Application of the EYTEX™ System to the Evaluation of Cosmetic Products and their Ingredients

Abstract

465 cosmetic product formulations and raw ingredients were evaluated with the EYTEX™ system to determine the potential of this in vitro alternative for identifying eye irritation potential. The EYTEX™ system is a non-animal, biochemical procedure developed by Ropak Laboratories, Irvine, CA, that was designed to approximate the Draize rabbit eye irritation assay for the evaluation of ocular irritation.

Avon Products Inc. provided all the test samples, which included over 30 different product types and represented a wide range of eye irritancy. All the EYTEX™ protocols available at the time of this study were used. Samples were evaluated double-blind with both the membrane partition assay (MPA) and the rapid membrane assay (RMA). When appropriate, the standard assay (STD) and the alkaline membrane assay (AMA) were used, as well as specific, documented protocol modifications.

EYTEX™ results were correlated with rabbit eye irritation data which was obtained from the historical records of Avon Products Inc. A positive agreement of EYTEX™ results with the in vivo assay was demonstrated by an overall concordance of 80%. The assay error was 20%, of which 18% was due to an overestimation of sample irritancy (false positives) and 2% was attributed to underestimation (false negatives). Overestimation error in this study was due in part to the inability of the protocols to accurately classify test samples with very low irritation potential. Underestimation of sample irritancy was generally associated with ethoxylated materials and high concentrations of specific types of surfactants.

100% sensitivity and 85% predictability were described by the data, indicating the efficiency of EYTEX™ in identifying known irritants. A specificity rate of 39% showed the EYTEX™ assay to be weak in discerning non-irritants. However, the EYTEX™ protocols used in this study were not designed to identify non-irritants. A compatibility rate of 99% proved the effectiveness of the EYTEX™ assay in accommodating a diversity of product types. The EYTEX™ system protocols, when used appropriately, can provide a conservative means of assessing the irritant potential of most cosmetic formulations and their ingredients.

Keywords

EYTEX™ system cosmetic Draize test ocular irritation assay

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References

Gordon

V C.

, & Bergman

H.C.

(1987). EYTEX™, an in vitro method for evaluation of ocular irritancy. In Alternative Methods in Toxicology, Vol 5, In Vitro Toxicology. Approaches to Validation, (ed. Goldberg

A.M.

), pp. 293–302. New York: Mary Ann Liebert

US Patent 4 613 574 (September 23, 1986, International patent applications pending in Australia, Europe, Japan, and Canada)

Benedek

G B.

(1971). Theory of transparency of the eye. Applied Optics 10, 459–473.

Jedziniak

J.A.

, Nicoh

D.F.

, Baram

, & Benedek

G.B.

(1978). Quantitative verification of the existence of high molecular weight protein aggregates in the intact normal human lens by light-scattering spectroscopy Investigative Opthalmology and Visual Science 17, 51–57

Gordon

V.C.

, & Bergman

H C.

(1988). The EYTEX™-MPA System: An in vitro method for the evaluation of ocular safety In Alternative Methods in Toxicology, Vol 6, In VitroToxicology Progress in New Directions (ed. Goldsberg

A.M.

), pp. 309–316. New York: Mary Ann Liebert.

Gordon

VC.

, Kelly

C P

, & Bergman

H C.

(1989). Applications of the EYTEX™ method for determination of the ocular irritation of surfactant formulations. In Alternative Methods in Toxicology, Vol 7, In Vitro Toxicology New Directions (ed. Goldberg

A.M.

), pp. 337–345 New York: Mary Ann Liebert

Kruszewski

F.H

(1991). The EYTEX™ system — A review of current methodology In Proceedings of the Second CTFA Ocular Safety Workshop. Evaluation of In Vitro Alternatives (ed. Gettings

S. D.

, McEwen

G. N.

), pp. 80–93

Washington, D C

The Cosmetic, Toiletry and Fragrance Association

Kay

, & Calandra

(1962). Interpretation of eye irritation tests. Journal of the Society of Cosmetic Chemists 13, 281–289.

Thomson

M.A.

, Dickens

M.S.

, & Gordon

V.C

Evaluation of the EYTEX™ biochemical assay for use in determining cosmetic product irritancy Abstract presented at the Symposium of the Johns Hopkins Centre for Alternatives to Animal Testing In Vitro Toxicology New Directions, April 4 1989, Baltimore, MD

10.

Anon. (1990). The EYTEX™ System Direction for Use Irvine, CA, USA. Ropak Laboratories.

11.

Anon (1991). The EYTEX™ System Directions for Use Irvine, CA, USA Ropak Laboratories.

12.

Draize

J H.

, Woodward

, & Calvert

H O

(1944). Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. Journal of Pharmacology and Experimental Therapeutics 82, 377–390.

13.

Snedecor

, & Cochran

W.G

(1971). Design and analysis of sampling. In Statistical Methods, pp. 504–538. Ames, IA, USA.: Iowa State University Press.

14.

Scala

R.A

(1987). Theoretical approaches to validation. In Alternative Methods in Toxicology, Vol. 5, In Vitro Toxicology: Approaches to Validation (ed. Goldberg

A.M.

), pp. 1–9. New York: Mary Ann Liebert.

15.

Gordon

V.C.

(1991). EYTEX™ Third Generation. In Alternative Methods in Toxicology, Vol. 8, In Vitro Toxicology: Mechanisms and New Technology (ed. Goldberg

A.M.

), pp. 241–251. New York: Mary Ann Liebert.

16.

Gordon

V.C.

, and Bergman

H.C.

(1988)’. External evaluation of the Standard EYTEX™ system in six laboratories to determine intra-laboratory and inter-laboratory accuracy and precision. In Alternative Methods in Toxicology, Vol.6, Progress in In Vitro Toxicology (ed. Goldberg

A.M.

), pp. 317–323. New York: Mary Ann Liebert.

17.

Gordon

V.C.

, and Bergman

H.C.

(1988). External evaluation of the EYTEX™ and EYTEX™-MPA systems in twelve laboratories to determine the correlation of EYTEX™ results with in vivo results. In Alternative Methods in Toxicology, Vol. 6 (ed. Goldberg

A.M.

), pp. 325–331. New York: Mary Ann Liebert.

18.

Soto

R.J.

, Servi

M.J.

, and Gordon

V.C.

(1989). Evaluation of an alternative method for ocular irritation. In Alternative Methods in Toxicology, Vol. 7, In Vitro Toxicology: New Directions (ed. Goldberg

A.M.

), pp. 289–296. New York: Mary Ann Liebert.

19.

Kruszewski

F.H.

, Dickens

M.S.

, Hearn

L.H.

, Smith

K.T.

, Teal

J.J.

, and Gordon

V.C.

Application of the EYTEX™ system to the evaluation of cosmetic products and their ingredients. Abstract presented at the Symposium of the Johns Hopkins Center for the Alternatives to Animal Testing: In Vitro Toxicology — Mechanisms and New Technology, November 27, 1990, Baltimore, MD.