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Abstract
The first phase in a series of investigations of the relationship between low-volume
eye test (LVET) data, Draize eye irritation test data, and comparable data from 25
in vitro assay protocols is presented. These investigations utilize Draize eye test
and in vitro assay data generated previously as part of the Cosmetic, Toiletry and
Fragrance Association (CTFA) Evaluation of Alternatives Program. LVET data were generated
de novo using the same 10 representative hydroalcoholic personal-care formulations.
The linear correlation between maximum average score (MAS) as determined by the Draize
test and the LVET (LVET-MAS) was 0.93. Comparison of in vitro assay performance with
that of the LVET was determined by statistical analysis of the relationship between
LVET-MAS and in vitro endpoint. As in the CTFA program, regression modelling is the
primary means of enabling such a comparison. The objective is to predict LVET-MAS
for a given test material (and to place upper and lower prediction interval bounds
in the range in which the LVET-MAS is anticipated to fall with high probability) conditional
on observing an in vitro assay score for that material. The degree of confidence in
prediction is quantified in terms of the relative widths of prediction intervals constructed
about the fitted regression curves. Four assays [EYTEX MPA (membrane partition assay),
HET-CAM (hen's egg test-chorioallantoic membrane HET-CAM) I, neutral red release and
HET-CAM II] were shown to have the greatest agreement with the LVET. These assays
were also among those with low discordance rates relative to the Draize test. Prediction
of LVET-MAS values from experimentally determined in vitro scores was more accurate
for hydroalcoholic formulations with lower rather than higher irritancy potential.