There was generally good agreement between the two laboratories in this study. The model seems to be more appropriate for evaluation of non-irritants or moder...Continue Reading

References

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Citations

Dec 7, 2007·Cutaneous and Ocular Toxicology·Holly M HoffmanHenry F Edelhauser
Apr 28, 2009·Regulatory Toxicology and Pharmacology : RTP·Pauline McNameeJulia Scheel
May 29, 2016·Biochimica Et Biophysica Acta·Yan LiFengshan Wang
Mar 13, 2008·Alternatives to Laboratory Animals : ATLA·Christina GrindonJohn F Garrod
Nov 16, 2001·Alternatives to Laboratory Animals : ATLA·P A JonesJ H Fentem
Nov 16, 2007·Alternatives to Laboratory Animals : ATLA·Robert D Combes
Dec 17, 2008·Alternatives to Laboratory Animals : ATLA·Christina GrindonJohn F Garrod
Oct 31, 2002·Alternatives to Laboratory Animals : ATLA·Richard ClothierLinda Noble

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