KANENGISER’S EVALUATION METHOD: AN EFFICIENT METHOD FOR DETERMINING OCULAR IRRITANT POTENTIAL IN COSMETICS

A growing interest in usage of cosmetics has created the need for greater precision in evaluation and has stimulated research into cosmetic medicine. Ocular irritation testing represents an important step in the safety evaluation of cosmetic products.  The objective of this study was to introduce a method of assessing ocular irritancy in human subjects and to illustrate the significance of a new expanded grading system, designed by Kanengiser, for the precise evaluation of ocular lesions and quantitative assessment of ocular surface responses to cosmetic products. Evaluation procedure is carried out using acute instillation method. A scoring scale for Palpebral Conjunctival Irritation, Eyelid Irritation, Lachrymation, Subjective Irritation, Bulbar Conjunctival Irritation, Corneal Abnormalities, Palpebral and Bulbar Conjunctival, Caruncular, and Corneal Fluorescein Ophthalmic Staining was designed by Kanengiser & observations are interpreted graphically. From the observations it is evident that frequency of occurrence of adverse events is minimal in the human ocular instillation studies. The area of corneal fluorescein staining was judged on a 0 to +4 scale using the same terminology as for corneal cloudiness (Draize). The statistical analysis of correlation between subjective irritation levels and area levels of corneal staining demonstrated better correlation for Kanengiser’s scoring system (r = 0.82) than for Draize’s scoring system (r = 0.74). From the above data we can illustrate that Kanengiser’s ocular grading system is an efficient, ‘evaluation method for determining the ocular irritant potential of cosmetic products in human eyes’.