Session 1
An in vitro method for estimating ocular irritation

https://doi.org/10.1016/0887-2333(90)90076-6Get rights and content

Abstract

Three variations of an in vitro assay system called EYTEX were evaluated by comparing maximum in vivo Draize scores for 70 experimental consumer product formulations. The EYTEX in vitro assay (EIA) was chosen for in-house evaluation because it is an economical, objective system that is easy to learn. In the present study, double-blind samples were tested at National Testing Corporation (Lab 1) and an in-house laboratory (Lab 2). All products were tested in the standard, membrane, and rapid membrane (RMA) EIA. Most samples qualified for the membrane and RMA EIA, whereas approximately half qualified for the standard EIA. Results from both Labs 1 and 2 were highly correlated. The RMA assay gave the best overall performance of the three assays. The RMA EIA demonstrated the best correlation with in vivo data and qualified the highest percentage of formulations. RMA showed a 7.5% false positive identification of irritants. False negatives or irritants not identified were 6.1%. The predictive value for identifying irritants was 89%. Specificity or the ratio of non-irritants giving negative results to the total was 84%. The ratio of positive irritants to the total or sensitivity was 93%. Based on these results, EIA has demonstrated value as a screening tool for a broad variety of consumer products. Advantages of EIA include the opportunity to test undiluted products, reduce animal use, and lower costs.

References (9)

  • J.A. Cooper et al.

    Describing the validity of carcinogen screening tests

    Br. J. Cancer

    (1979)
  • J.H. Draize et al.

    Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes

    J. Pharmac. exp. Ther.

    (1944)
  • V.C. Gordon

    EYTEX; An in vitro screen for ocular irritation

  • V.C. Gordon et al.

    External evaluation of the EYTEX system in twelve labs to determine the correlation of results with in vivo results

There are more references available in the full text version of this article.

Cited by (5)

  • Design and ocular tolerance of flurbiprofen loaded ultrasound-engineered NLC

    2010, Colloids and Surfaces B: Biointerfaces
    Citation Excerpt :

    The changes in protein structure that are induced by the test product may be quantified by measuring the resulting changes in turbidity (OD405) of the reagent solution. Comparison of these optical density measurements to those produced by standard chemical irritants allows calculation of an “irritancy score” called “Irritection draize equivalent” (IDE) that has been shown to be directly related to the potential corneal irritancy of the sample [31]. The analysis of the data and the IDE calculations were performed by Tecan® software (InVitro International, Irvine, CA, US).

View full text